Humans and Devices in Medical Contexts: Case Studies from Japan (Health, Technology and Society) 9813362790, 9789813362796

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HEALTH, TECHNOLOGY AND SOCIETY

Humans and Devices in Medical Contexts Case Studies from Japan Edited by Susanne Brucksch Kaori Sasaki

Health, Technology and Society

Series Editors Andrew Webster, Department of Sociology, University of York, York, UK Sally Wyatt, Faculty of Arts and Social Sciences, Maastricht University, Maastricht, The Netherlands Rebecca Lynch, Life Sciences and Medicine, King’s College London, London, UK Martyn Pickersgill, Usher Institute, University of Edinburgh, Edinburgh, UK

Medicine, health care, and the wider social meaning and management of health are undergoing major changes. In part this reflects developments in science and technology, which enable new forms of diagnosis, treatment and delivery of health care. It also reflects changes in the locus of care and the social management of health. Locating technical developments in wider socio-economic and political processes, each book in the series discusses and critiques recent developments in health technologies in specific areas, drawing on a range of analyses provided by the social sciences. Some have a more theoretical focus, some a more applied focus but all draw on recent research by the authors. The series also looks toward the medium term in anticipating the likely configurations of health in advanced industrial society and does so comparatively, through exploring the globalization and internationalization of health.

More information about this series at http://www.palgrave.com/gp/series/14875

Susanne Brucksch · Kaori Sasaki Editors

Humans and Devices in Medical Contexts Case Studies from Japan

Editors Susanne Brucksch German Institute for Japanese Studies (DIJ) Tokyo, Japan

Kaori Sasaki Center for Medical Education Sapporo Medical University Sapporo, Japan

Health, Technology and Society ISBN 978-981-33-6279-6 ISBN 978-981-33-6280-2 https://doi.org/10.1007/978-981-33-6280-2

(eBook)

© The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Cover image: © shuoshu This Palgrave Macmillan imprint is published by the registered company Springer Nature Singapore Pte Ltd. The registered company address is: 152 Beach Road, #21-01/04 Gateway East, Singapore 189721, Singapore

To our families and friends

Series Editors’ Preface

Medicine, health care and the wider social meaning and management of health are undergoing major changes. In part this reflects developments in science and technology, which enable new forms of diagnosis, treatment and the delivery of health care. It also reflects changes in the locus of care and burden of responsibility for health. Today, genetics, informatics, imaging and integrative technologies, such as nanotechnology, are redefining our understanding of the body, health and disease; at the same time, health is no longer simply the domain of conventional medicine, nor the clinic. The “birth of the clinic” heralded the process by which health and illness became increasingly subject to the surveillance of medicine. Although such surveillance is more complex, sophisticated and precise, as can be seen in the search for “predictive medicine”, it is also more provisional, uncertain and risk laden. At the same time, the social management of health itself is losing its anchorage in collective social relations and shared knowledge and practice, whether at the level of the local community or through state-funded socialized medicine. This individualization of health is both culturally driven and state sponsored, as the promotion of “self-care” demonstrates.

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The very technologies that redefine health are also the means by which this individualization can occur—through ‘e-health’, diagnostic tests and the commodification of restorative tissue, such as stem cells, cloned embryos, and so on. This series of books explores these processes within and beyond the conventional domain of ‘the clinic’, and asks whether they amount to a qualitative shift in the social ordering and value of medicine and health. Locating technical developments in wider socio-economic and political processes, each book discusses and critiques recent developments within health technologies in specific areas, drawing on a range of analyses provided by the social sciences. The series has already published twenty-five volumes that have explored many of these issues, drawing on novel, critical and deeply informed research undertaken by their authors. In doing so, the books have shown how the boundaries between the three core dimensions that underpin the whole Series—health, technology and society—are changing in fundamental ways. Among the substantive issues covered in the series has been the role of medical devices in the healthcare system. One of the earliest texts to provide a detailed discussion of the meaning, use and regulation of devices, was Alex Faulkner’s excellent Medical Technology into Healthcare and Society (2009). Later books have examined devices both within and also beyond formal healthcare, as in the volume edited by Rebecca Lynch and Conor Farrington called Quantified Lives and Vital Data (2018), which focused on personal medical devices and the possibilities and new relationships that such devices afford. Similar themes are explored in Nelly Oudshoorn’s Resilient Cyborgs (2020), which focuses on medical device implants to manage heart conditions—what she terms “wired heart cyborgs”—and the resulting experiences of these “hybrid bodies”. This book, Humans and Devices in Medical Contexts, edited by Susanne Brucksch and Kaori Sasaki, makes an important contribution to this body of literature in two ways. It offers the first detailed examination of the emergence and role of medical devices in Japan. Second, in doing so, it shows how the specific Japanese context, and thus also the contexts of other countries, must be understood if we are to make sense of the meaning and role of these technologies. In other words, an apparently

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identical device may have quite distinctive meanings across different contexts, what the editors call ‘socio-technical settings.’ Brucksch and Sasaki provide an impressive theorisation of these processes early on in the book which focuses on the co-constituted nature of the device/society relationship. This is followed by a series of case studies in ten chapters, rich in empirical detail and rooted in different disciplinary perspectives. More broadly, the text offers much that will be useful for those working in Science and Technology Studies, which itself has a growing presence in Japan. Brucksch and Sasaki have succeeded in bringing together expertise and empirical material that shed new light on the historical and current development of medical devices in Japan, offering a novel and fascinating account of the socio-technical setting of East Asia. York, UK Maastricht, The Netherlands

Andrew Webster Sally Wyatt

Preface and Acknowledgments

This edited volume is an outcome of the “Humans and Machines in Medical Contexts: Case Studies from Japan” workshop held in March 2017 at the German Institute for Japanese Studies (DIJ), Tokyo. The workshop was organized by the editors of this volume, Susanne Brucksch and Kaori Sasaki. Our intention was to invite an interdisciplinary group of scholars to explore intersections between medical technologies and human beings from diverse perspectives and to explore ways of stimulating academic exchange between related disciplines: STS (Science and Technology Studies), Japanese Studies, Political Science, Medical Sociology, History of Science and Medicine, Business and Economy, Law, Ethics, Biomedical Engineering and Medicine. This scholarly approach evolved from “Technikstudien and STS: Research Initiative Regarding Intersections between Technology and Society in Japan”, initiated by Susanne Brucksch and Dr. Cosima Wagner (Freie Universität Berlin) in January 2015 in Berlin. We would like to express our gratitude to the participants for their valuable comments, including Prof. Franz Waldenberger (DIJ), Prof. Emer. Christa Altenstetter (City University of New York), Prof. Akihito

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Suzuki (Keio University), Prof. Masahiro Morioka (Waseda University), Prof. Koichi Mikami (Keio University), Dr. Yumiko Kawaguchi (NPO ALS MND Support Centre Sakura-Kai) and Dr. Celia Spoden (Leibniz University, Hannover). With their encouragement and important feedback, the editors resolved to disseminate the workshop’s outcomes. We would like to extend our great appreciation to a number of people and organizations for their constant support for this book project: first, to all the contributors who co-operated with us in this highly interdisciplinary endeavour. We particularly acknowledge those who kindly acted as anonymous referees of the individual chapters of this anthology. Their critical reviews were an essential part of each contributor’s revision process. Likewise, our cordial appreciation goes to Joshua Pitt, Senior Commissioning Editor at Palgrave Macmillan. Without his constant editorial support, this book could not have been realized. Finally, we would especially like to express our gratitude to the German Institute for Japanese Studies (DIJ), which gave both moral and financial support to the workshop, related research activities and this book project under its research programme “Risks and Opportunities in Japan: Challenges in the Face of an Increasingly Uncertain Future”. Thank you all very much. Tokyo, Japan

Susanne Brucksch Kaori Sasaki

Contents

Part I

Introduction and Theoretical Reflections

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Introduction Susanne Brucksch and Kaori Sasaki

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Theoretical Reflections on Medical Devices and the Sociocultural Context in the Locale of Japan Susanne Brucksch and Kevin Wiggert

Part II 3

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Experiences with Radiation

Knowledge and Culture Behind the Dosimetry System: Japanese Scientists, Radioactive Disasters and the Technologies for Measuring Radioactivity in the Twentieth Century Maika Nakao Monitoring Disaster: 3.11, Radiation Measurement and Public Health in Fukushima Shi Lin Loh

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Part III 5

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Standardized Brain-Death Diagnostic Procedure: The Japanese Controversy of the 1980s and 1990s Kaori Sasaki

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Medical Technology, Terminal Care and Criminal Law: Court Cases from Japan Yuji Shiroshita

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The Role of Incident-Reporting Systems in Improving Patient Safety in Japanese Hospitals: A Comparative Perspective Naonori Kodate, Ken’ichiro Taneda, Akiyo Yumoto, and Yoshiko Sugiyama

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Part IV 8

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Patient Safety, End-of-life and High-tech Medicine

Innovation and Diffusion of Medical Devices

The Postwar Medtech Industry in Japan: A Business History Perspective Pierre-Yves Donzé Close Collaboration Between Medical Professionals and Engineers in Medical-Device Innovation: The Commons for Medicine and Engineering Japan Liaison Platform Kazuo Tanishita

Part V

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Engineering and Evaluating Medical Technology

10 Empowering Patients in Interactive Unity with Machines: Engineering the HAL (Hybrid Assistive Limb) Robotic Rehabilitation System Patrick Grüneberg

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Innovative Technology, Clinical Trials and the Subjective Evaluation of Patients: The Cyborg-type Robot HAL and the Treatment of Functional Regeneration in Patients with Rare Incurable Neuromuscular Diseases in Japan Takashi Nakajima

Part VI 12

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Conclusions

Conclusions on Socio-Technical Settings in Medical Contexts from the Locale of Japan Susanne Brucksch

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Editors and Contributors

About the Editors Susanne Brucksch is a principal researcher at the German Institute for Japanese Studies (DIJ), Tokyo. From 2009 to 2016, she worked as a senior research fellow at Freie Universität Berlin, and was a visiting scholar at Waseda University in Tokyo in 2016 and at the Max Planck Institute (MPI) for Innovation and Competition in Munich in November 2019. Her current research covers topics such as Science and Technology Studies (STS), Innovation Studies (e.g., medtech partnerships), medical device innovation, research collaborations, sociotechnical settings in healthcare (e.g., telehealth, care robots, monitoring systems), and several others in the field of Japanese studies. Brucksch has served as chair of the advisory board of DWIH Tokyo (German Centre for Science and Innovation) since 2019, and as a board member of VSJF e.V. (German Association for Social Science Research on Japan) since 2016, where she also co-organizes the STS Technology Section (Fachgruppe Technik).

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Kaori Sasaki is a professor at Sapporo Medical University in Japan. As a sociologist, her main interest is the ways in which the bio-politics of humanity have been shaped and reshaped alongside cultural (identity) politics. She is currently engaged in research exploring how Japanese utilization of electronic health records to enhance collaboration amongst various healthcare providers and Japan’s development of a universal information management system for health research have been reflected in the sociopolitical and sociocultural conception of humanity and life itself. This derives from her previous project on the public understanding of electronic patient records in the UK. Since her dissertation on “Politicised Culture, Culturalised Life and Death: The Japanese Organ Transplantation and Brain Death Debates” (2006), she has continued to research the changing definition of human life and death, cultural representations of human life, death and body parts replacement, mainly in connection with technological advances in life support, diagnosis of brain conditions and transplant medicine.

Contributors Susanne Brucksch German Institute for Japanese Studies (DIJ), Tokyo, Japan Pierre-Yves Donzé Osaka University, Suita, Japan Patrick Grüneberg Kanazawa University, Kanazawa, Japan Naonori Kodate School of Social Policy, Social Work and Social Justice, University College Dublin, Dublin, Ireland Shi Lin Loh National University of Singapore, Singapore, Singapore Takashi Nakajima National Hospital Organization, Niigata National Hospital, Kashiwazaki, Japan Maika Nakao The Graduate School of Integrated Arts and Sciences, Hiroshima University, Hiroshima, Japan

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Kaori Sasaki Center for Medical Education, Sapporo Medical University, Sapporo, Japan Yuji Shiroshita Graduate School of Law, Hokkaido University, Sapporo, Japan Yoshiko Sugiyama Technology Division, Paramount Bed Co. Ltd., Tokyo, Japan Ken’ichiro Taneda Department of International Health and Collaboration/Department of Health and Welfare Services, National Institute of Public Health, Wako, Japan Kazuo Tanishita Keio University, Tokyo, Japan Kevin Wiggert Technical University Berlin, Berlin, Germany Akiyo Yumoto Graduate School of Nursing, Chiba University, Chiba, Japan

List of Figures

Chapter 5 Fig. 1

Brain-death diagnosis checklist

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Chapter 7 Fig. 1 Fig. 2

Fig. 3

Fig. 4

Reporting processes in a Japanese hospital Medical accidents, by type, reported from 274 healthcare facilities with mandatory reporting obligations (Total number of accidents reported: N = 4030; January to December 2018) Near-misses, by type, reported from 514 healthcare facilities with mandatory reporting obligations (Total number of near-misses reported: N = 921,140; January to December 2018) Number of medical accidents and near-misses reported to JQ, 2010–2018

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List of Figures

Chapter 8 Fig. 1 Fig. 2 Fig. 3

Production of medical devices in Japan (in million yen and as % of GDP) Import and export of medical devices in Japan (in million yen) Number of mergers and acquisitions in the Japanese medtech industry, 1986–2017

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Chapter 9 Fig. 1 Fig. 2 Fig. 3 Fig. 4

The range of clinical needs producing varied outcomes Clinical needs comprising low-specificity needs and refinement of high-specificity needs Marketing authorization holders as mediators Schema of a desirable ecosystem for medical-device development

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Chapter 10 Fig. 1 Fig. 2

Patient wearing HAL in a walking device (side view) Interactive unity of patient and HAL

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List of Tables

Chapter 5 Table 1 Table 2 Table 3 Table 4

Three different approaches to brain death Major Japanese neurologists’ view on the Society of EEG Criteria Takeuchi criteria for diagnosing brain death in Japan Tachibana’s recommendation on diagnosing brain death in Japan

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Chapter 6 Table 1 Table 2

Cases of active euthanasia in Japan Extract from the “Guidelines on the Medical Decision-Making Process in the Terminal Stage of Life”

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Chapter 7 Table 1 Table 2

Outline of incident-reporting systems of examined countries (acute care) Summary of incident-reporting systems of the examined countries

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List of Tables

Chapter 8 Table 1 Table 2

Top 10 largest Japanese firms for patent applications in the medtech industry, 1960–2014 Top 10 largest manufacturers and importers of medical devices in Japan, 2012 (in billion yen)

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Chapter 9 Table 1 Table 2

Outline of Commons Types of interaction between medical and technology professionals

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Part I Introduction and Theoretical Reflections

1 Introduction Susanne Brucksch and Kaori Sasaki

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Prologue: Background and Purpose

On any visit to a hospital, we might notice that contemporary medicine depends greatly upon instruments and advanced technology. A medical specialist may listen to us relating details of a headache, and then type notes into our electronic medical records. After asking a nurse to take a blood sample, the physician might use various measuring devices to test it for any anomaly, or carefully examine digital visualizations generated by X-ray, ultrasound, computed tomography (CT) or magnetic resonance imaging (MRI), before eventually reaching a diagnosis and establishing a plan for clinical treatment. In an operating theatre, a medical specialist performing neurosurgery could be assisted by medical S. Brucksch (B) German Institute for Japanese Studies (DIJ), Tokyo, Japan K. Sasaki Center for Medical Education, Sapporo Medical University, Sapporo, Japan

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Brucksch and K. Sasaki (eds.), Humans and Devices in Medical Contexts, Health, Technology and Society, https://doi.org/10.1007/978-981-33-6280-2_1

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imaging devices and robotic surgical systems. If, after the operation, the patient suffers loss of a certain bodily function, a rehabilitation technology—such as a cyborg-type body suit—might support physical therapy. Practices that would once have sounded like science fiction are now ubiquitous in hospitals and medical settings around the world. Japan has enjoyed technological advancement comparable to that of many other members of the Organisation for Economic Cooperation and Development (OECD), counts as the third-largest market for medical devices after the US and the EU, and displays an exceptionally high number of certain technologies per capita, such as CT and MRI units (OECD 2019, 193). The country is evaluated by the World Health Organization (WHO) as a reliable medical service provider (see Ikegami 2014). However, there are several social, cultural and historical backgrounds distinctive to Japan, perhaps most notably her experience with radiation in Hiroshima and Nagasaki in 1945 and in Fukushima in 2011. Similarly, medical devices such as artificial respirators and heart-lung machines, and the clinical practices associated with them, have sparked long-lasting public controversies over the brain-death concept, organ donation, end-of-life care and euthanasia, but are also strongly associated with device innovation and robotic technologies that are increasingly entering the medical field. Accordingly, Margaret Lock (2008, 877), medical anthropologist and an expert on Japan, emphasizes the importance of sufficiently considering social, cultural and historical particularities when studying medical contexts in a specific locale and in comparison: Once the significant cross-cultural differences in the application of biomedical technologies are recognized, it is all too easy to account for this by means of cultural relativism while at the same time assuming that practices in the West are in effect devoid of culture and better accounted for in terms of politics.

The editors of this anthology hence argue that research on Japan can contribute to the exploration of varying configurations of socio-technical settings in medical contexts, whilst also facilitating critical reflection on

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the current interpretations, unchallenged narratives, underlying assumptions, economic priorities and conclusions in the prevailing scholarship. Accordingly, the aim of this volume is to explore and seek answers to the question: In what ways and on what grounds are variations of sociotechnical settings articulated in medical contexts in general and exemplified in the locale of Japan in particular? To do so, the anthology brings together case studies from various disciplines, each of which reflects upon the relationship of humans and medical devices in the locale of Japan. Whilst there has been research on relationships between humans and devices in Japan within the disciplines of engineering, as well as life and natural sciences, contributions from the humanities and social sciences have been limited, particularly in English-language publications. To address this research lacuna, in March 2017 we conducted a workshop at the German Institute for Japanese Studies (DIJ) in Tokyo. This functioned as a starting point to reflect on variations in the relationships between humans and devices in medical contexts in Japan. Case studies from different disciplines served the purpose of a groundwork volume for a research field that had previously received little or no academic attention in Japan (see Sasaki and Brucksch 2018). The presence of experts from diverse backgrounds provided an extraordinary opportunity to learn about disciplinary perceptions on a range of topics, which then developed into this anthology. The edited volume is hence intended to shed light upon intersections between the Japanese locale and the process of making and applying medical devices. It covers a great diversity of apparatuses and instruments, and a multi-stage process ranging from development and approval to application and adjustment in the medical field. In the light of this, it is essential that this groundwork volume encompasses an interdisciplinary selection of case studies to address the manifold aspects involved. Specifically, the selection of case studies from a range of disciplines including law, business history, engineering and medicine, with explicit links to humanities and social sciences, sets this book apart from earlier works on medical devices in Japan and abroad. To explore devices in medical contexts, this volume draws widely on Linda F. Hogle’s (2008) discussion in her article “Emerging Medical Technologies”, with regard to which aspects of medical technologies should attract

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the attention of social scientists. Taking Hogle’s conception as a valuable starting point for discussion on topics of social-technical settings in medical contexts, both in the Japanese locale and for wider comparison, the editors were able to sketch the landscape and to gather scholars from different backgrounds at the aforementioned workshop, where they presented cases and empirical findings from their discipline in a field in which there had previously been hardly any academic exchange. Hence, Hogle’s contribution became the conceptual backbone to structure this anthology—presenting various case studies and employing an interdisciplinary approach. Some readers might consider the interdisciplinary approach challenging. Nevertheless, the editors are convinced that the inclusion of diverse theoretical frameworks and methodological approaches helps not only to avoid one-sided interpretations and unduly narrow frameworks but also to encourage academic exchange. We maintain that this approach promotes novel and profound insights beyond the manifold findings of each case study, thereby enriching academic discussions amongst affiliated disciplines such as social sciences, humanities, business and law, as well as engineering and medicine. Whilst this anthology aims to go some way towards filling the research lacuna, the conceptual framework outlined above makes it distinctive amongst the existing literature. To ensure some level of consistency whilst applying an interdisciplinary approach, each chapter addresses devices applied in the narrow sense of medical contexts. This includes devices for measuring and rehabilitation purposes but excludes the wider topics of orthopaedics and technologies for elderly care (see definition below). Whilst drawing connections to the existing scholarship and referring to the aforementioned theoretical ground, each case study here adopts an analytical approach from its respective discipline. Consequently, this edited volume is able to cover the manifold aspects and dimensions that the editors consider important for such research in relationships between humans and medical devices. The anthology comprises nine case studies encompassing a range of shared grounds in order to cover the different facets of the making and application of medical devices. Specifically, these grounds are: experiences with radiation; patient safety, end-of-life and high-tech medicine; innovation and diffusion of medical devices;

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and engineering and evaluating medical technology (see also chapter outline below). The editors faced some challenges with regard to the relatively small number of scholars currently working on medical devices in Japan and able to commit to contributing to the workshop and/or the anthology. Consequently, some topics may appear overrepresented for the time being. Whilst this could be seen as a limitation, the editors argue that it provides a consistency of subject material whilst also highlighting the diversity of disciplinary perspectives used to explore those topics. We fully recognize that there are a number of other aspects of socio-technical settings in medical contexts in Japan which are not covered in this edited volume but certainly deserve more scholarly attention. Some of them might become subjects of future research and follow-up publications. The editors make their contribution by launching this edited volume as a step towards establishing this nascent field of study within Japan.

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Shortcomings in Current STS Scholarship

High technology is now ubiquitous across medical contexts. This gives rise to numerous issues regarding the production of medical knowledge and clinical practices, and legal and ethical considerations in terms of patient rights, safety, efficacy and cost coverage as well as adjusted guidelines, legal reforms or even prohibition of certain devices. Meanwhile, social, philosophical, political, economic, historical and academic conditions become inscribed into socio-technical settings during the course of development, approval and application of emerging medical technologies. Consequently, there is great academic interest in the diversity of configurations against the backdrop of an ongoing socio-technical transformation of medical contexts. Much research from the social study of technology, or Science and Technology Studies (STS), has sought a critical understanding of the production and application of medical devices, infrastructures and sociotechnical settings in the medical field. However, the existing literature also shows several shortcomings; in particular, it tends to concentrate on case studies from European and North American countries, often without critical reflection on their specific sociocultural contexts (see

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Hogle 2008, 849, 852; Lock 2008, 876–877 and below). A number of authors, pointing out the necessity to fill this gap, have suggested an East Asian approach within STS (Chen 2012; Fu 2007; Shineha and Nakamura 2013), which includes the field of medicine and healthcare. For instance, Shineha and Nakamura (2013, 145) state that “the diversity of the Japanese example appears to stem from a set of historical, political, and cultural contexts” and emphasize that “the diversity of STS and its background permits us to rethink the meaning of research within local contexts”. This suggests that it would be worthwhile to consider the shortcomings in current STS research. Yamanaka (2009, 245), a Japanese medical sociologist, emphasizes a research lacuna regarding new technological domains and their specialist associations in medical contexts, as well as the resulting pressure for quality control, standardization, objectivity and factuality generated by the interoperability of medical devices. Oudshoorn and Pinch (2008, 551) stress that the “world of users, particularly the cultural and social processes that facilitate or constrain the emergence of users’ antiprograms, remain largely unexplored” in STS such as actor-network approaches. In addition, Faulkner (2009, 19, 24) criticizes the tendency of many STS scholars and medical sociologists to concentrate on medical consultation, the patient–physician relationship, healthcare practices and the micro-level of socio-technical settings whilst paying little attention to theoretical approaches that address social structures, political economy, scientific evaluation of safety and device performance or even industrial capitalism. Therefore, the making of medical devices in specific innovation systems and healthcare states arguably remains understudied within STS research. In STS research in Japan, the social study of medical devices remains largely unaddressed, partly because current STS scholarship has tended to focus on topics such as science communication, technology assessment, nuclear power, artificial intelligence and robotics, bioethics and regenerative medicine (see Brucksch and Wagner 2016, 10–12; Fujigaki et al. 2020a, b, c). Furthermore, as noted by It¯o (2012, 552), “until recently, very few trained in sociology or anthropology participated in STS research in Japan, and many of those trained in the history of science tended to work on premodern or early modern European science,

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often focusing on intellectual history rather than social history”. This situation might explain the shortcomings in the social study of medical devices and their sociocultural, institutional and historical situatedness. As STS scholars are required to keep a “methodological openness” when conducting research (Beck et al. 2012, 16), the editors conclude that launching an interdisciplinary anthology comprising diverse case studies and empirical findings can best serve to address the range of aforementioned shortcomings of current STS scholarship, both within Japan and abroad, regarding socio-technical settings in medical contexts.

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Defining Devices in Medical Contexts

Hogle (2008, 841) shows a broad understanding of medical technologies, which she defines as including regenerative medicine and genetic testing. Faulkner (2009, 28), however, labels this perception “sociological and anthropological thinking”, whilst in the context of innovation, regulation and technical assessment, medical technologies are mainly framed as “medical devices”. For instance, the IMDRF (International Medical Device Regulators Forum) is “a voluntary group of medical device regulators from around the world who have come together to … accelerate international medical device regulatory harmonization and convergence” (IMDRF n.d. (a)). Its members include the Food and Drug Administration (FDA) in the US, the Pharmaceutical and Medical Device Agency (PMDA) in Japan and the Medical Device Regulation (MDR) in the EU (FDA 2018; IMDRF n.d. (b); IMDRF/GHTF 2012, 6; MDR 2017/745 Art. 2). Regulatory definitions by these members resemble each other in their understanding of devices for medical purposes, by distinguishing them from pharmaceuticals, biotechnologies and assistive technologies. In Japan, medical devices are defined by the Pharmaceutical Affairs and Medical Device Act as “such machinery and appliances, which are either used for diagnosis, medical treatment or prevention of human and animal injuries and diseases, or which aim at influencing the structure or function of the human or animal body as well as at correcting physical disabilities” (Art. 2 § 4, Iyakuhin iry¯o kiki t¯o-h¯o ). As such, they are

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similarly separated from pharmaceuticals and regenerative medicine in legal terms. As the case studies of this edited volume concern mainly machines, instruments and apparatuses, we follow the legal terminology by referring to these material artefacts as medical devices to distinguish them from biotechnologies or regenerative medicine, which are included by Hogle (2008) under the general term of medical technologies. Medical devices can be found “in massive numbers, shapes, sizes, materials and designs” (Faulkner 2009, 27). Nowadays, rather than being stand-alone machines and apparatuses situated only within their physical place, they are often connected in a digital sense, so that it is necessary to take into account the “data and information that is collected, stored, analysed and conveyed via those artefacts” (Petersen 2019, 41). Similarly, the boundaries between medical devices and biotechnology are becoming increasingly contested and renegotiated with a growing number of hybrids between pharmaceuticals, machines and biological tissues (Faulkner 2009, 30). Due to the high diversity of devices and device families, it appears once more most appropriate to approach this research field through case studies (Faulkner 2009, 31–32). For the purpose of this book and in accordance with earlier specifications (see Brucksch and Wagner 2016, 7), we understand by devices in medical contexts the various machines, instruments, apparatuses and infrastructures, which are supposed to be used for a medical purpose and produce reliably and permanently intended effects in a mechanical and/or electrical way. The case studies presented here predominantly refer to electrical devices as “active medical products”, commonly called “machines”. However, we decided to employ the terms “socio-technical settings” and “medical devices” rather than “human–machine relations” throughout the anthology. This is because our interest here is not in the interaction between an individual human and a particular machine, but in the relationships between humans and devices in medical contexts, the implications and wider meaning of those relationships. More detailed explanation on the development, approval, usage and agency of medical devices can be found in Chapter 2, which clarifies the theoretical background to this anthology. To reiterate, whilst introducing various case studies from different disciplines, we mainly concentrate on such devices,

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their relationships to the clinical workplace and their embeddedness in the sociocultural context, which is clarified in the next section.

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Approaching the Sociocultural Context

In general, social research on technology tends to pay little attention to sociocultural contexts. This is especially true for case studies from European and North American countries, partly because those contexts are taken for granted (e.g., Hogle 2008, 849, 852; Lock 2008, 876–877; Rammert 2002, 173; Yamanaka 2009, 31). Despite this academic trend, some scholars maintain that there are variations in specific contexts and locales. For instance, Feenberg (1992, 309) argues that constraints on technological development are characterized “by cultural norms originating in economics, ideology, religion, and tradition”. He also states that “legitimating effectiveness of technology depends on unconsciousness of the cultural-political horizon under which it was designed”, which requires a “recontextualizing critique of technology” to “uncover that horizon, demystify the illusion of technical necessity, and expose the relativity of the prevailing technical choices” (Feenberg 1992, 311). Hogle (2008, 846) similarly suggests that such perspectives would be “important contributions to STS literature on technology”, where comparative and historical studies are suitable methods to study variations and underlying assumptions. In the context of this edited volume, this condition would imply the combined study of the relationship of humans and medical devices whilst considering the locale of Japan. Hence, this anthology elucidates how a locale such as Japan can be systematically addressed. Referring to medicine and bodies, Mol (2002, 10) argues that “[b]odies only speak if and when they are made heavy with meaning … [T]his is a meaning that has been attributed. Such attributions have a history, and they are culturally specific.” As discussed in Hogle (2008, 856) and Lock (2008, 876), emerging medical technologies contribute to shifts in body boundaries, identity and subjectivity. Likewise, Fetters (2015, 320), Hogle (2008, 842), and Webster (2007, 1) note that medical technologies have developed in accordance with varying notions of health, normalcy, illness, disease and pathology as

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well as different legal frameworks and social institutions in each society. These varying notions might not only influence diagnosis, therapies and prognosis (Hogle 2008, 842) but are also “subjected to national (and international) evaluation, regulation and monitoring” (Webster 2007, 2–3). Therefore, we understand medical devices and the surrounding context as co-constituted phenomena, which can be analyzed with methods from humanities, social sciences, business and law, as well as engineering und medical science. Lock (2008, 877) nonetheless warns against the “problematic concept of culture” that is frequently employed in reasoning about variations of a locale, thereby leaving decisive factors unspecified or not applying the concept of culture equally to all societies. Despite this problem, scientists and officials in Japan apparently adopt the notion of culture “as another tool to produce or reorder worlds in alignment with both national economic priorities and ideals of Japanese society” (Hogle 2008, 863). In research on Japan, many studies, both within Japan and abroad, tend to explain particularities by an East–West dichotomy without considering the manifold variations among European, North American and East Asian countries. For instance, attributing a “robotfriendly culture” to Japanese society is one stereotyping pattern that can be frequently observed, but there is less reflection upon this assumption in academic literature. Against this backdrop, in this edited volume we decided to focus on medical devices and to address robotic technology only in terms of its application in medical contexts, and only in the case studies that refer directly to this technology. Hence, “culture” as an analytical category here seems less suited to specifying a particular locale and to identifying factors causing variations in socio-technical settings. Systematically addressing a particular locale, however, is relevant to avoiding essentialism, reductionism, universalism, stereotyping or techno-orientalism, which can be frequently observed in connection with technology usage in Japan (Brucksch and Wagner 2016, 6). In response to such difficulties, Rammert (2002, 173) widens the angle for research by referring to cultural attributes and variations in social institutions. He distinguishes three layers: (a) configurations of valued signs, symbols and beliefs (semantic dimension); (b) patterns of practices, behaviour and interactions (pragmatic dimension); and (c)

1 Introduction

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regimes and styles in how something is instituted (institutional dimension). In other words, these layers are the modes of “how things are viewed differently, how things are done differently, and how these activities are institutionally arranged differently” (Rammert 2002, 175). In his view, multiple factors are important when considering the shaping of technology, the co-constitutive nature of technology and society, multiple “technical representations of social form”, “the public construction of the sensible uses and rules” as well as their situatedness in time and space (locale/context). According to Rammert, the “shaping of technologies, however, cannot be conceived as a single closure process” (2002, 174–175, 184), but as a “continuous process of creative variation … closed and re-opened by negotiations in multiple arenas of conflict and selected by some institutional filters”. Lock (2008, 893) similarly points to the fluid nature of culture, the embeddedness in power relationships and the “perennial openness” to dispute, whilst stressing the uneven distribution of validation of medical technology across different societies. In this sense, reaching a societal consensus about a specific technology and related aspects such as design and safety could be interpreted as both a temporary closure (Rammert 2002, 178–179) and a “reformulation of material, social, and national boundary demarcations associated with these particular technologies” (Lock 2008, 875). Medical devices can thus be understood as socio-technical settings in medical contexts, formulated through multiple factors and finding various representations on the semantic, pragmatic and institutional levels in particular locales. These analytical dimensions, which each analysis of this volume adopts implicitly or explicitly, help to systematically address emerging technologies in their specific locales.

5

Overview of the Chapters

Under the research framework outlined above, Chapter 2 has been designed to cover the central aspects of socio-technical settings in medical contexts in the locale of Japan. There, Susanne Brucksch and Kevin Wiggert provide the theoretical backgrounds to this volume in Part I. Building on Hogle (2008) and Rammert (2002), they specify various

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aspects of emerging medical devices and explore the socio-technical settings in the medical field with regard to their semantic, pragmatic, institutional and historical situatedness. Describing the sociocultural milieu and characteristics of medical contexts in Japan, Chapter 2 elucidates aspects such as technological complexity and clinical workplaces; subjectivity and standardization; the situations of patients, nurses and physicians; user needs and device development; clinical trials, approval and evidence-based judgement; manufacturing and diffusion, as well as hospitals and the public health system, each of which is analyzed in one of the case studies. The subsequent chapters are divided into four sections according to the context of their case-study exploration. These are experiences with radiation; patient safety, end-of-life and high-tech medicine; innovation and diffusion of medical devices; and engineering and evaluating medical technology. In each case, the discussion exemplifies various aspects of relationships of humans and medical devices in the locale of Japan. In Part II, both Maika Nakao and Shi-Lin Loh illustrate how the application of radiation technologies has been advancing and increasing in tandem with the Japanese experiences with radiation. In Chapter 3, describing post-war collaboration between Japanese and American scientists attempting to determine the safe dose of radiation, Nakao shows how the Japanese process has been influenced not only by the pre-war Japanese endeavour and achievement in radiology, but also by wartime research into the production of radioactive isotopes with cyclotrons. Nakao then describes how, in the post-war period, the work of these scientists owed much to the mobilization of survivors of the Hiroshima and Nagasaki bombings as well as the 1954 Bikini Incident, when Japanese fishermen accidentally encountered the US hydrogen bomb test in the Bikini Atoll. In Chapter 4, Loh examines technologies for radiation monitoring for public health in connection with the nuclear disaster that took place at Fukushima on 11 March 2011. The chapter reveals that a number of socio-technical settings and human networks have been established for radiation monitoring, and have produced alternative voices and interpretations. Loh demonstrates how this process has been reflected in the difficulty of building trust in the reliability of techno-scientific measurement of radiation alongside the political and

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scientific attempt to produce an objective sense of safety and reassurance for concerned citizens. Part III addresses the ways in which the use of technology in hospitals has been interwoven with not only the shaping of clinical and legal practice and the evaluation of end-of-life care, but also the determining of patient safety systems with standardized protocols for medical treatment. In Chapter 5, Kaori Sasaki elucidates the process of articulating the Japanese brain-death diagnostic procedure, arguing how this process is entwined with Japan’s intensive evaluation of the safety, reliability and feasibility of application of each medical device relevant to brain-death diagnosis. She conducts this analysis with reference to Japan’s selfrecognition of her own difference in the application of these technologies compared with several European and North American countries. Sasaki’s work hence includes an analysis of the role of cultural argumentation in adapting knowledge and technology from countries in Europe and North America. In Chapter 6, Yuji Shiroshita examines the Japanese application of medical technology—notably a respirator, intravenous drip injection and catheter—and its withdrawal in the medical care of the terminally ill in connection with the legal terms for euthanasia. His scrutiny illuminates how the clinical practice of “evoking a patient’s death artificially” and “the right to self-determination of patients” was formulated, and the role it plays during deathbed care. Thereafter, analysis in Chapter 7, conducted by Naonori Kodate, Ken’ichiro Taneda, Akiyo Yumoto and Yoshiko Sugiyama, demonstrates how information and communication technology (ICT) has been applied to establish an appropriate incidentreporting system in Japan. This system, based on the concept of patient safety, has been employed to reformulate safety management and its related clinical protocols in Japanese hospitals. Juxtaposing Japan’s system with that of her European counterparts in Denmark, Germany, Ireland and the Netherlands, Chapter 7 reviews the extent to which institutional and social situatedness is reflected in its entire process. Part IV focuses on relationships between humans and medical devices in the light of Japan’s development and biomedical engineering. Here, the authors explore in what ways and to what extent economic and political channels have played a role in the innovation and diffusion of particular medical devices in Japan. In Chapter 8, Pierre-Yves Donzé

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describes the process of innovation and diffusion of specific medical technologies, notably medical imaging, from a business history perspective. He clarifies how business activities have been inscribed in such processes whilst responding to the specific structure of Japan’s hospital landscape and public health system, with variations in device design and production strategies. In contrast, in Chapter 9, Kazuo Tanishita explicates how socio-political interventions have sought to promote close collaboration between medicine and engineering for the innovation of medical devices via the Commons for Medicine and Engineering Japan liaison platform. Examining the organizational and disciplinary boundaries that prevail between the medical and technological fields, Tanishita demonstrates how the platform has worked to overcome these barriers in order to enhance such collaboration. Chapters 8 and 9 demonstrate the significance of specific dimensions in the making of medical devices, which may go beyond even what Hogle (2008) suggested. In Part V, both Patrick Grüneberg and Takashi Nakajima examine the engineering and evaluation process of the HAL (Hybrid Assistive Limb) for Medical Use robotic rehabilitation system, each author pursuing their investigation from a different angle. Chapter 10 addresses the development of HAL from the perspective of applied ethics in line with critical reflection on the governmental vision of Society 5.0 and its implementation in the Cybernics programme at the University of Tsukuba. In his analysis, Grüneberg tackles the capability-oriented approach and builtin ethics for applying robotic technology in rehabilitation to explore the question of how empowerment technology (ET) is constructed and legitimized in Japan, and what relationship between humans and devices is envisaged in the context of healthcare. He also critically reflects on the “self-orientalization” practices frequently employed by officials and business circles in Japan to promote images of their country, including the popular image of a robot-affine society, even if the Japanese reality contradicts these conceptions. Conversely, Chapter 11 investigates the process of evaluation in connection with an investigator-led clinical trial of HAL for Medical Use, its technological improvement and its official approval as a medicinal product in Japan. Nakajima casts light upon the clinical evaluation by his research team and patients’ subjective feedback during the trial of this rehabilitation system. His argument includes

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not only the significance of patient-reported outcomes in terms of the improvement of a medical device, but also the potential to reformulate critically the problematic WHO definition of health as complete well -being. The volume closes with Chapter 12 in Part VI, where Susanne Brucksch provides concluding remarks. Brucksch reviews the case studies of this anthology, which explore a range of dimensions in medical devices and situatedness in the locale of Japan, by referring back to the semantic, pragmatic and institutional dimensions extrapolated above and theoretically specified in Chapter 2. She argues that these dimensions further the understanding of variations of socio-technical settings in medical contexts, especially in different locales. Brucksch’s reflection shows how case studies from Japan could elucidate relevant socio-historical, cultural and political situatedness in medical device development and application in society by ensuring that they are not taken for granted. She ends by drawing conclusions for the field of STS and the study of sociotechnical settings in the medical domain. The editors therefore hope that Chapter 12 shows the distinctive contribution of this volume to the relevant academic fields, in particular social sciences and medical humanities explorations of the development of socio-technical settings in medical contexts, STS and Japanese Studies. It is now time to hand over to the authors of the chapters that comprise the main content of this volume, each of which responds to the guiding question and purpose stated at the beginning of this introduction. The editors invite readers to browse and then look more deeply at the content in whichever order they choose. Each chapter can be read as a stand-alone essay. However, we recommend that readers should explore Chapter 2 at some point, especially if they are interested in grasping the concept of situatedness, specific aspects of socio-technical settings or the Japanese medical system. It will also help to further their understanding of each case study in terms of their references to these concepts and contexts. Finally, the editors hope that readers will not only earn valuable insights into the field, but will also utilize the research to further the

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enhancement of STS in various ways, including those not yet considered or even imagined.

References Beck, Stefan, Jörg Niewöhner, and Estrid Sörensen (eds.). 2012. Science and Technology Studies. Eine sozialanthropologische Einführung. Bielefeld: Transcript Verlag. Brucksch, Susanne, and Cosima Wagner. 2016. Introduction to the Technikstudien: Science and Technology Studies (STS) Research Initiative on Japan. ASIEN 140 (July 2016): 5–21. Chen, Ruey-Lin. 2012. A Voyage to East Asian STS Theories: or, What Might Make an STS Theory East Asian? East Asian Science, Technology and Society (EASTS) 6 (4): 465–485. Faulkner, Alex. 2009. Medical Technology into Healthcare and Society. London, UK: Palgrave Macmillan. FDA (US Food & Drug Administration). 2018. Medical Device Overview. https://www.fda.gov/industry/regulated-products/medical-device-overview. Accessed 21 September 2020. Feenberg, Andrew. 1992. Subversive rationalization: Technology, power, and democracy. Inquiry 35 (3–4): 301–322. Fetters, Michael D. 2015. Bioethics and Medico-legal Issues in Japan. In The Sage Handbook of Modern Japanese Studies, ed. J. Babb, 320–331. London et al.: Sage. Fu, Daiwei. 2007. How Far Can East Asian STS Go? A Position Paper. East Asian Science, Technology and Society (EASTS) 1(1): 1–14. Fujigaki, Yuko; Tadashi Kobayashi, Sh¯uichi Tsukahara, K¯oji Hirata, and Hideto Nakajima (eds.). 2020a. Kagaku-gijutsu shakai-ron no ch¯osen 1: Kagaku-gijutsu shakai-ron to wa nani ka [The Challenge of STS 1 (Science and Technology / Science, Technology and Society): What is this thing called STS?]. Tokyo: T¯oky¯o Daigaku Shuppankai. Fujigaki, Yuko; Tadashi Kobayashi, Sh¯uichi Tsukahara, K¯oji Hirata, and Hideto Nakajima (eds.). 2020b. Kagaku-gijutsu shakai-ron no ch¯osen 2: Gutaiteki kadaigun [The Challenge of STS 2 (Science and Technology / Science, Technology and Society): Case Studies]. Tokyo: T¯oky¯o Daigaku Shuppankai.

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Fujigaki, Yuko; Tadashi Kobayashi, Sh¯uichi Tsukahara, K¯oji Hirata, and Hideto Nakajima (eds). 2020c. Kagaku-gijutsu shakai-ron no ch¯osen 3: “Tsunagu”, “koeru”, “ugoku” no h¯oh¯o-ron [The Challenge of STS 3 (Science and Technology / Science, Technology and Society): Methodologies for bridging plural fields and sites]. Tokyo: T¯oky¯o Daigaku Shuppankai. Hogle, Linda F. 2008. Emerging Medical Technologies. In The Handbook of Science and Technology Studies, 3rd ed, ed. Edward J. Hackett, Olga Amsterdamska, Michael Lynch, and Judy Wajcman, 841–873. Cambridge, MA: MIT Press. Ikegami, Naoki (ed.). 2014. Universal Health Coverage for Inclusive and Sustainable Development: Lessons from Japan. Washington, DC: The World Bank. IMDRF (International Medical Device Regulators Forum). n.d. (a). International Medical Device Regulators Forum. http://www.imdrf.org/ Accessed 15 September 2020. IMDRF (International Medical Device Regulators Forum). n.d. (b) GHTF/SG1/N071:2012. Final Document. http://www.imdrf.org/docs/ ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012-definition-of-terms-120 516.docx. Accessed 12 March 2018. IMDRF/GHTF (International Medical Device Regulators Forum / Global Harmonization Task Force on Medical Devices). 2012. International Medical Device Regulators Forum. http://www.imdrf.org. Accessed 12 March 2018. It¯o, Kenji. 2012. Thomas Kuhn’s The Structure of Scientific Revolutions and Early Social Studies of Science in Japan. East Asian Science, Technology and Society (EASTS) 6 (4): 549–554. Lock, Margaret. 2008. Biomedical Technologies, Cultural Horizons, and Contested Boundaries. In The Handbook of Science and Technology Studies, 3rd ed, ed. Edward J. Hackett, Olga Amsterdamska, Michael Lynch, and Judy Wajcman, 875–900. Cambridge, MA: MIT Press. Mol, Annemarie. 2002. The Body Multiple: Ontology in Medical Practice. Durham: Duke University Press. OECD (Organisation for Economic Cooperation and Development). 2019. Health at a Glance 2019: OECD Indicators. Paris: OECD Publishing. Oudshoorn, Nelly, and Trevor Pinch. 2008. User–Technology Relationships: Some Recent Developments. In The Handbook of Science and Technology Studies, 3rd ed, ed. Edward J. Hackett, Olga Amsterdamska, Michael Lynch, and Judy Wajcman, 541–566. Cambridge, MA: MIT Press. Petersen, Alan R. 2019. Digital Health and Technological Promise: A Sociological Inquiry. Milton Park, Abingdon, Oxon, New York, NY: Routledge.

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Rammert, Werner. 2002. The Cultural Shaping of Technologies and the Politics of Technodiversity. In Shaping Technology, Guiding Policy: Concepts, Spaces and Tools, ed. K.H. Sørensen and R. Williams, 173–194. Cheltenham: Elgar. Sasaki, Kaori, and Susanne Brucksch. 2018. Iry¯o kiki to igaku ni matsuwaru STS kenky¯u: Soshite Nihon wo jirei to suru STS kenky¯u no kan¯osei: W¯akushoppu [Workshop on Humans & Machines in Medical Contexts: Case Studies from Japan: Seeking Various Potentials for Further Developments of STS Case Studies on the Relation between Medical Devices and Medical Practice in Japan], Kagaku-gijutsu shakai-ron kenky¯u [Journal of Science and Technology Studies] 15 (11): 148–153. Shineha, Ryuma, and Masaki Nakamura. 2013. Diversity in STS Communities: A Comparative Analysis of Topics. East Asian Science, Technology and Society (EASTS) 7 (1): 145–158. Webster, Andrew. 2007. Health, Technology and Society. A Sociological Critique. Basingstoke: Palgrave Macmillan. Yamanaka, Hiroshi. 2009. Iry¯o gijutsu to kigu no shakaishi. Ch¯oshinki to kenbiky¯o wo meguru bunka [Social History of Medical Technology and Instruments. ¯ The Culture Surrounding Stethoscopes and Microscopes]. Osaka: Osaka Daigaku Shuppankai.

2 Theoretical Reflections on Medical Devices and the Sociocultural Context in the Locale of Japan Susanne Brucksch and Kevin Wiggert

1

Background

Medical devices can be understood as socio-technical settings in medical contexts, formulated through multiple factors and finding various representations on the semantic, pragmatic and institutional levels in particular locales (Rammert 2002, 173; for more detail see Chapter 1). These analytical dimensions help to systematically address emerging technologies in their specific locales. This chapter elucidates how the relationship between humans and devices in medical contexts can be clarified when the sociocultural dimension of a particular locale is included. It briefly introduces theoretical approaches to socio-technical settings in medical contexts using the example of the Japanese locale (genba). The following sections consider in what ways and on what grounds variations of S. Brucksch (B) German Institute for Japanese Studies (DIJ), Tokyo, Japan K. Wiggert Technical University Berlin, Berlin, Germany © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Brucksch and K. Sasaki (eds.), Humans and Devices in Medical Contexts, Health, Technology and Society, https://doi.org/10.1007/978-981-33-6280-2_2

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socio-technical settings are articulated in medical contexts in general and exemplified in the locale of Japan in particular. Specifically, this chapter examines aspects such as technological complexity and clinical workplaces, subjectivity and standardization, the situations of patients, nurses and physicians, user needs and device development, clinical trials, approval, and evidence-based judgement, manufacturing and diffusion, as well as hospitals and the public health system in Japan.

2

Technological Complexity and Clinical Workplaces

Recent decades have seen an increase in technological innovation in clinical workplaces that has influenced medical practices and regulatory requirements alike (Faulkner 2009, 1; Yamanaka 2005, 11). Nowadays, medical devices are not purely material objects but highly contextspecific artefacts based on scientific knowledge and operated by a skilled workforce. With the increase in information and communication technology (ICT) integrated into devices, such artefacts become interwoven even on the digital level (Faulkner 2009, 14). Medical devices can be perceived both as a representation of complex infrastructures necessary to operate them and as an assemblage shaped by the necessities of various disciplines and fields of expertise. They represent not only materialized aggregates of the processes of tinkering and inventing, crafting of needs and users, producing clinical knowledge, histories and futures, but also content for regulatory and organizational requirements to become an approved fabric for medical contexts (Hogle 2008, 847). Yamanaka (2009, 243), a Japanese medical sociologist, describes the clinical workplace today as occupied by enhancing machine-mediated actions alongside decreasing manual work. The growing distance from the patient body might have its roots in the introduction of the stethoscope, but has reached a new level with highly complex technology such as the robotic da Vinci surgical system (Yamanaka 2009, 7, 255). As Foucault (1988 [1963], 104–106) has shown, the development of modern medicine can be described as moving towards symptoms of particular diseases being represented by signs such as sounds, pictures

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or graphs generated by measuring and imaging devices. In particular, the “improvements in imaging algorithms can be hardly overstated”, as they have shortened examination time for displays or whole-body scans of “moving organs”, such as the heart and lungs (Gelijns and Rosenberg 1999, 330–331; see also Chapter 5). According to Gelijns and Rosenberg (1999, 312–313, 319–320), major innovations in biomedical engineering have taken place since the 1970s, primarily in the field of diagnostics, such as computed tomography (CT), magnetic resonance imaging (MRI), ultrasound and fibre-optic endoscopes. Likewise, fibre optics and digital visualization have opened the way to the adoption of minimally invasive surgery and training in new surgery practices carried out mainly outside the human body. These developments are based on “advances of computers and mathematics”, progress in microelectronic and “digital transmission of diagnostic information” or spillover from other disciplines that have “undoubtedly transformed modern medical practice”. Accordingly, medical technology originates to a great extent in physics departments, engineering schools, the military, the electronics industry and a range of firms manufacturing essential specialized materials, such as high-quality glass for fibre optics or inert materials for prosthetic devices (Gelijns and Rosenberg 1999, 314, 341; see also Chapters 3 and 8). Furthermore, clinical practices have experienced an increase in data gathering and data processing due to laboratory medicine, automatic measuring and computer-assisted diagnosis (Schubert 2011b, 193–196; Yamanaka 2005, 24–26; 2009, 6–7, 254). The pressure for more evidence-based medicine is one major driver behind this trend, and the digitalization of patient records has supported this development since the 1970s. Yamanaka (2009, 252–253) interprets this change in the medical field as a growing instrumentation of medical practices and machinemediated objectivity (kikai-teki kyakkansei) as a prerequisite for the legitimizing evidence. On the other hand, the increasing complexity of medical apparatuses brings with it an opacity of machine measurements (known as blackboxing ), as we cannot see what these devices precisely do (Schubert 2011a, 176; Yamanaka 2009, 256–257; see also Chapters 3 and 4). The influx of complex devices and ICT integration indicate a

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growing machine-mediated datafication, which requires standardization and interoperability to make different devices and users work together. In clinical workplaces, health management, patient treatment and technology are closely interlinked, ranging from measuring devices, and apparatuses for diagnosis and treatment, to the ICT infrastructure within and between clinics and personal medical devices (Farrington and Lynch 2018). Barad (2007, 141, 203), a quantum physicist and feminist studies scholar, stresses that pieces of apparatus should not be perceived as “static prefab laboratory setups” but are “themselves constituted through particular practices”. Therefore, it can be stated that medical devices are growing in significance and having agency in clinical practices. They “play an important role in delegating and redistributing tasks among healthcare professionals, between healthcare professionals and patients, and between humans and machines” (Oudshoorn 2008, 273). In other words, Oudshoorn and Barad support the insight that agency does not only belong to the human domain. According to Mort et al. (2005, 2030), all actors “are hybrids in action and each is unable to act independently” in clinical workplaces. Moreover, Barad (2007, 170) emphasizes the difficulty of “getting the instrumentation to work in a particular way for a particular purpose”, which might shift “across laboratories, cultures, geopolitical spaces”. Physicians, nurses and clinical technicians hence often do interpretational work (Mort et al. 2005, 2033) to translate content during diagnosis and treatment. This leads to variations in clinical practices in different locales, despite joint rules and values (Suchman 2007, 75). Correspondingly, clinical staff “adapt social roles, supplies, and procedures to make the technology work in a more routinized way” (Hogle 2008, 852). More advanced complex technologies can cause uncertainties, opacities and invisibilities in clinical workplaces, partly because the distinction between “human error” and “machine failure” is blurred (Schubert 2006, 186; 2016, 9; see also Chapters 4, 5, 6 and 7). Uncertainties, as Schubert (2006, 186) indicates, affect clinical routines such as surgical procedures, forcing clinical staff to improvise. Schubert (2011a, 176) also observes that clinical users of medical devices do not always employ instruments and devices in the designated way. Instead, the application of devices is dominated by local practices or pragmatic

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usage. These practices may not fully conform with the “script” but evolve during the human–device interaction; clinical staff tend to apply local practices also to new devices. However, technical professions and local practices in socio-technical settings in clinical workplaces remain understudied, despite their wide relevance for modern healthcare. Furthermore, the intrusion of high technology into clinical workplaces has produced new medico-technical professions, such as radiologists, clinical technicians, computer specialists or medical physicists, while traditional specialties are predominantly based on body areas, for example, cardiology, neurology or ENT (ear, nose, throat) (Gelijns and Rosenberg 1999, 314; Hogle 2008, 844; Yamanaka 2009, 243; see also Chapter 3). For instance, hospitals operate complex banks of clinical devices and equipment requiring continuous attention, monitoring and maintenance work (Schubert 2011a, 177). In 2016, about 130,000 technicians were employed in Japanese hospitals, accounting for 6.2% of the overall hospital workforce: clinical laboratory technicians (42.3%), radiology technicians (34.1%), clinical engineers (15.7%), technicians engaged in medical care etc. (7.3%), dental technicians (0.5%), radiological X-ray technicians (0.1%), and medical technicians (0.1%) (MHLW 2017). Their number has apparently been growing with the increase of high technology in clinical workplaces over the decades. Yamanaka (2009, 37, 260–262) therefore contends that technical innovation influences clinical culture, knowledge production, practices and professions, in ways reminiscent of a paradigm shift, as suggested by Thomas Kuhn. In Japan, however, the shortage of trained physicists and engineers in clinical workplaces and the shortage of curricula in biomedical engineering at universities pose an obstacle to hospitals and the medical device industry alike (Altenstetter 2014, 141; see also Chapter 9).

3

Subjectivity and Standardization of Bodies

As mentioned above, the process of articulating a meaning to bodies entails standardization and categorization, which enables “protocols and

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instruments [to] work across locales” (Hogle 2008, 848; see also Chapters 3 and 5). Medical records are also important for the production and storage of body knowledge (Schubert 2011b). These practices might be less visible than the manual work of physicians but are crucial because they are the dimension “where cultural forms, power relations, and gatekeeping are established” (Hogle 2008, 848). In other words, they serve as the basis on which to conduct governance of health and operate health systems for citizens. Moreover, medical devices “serve to categorise individuals into groups and reorder social relationships on the basis of classifications” and provide a “rationale for justifying giving or withholding treatment” (Hogle 2008, 848–849; see Chapters 6 and 11). Hence, bodies can be shaped by technological, structural and cultural orderings “which in turn shape the ways in which health and illness are framed and experienced” (Webster 2007, 81; see Chapter 4). While supporting Hogle’s argument, Yamanaka (2009, 246, 250) adds the aspect of evidence to support such standardization, similarly emphasizing the manifold variations in human bodies and in diagnosing practices between medical staff and various healthcare locales that cannot be easily aligned. Similarly, health technologies such as implants, prostheses or digital tools are meaningful objects “to enable individuals to function socially as well as physically” and can “alter human experiences and subjectivity” (Hogle 2008, 849, 854). Haraway (1991, 177), a social feminist, maintains that biological “organisms have become biotic systems, communications devices like others. There is no fundamental, ontological separation in our formal knowledge of machine and organism, of technical and organic.” These symbiotic relations between human body and (medical) devices such as cochlear implants or pacemakers mean that the devices become part of the body and the human identity. Such bodies are, therefore, also labelled as cyborgs, hybrid or even prosthetic bodies, shifting conventional concepts of bodily boundaries (Barad 2007, 155; Blume 2010; Hogle 2008, 854; Matthewman 2018, 38). Thus, human bodies could be perceived as “simultaneously carriers of physical and social life” (Webster 2007, 81). Furthermore, Rabinow (1992, 10) considers the emergence of a bio-sociality where identities or citizens are increasingly built on medical data. However, “there are

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tensions between attempts to standardize, normalize, and unify bodies and technological practices and the diversity that bodies display under varying conditions” (Hogle 2008, 849). Specifically, body modifications are discussed in terms of both (re-)empowerments of (disabled) persons (Lock 2008; Petersen 2019; see Chapter 10) and the enhancement of body functions (Hogle 2005). Hogle (2005, 697) hence concludes that body modification should be considered against “what is viewed as needing fixing and what exactly is being enhanced, and that one must first consider the cultural assumptions that constitute ‘normal’”, while these “cultural assumptions” vary among societies and specific locales. What is more, prostheses and empowerment technologies might also be attributed to the topics of “robotics”, “cyborg” and “transhumanism”, which are addressed in greater detail in Chapters 10 and 11.

4

Patients, Nurses and Physicians in Japan

In Japan, informed consent and dying with dignity are widely recognized as a standard in the patient–physician relationship (Fetters 2015, 324). Furthermore, “a lack of trust in the medical profession, a conservative legal profession, extensive media criticism of hospital practices, and the movement of citizen groups to block the formal recognition of brain death as the end of human life” are among the more controversial topics concerning the relationship of humans and devices in clinical workplaces (Lock 2008, 886). In particular, the “centrality of the family in making end-of-life decisions” and their right to overrule advance directives on applying life-sustaining technology, as well as the notions of “public consent” and “national character” as arguments during discussion on terminal care, end-of-life or euthanasia can be understood as “culturally informed practices in connection with death” (Fetters 2015, 322; Lock 2008, 886; see also Chapter 6). Public scrutiny of the clinical culture—perceiving patients as an object for medical experimentation— was profoundly spurred by the 1968 Wada case, the first Japanese heart transplant case, which was conducted by a medical team led by the physician Jur¯o Wada without sufficient medical proof of the necessity for a heart transplant (Fetters 2015, 321; Yamanaka 2005, 18). The legacy

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of this case and its aftermath is thereby incribed in a lasting discussion about brain death and organ transplantation from brain-dead donors, which was eventually legalized in 1997 (see also Chapter 5). Furthermore, a series of medical errors has fuelled public scrutiny since the late 1990s (Fetters 2015, 325), giving rise to additional monitoring of patient safety and unruliness of technology in clinical workplaces (Schubert 2011a, 184). In other words, machine-mediated actions are at the core of these controversies and patients are the most vulnerable group affected by the application of medical devices. This is partly a result of the then legal situation. Until 2014, unnatural death after a medical intervention had to be reported to the police, according to Art. 21, Medical Practitioners Law. This circumstance has been described by Fetters (2015, 321, 328–329) as an “over-intrusion of criminal law into the practice of medicine”. The emerging climate caused by this criminalization of medical staff (Kodate 2018, 216) inhibits transparency and learning processes related to medical errors and malfunctioning devices. Public pressure as a result of such incidents prompted some institutional changes regarding risk regulation and patient safety, such as the establishment of the Patient Safety Unit within the Ministry of Health, Labour and Welfare (MHLW) in 2001, the Japan Council for Quality Healthcare (JQ) in 2004 and the Japan Medical Safety Research Organisation (JMSRO) in 2010, followed by the introduction of a medical accidents investigation system in 2015. The new system avoids direct interference by the police and potential criminalization of medical staff without legal proof (JMSRO 2019; JQ n.d.). Kodate (2018, 218–219) nonetheless argues that the mechanism remains powerless in terms of data accuracy and responsiveness to patients’ voices. Moreover, informal modes persist, because Japan seems to be used to “non-interference in the sphere of the medical professional community” (Kodate 2018, 207, 213, 215; see also Chapter 7). According to Beck (2006, 333), a German sociologist who introduced the concept of a “risk society”, risk and safety are also socioculturally constructed phenomena. Research on risk and safety leads to knowledge on further risk, particularly awareness of non-knowledge and scienceinduced uncertainties (Beck 2006, 332–334; Kishimoto 2013, 376). Kamisato (2017, 160–161) identifies a Japanese version of a “risk society”

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that refers to the anzen-anshin concept, in which the concept of scientifically proven safety (anzen) is coupled with the societal expectation for “reassurance” (anshin). Kamisato (2004, 72, 160–163) opines that this indicates a sense of distrust in political institutions and uncertainty within Japanese society resulting from a series of scandals in various fields and the ongoing socioeconomic transformation since the 1990s. Therefore, the anzen-anshin concept developed into a catchphrase used in official documents and the mass media to gain public consent and legitimacy for decision-making. In contrast, Kishimoto (2013, 370, 374) levels criticism against the coupling, as “a ‘safe’ feeling can never ultimately be achieved until the level of risk has reached zero, which would obviously involve infinite cost”, necessitating an adjustment to a definition of safety as “freedom from unacceptable risk”. Chapters 4, 7, 10 and 11 illustrate how the societal expectation of safety and reassurance plays out in different cases regarding socio-technical settings in medical contexts in Japan. In clinical workplaces, nurses may care most about patients’ dignity, autonomy and safety. Kamei (2013, 154, 156) regards consent, privacy and confidentiality as essential principles of nursing to increase patient confidence, including in the application of medical technologies. There are two different types of nurses in Japan: registered nurses (kangoshi ) and licensed practical nurses (jun-kangoshi ). The former status requires a three-year education and a national exam; the latter is achieved after a two-year education with a prefectural exam, often provided by local medical associations and focusing on practical training. Licensed practical nurses are expected to work for local medical facilities and for lower wages than registered nurses (Ikegami and Buchan 2014, 135–136, 140– 141). In 2016, registered nurses accounted for 86.4% of nursing staff in hospitals and 57.9% in clinics/medical practices (MHLW 2017). In 2017, the ratio of 11.3 nurses per 1000 capita was far above the OECD average of 8.8, but this number includes those working as managers and educators in the health sector (OECD 2019, 179), whose role in sociotechnical settings remains understudied. Chapter 7 examines the role of nurses in patient safety while addressing institutional and socialcultural patterns in Japanese hospitals.

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In addition, it is said that physicians in Japan tend to form hierarchical and closed professional communities towards other groups in the clinical workplace, including nursing staff, clinical technicians, hospital administration, and patients and their families (Fetters 2015, 320). Fetters and Yokoyama (2015, 306) find this influence most present among the heads of clinical departments (ikyoku-ch¯o ), who broadly direct the content of “clinical care, education, and research within a clinical department in the hospital”. These closed networks inhibit smooth communication with other clinical staff, device developers and other hospital departments regarding appointments, academic duties and budgets (Fetters and Yokoyama 2015, 306; see also Chapter 9). Webster (2007, 131) argues that “professional hierarchies are quite resilient to changing working practices and where technologies are implicated in this process, evidence indicates that such resilience is put to good effect – at least with respect to serving existing professional interests”. The hierarchies in the medical community in Japan have been ascribed not only to the introduction of the German model at Japanese medical schools in the 1870s as a “step on the road to independence for medical education”, because licensing as medical practitioners became limited to university graduates under the Medical Practitioners Law of 1906. They are also attributed to the resemblance of former structures in feudal Japan to “rigid vertical hierarchy” (Fetters 2015, 320; Fetters and Yokoyama 2015, 303–307; Powell and Anesaki 2011, 34; Rodwin 2011, 178). Yet Ikegami (2014, 121) considers the emergence of these networks rather as resulting from a shortage of physicians, surgeons and wellequipped hospitals, leading to close ties between hospitals and clinical departments at universities, the latter educating the next generation of physicians. Indeed, in 2017, the ratio of 2.4 physicians per 1000 capita was far below the OECD average of 3.5 (OECD 2019, 173). Accordingly, for decades almost all staff have been recruited through personal ties between hospital owners and clinical department heads, particularly in rural regions. The uneven distribution between metropolitan and rural areas also remains unchanged, and hospital closures in rural areas have occurred in some extreme cases (Campbell et al. 2014, 24; Fetters 2015, 330; Fetters and Yokoyama 2015, 311).

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The popular image of a physician in Japan has been of a general practitioner (ippan naika-i) seeing sick patients and wearing a stethoscope, while other medical professionals are perceived as clinical specialists in surgery, gynaecology, ophthalmology, dentistry and so on (Yamanaka 2005, 12–13; 2009, 32). However, the Japan Primary Care Association (JPCA) was founded in 2010 and it is only since 2015 that the Japanese government has officially recognized general medicine (s¯og¯o-i) as a medical specialty. This was in response to the policy of supporting local health systems based on primary care physicians to respond better to community health needs (see below). Previously, most medical practitioners functioned in their community as medical specialists with an “excessive reliance on extensive laboratory and radiological testing” (Fetters and Yokoyama 2015, 315). In contrast, medical specialties have organized professional associations since the foundation of the Japanese Society of Anaesthesiologists in 1962. In response to new technologies and fields of expertise, this was followed by societies for radiologists and neurosurgery, and by medical engineering associations such as the Society for Nursing Science and Engineering and societies for endoscopic surgery, artificial organs and life-support engineering (Ikegami 2014, 122; Yamanaka 2009, 32; see Chapter 9). Despite these developments, hardly any formal accreditation schemes were released by medical associations until the 1980s, and it was only in 2008 that the Board of Medical Specialties was commissioned to monitor them (Fetters and Yokoyama 2015, 314–316; Ikegami 2014, 122, 124; Yamanaka 2005, 22). Likewise, since 2004, postgraduate medical students have received clinical training in the specialties of “internal medicine, surgery, emergency medicine or anaesthesiology, paediatrics, psychiatry, community-based medicine, and obstetrics and gynaecology” to gain holistic knowledge of patient health. Afterwards, they continue as clinical specialists in a teaching hospital for four to six years, entering a graduate school for an academic career or working as medical practitioners in the community (Fetters and Yokoyama 2015, 309–310, 313–314; Rodwin 2011, 171). While CT, MRI and positron emissions tomography (PET) have recently become more equally distributed across Japan, many specialists such as pathologists or radiologists are concentrated in urban regions.

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Consequently, many telemedicine projects entail telepathology and teleradiology at present (Matsumoto et al. 2015, 7–9; Park 2010, 34–35, 43). What is more, telehealth networks have been introduced to secure access to medical services because of the shortage of healthcare staff in several Japanese regions. This development has not only contributed to shifting the initiative in medicine from practitioners and nurses to patients, but also provides alternative channels for remote psychological support for people with serious health conditions (Brucksch 2020, 147–148; Kamei 2013, 155, 159; Oudshoorn 2011, 19, 126, 136). In summary, the relationships between patients, nurses and physicians exemplify the manifold variations in the institutionalization of medical and nursing science, patient–device safety, professional specialization and resulting controversies in specific locales.

5

User Needs and Device Development

Much scholarship focuses on device innovation, with the question of potential users featuring later. However, this perspective ignores the fact that needs evolve from the process of understanding diseases or emerge from ideas for finding solutions (Galbrun and Kijima 2009, 203; Hogle 2008, 850, 855). Indeed, Oudshoorn and Pinch (2008, 542, 544, 546, 549) point to the crucial role of users in crafting the needs, design and acceptance of health technologies, referring to von Hippel’s study of scholars as constructors of scientific instruments. They underline the heterogeneity of users such as clinicians, nurses, patients and their families, medical scientists and clinical technicians. Furthermore, policy makers, public health officials, patient organizations, clinical trial researchers or company representatives (e.g., marketing authorization holders) in Japan may become spokespersons for or mediators of user needs. Both physicians and hospital administration play a decisive role in purchasing innovative medical technologies and are therefore crucial agents for the diffusion of innovative devices (Gelijns and Rosenberg 1999, 315). Thus, different stakeholders have different “resources to inscribe their views in the design of technical objects”, such as “gender,

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age, socioeconomic, and ethnic differences” or with special requirements referring to findings of disability studies (Oudshoorn and Pinch 2008, 546). This suggests that there are also voices going unheard, for example, those of children and patients suffering from rare diseases such as muscular dystrophy, in which “both researcher and pharmaceutical laboratories have lost interest” (Oudshoorn and Pinch 2008, 543, 546, 551; see Chapter 11). For instance, Barad (2007, 193– 194) impressively describes the variety of needs and practices involved in the process of making and applying foetus ultrasonography and shaping the agency of the integrated piezoelectric transducer, where the unborn child is regarded as a phenomenon that is historically, culturally, economically and geopolitically “constituted and reconstituted” through material-discursive practices: For example, piezoelectric transducers materialize (and are iteratively rematerialized) in intra-action with a multitude of practices, including those that involve medical needs; design constraints (including legal, economic, biomedical, physics, and engineering ones); market forces; political issues; other R & D projects using similar materials; the educational background of the engineers and scientists designing the crystals and the workplace environment of the engineering firm or lab; particular hospital or clinic environment where the technology is used; receptivity of the medical community and the patient community to the technology; legal, economic, cultural, religious, political, and spatial constraints on its uses; positioning of patients during examination; and the nature of training of technicians and physicians who use the technology. Hence the production and reproduction of the technology involves particular disciplinary practices that Foucault specifically mentions such as those involving legal, educational, hospital, medical, architectural, military, industrial, and state apparatuses, and much more. (Barad 2007, 203–204)

Collective expectations of users, too, provide a direction that both initiates and limits innovation activities in a specific “technological frame” (Faulkner 2009, 6). For instance, innovation in medical imaging was a co-evolutionary learning process by heterogeneous stakeholders, with firms and clinicians as lead users, supported by the experiences of diagnosing patients, treatment and possible technology solutions,

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such as interaction with user communities and professional associations (Galbrun and Kijima 2009, 208). Against this backdrop, “intensive lobbying by manufacturers of the new technology” arises to constitute scenarios and imaginaries of use and influences the direction of technology advancement (Hogle 2008, 845). These imaginaries generate a strong incentive (promissory paths) for R&D activities, directing the attention of developers, users, patients, investors and funding organizations. They can be perceived as “a rhetorical fabric of hope, health and an improved future through increasing biological control” (Hogle 2008, 862). They are shaped by sociocultural images of health and often framed as expressions of modern societies, technological strength and advanced healthcare, but can raise controversies as well (Hogle 2008, 850, 855; Faulkner 2009, 1). Robertson (2016, 33) thus calls developers and engineers of social robots “imagineers”, as their ideas are infused with specific modelling practices, socially scripted ideas, approaches to social problems, values and takes on society. Hence, expectations and imaginaries are similarly shaped by sociocultural values held by users and developers alike (see also Chapter 10). It is in the development of technologies that a “number of tinkering strategies, including changing definitions and techniques” are involved, until a technology or technique becomes accepted as a standard method (Hogle 2008, 846). The “coordinating and negotiating activities that take place across disciplines and domains have become a key to understanding innovation and knowledge production”, as well as constituting a joint basis for perceiving, articulating and dealing with a problem (Hogle 2008, 846). More specifically, “(t)racing the role of patients and various users in the design and deployment of specific technologies” reveals “the multiple origin stories that bear on a technology’s biography”, which also elucidates the “understanding of the particular skills and techniques that develop around particular instruments” (Hogle 2008, 844; see also Chapter 3). Device safety and efficacy also need to be estimated for future investment, but too many devices fail to adequately meet the needs of clinical users (Becker 2006, 4). Technological advancement thus owes much to networks of innovation producing the multi-layered and manifold relationships amongst the political, industrial and user spheres. Considering the interdisciplinary

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nature of medical instruments, a process of exchange between clinical staff and medical engineers as well as close collaboration amongst manufacturers, research institutions and medical centres are crucial (Faulkner 2009, 6, 16, 20; Gelijns and Rosenberg 1999, 314, 355; Hogle 2008, 851). In Japan, however, developers have faced such difficulties as a lack of specialist university curricula for biomedical engineering, a lack of career opportunities for graduates and limited access to clinical sites due to ethical and regulatory constraints regarding patient safety (Altenstetter 2014, 141; see Chapter 9). This indicates that there are factors inhibiting extensive change in informal and institutional boundaries. Ibata-Arens (2019, 67, 70) states that the country has become “trapped in closed and insular knowledge and business networks that have limited its innovative and entrepreneurial potential” and low cross-organizational mobility “preventing them from participating in tacit knowledge exchange or open network activities” (Ibata-Arens 2019, 71, 76). Accordingly, the national, prefectural and local governments have begun to support industry–university collaboration (sangaku renkei ) in biomedical-related innovation and other fields, partly under the Innovation Cluster Initiative, and with programmes to improve human resources and knowledge transfer to technology licensing organizations (TLOs) at universities in Japan. The most prominent knowledge clusters with high-level medical device infrastructure are concentrated in the Kanto region (Tokyo, Yokohama, Tsukuba) and the Kansai region (Osaka, Kyoto, Kobe) (Collins 2008, 115–117; Ibata-Arens 2019, 80– 81, 86). Consequently, an increase in medtech partnerships and research collaborations between universities, manufacturers and hospitals, leading to the patenting and licensing of innovative medical devices, can be observed. Moreover, over the past two decades, medical research, including medical devices, has received growing attention through public research funding, with the launch of the Science and Technology Basic Law of 1995 and subsequent basic plans. Competitive funding by the MHLW and the foundation of AMED (Japan Agency for Medical Research and Development) in 2014 under the administrative guidance of the Cabinet Office has generated even more resources for research by universities, public research institutions and corporations (Fetters and Yokoyama 2015, 316–317).

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Nevertheless, critical voices remain, arguing that the medical device industry is “hardly among METI’s priorities [Ministry of Economy, Trade, and Industry]” and that it does not sufficiently reflect the global interdependence of this field in terms of research, knowledge transfer, manufacturing and commercialization, lacks specialized education at universities and training infrastructure, and suffers from communication barriers between institutions and disciplines as well as insufficient reimbursement for such activities (Altenstetter 2014, 141–142). In view of this, Chapters 9 and 10 show how technological and political scenarios influence innovation activities as well as how disciplinary boundaries and the lack of training opportunities inhibit medtech collaborations for device development in Japan.

6

Clinical Trials, Approval and Evidence-Based Judgement

Clinical workplaces, as technology-dense environments, require a high level of regulatory compliance. According to Hogle (2008, 851), through the search for “objective measures to replace individual skill and judgment, the randomized clinical trial became the ‘gold standard’ by which more subjective evaluations of new diagnostics and therapies were evaluated scientifically” to achieve wider societal acceptance for high-risk technologies. The regulatory approach is based on the risk “posed to the patient from the use of the device” owing to their closeness to human bodies (Becker 2006, 4–5). In many countries, including Japan, safety risk assessment and technical performance are central criteria for medical devices and obviously “key parts of the evolving regimes of evidencerelated governance” (Faulkner 2009, 2; PMDA 2019). Clinical trials of medical devices differ from the testing of pharmaceuticals, because the outcome is influenced not only by medicinal products and patients but also by the skill of healthcare staff, while placebo-operated control groups are often precluded (e.g., for invasive devices such as pacemakers). In other words, the user–device interaction contains a third parameter, the “device user”, to be controlled by sufficient training to “demonstrate

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reliability of the performance resulting from product design, verified by in vitro studies and cross-locale consistency” (Becker 2006, 3–7). In Japan, clinical trials are regulated by the MHLW and correspond to the ICH Guidelines for Good Clinical Practice.1 They are under the oversight of an ethical committee (rinri iinkai) and an institutional review board (chiken shinsa iinkai ), both self-governing bodies in medical facilities to secure data quality and ethical compliance (Fetters 2015, 330). Altenstetter (2014, 135), however, explains that the infrastructure for clinical trials in hospitals and basic research in universities has remained weak, because clinicians have had few incentives to conduct trials and support clinical research. Only since 2003 have the MHLW and Cabinet Office taken substantive measures to establish the necessary infrastructure and to allow investigator-led clinical trials (see Chapter 11). Criticism of an ambivalent regulatory framework, a lack of specialized education at universities and training infrastructure, and persistent communication barriers has nonetheless remained (Altenstetter 2014, 141–142; see Chapter 9). The process of approval is usually conducted by national or quasigovernmental institutions carrying a “high degree of authority within healthcare” and which also provide credibility and social legitimization through conducting evidence-based control procedures (Faulkner 2009, 10). In Japan, efforts to improve clinical research and approval led to the establishment of the Pharmaceutical and Medical Device Agency (PMDA) in 2004. It enables the harmonization of regulation and approval procedures with partner organizations abroad and additional budget for device-related R&D, the improvement of advisory services and training for personnel involved in clinical trials (Altenstetter 2014, 127, 135–140). Since 2014, fast-track approval for cutting-edge medicinal products has been applied to devices, pharmaceuticals and regenerative medicine (Ibata-Arens 2019, 83–84). The harmonization of national frameworks seems to be crucial for aligning actors from the clinical field, manufacturing and policy makers (Faulkner 2009, 9, 22,

1 ICH

refers to “The International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use”.

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30). Thus, international harmonization hints at country-specific interpretations of formalized rules and evidence-based judgement, but also includes efforts towards improving business opportunities abroad and accessibility of advanced treatments for patients. Hogle (2008, 852) nonetheless demonstrates that “knowledge production through clinical trials, instrument design, and data interpretation” shows that “evidence is malleable and takes multiple forms to do what we ask it to do”. Moreover, clinical apparatuses “may change what constitutes evidence of both the presence of disorder and of the utility of certain therapeutic approaches” (Hogle 2008, 842). Medical technologies are at work in “defining professional expertise and skill in different branches of medicine” because they “express and enable different ‘ways of knowing’” within different medical specialties (Webster 2007, 101). We therefore need to keep in mind that apparatuses produce data for the approval of medical devices and medical outcomes. In this sense, Mol (2002, 15, 16) emphasizes there “is such a thing as embedded knowledge. … It is incorporated in nonverbal schemes, in clinical procedures, in apparatuses”. Therefore, “unravelling medical knowledge requires an investigation into clinical procedures and apparatuses rather than into the minds and cognitive operations of physicians” (see also Chapters 3, 4 and 5). Barad (2007, 203) similarly argues that in order “to understand the complex nature of the phenomenon in question, it is necessary to understand the nature of apparatuses and the processes by which they are produced”. This evidence production regarding emerging technology is shaped “by complexity, hybridity, non-linearity, reflexivity, heterogeneity and transdisciplinarity”. This circumstance may increase the importance not only of transdisciplinary approaches in epistemology and methodologies but also approaches from the social sciences to consider patients’ experiences with healthcare and medical technologies (Faulkner 2009, 9–10; Mol 2002, 9). Hence Chapter 11 exemplifies the difficulties of evidence-based judgement by hinting at varying notions of health as a baseline for medical treatment and by discussing the importance of patients’ self-reported outcomes in reference to their sociocultural context.

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Manufacturing and Diffusion

Innovation in medical devices, markets and regulatory regimes with their classifications often co-evolve while providing an ex-ante pathway for innovation activities (Faulkner 2009, 29; Galbrun and Kijima 2009, 204; see Chapters 6 and 8). Manufacturers test medical devices through pilot studies and clinical trials, which usually requires a risk analysis, a quality management plan and informed consent from participants. Long-term application is accompanied by post-marketing surveillance for adverse events in patients, returned devices and complaints from clinical sites. This is a crucial source of data for further device improvement (Becker 2006, 10–11, 16–17). Patents are the most common way to secure intellectual property rights in medical device innovation, granted to “exclude others from making, using, selling, offering for sale, or importing the claimed invention without first obtaining a licence from the patent holder” (Moazzam and Bednarek 2006, 117). The manufacturing and diffusion of innovative devices is conducted by corporations dealing with “the classical engineering constraints of reliability, cost, governmental regulation and societal acceptance”, while devices also need to be culturally appropriate to be accepted by users (Hogle 2008, 859). In other words, considering corporations as locales for manufacturing and diffusion in a particular sociocultural context moves the research focus beyond the neoclassical assumption that perceives them as contextless black boxes. In addition to large manufacturers from the US and Europe, Japanese firms have played a dominant role as global exporters of diagnostic devices. Beginning in the 1910s, Shimadzu and Toshiba were the first Japanese firms to enter the market for X-ray devices, followed by Hitachi. Toshiba started to distribute CT scanners by the mid-1970s, but the other two companies also started to produce CT devices and MRI scanners from the 1980s onwards. Endoscopic technology, used in surgical instruments, took a slightly different route. The Japanese company, Olympus, together with the physician Tatsumo Uji, developed a gastrocamera, proceeding with fibre optics and later with digitalized visualization and computer assistance during surgery. However, the country continues to rely heavily on imports of therapeutic devices such

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as pacemakers and defibrillators (Donzé 2013, 204; Gelijns and Rosenberg 1999, 312, 316–319, 322, 326, 331, 336–337, 349–350). Japanese hospitals’ reliance on imports of crucial medical equipment such as artificial ventilators and virus-proof gowns became apparent once more during the pandemic caused by the novel coronavirus (Asahi Shimbun, 3 April 2020). Moreover, the medical device market consists of many small manufacturers developing instruments shaped by frequent innovation and high diversity of niche products with a wide variety of intended uses and principles of operation, in the US and Japan alike (Becker 2006, 5, 9; see Chapters 8 and 9). These characteristics have produced corporate strategies for launching clinical trials, securing intellectual property, commercializing products and calculating overall long-term costs. In general, medical economists rely on prospective cost–profit calculations when introducing high-tech devices into hospitals, although the cost/benefit of emerging medical devices is difficult to estimate. Investment in medical devices requires more complex calculations for both medical facilities and health insurance coverage by demonstrating their comparative advantage over established treatments or sufficient patient benefit (Becker 2006, 4; Yamanaka 2009, 246–247). In Japan, cost containment in health care and strict reimbursement procedures are decisive constraints within many medical institutions and regions, which limits the procurement of innovative technology. Hogle (2008, 844) points out that “costly, large-scale equipment” results in services being predominantly available “at centralized, often urban locales” in many countries. Gelijn and Rosenberg (1999, 326, 331, 351, 354), however, note the rapid diffusion of medical imaging technology into Japanese clinics and hospitals since the 1970s. In 2017, the ratios of 112 CT scanners and 55 MRI units per 1000 capita in Japan were far above the OECD averages of 27 and 17 respectively (OECD 2019, 193). Even today, medical technologies are apparently more equally distributed across the Japanese regions than are medical specialists in hospitals (see above). These medical devices are covered by the fee schedule of the national health insurance, which supports universal coverage of medical services in Japan’s regions as well as mass screening programmes for the early detection of diseases such as colon cancer by CT colonography (Galbrun and Kijima 2009, 199). Nevertheless,

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reimbursements for having necessary medical equipment in place have remained comparatively low, which has provided a strong incentive to increase per-capita utilization to cover costs, as the national health insurance predominantly pays on a fee-for-service basis. A large number of small hospitals are thought to have prompted the development of smaller and less expensive CT head scanners and MRI scanners (Gelijn and Rosenberg 1999, 351, 354). In other words, manufacturers in Japan have responded to specific clinical needs with variations in device size and post-marketing services, and to the institutional settings, which, like the universal coverage and sufficient reimbursement, have supported the widespread availability of imaging technology.

8

Hospitals and the Public Health System in Japan

The structure of the health system in Japan changed dramatically with the introduction of “modern” medical science from the mid nineteenth century. Clinics and hospitals became the central location for medical services, and both medical apparatuses and sickbed treatment increased (Yamanaka 2005, 11; 2009, 6–7). Accordingly, Japan saw a shift from a predominantly practical profession towards a data-based discipline with laboratories and experiments. This was symbolized by the application of microscopes, education and knowledge production at universities and by the introduction of public health, health-related administration and a health insurance system. These developments supported the diffusion of complex technology into the medical field. Although some instruments were already in place, further standardization facilitated the introduction of new apparatuses that widely influenced medical techniques (Foucault 1988 [1963]; Lachmund 1992, 235–239; Yamanaka 2005, 16–19). Against this background, medicine turned into a multi-layered entanglement of socio-technical settings and medical devices became a major driver for the rise of clinical medicine. Before the Meiji Restoration in 1868—the major social and economic transformation towards “modernization” in Japan—healthcare was mainly influenced by Chinese medicine (kanp¯o ). Medical practitioners

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and nurses, who attended patients in their homes and were paid for their services in cash, were established professions outside the feudal system but without formalized qualifications (Yamanaka 2005, 14). Medical knowledge on practices, drugs and technology from Europe was introduced by Spanish and Portuguese missionaries in the late sixteenth century and by medical officers from Dutch trading companies in the seventeenth to nineteenth centuries. Over 1500 European medical books, translated into Japanese, were apparently available in 1774. Medical knowledge and concepts introduced from Europe, such as anatomy, surgery and pharmacy, became recognized among Japanese medical practitioners and were called “Holland Studies” or “Dutch medicine” (rangaku or ranp¯o ), because Dutch was the prevailing language of imported textbooks (Powell and Anesaki 2011, 16, 22). In other words, the exchange of medical knowledge between Japan and Europe was already taking place before the Meiji Restoration. Yet it was only after the late nineteenth century that the concept of Foucault’s “Birth of the Clinic” became applicable to Japan, because the Meiji government sought “modernization” by chosing models from Europe and North America (Yamanaka 2005, 15–17). Specifically, the Japanese health system initially followed the Bismarckian model of Germany after 1869 and was later transformed by the Allied Powers during the period 1947–1951. From 1877, Japan established formalized medical education with the medical faculty at Tokyo University at its centre, together with a public health administration, a licensing system for medical practitioners, a drug control system, and a network of public and private hospitals (Fetters and Yokoyama 2015, 302; Ikegami 2014, 120; Powell and Anesaki 2011, 28–29, 31). According to Powell and Anesaki (2011, 22), the “introduction of the smallpox vaccine into the country and the use of the stethoscope were critical factors in the acceptance of western medical knowledge”. This was accompanied by appreciation of the surgery specialty and the introduction of “modern” medical instruments such as the stethoscope and the microscope. Medical practitioners thus took pride in their ability to “provide their clinics with modern equipment and to dispense the latest medication” (Powell and Anesaki 2011, 34, 37; Rodwin 2011, 170). Early users of X-ray apparatuses in

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Japan were military hospitals, followed by university and larger private hospitals, ordering from German importers such as Siemens during the early years. This circumstance owed much to personal links in the medical community between Japan and Germany during this period (Donzé 2013, 208–209). Later, Japanese companies developed even into global exporters of imaging technology (see above). During the Allied occupation (1945–1952) after Japan’s defeat in World War II, the Allied Powers introduced a market-driven model to Japanese medical practice in the hope of relegating the state-control model, but kept the centrally organized nature of the health system (Powell and Anesaki 2011, 48–49; Tsugawa et al. 2014, 164). Nowadays, this system can be found in public health centres (hokenjo) in all prefectures and designated municipalities, where public health nurses (hokenshi) are assigned and are responsible for services such as public hygiene, vaccination and mass screening to avoid epidemics and the transfer of infectious diseases such as tuberculosis and measles, general health information and children’s health, based on the Public Health Centre Law of 1937 (Rodwin 2011, 170; Tsugawa et al. 2014, 163– 165, 169–172; see also Chapter 4). As the preventive approach to public health has high priority, screening technology in medical facilities is still widespread today (Galbrun and Kijima 2009, 199). In 1997, the health system was reformed by the Community Health Law, a response to the rapid ageing of Japanese society, growing medical costs and the lack of medical staff, including healthcare and medical engineers. The Law allows subsidiary public health centres in local communities and adjusted the financial burden from 2005 (Kodate 2018, 207, 215; Tsugawa et al. 2014, 166). In pre-war Japan, social movements campaigned for a better national health insurance system, which serves as an egalitarian principle for access to medical care and universal health coverage to this day (Powell and Anesaki 2011, 36–37; Rodwin 2011, 170). Nowadays, 80% of hospitals are private (investor owned) and 20% are public organizations, affiliated to municipalities, national government or semi-public welfare organizations such as the three hospital networks of the Red Cross Society, the Saiseikai and the Koseiren. Both types receive payments according to the fee schedule of the national health insurance, thus

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turning private hospitals into semi-public institutions (Rodwin 2011, 170; Tagawa et al. 2014, 149–150). There are no gatekeepers or assigned primary care practitioners for each patient. Patients can freely access any medical service providers in principle, even if the cost is covered by public funds. In 2018, there were 8372 hospitals, 102,105 clinics/medical practices (6934 with beds) and 68,613 dental clinics (21 with beds); facilities with fewer than 20 beds are counted as clinics (MHLW 2018, 5). Ikegami (2014, 121–122) describes the Japanese hospital landscape as a two-tier system: “premier medical schools” equipped with the most advanced devices, mainly affiliated with public hospitals and “less prestigious medical schools”, mostly affiliated with private hospitals. Public hospitals have special functions, such as securing health services in remote places, medical treatment for patients with specific diseases and disabilities (e.g., tuberculosis, muscular dystrophy), clinical research and training of healthcare workers. They accordingly receive additional financial compensation from the MHLW (Tagawa et al. 2014, 149–151; see Chapter 11). On the other hand, the high percentage of small private hospitals obviously contributes to the low proportion of intensive care units (ICU), which became apparent during the coronavirus pandemic (Mainichi Japan 5 May 2020). However, the health reform that came into force in 1998 later changed the status of public hospitals to independent administrative entities under the umbrella of the National Hospital Organization (NHO). This reform requires a person to have specific qualifications in medicine to be a hospital director and encourages institutional autonomy and clinical research. While allowing more personnel and financial discretion, it has also enforced more organizational accountability, regular evaluation and performance-based remuneration for senior physicians (Kodate 2018, 212; Rodwin 2011, 180; Tagawa et al. 2014, 149–151, 152–154). It has produced two positive effects: a higher nurse–patient ratio and higher patient acuity (Tagawa et al. 2014, 153, 155). Conversely, the securing of standards for nursing staff and patient safety are based on legal statutes: licensing is controlled by ministerial departments instead of a system of professional self-regulation through an “autonomous nursing council”, in contrast to other countries (Ikegami and Buchan 2014, 139–141; see Chapter 7). Kodate (2018, 219) accordingly argues that

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the resilience to institutional changes, the closed medical community and the underrepresented voices of patients derive from the Bismarckian background of the Japanese health system. This historical path would, he concludes, contribute to insufficient accountability in hospital accreditation, specialty certification, civil liability for inquiries into clinical misconduct or malfunctioning devices. On the other hand, this institutional resilience is supported by the resistance of the Japan Medical Association (JMA, Nihon ishikai), mainly advocating investor-owned facilities, to public interference in the medical system as a legacy of the state’s wartime control (Rodwin 2011, 174–177; Tagawa et al. 2014, 149–150). To summarize, the transition of the health system over time exemplifies the manifold entanglements and factors contributing to specific institutional-technical settings, such as the high prevalence of medical imaging and mass screening programmes or little public interference in the regulation of body–device safety in the medical field in Japan.

9

Conclusion

As demonstrated above, the meaning of medical technologies changes with the professional, disciplinary or organizational context, and its variety is found in specific locales at the semantic, pragmatic and institutional levels. The semantic dimension encompasses changing notions, interpretations and controversies in health, bodies, risk/safety, patient benefit, clinical needs or professional identities as well as different future scenarios of advanced (technological) healthcare or promissory markets. Semantic variations also affect the pragmatic dimension, such as clinical practices and innovation activities (e.g., inscribing values/future images into technology). In view of this, the agency of medical technology and power structures deserves attention during knowledge production, evidence-based judgements, decision making and/or machine-mediated action in medical contexts. The institutional dimension refers to rules, regulatory and organizational aspects, such as bioethical principles or the ICH Guideline for Good Clinical Practice directing the application of devices in vulnerable groups, hospitals and public health systems,

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risk management, infrastructures, education and disciplinary boundaries within the research and innovation system, which not only stabilizes societal contexts but also evolves over time. The following chapters hence illuminate how the relationship of humans and medical devices vary in different socio-technical settings and what configurations can be observed in a specific locale such as Japan through case studies from the authors’ respective disciplines.

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Part II Experiences with Radiation

3 Knowledge and Culture Behind the Dosimetry System: Japanese Scientists, Radioactive Disasters and the Technologies for Measuring Radioactivity in the Twentieth Century Maika Nakao

1

Introduction

The effect of low-level radiation on the human body is not yet fully understood, and different stakeholders’ opinions remain a frequent cause for dispute. The nuclear industry, government, and some scientists are even criticized for hiding or underestimating the negative effects of radiation exposure. This chapter uses the history of technologies for measuring and visualizing radioactivity to examine the historical context and cultural authority behind the production of knowledge about radiation exposure. Medical technologies have changed our ways of understanding, diagnosing, and classifying diseases (Hogle 2008), and medical technologies are especially important in radiology because radiation is invisible, M. Nakao (B) The Graduate School of Integrated Arts and Sciences, Hiroshima University, Hiroshima, Japan © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Brucksch and K. Sasaki (eds.), Humans and Devices in Medical Contexts, Health, Technology and Society, https://doi.org/10.1007/978-981-33-6280-2_3

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tasteless and odourless. Since its discovery at the end of the nineteenth century, radiation has been visualized, generated, measured and controlled with various instruments, such as the electroscope, fontactoscope and Geiger–Müller counter. The discovery of X-rays opened a new era in medicine; it soon became apparent, however, that exposure to X-rays could cause serious bodily injury. Thus arose the endeavour to determine the permissible dose of radiation, but to achieve this, scientists needed both exposed humans and reliable technologies. This was not an easy endeavour because there are various kinds of radiation and various units of measurement, including the roentgen, curie, sievert and rem, that are associated with different measurement methods. In a tautological definition, dosimetry is the measurement of a dose by dosimeters. In other words, the measurement method defines the doses and dosimetry. Dosimetry requires the measurement of an adequate number of parameters of a radiation field to permit the calculation of an absorbed dose and/or dose equivalent in the organs of humans irradiated by the field. Dosimetry is composed of several fields of science and technology and has been determined by advances in science and technology, but there is so far no completely satisfactory definition of the word dosimetry. Lorraine Daston and Peter Gallison argued that, throughout the nineteenth century, images created by mechanical devices guaranteed the objectivity of science and technology (Daston and Gallison 1992). Conversely, however, dosimetry—created by measuring instruments—is also dependent on each instrument, and the measuring instruments that are used in dosimetry challenge the objectivity of science and technology. Though the notion of dosimetry emerged and developed along with radiology, the dosimetry system, which is the calculation of the absorbed dose in tissue resulting from exposure to ionizing radiation, was established only after the atomic bombing of Hiroshima and Nagasaki, in which a huge number of citizens were killed and injured. Since then, American and Japanese scientists have been collecting data from atomic bomb survivors (hibakusha) and seeking to classify the absorbed dose of radiation. They introduced different dosimetry systems such as T65D, DS86 and DS02 based on and shaped by the underlying instruments and technology. This leads to the question how these dosimetry systems

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were actually established and standardized, and how Japanese and American scientists collaborated to establish them. The Japanese people who survived the nuclear bombs became the most essential human subjects for creating a dosimetry system, even while measurements of radioactivity and estimations of dosimetry at the bombsites were needed. Japanese scientists, some of whom were also survivors of the bomb, measured radioactivity at the bombsites and contributed to determining the dosimetry of the survivors; they thus contributed to the development of a dosimetry system both as research subjects and as subjective agents. From the history of dosimetry in the Japanese context, this chapter discusses the politics and culture behind the instruments and technologies. In what context, for what purpose and by which group of people was the dosimetry system developed? What role was played by Japanese scientists and atomic bomb survivors in this context? Medical knowledge on atomic bomb survivors has been created alongside the conflict and collaboration between Japanese and American scientists. After the atomic bombings of Hiroshima and Nagasaki, Japanese and American scientists investigated several aspects of the effects of the bombs. During the occupation era (1945–1952), the United States established the Atomic Bomb Casualty Commission (ABCC) to study the long-term effects of the atomic bomb on the human body, and Japanese scientists had to collaborate with them. The ABCC was operated through the budget of the Atomic Energy Commission (AEC), which advanced nuclear development, and the US intended to use its results in its nuclear strategy during the Cold War. The investigation conducted by the ABCC was criticized for regarding the atomic bomb victims as human guinea pigs, monopolizing and disguising their data or underestimating the effects of atomic bombs. The tensions between Japanese and American scientists became obvious when Japanese fishermen were exposed to radiation fallout from the US hydrogen bomb test at Bikini Atoll in 1954. This bitter experience of the early to mid1950s forced the ABCC into self-examination. They had to change their strategy in order to continue their investigations in Japan. Later, from 1975, the ABCC was reorganized into the RERF (Radiation Effects Research Foundation) and became a “real” joint research institute (Lindee 1994, 2016). Alongside the medical investigations, attempts

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to create a dosimetry system started with an American initiative in the 1950s and became a US–Japan joint project in the 1980s. Previous studies on the scientific investigation of atomic bomb survivors have analyzed the way in which American and Japanese scientists collaborated (Beatty 1993; Lindee 1994; Sasamoto 1995). Lindee (1994) points out that the medical studies of the ABCC were “colonial science”. Lindee (1994, 20) suggests that “the American studies of the survivors were a form of science comparable to colonial indirect rule, in which existing systems of administration (in this case data collection systems) were maintained, but were overlaid with a level of colonial control” and suggested a different meaning for “colonial science”: science conducted by outsiders that depends on local knowledge, particularly when that knowledge is invisible to the colonizers themselves. However, Lindee did not examine what she calls local knowledge itself. This chapter focuses on the “colonized place” and will offer a new perspective on this issue. It focuses on the science that existed in the colonized place and seeks the motivation behind it. Knowledge on radiation and dosimety relies heavily on measuring technology and the culture surrounding it. Taylor (1871, 1) defined culture as follows: “Culture or civilization, taken in its wide ethnographic sense, is that complex whole which includes knowledge, belief, art, morals, law, custom, and any other capabilities and habits acquired by man as a member of society.” The sociocultural context of technology has been analyzed in many ways, especially since the late twentieth century. Feenberg (1992, 309) argues that cultural norms originating in economics, ideology, religion and tradition constrain technological development. In the context of medical technologies, Hogle (2008, 842) points out that diagnostic and research data from instruments are not only essential to the determination of the nature and cause of disease but are also in constant interaction with systems of expertise, theories and the institutions in which they exist. The history of radiation and dosimetry in Japan, therefore, provides a case to understand how emerging technologies may generate hopes in medical treatment, and how new measuring technologies may influence theories on bodies and diseases.

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The chapter first summarizes the notion and early history of dosimetry, then discusses the Japanese scientific development of measuring instruments and the technology of radioactivity; investigations of the atomic bomb; and the development of dosimetry systems by the US and Japan. The history of instruments and devices for measuring radiation exposure will provide an insightful perspective for thinking about the role of measuring instruments and technologies in modern society.

2

The Birth of Radiology and the Dose Evaluation System

Scientific research into X-rays and radioactivity was quickly followed by medical implementation of what had been learned. Wilhelm Conrad Röntgen’s discovery in 1895 that X-rays could penetrate the human body created a sensation both in scientific circles and with the public. The first person to use X-rays in the treatment of skin diseases was physician Leopold Freund of Vienna, who treated a patient’s pigmented nevi. This medical use had been influenced by similar therapies such as electrotherapy and light therapy, which was invented by Niels Ryberg Finsen for tuberculosis of the skin. Finsen was awarded a Nobel Prize in Physiology or Medicine in 1903. In these therapies, machines were important for making artificial sources of radiation, and by building on these machine therapies, radiation therapies emerged. Radiation therapies spread quickly, and X-ray technologies were introduced in many hospitals for the diagnosis and treatment of conditions such as broken bones, eczema and skin cancer. A further development came with the discovery of the properties of radium in 1898. Radioactivity from radium seemed similar to X-rays, and scientists and medical doctors wondered if radium could also have clinical utility. Before the actual chemical and physical conditions of such a use were understood in terms of modern science, physicians around the world, from Germany to the United States, used radium in the treatment of diseases like keloids, tuberculosis, syphilitic ulcers, hyperthyroidism, tumours and cancers.

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However, it came to be known that X-rays and radium also had harmful effects on the human body. Even early in their use as a treatment, some physicians had noticed inexplicable burns on the bodies of patients after lengthy exposure to X-rays. Within two decades after they were first used, scientists and physicians had concluded that exposure to X-rays could cause sterility, bone disease, cancer and other harmful consequences because of the ionization caused by radiation. Several guidelines were established to shield X-ray operators from excessive radiation exposure. The German Roentgen Society set out guidelines in 1913, and the British Roentgen Society in 1915. The use of X-ray machines increased during World War I, and in 1921, British radiologists and physicians created the British X-Ray and Radium Protection Committee, which issued a series of recommendations for radiation workers. Along with awareness of the harmful effects of X-rays and radium, there arose a strong interest in establishing a unit for the measurement of radiation doses and the development of a standard measuring instrument, especially among radiologists and physicians. In 1925, the First International Congress of Radiology was held, and the X-Ray Unit Committee was formed. Its objective was “to develop concepts, definitions and recommendations for the use of quantities and their units for ionizing radiation and its interaction with matter, in particular with respect to the biological effects induced by radiation”. The primary concern of this commission was to set the X-ray unit, because at that time, there was no universal unit of measurement. At the Second International Congress of Radiology in 1928, the International X-Ray and Radium Protection Committee (IXRPC) was formed, and the tolerance dose was specified in roentgen units. However, there were still no specific definitions; the committee only made recommendations regarding factors such as working hours and general guidelines, without mentioning a tolerance dose. The problem was that there was no standard for defining the level of exposure. At that time, medical scientists urged the setting of a universal unit and the development of a standard measuring instrument. However, they could not achieve it by themselves because there were problems of physics, such as the selection of appropriate physical phenomena and the consideration of measurement methods. Physicists were focused on the

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standardization of measurement methods and the development of appropriate instruments. However, by focusing on measurement precision, the physicists appeared to the medical scientists to be delaying the setting of a universal unit (Sugimoto 1994). It was not until 1934 that the IXRPC concluded that they had sufficient information to recommend a quantitative tolerance dose. Based on research that calculated the amount of radiation it took to cause erythema, the committee recommended a tolerance dose daily limit of 0.2 roentgen. The US Advisory Committee on X-Ray and Radium Protection, formed in 1929, also recommended a tolerance dose of 0.2 roentgen in 1931. In addition, the IXRPC made an important change in the wording of the definition of the roentgen in 1937. It recommended “the international unit of quantity of dose of a rays shall be called the ‘roentgen’ by the symbol ‘r’. … The roentgen shall be the quantity of x or γ radiation such that the associated corpuscular emission per 0.001293 gram of air produces, in air, ions carrying 1 e.s.u. of quantity of electricity of either sign.” In effect, it declared that the roentgen was to be a unit describing the X-ray field at the point of interest rather than the energy absorbed locally there. Although this change was important, it had little effect on the method used for the experimental realization of the roentgen because there was no practical way to directly measure the ionization specified in the 1937 definition. Though the IXRPC made no recommendation between 1937 and 1950, the boundaries of radiation dosimetry were dramatically widened during this period by the use of atomic bombs and nuclear reactors (Attix and Roesch 1968). In 1950, the IXRPC was renamed the International Commission on Radiation Protection (ICRP) and the X-Ray Unit Committee was renamed the International Commission on Radiation Units and Measurements (ICRU). The US Advisory Committee on X-Ray and Radium Protection was reorganized as the US National Committee on Radiation Protection (NCRP) in 1946 and reassessed its position on radiation exposure levels. The NCRP replaced the term “tolerance dose” with “maximum permissible dose (MPD)”. The concept of the MPD came from consideration of the genetic effects of radiation exposure and the genetic study of the atomic bomb survivors became the central interest of the ABCC when it was established in 1947.

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Visualizing Technologies of Radioactivity in Prewar Japan

In Japan, the first report on radioactivity measurement, published in 1910 by scientists at Tokyo Imperial University, was about the radioactive content of Japanese hot springs (Ishitani and Manabe 1910). In 1909, a medical doctor, Kaichiro Manabe, and a physicist, Den’ichiro Ishitani, began investigating radium emanations (radon) from Japanese hot springs with the support of Tanemichi Aoyama and Hantaro Nagaoka, both pioneers of Japanese medicine and physics. At that time, the science of radiation was beginning to receive attention from several scientific fields and was becoming a trendy, foremost science. Manabe and Ishitani measured radioactivity in Japanese hot springs, such as Yugawara, Izu, Atami, Arima and Ikaho, and published a paper stating that several such springs contained high levels of radiation. Manabe concluded that “all mineral springs must contain radium” and that radium was the true origin of what was believed to be the potency of hot springs (Manabe 1910). The instrument used in their investigations was the fontactoscope of C. Engler and H. Sieveking. However, their technique for using the instruments appeared to leave some room for improvement, as was implied in their paper. Despite this, after their report, many hot springs began to claim the potency of the radium contained in their mineral springs, and the boom of radium hot springs arose in Japan (Nakao 2013). Within a few years of the appearance of Manabe and Ishitani’s report, investigations of the radium content of mineral springs became a concern of national institutions. The Health Office of the Home Ministry published a report in 1915, entitled The Mineral Springs of Japan, which was exhibited at the Panama–Pacific International Exposition, held in San Francisco. The army medical team also summarized its findings in a report entitled The Table of the Radium Emanation Content in Japanese Mineral Springs. The rapid progress of the investigation of mineral springs may have been driven by the Japanese vision of imperialism, in addition to its economic value, and the investigations may have been motivated by a desire to rewrite the world map of the centre and periphery. The

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centre–periphery model was proposed by the historian George Basalla (1967), and historians of Japanese science have discussed the possibility of depicting a different centre–periphery during Japan’s imperial period, placing the Japanese mainland at the centre and the Japanese colonies at the periphery (Low 1989; Bartholomew 2000; Kim 2007a). For instance, the introduction of the book The Mineral Springs of Japan emphasizes the richness of the empire’s terrain (Ishizu 1915). It starts with the following phrase: “The Empire of Japan is situated at the eastern extremity of Asia and consists of a group of islands, known as the Japanese archipelago, which stretch in a long curve in the north-western corner of the Pacific Ocean, and the Korean Peninsula (now called Chosen) projecting from the Asiatic Continent.” The book emphasizes the richness of the Japanese natural environment and visualizes the terrain of the Japanese empire, which included Taiwan and Korea, with several types of maps. In such investigations, regional places were listed and ranked by national institutions. During the First World War, Japan made enormous profits thanks to the munitions sales boom. This boom was connected to the establishment of a high-level research institute that promoted the national interest—the Institute of Physical and Chemical Research (RIKEN)—in 1917. RIKEN amassed donations from Japan’s big financial corporations and became the stage on which the Japanese scientific “miracle” would be played out in the following decades. The technique of radiochemical analysis was also developed by chemists at RIKEN and other institutes, with Satoyasu Imori and Kenjiro Kimura playing important roles. Satoyasu Iimori (1885–1982) studied at the Department of Chemistry at Tokyo Imperial University and entered RIKEN in 1917, where he worked on radiochemical analysis. Iimori went to the UK in 1919 and studied under Frederick Soddy at Oxford University during 1920 and 1921. After his return from Oxford, systematic studies of radiochemistry started in Japan (Tanaka and Yamasaki 1986). Iimori began teaching a course entitled Chemistry of the Radioelements at Tokyo Imperial University (from 1922 to 1943) while primarily working at RIKEN. He developed instruments such as the Lauritsen electroscope, radioscopes for α, β, and γ radioactive measurements, the IM fontactoscope and the thoron quantitative electroscope, for simple and accurate measurement

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of radioactivity. The IM fontactoscope (IM being Iimori’s initials) was invented in 1935 and made quantitative measurement of radon in water easy, enabling more systematic research in radiochemistry. Knowledge of radiochemical analysis led to clarification of the artificial radioactive elements in the late 1930s by scientists such as Kenjiro Kimura. Kenjiro Kimura (1896–1982) studied chemistry at Tokyo Imperial University under Yuji Shibata, the founder of Japanese geochemistry. Together with Shibata, Kimura published a paper entitled “Chemical Investigation of Japanese Minerals Containing Rarer Elements” in 1921 (Shibata and Kimura 1921). This was the beginning of the chemical study of minerals in Japan, and the chemical analysis of rare elements became Kimura’s lifelong work. His dissertation, which was accepted by Tokyo Imperial University in 1931, was on “the chemical investigations of Japanese minerals containing rarer elements”. In 1922, Kimura became assistant professor in the Department of Science at Tokyo Imperial University, becoming a professor in 1933. From 1925 to 1927, Kimura worked at the Niels Bohr Institute at Copenhagen University. In Copenhagen, Kimura worked on the chemical analysis of radioactive elements under the supervision of George de Hevesy; after de Hevesy left, Kimura worked on quantitative analysis with Yoshio Nishina, a Japanese physicist who also worked there at that time. Their collaborative research led to the analysis of artificial radioisotopes produced by cyclotrons at RIKEN in the late 1930s.

4

Cyclotrons and Wartime Research

In the 1930s, the beginning of large-scale nuclear physics in Japan, physicists began to create new radioactive isotopes with cyclotrons. The cyclotron, invented by Ernest Lawrence in 1930, became an essential device for research in nuclear physics and radiochemistry in the 1930s. It required high technology and materials. By using artificial radioisotopes and neutron rays produced by cyclotrons, John Lawrence, a brother of Ernest, established a new field of medicine called nuclear medicine. In Japan, four cyclotrons were constructed from the mid-1930s to the end of the Second World War (Hinokawa 2009). The first Japanese cyclotron

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was completed in 1937 at RIKEN. It was the only cyclotron outside the US (and possibly USSR) at that time. Its construction can be regarded as marking the appearance of big science in Japan. The cyclotron at RIKEN was constructed under Yoshio Nishina’s supervision. Yoshio Nishina (1890–1951) played a significant role in modern Japanese physics and is regarded as the most important physicist in prewar Japan (Tamaki and Ezawa 2005; Nakane et al. 2006–2007; Kim 2007b). In 1921, after studying electrical engineering at Tokyo University, he went to Europe and, from 1923 to 1928, worked at the Niels Bohr Institute in Copenhagen, where he worked with Kimura and others. He is known for the 1929 Klein–Nishina formula and his work on theoretical physics. In 1931, after returning to Tokyo, he opened a laboratory at RIKEN, which was modelled after that in Copenhagen. The biggest project for Nishina was constructing the cyclotron. After the first 37-inch cyclotron was completed in 1937, artificial radioisotopes started to be produced, serving several fields of science. The artificial radioisotopes were used in biology, medicine and agriculture, as well as in chemistry, and drove research collaboration between different scientific fields. Kimura became Nishina’s principal partner in the chemical analysis of artificial radioisotopes. Together with members of their laboratory, they discovered several new radioactive elements and published around 10 papers in Nature and Physical Review in only three years. One of the radioactive elements they found was uranium-237, which was discovered in 1940. The radioactive elements that could be discovered by cyclotron were defined by the size of the machine. Soon after the completion of the first 37-inch cyclotron, Nishina started to construct a larger, 60-inch cyclotron—the largest in the world at that time. The cyclotrons needed a lot of funding and materials to construct. Nishina’s laboratory received significant funds for construction of the cyclotron from both national and private foundations, including the Japan Society for the Promotion of Science and the Mitsui Foundation. Both aimed to enhance national power through development of science and technology. The Mitsui Foundation attracted people’s attention by providing one million yen to the Tokyo Cancer Research Centre for the purchase of radium in 1935. Mitsui’s funding of the cyclotron may

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have been driven by expectations of nuclear medicine. Physicists therefore appealed to both sponsors and the public for funds and materials, citing the necessity of cyclotrons. During construction of the cyclotrons, Nishina became a spokesman in the popular media. With the role of scientists in society expanding because of the war effort came explanations in the media of how to manage science in wartime. Nishina knew the great expectations of their research and tried to respond to these expectations, proving himself a scientist who was devoted to the nation. With the Japanese invasion of China in the late 1930s, RIKEN received public attention as a great research institute that demonstrated Japan’s scientific “superiority”, and the cyclotron was its eye-catching device. The cyclotron was reported as being a machine for making “artificial radium” which exemplified the greatness of Japanese science and technology. In November 1940, RIKEN held a special public lecture in association with the festival celebrating 2,600 years since the nation’s founding. During the lecture, Nishina’s laboratory exhibited a “radiation man”. Nishina asked a laboratory assistant to drink radioactive salt, so that the assistant had a level of radioactivity high enough to be read on a Geiger–Müller counter. The public was excited by this experiment and the public lecture was reported as a key event that brought RIKEN into the public’s imagination. The Japanese media were proud of the cyclotron, and, after the discovery of nuclear fission, the cyclotron came to be regarded as an essential machine for the release of nuclear energy or for making nuclear weapons. The expectation that an atomic bomb would be made in Japan grew during the war, along with the public image of the cyclotron and the scientists at RIKEN, with Nishina as a key figure (Nakao 2009). Around 1942, Japanese scientists embarked on two nuclear weapons research projects: the Imperial Japanese Army’s Ni-go project and the Imperial Japanese Navy’s F project (Dower 1993; Grunden 2005; Yamazaki 2011). The leader of the Ni-go project was Nishina at RIKEN. Bunsaku Arakatsu, the leader of the F project, was a professor of physics at Kyoto Imperial University. Arakatsu was the first person in Japan—and in the East—to accomplish a Cockcroft–Walton accelerator, and he achieved nuclear transmutation at Taipei Imperial University in 1933. After returning to Kyoto Imperial University in 1936, Arakatsu

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embarked on the construction of a cyclotron, which became a part of the F project but was still under construction when Japan was defeated by the Allied forces (Masaike 2017). Japanese attempts to make a nuclear weapon were far from completion in any sense, and the lack of human resources, natural resources, mechanical devices and budgets contrasted with public expectations. At RIKEN, some research on isotope separation and theoretical calculations was conducted within the Ni-go project, while the army made significant efforts to find uranium ore in Japanese territory. Satoyasu Iimori, who opened the field of radiochemical analysis in Japan, joined the Ni-go project as one of the principal researchers. Iimori had devoted himself to surveying uranium- and thorium-containing minerals in the Japanese empire. Iimori advised Toranosuke Kawashima, the major general in charge of searching for uranium and the army’s liaison at RIKEN, to begin searching at the Ishikawa mine in Fukushima prefecture, where he had found traces of uranium and thorium before the war. The army mobilized 150 middle-school students in Ishikawa to dig the mine. Though the army made significant efforts to find uranium ore in Japanese territory, including in Manchuria, Malaya, Burma, China and Korea, in addition to the Japanese mainland, their efforts were almost entirely in vain. Kawashima also ordered shipments of uranium from Germany, but, while the U-boat carrying the uranium was on its way, Germany was defeated by the Allied forces and the U-boat surrendered to the US navy. Two Japanese colonels who were aboard the U-boat killed themselves.

5

Scientific Investigations in Hiroshima and Nagasaki

Although Japanese scientists had embarked on nuclear weapons research, none of them believed that the atomic bomb could be created by any country during the Second World War. The bombing of Hiroshima on 6 August 1945 therefore came as shocking and unbelievable news. Both during and after the war, active scientific investigations were conducted at the bombsite to determine the nature of the bomb (Sasamoto 1995).

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The Japanese Imperial General Headquarters, the army and the navy organized several investigation teams, in which many scientists from imperial universities took part. Teams from Tokyo Imperial University and Kyoto Imperial University arrived in Hiroshima and teams from Kyushu Imperial University and Kumamoto Medical University arrived in Nagasaki before the end of the war on 15 August. In mid-September, the National Research Council of Japan (Gakujutsu Kenky¯u Kaigi) set up a Special Committee for the Investigation of the Atomic Bomb Disaster (Genshi Bakudan Saigai Ch¯osa Tokubetsu Iinkai), which became a parent organization for Japanese scientific investigations into the atomic bomb disasters. The investigation encompassed nine scientific fields, and the report of the investigation, which was published partly in 1951 and fully in 1953, was divided into two parts—physics and biology (part 1) and medicine (part 2)—and became an important publication for understanding Japanese scientists’ activities at the bombsites (Japan Science Council 1953). During the investigation, measurement of radioactivity was performed by groups of scientists, including Bunsaku Arakatsu of Kyoto Imperial University, Fumio Yamasaki of RIKEN, Ken’ichi Shinohara of Kyushu Imperial University, and Kenjiro Kimura of Tokyo Imperial University. From the soil that Kimura brought back to Tokyo, radioactive elements such as Sr-89, Ba-140 and La-140 from the soil at Takasu in Hiroshima and Sr-89, Ba-140, Pr-144 and Zr-95 from the soil at Nishiyama in Nagasaki were detected. The main measuring instrument used by the scientists was the Lauritsen electroscope (used by Kimura, Shinohara and Yamasaki), designed in 1937 by Charles Lauritsen. The scientists who conducted the investigations overlapped with those conducting nuclear weapons research during the war; no doubt their knowledge was useful for determining the nature of the bomb. Yoshio Nishina went to Hiroshima on 8 August with a team from the army general staff and, that evening, reported in tears to the Chief Secretary of the Cabinet, that the bomb that was dropped on Hiroshima was an atomic bomb. Before Nishina left RIKEN for Hiroshima, he left a letter to one of his laboratory members, Hidehiko Tamaki, including the following passage: “If Truman’s statement was correct, it’s time for us, the members of the Ni-go project, to commit hara-kiri….in short,

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if this is a fact, the researchers of Western countries achieved a great victory over the Japanese researchers. This means that the personality of Western researchers overwhelmed that of the Japanese.” Hara-kiri is a traditional Japanese way of committing suicide. Ito (2002) writes that Nishina was allegedly “a conscientious and sincere man who tried to reconcile his identity as a scientist and his obligation to the country”, who confronted defeat in the war as a scientist. As a Japanese, he fought against the Western countries during the war and felt ashamed that he could not succeed in making an atomic bomb. When he came back from the bombsite, Nishina felt that the war was over and that he could return to the world of science as Japan’s defeat was obvious and there was no pressure from the military to commit suicide. This surprised his laboratory member, who was thinking about suicide because of Nishina’s letter (Okamoto 2011). However, this prospect had not materialized in his country by the time Nishina died in 1951. Between September 1945 and April 1952, Japan was under Allied occupation. During the era of occupation, Japanese scientists were unable to conduct their scientific research satisfactorily. The Allies investigated and prohibited Japanese scientific research into military technology. Along with the policy of prohibiting all nuclear-related research in Japan, the four cyclotrons in Japan were destroyed by Allied forces in November 1945. The Japanese zaibatsu (financial cliques) were dismantled, as was RIKEN, which restarted as the Scientific Research Institute (Kagaku Kenky¯ujo, abbreviated as KAKEN) in 1948. The US had a strong interest in the effects of the atomic bomb, and they also embarked on scientific research at the bombsite. Teams from the US Army, US Navy and Manhattan District came to Hiroshima and Nagasaki in early September 1945 to study atomic bomb casualties. These teams were unified as the Armed Forces Joint Commission for Investigating Effects of the Atomic Bomb in Japan. The Americans asked Japanese scientists to support their research—a request to which the Japanese scientists responded. In Japan, the commission was called the Japanese American Joint Commission (Nichibei G¯od¯o Ch¯osa Dan), and Masao Tsuzuki headed the Japanese delegation. Masao Tsuzuki (1892–1961)—rear admiral of the Naval Medical Corps and professor at Tokyo Imperial University—was a leading

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authority on the biological effects of radiation in Japan at that time. On 24 August 1945, when an actress died at Tokyo Imperial University Hospital after being exposed to the atomic bomb explosion in Hiroshima, Tsuzuki coined the term “atomic bomb injury (genshi bakudan sh¯o )”. However, there was considerable inequality between the Japanese and the American scientists of the Joint Commission. The American scientists were obtaining huge amounts of medical records, such as clinical records and specimens, from the Japanese scientists but often against their will. These records were sent to the US Armed Forces Institute of Pathology (AFIP) and returned to Japan only in the 1960s and 1970s after the American scientists published papers using these materials (Lindee 1998; Takahashi 2011). Additionally, the Japanese scientists were restricted in publishing their academic articles on atomic bomb casualties during the occupation era. Furthermore, the United States established the ABCC in Hiroshima and Nagasaki to study the long-term effects of atomic bombs on the human body, and Japanese scientists collaborated with them. The situation changed after the occupation ended in 1952, when the Japanese press began to criticize the ABCC for neglecting to provide medical treatment while collecting survivors’ data.

6

The Bikini Incident and the Activity of Japanese Scientists

Further conflict between Japanese and American scientists surfaced when Japanese fishermen were exposed to radiation fallout from the US hydrogen bomb test at Bikini Atoll in 1954. On 1 March 1954, the United States conducted its most powerful hydrogen bomb test, codenamed Bravo, at the Bikini Atoll in the Marshall Islands (Hewlett and Holl 1989). At the moment of the explosion, the Daigo Fukury¯u Maru, a pelagic Japanese tuna fishing boat, was close to the danger zone of the test (Lapp 1956; Oishi 2011). Ash from the explosion covered the boat, and 23 fishermen, their tuna and the ash itself were later found to be strongly radioactive; the fallout was dubbed the “ashes of death”. This incident

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was widely covered in Japanese newspapers and became a trigger for the nationwide Japanese nuclear test ban movement (Maruhama 2011). Japanese scientists started analyzing the “ashes of death”. On 16 March 1954, groups from Shizuoka University, the University of Tokyo and Kyoto University went to Yaizu to measure the radiation levels of the Daigo Fukury¯u Maru, bringing the white ash that remained on the boat back to their laboratories. At the request of Tokyo University Hospital, a team from the University of Tokyo, headed by Kenjiro Kimura, started analyzing the fallout two days later. To find a proper method for medically treating the affected men from the Daigo Fukury¯u Maru, it was necessary to know the species and amounts of the radioactive elements. Kimura faced the same problem of identifying dangers as he had after Hiroshima and Nagasaki—this time due to a thermonuclear bomb. Within a month, Kimura’s group had successfully identified almost 30 different nuclides (Miyake 1972). “A combined method of chemical separation with the use of carriers and separation with the use of ion exchange resin was applied; 17 nuclides were detected and the results of quantitative estimation of alkaline earth metals were reported on 31 March. The presence of 237U was confirmed from its radioactivity and chemical properties. A-tracks of 239Pu were also detected by the autoradiographic method” (Kimura et al. 1954). This quick identification was possible because of advances in radioactive measurement understanding and instrumentation. By this time, measuring instruments and technologies, such as the Geiger–Müller counter and ion exchange resin, had been introduced into Kimura’s laboratory, and identification techniques had developed radically. In the following month, Kimura and his team detected U-237, the element discovered by Nishina and Kimura in 1940. It is said that the reunion with U-237 moved Kimura deeply (Kimura Kenjiro Sensei Kinen-shi Hensh¯u Iinkai 1990, 321–322). Kimura wrote: In connection with the present studies, it should be remembered that U-237 and a variety of fission-produced nuclides, such as Ru-103, Ru105, Pd-111, Pd-112, Ag-111, Ag-112, Cd-111m2, Cd-115, Cd-117m, In-115m and In-117, were first discovered in the history of nuclear fission by Dr Nishina, Prof. Kimura, and co-workers about 1941 at the

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Institute of Physical and Chemical Research in Tokyo (now the Scientific Research Institute). In addition to the above-mentioned study, other radiochemical analyses were made in 1945 and in 1951 by Prof. Kimura and co-workers at the University of Tokyo on the radioactive fallout at Hiroshima and Nagasaki.… The detection of Pu-239 in the samples from Nagasaki afforded the Japanese scientists the opportunity to study radiochemical aspects of the transuranic elements. These past experiences were very helpful to Japanese chemists in their performing of rapid analysis of the radioactive dust due to the nuclear detonation at the Bikini Atoll on 1st March 1954. (Kimura 1956)

Thus their activity before and soon after the Second World War supported the rapid analysis of the Bikini ash. News of the Daigo Fukury¯u Maru quickly travelled around the country, and fear of radiation spread in Japan. Consumers were reluctant to buy tuna for fear it might have been exposed to radiation, and the price of tuna dropped, hitting the fishing industry hard. In addition, radioactive rain started to fall on Japan. Japanese government institutions responded quickly: on 30 March, the Ministry of Health and Welfare set an inspection standard for fish at harbours in response to “atomic tuna” issues, mandating that fish be disposed of if it contained radioactive substances disintegrating at a rate greater than 100 counts per minute for the total of β and γ rays when measured 10 cm away from the epidermis. By November, more than 450 tons of fish had been dumped based on this standard. In addition, the Fisheries Agency formed a research group that embarked on a ship—the Shunkotsu-maru—from May to July 1954, to determine how much of the ocean was contaminated with radioactive fallout. On 23 September 1954, Aikichi Kuboyama, one of the crew members of the Daigo Fukury¯u Maru, died, fuelling the nuclear test ban movement. While the US refused to disclose the nature of the bomb, Japanese scientists began to let the global scientific community know about it. Yasushi Nishiwaki, a Japanese scientist who toured Europe in the summer of 1954 to alert others to the dangers of the US nuclear testing by lecturing on the nature of the Bikini ash, told Joseph Rotblat about U-237 (Nakao et al. 2015). Through Rotblat, U-237 was found to be an element that revealed the bomb to be a fission–fusion-fission bomb (3F

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bomb). In 1955, Rotblat wrote that neutrons released in the thermonuclear reactions could produce fission in the shell of uranium-238 around the hydrogen bomb. The “so-called hydrogen bomb”, he concluded, “was in reality a fission–fusion-fission bomb”. Bertrand Russell, who was informed about the Bikini ashes by Rotblat, advocated the Russell– Einstein Manifesto in 1955, together with Albert Einstein and the Pugwash Conferences of the scientists’ anti-nuclear movement. The Japanese scientists’ work on the Bikini ash thus paved the way for the global scientists’ anti-nuclear movement. Worldwide anxiety over radioactive fallout resulted in the foundation of the United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) in 1955. However, while Japanese scientists attempted to reveal the nature of the Bikini ash and the radioactive contamination of the Pacific Ocean, the Japanese and American governments tried to draw a line under the incident. In November 1954, the Japan–US Conference on the Effects and Use of Radiation was held in Tokyo and the Japanese scientists were “educated” about radiation exposure by the American scientists—eight out of nine of whom were affiliated to the US Atomic Energy Committee (Takahashi 2008). After the conference, the Ministry of Health and Welfare announced that it would end fish inspections by the end of the year. In January 1955, the governments agreed that Japan would receive two million dollars from the American government for the Japanese exposed to radiation from the Bravo testing. Nominally, it was given in sympathy for the Japanese fishing industry and not as compensation. On the Bikini Incident, many Japanese scientists showed their professional responsibility and independence from the US. A research field in radiological science was opened, bringing together Japanese scientists who were working on radiation exposure. A national research institute and an academic society on radiation research—the National Institute of Radiological Sciences (NIRS) and the Japanese Radiation Research Society—were founded in 1957 and 1959.

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The Survivors of the Atomic Bombs and Dosimetry Systems

It was the survivors of atomic bombings who provided the epidemiological data on radiation’s effects on the human body. The United States established the ABCC under the National Academy of Sciences in 1947 to investigate the effects of the atomic bomb on human survivors (Lindee 1994). One of the main research programmes of the ABCC was the Life Span Study, started in 1950, which investigated the lifelong health effects of atomic bomb survivors based on epidemiological studies, with the major objective of investigating the long-term effects of atomic bomb radiation on causes of death and incidences of cancer. About 100,000 subjects—73,000 atomic bomb survivors and 26,000 unexposed individuals—were selected from among the residents of Hiroshima and Nagasaki, as identified by a national census in 1950, and have been followed since that time. The number of subjects subsequently increased to 120,000. Among the problems with this study, it has been pointed out that the census did not include individuals who had died before 1950 and some of the “unexposed individuals” were also exposed to the atomic bomb. The research programmes of the ABCC only became possible because of Japanese collaboration. In 1948, the Japanese National Institute of Health joined the ABCC research programme and established the Atomic Bomb Effect Research Institute as its Japanese counterpart. There was a lack of information available to identify the individual dose exposures of atomic bomb victims in order to determine the relationship between radiation exposure and its different symptoms. Among the several types of radiation emitted from atomic bombs, gamma rays and neutrons were known to be harmful to the human body, and scientists needed to clarify the amounts of gamma rays and neutrons emitted from the bombs at Hiroshima and Nagasaki. The United States conducted repeat nuclear tests after 1946, measuring the radiation as well as developing technologies for the measurement of radiation. Against this backdrop, the US Atomic Energy Commission started a secret project, called ICHIBAN, in 1956, aimed at estimating the individual doses received by each survivor of the atomic bombs using these advanced measurement technologies. The person heading the project was a young

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scientist named John A. Auxier, from the Health Physics Division of the Oak Ridge National Laboratory (Auxier 1964, 1977). Auxier secretly ordered materials used in building Japanese houses to be brought from Japan to construct Japanese-style houses in Nevada, where the nuclear testing was being carried out, so that data could be obtained about the shielding effect of a Japanese-style home. This was done because 75% of the atomic bomb survivors were inside their homes at the time of the bombings. However, the biggest problem for Auxier was that the nuclear testing being done in Nevada used plutonium-type bombs (Kobayashi 1984). Auxier asked for nuclear testing of uranium-type bombs, but this did not happen, and the United States stopped atmospheric nuclear testing in Nevada in 1962. Operation BREN (Bare Reactor Experiment, Nevada) then began as a part of the ICHIBAN project. A 465-m-high iron tower was built in Nevada, and, to mimic an atomic bomb, a research reactor was set atop the tower to emit radiation. While scientists in the United States were trying to estimate the dosimetry of atomic bomb survivors in the laboratory and at the test site, Japanese scientists were trying to figure out the same thing using the remaining rubrics from the bombed sites (Higashimura et al. 1963). Ultimately, the Japanese succeeded in estimating the dosimetry from bombed materials. Masaru Hashizume at the NIRS—the institute founded after the Bikini Incident—was asked to conduct dosimetry research by his former teacher at ABCC, and he collaborated with the ICHIBAN project. For Hashizume, Auxier was both a client and a rival. Hashizume measured thermoluminescence and cobalt-60 in bombed bricks and compared his measurements with gamma and neutron radiation doses (Hashizume et al. 1967). The technology he used was thermoluminescent (TL) measurements, adapted from technology used to measure age in archaeology, which had been developed in the old Japanese capital of Nara. There was a distinct contrast between the American experimental calculations and the Japanese direct observations. Using data obtained from atomic bomb survivors and the ICHIBAN project, the tentative 1965 dose (T65D) was set. However, the process of determining it was not openly known, and even the Japanese scientists who provided data to the ICHIBAN project did not know how their data was being used. In 1981, an article published in Science claimed

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that T65D was inaccurate (Marshall 1981). The article was written by a journalist who had been collecting information about ICHIBAN from scientists working in many fields affiliated to national institutes. According to the article, neutron rays were overestimated, while gamma rays were underestimated. One of the reasons for this inaccuracy was the different climatic conditions in Nevada and Hiroshima/Nagasaki. The nature of neutron rays, in particular, means they can be impeded by humidity, and the neutron spectrum from the research reactor had greater energy than Little Boy. The dosimetry reassessment project was started in 1983 by a joint US– Japan committee. By that time, the relationship between the Japanese and American scientists had changed. The ABCC had been symbolically reorganized as the RERF in 1975, and it became a joint research institute with equal Japanese and American partnership. The Japanese dealt with the exposure data, and the Americans calculated the individual exposure dose of each survivor using supercomputers. The Japanese scientists tried to utilize the Japanese scientific investigation at the bombsite soon after the bombing by recalculating the data obtained at that time. For example, in the first US–Japan Joint Workshop for Reassessment of Atomic Bomb Dosimetry held at Nagasaki in February 1983, Tatsuji Hamada of the Institute of Physical and Chemical Research (RIEKN—the successor to RIKEN) stated that the “data on the activity on 32P in sulfur was prepared by Yamasaki et al. and seem useful for the present revaluation of doses”. Yamasaki was a member of Nishina’s laboratory at RIKEN. Together with his colleague Asao Sugimoto, Yamasaki had measured 32P in 1945. In the second US–Japan Joint Workshop for Reassessment of Atomic Bomb Dosimetry, held at Hiroshima in November 1983, Eizo Tajima, joint chair with Frederick Seitz of the Dosimetry Committees of the US and Japan, noted the importance of the Japanese scientists’ investigation soon after the bombing. Eizo Tajima (1913–1998) was a professor of physics at Rikkyo University who played an important role in Japanese nuclear energy administration. He was a scientific officer at UNSCEAR from 1956 to 1957, a committee member of the Japanese Atomic Energy Commission from 1978 to 1984 and part of the Japanese Nuclear Safety Commission from 1978 to 1987. After quoting a report of the Special

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Committee for the Investigation of the Atomic Bomb Disaster, which was published in 1953, Tajima pointed out that: Much valuable information for our purposes of reassessment of dose are included in this document. The radioactive phosphorus data of Yamasaki and Sugimoto is one example. One of the major problems to be solved for the dose reassessment is the yield of the Hiroshima bomb. The document I have quoted above includes also some articles which may serve as help for us to estimate the yield of the bomb. The articles compiled in this document were prepared in postwar chaos with poor equipment. Thus, descriptions are generally brief, and some of them are rather difficult to fully appreciate in today’s context. They are not necessarily complete in nature.

Tajima then recalculated the yield of the Hiroshima bomb using the articles (Tajima 1984). He experienced the atomic bomb investigation as a member of RIKEN and remembered his experience at the reassessment project. As a result of the US–Japan reassessment project, the Dosimetry System 1986 (DS86) was established. According to DS86, the harmful effects of atomic bomb radiation on the human body were twice what they had previously been believed to be. The ICRP 1990 statement reflected DS86 and drastically reduced the permissible dose from 5 to 2 rem. However, along with the development of measuring instruments and calculating technologies, it became obvious that there was a discrepancy in the thermal neutron activation data of DS86 (Imanaka 2012). In 2002, the new Dosimetry System 2002 (DS02) was established, which compiled a database of all measurement data that could be used for radiation dose assessment and comprehensively reviewed the explosive powers, ground zero coordinates and explosion heights. Advances in computing and measurement technologies enabled this change, and it is the most reliable dosimetry system to date. However, nobody can tell if DS02 is completely accurate for estimating the doses that survivors of the atomic bombs suffered; scientific endeavours are ongoing, and the dosimetry system is updated with each advance in technology.

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Conclusion

The history of radiation and dosimetry in Japan demonstrates the continuing focus of Japanese science on radioactive measurement. Throughout the twentieth century, Japanese scientists played or tried to play an active role in measuring radioactivity. The technology for measuring radioactivity in Japan started with and developed from mineral investigations, which cannot be separated from the hot springs culture and the topographical vision of the Japanese Empire. The measuring technology of mineral springs and chemical analysis of radioactive elements developed in prewar Japan were helpful to Japanese scientists in wartime nuclear weapons research and in their investigation of the atomic bombs in Hiroshima and Nagasaki. The experiences of atomic bomb investigation were useful for the analysis of the radioactive dust due to the nuclear detonation at the Bikini Atoll and the dosimetry reassessment project. Thus their activity before and soon after the Second World War helped their postwar activity. The active role of Japanese scientists was supported by their professional identity and, sometimes, rivalry with the Americans. Though they collaborated with the American scientists in the investigation of atomic bomb casualties, they wanted to conduct their own research, as they demonstrated on the occasion of the Bikini Incident and with the dosimetry reassessment project. The science on dosimetry has been created and changed along with personal motivation in addition to society’s needs. In summary, the history of radiation and dosimetry in Japan shows the importance of standardization that works beyond local conditions and how malleable evidence can be produced by different dosimeter methods or influenced by varying motivations, research techniques and environmental conditions. What is more, the study of dosimetry demonstrates how cultural authority may vary between countries like Japan and the United States and in the different eras in terms of which research is conducted and how knowledge was produced on dosimetry. The dosimetry system has been created and changed through numerous sacrifices and technological developments. The difficulties in understanding the effects of low-level radiation on the human body came not only from different stakeholders’ viewpoints, but also from

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difficulties with the measuring technologies. Measuring instruments have changed our way of understanding radiation dosimetry, but we have no choice but to evaluate radiation dosimetry using measuring instruments and technologies. The tautological definition of dosimetry exemplifies this complexity. Dosimetry cannot be separated from each exposure’s physical and environmental conditions, as the ICHIBAN project showed. However, it is impossible to reproduce and estimate past conditions perfectly. Created by instruments and devices, dosimetry is beyond our senses, and, therefore, dosimetry moves itself forward.

References Attix, Frank H., and William C. Roesch. 1968. Radiation Dosimetry, vol. 1, 2nd ed. New York: Academic Press. Auxier, John A. 1964. Ichiban: The Dosimetry Program for Nuclear Bomb Survivors of Hiroshima and Nagasaki—A Status Report as of April 1. Washington, DC: US AEC. Auxier, John A. 1977. Ichiban: Radiation Dosimetry for the Survivors of the Bombings of Hiroshima and Nagasaki (ERDA Critical Review Series). Technical Information Center (Energy Research and Development Administration). Bartholomew, James R. 2000. Overcoming Marginality in Japan’s Scientific Community. Ritsumeikan Journal of Asia Pacific Studies 6: 89–100. Basalla, George. 1967. The Spread of Western Science. Science 156 (5): 611– 622. Beatty, John. 1993. Scientific Collaboration, Internationalism, and Diplomacy: The Case of the Atomic Bomb Casualty Commission. Journal of the History of Biology 26: 205–231. Daston, Lorraine, and Peter Gallison. 1992. The Image of Objectivity. Representations 40: 81–128. Dower, John W. 1993. ‘NI’ and ‘F’: Japan’s Wartime Atomic Bomb Research. In Japan in War and Peace: Selected Essays, 55–100. New York: New Press. Feenberg, Andrew. 1992. Subversive Rationalization: Technology, Power, and Democracy. Inquiry 35 (3–4): 301–322. Grunden, Walter E. 2005. Secret Weapons and World War II: Japan in the Shadow of Big Science. Lawrence, KS: University Press of Kansas.

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4 Monitoring Disaster: 3.11, Radiation Measurement and Public Health in Fukushima Shi Lin Loh

1

Introduction

Around 2.46 p.m. on 11 March 2011, an earthquake of magnitude 9.0, approximately 30 kilometres below sea level on the floor of the western Pacific Ocean, struck Japan’s north-eastern coast in the T¯ohoku region, producing a tsunami that peaked at about 16.7 metres. Earthquake and tsunami were the largest recorded in Japan, and their combined seismic and hydrological force further shut off the cooling systems to the nuclear reactors at the Dai-ichi plant in Fukushima Prefecture, causing explosive meltdowns in three reactors. The explosions released a large unknown and unknowable quantity of radioactive materials that have chronically

S. L. Loh (B) National University of Singapore, Singapore, Singapore e-mail: [email protected]

© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Brucksch and K. Sasaki (eds.), Humans and Devices in Medical Contexts, Health, Technology and Society, https://doi.org/10.1007/978-981-33-6280-2_4

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contaminated environments across Japan’s north-eastern and northern regions (Hasegawa and Sato 2015, 1–58).1 Fukushima, or 3.11, as this triple devastation of earthquake, tsunami and nuclear meltdowns is alternately called in Japan, has generated chronic problems to which there is no easy solution. These include the decommissioning of the Dai-ichi nuclear plant and the disposal of radioactive waste generated by regional decontamination efforts. Since April 2017, the Japanese government has lifted evacuation orders in most parts of Fukushima Prefecture, although restricted zones remain in six municipalities (Fukushima Prefectural Government 2019). The government is basing this policy on radiation monitoring data that shows levels of radioactivity in the former evacuation zones have decreased to a point where returning residents can live without significant risk to their health (MoE 2018). Deep distrust of the responses of government authorities and Dai-ichi’s operator, the Tokyo Electric Power Company (TEPCO), has led some residents to leave for good. Families have suffered conflicts over where to work and live (Haworth 2013). Faultlines in T¯ohoku communities arise in part from fears that radiation contamination in the affected regions will damage human health— fears that persist despite a growing volume of scientific literature and announcements by Japanese and international authorities that environmental radiation levels in T¯ohoku are low enough, or safe enough, to permit everyday life (Morris-Suzuki 2014, 342). Which science enables such official conclusions about the low (or insignificant) risk of radiation exposure in Fukushima, and how does it function? Here I argue that the ten years since 3.11 have demonstrated the establishment of a monitoring regime which forms a vital component of how government authorities, scientific researchers, medical practitioners and citizens seek to assess and maintain individual and social health in Fukushima Prefecture. Radiation monitoring has linked the understanding of human health in 3.11 to the data produced by the instruments of its practice—the personal dosimeter, the monitoring post, the scintillation detector and their analogues. These have acquired new 1 Japanese

names are given in the East Asian order (family name first) except when authors’ names appear otherwise.

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prominence in a socio-technical assemblage that comprises “machines, knowledges, practices, people, histories and futures” (Hogle 2008, 847). In Fukushima Prefecture, the creation of a government radiation monitoring regime began in the early phase of 3.11, expanding to incorporate both public and private monitoring initiatives at the level of state, society and individual. Government bureaus maintain data on radiation levels in the environment; citizen scientists collect data on the same to share with concerned fellow citizens; individuals wear personal dosimeters to check the amount of external exposure accruing to their own or their families’ bodies. This could be seen as surveillance through technology, a prominent topic in the social studies of science and technology (Vogel et al. 2017). Surveillance also constitutes a new frontier of the human–machine interface in public health. In this sense it may be understood as a technology of knowledge production which mobilizes specific devices and practices to generate information about health and to construct response systems based on that knowledge. I have here chosen to use the term “monitoring” rather than “surveillance”, arguing that agency and purpose can be distinguished from each other. “Surveillance” often denotes, as in Foucault’s original formulation, punitive or repressive surveying that is enacted through the encroachment of state, military and corporate power in everyday life. However, as studies of the geosciences show (Turchetti and Roberts 2014, 3), surveillance conducted for the purpose of scientific research, such as environmental and planetary monitoring, generally lacks these negative connotations. The same is true of surveillance in medical care. For instance, information and communications technology (ICT) systems are designed to provide remote support for individuals living on their own; this type of surveillance facilitates patients’ ability to lead independent lives, while extending medical practitioners’ capacity to care for them, and also implies patients’ consent to being observed (Brucksch and Schultz 2018, 43–53; Oudshoorn 2011, 37–47). “Monitoring” as a term thus reflects the potential for non-repressive uses of technological systems that produce data on radiation. In the 3.11 context, radiation monitoring also involves the exercise of individual agency when concerned citizens participate in state monitoring programmes on a voluntary basis, or when they construct their own systems of self-monitoring. I do not

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imply, however, that consent and transparency make monitoring an apolitical process.2 Radiation monitoring retains an inherently political dimension insofar as it is carried out to provide data that serves specific ends—data which organizations can use to shape people’s choices, as well as the choices available to them. My point in using “monitoring” here is simply that those ends and choices are not always negative ones. Examining the monitoring measures employed in the aftermath of 3.11 accomplishes several things. In terms of research on disaster and public health, 3.11 provides an important case study of countermeasures taken for a large-scale nuclear disaster, as comparative analyses with Chernobyl show (Uyba et al. 2018). As Chernobyl provided studies on 3.11 with a valuable comparative context, so studies on 3.11 will inform future disasters of similar magnitude that, unfortunately, seem probable given the risk inherent in complex technological systems like nuclear power (Perrow 1999). On the issue of radiation monitoring, this chapter reviews scholarship that critically engages technical studies on the construction of monitoring programmes and the scientific analysis of resultant data, emphasizing the value of a co-constructivist perspective that critically engages the technoscientific nature of radiation risk. Rather than attempting an exhaustive analysis of studies conducted on radiation monitoring, I highlight problems that underpin its implementation, and examine its socio-technical ramifications in a historical context. The specific case of 3.11 Japan further demonstrates the importance of understanding local context and consequence against the backdrop of a “world risk society” of globalized, interdependent and diffused risks inherent in modern existence (Beck 2006). Although compelling, this framework risks obscuring the particularities of how global risks play out in localities that employ alternate modes of understanding, inflected by specific aspects of language and culture. Here I draw on the articulation of a “Japan-style risk society” (Nihon-gata risuku shakai) that frames risk in terms of anzen-anshin, a concept that incorporates both objective (material) and subjective (psychological) dimensions of risk (Kamisato 2017, 159–64). In English, anzen roughly corresponds to “safety” and 2 See

Kimura (2016, Chapter 5) for the political significance of monitoring in the broader context.

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anshin to “trustworthiness”; the former gestures to scientific or technical expertise, while the latter describes an emotional state of trust that, while related to anzen, cannot always be produced by officially recognized experts (Kamisato 2017, 160–161; Sternsdorff-Cisterna 2019, 11–13). The rest of this chapter proceeds as follows. First, I trace the emergence of radiation monitoring in the history of science and technology to explain its trajectory as an international practice and to contextualize its manifestations in the case of 3.11. Next, because official systems of radiation monitoring are designed and implemented by scientific, medical and public health practitioners, whether based inside or outside Japan, I review relevant research literature on 3.11 published by such experts, in order to examine radiation monitoring regimes at the state level that take two main forms: data production and educational programmes. After providing an overview of the major strands of radiation monitoring, I discuss the limits of material technology, shifting the focus to educational scientific communication initiatives that complement monitoring programmes. To conclude, I reflect on radiation monitoring in global and Japanese contexts. Throughout the chapter, to highlight the contingencies and complex nature of radiation monitoring in the context of disaster response, I draw on six unstructured personal interviews with medical practitioners in Fukushima Prefecture about their involvement in radiation health and monitoring practice, conducted between December 2015 and March 2016.

2

Radiation Monitoring and Human Health

Monitoring is an established mode of human interactions with ionizing radiation intimately linked to the history of radiation detection and measurement—two areas of research aimed at solving the problem of radiation being imperceptible to human senses. Since Wilhelm Roentgen’s discovery of X-rays (1895) and the Curies’ isolation of radium and polonium (1898), radiation users have worked to detect, identify and measure its different types. In the first decades of radiation science and medicine, workers in Europe and the United States had to choose

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from a range of measurement techniques and instruments. These, along with their corresponding units to quantify radiation, often proved unreliable or resisted standardization (Mould 1993, 168). In Japan, which also developed a community of X-ray and radium practitioners in the late 1890s, measuring instruments and devices had become a standard part of working with radiation by the 1910s (Nihon H¯oshasen Gijutsu Gakkai Gijutsushi Hensan Iinkai 1989, 138). Scientific discoveries of the late nineteenth and early twentieth centuries identified radioactivity and radioactive elements, and sought to investigate the structure of the atom, speeding up efforts to achieve precise measurements of radiation (Mould 1993, 1–19). In 1908, the German physicist Hans Geiger and his young British colleague Ernest Marsden invented a device to detect the presence of alpha particles; this invention played a key role in Ernest Rutherford’s subsequent discovery of the atomic nucleus in 1911 (Halpern 2009, 63– 65). Two decades later, in 1928, Geiger’s student Walther Müller assisted him in refining the device to the electric-powered, gas-filled version that remains in wide use today; it correctly bears both its inventors’ names, although Müller’s is often elided in popular references (Shultis and Faw 2007, 219). The Geiger-Müller (GM) counter provided a relatively inexpensive, durable and portable tool for detecting and measuring external radiation in environments, which led to its widespread use as a standard instrument for radiation monitoring. The US and Japanese teams that entered Hiroshima and Nagasaki after the atomic bombings to conduct surveys of residual radiation used a variety of such handheld survey meters, including GM counters and Lauritsen electroscopes (Imanaka 2014). In the age of nuclear weapons, scientific breakthroughs in making monitoring devices to detect the presence and activities of subatomic particles produced more sophisticated particle-detector instruments, such as scintillation counters and calorimeters, in the 1940s and 1950s (Halpern 2009, 126–127). In this evolutionary trajectory, 3.11 has generated new tools for radiation monitoring, including a gammaray spectrometer built by Osaka University engineers in 2015 that detects radioactive caesium (Yano et al. 2015). Aside from basic research and disaster countermeasures, radiation monitoring is also a key aspect of nuclear weapons management. During

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the Cold War, radiation monitoring evolved into a management tool for both public health and anti-proliferation measures. International radiation monitoring regimes can be traced back to 3 December 1956, when the United Nations established the Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) to collect and evaluate information on the levels and effects of ionizing radiation worldwide, spurred in large part by concerns over the possible impact of radionuclides from nuclear testing fallout on human health (Herran 2014). Radiation monitoring is also an important aspect of the verification process in arms control treaties (Dreicer and Pregenzer 2014, 592; Jeanloz et al. 2013). Monitoring projects involved with nuclear weapons are thus conducted in an anticipatory sense: they seek to identify possible public health crises, and to identify potential violations of arms control agreements. In contrast, monitoring projects in radiological disasters are established as a form of damage control after the event. For catastrophes on the scale of Chernobyl or Fukushima, long-term local monitoring is conducted in evacuation and inhabitation zones immediately following the accident. Air, water and soil are screened to assess the amount of and potential impact of radiation exposure; agricultural and livestock produce are also monitored. In 3.11, the dispersal of radioactive substances over the T¯ohoku region and the Kant¯o Plain heightened fears about the increased risk of internal exposure, sparked in part by the discovery of radioactive caesium and iodine from seawater, piped water, produce and dairy products. From 20 March, the national government called on producers in the affected areas to halt shipments of leafy vegetables, milk, marine products and other comestibles; real-time measurements of the radiation dose in air and soil using germanium semiconductor detectors continue today (Fukushima Prefectural Government 2018). Long-term monitoring stems from the persistence of radioactivity from the explosions at Dai-ichi, which directly released a mixture of radionuclides with short and long half-lives into the atmosphere. Halflives refer to the amount of time it takes for the radionuclides to lose their radioactive properties and become stable, neutral particles. Iodine-131, for instance, has a half-life of eight days, while that of caesium-137 is about 30 years. Responses to a radiological accident have an emergency phase and an intermediate phase (Nomura et al. 2017b). The former

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identifies people (i.e., workers at the affected facilities) exposed to high levels of radiation who require urgent medical treatment, while the latter adopts a broader, long-term strategy for monitoring the general public and reducing the risk of chronic radiation exposure, including the implementation of practices such as screening and restricting the consumption of agricultural produce (Nomura et al. 2017b). This latter phase requires monitoring environments and individuals within a target population. In Fukushima, state-sponsored networks of devices monitor radiation exposure levels in the environment. These are funded and maintained by national and local government bodies, along with universities and research institutes from the region and across Japan. Monitoring devices deployed for this purpose assess two main pathways of exposure to radioactive substances: external exposure from environmental contamination and internal exposure from consumption or ingestion of contaminated substances. Monitoring posts, portable survey meters and survey vehicles conduct the former kind of monitoring, while the latter is assessed through whole body counters (WBCs). As of October 2018, the prefecture has placed 3,629 monitoring devices at public facilities throughout its jurisdiction, with the majority installed in places frequented by children, such as playgrounds and day-care centres. Public organizations and universities have also conducted studies on radiation exposure rates of prefectural residents that used a combination of monitoring practices, including the wearing of personal dosimeters as well as air and food sampling (Harada et al. 2014; Naito and Uesaka 2018). Self-monitoring is another prominent feature of the new regimes, independently carried out by individuals or citizen associations not affiliated with public institutions. As Reiher (2016) argues, such citizenmeasuring organizations constitute an important source of alternative knowledge that serves the needs of laypeople who do not trust the monitoring efforts of the Japanese government or scientific experts affiliated to it. Monitoring projects conducted by citizen scientists crowd-source radiation readings and compile open-access data. Prominent amongst such groups, the Safecast Project, formed soon after 3.11, mobilizes citizen volunteers to take radiation readings around disaster-affected areas in east and north-east Japan, using homemade GM counters. Citizen-science

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projects provide alternate sources of data to government-provided radiation readings that are judged untrustworthy (Schanen 2018; South China Morning Post 2018). Personal dosimeters and GM counters, such as those available from Safecast, are a daily fixture for individuals who have come to rely on this form of collective, crowd-sourced intelligence (Abe 2014). Some consumers have even acquired their own monitoring devices to measure the degree of radiation contamination in their food (Reiher 2016, 57). Residential areas have also been altered to reduce the risk of potential exposure. Got¯o Aya, a public health specialist at Fukushima Medical University (FMU), recounted at a public symposium how the parents at her son’s elementary school cut off half the canopy of a tree overhanging the school’s swimming pool to prevent radioactive debris from falling into it (Amir 2016, minute 50:12 to 51:13). At the level of civil society, such communities of self-monitoring pre-date 3.11, as citizen radiationmeasurement organizations emerged after the Chernobyl accident in 1986 (Kimura 2016, 107–108). Radiation monitoring is conducted in tandem with public health projects aimed at promoting residents’ sense of security and safety. As the Dai-ichi disaster unfolded, the medical staff at FMU conducted multiple follow-up screenings to check residents’ external exposure to radiation. Kumagai Atsushi, a radiation medicine specialist from Nagasaki University dispatched to FMU to aid the relief effort, explains that medical responses had initially focused on conducting second screenings of local residents, “mostly to reassure people they were fine”. In addition to check-ups conducted under the Fukushima Health Management Survey (FHMS), concerns over internal radiation exposure led prefectural and local governments, as well as hospitals, to install over 50 WBCs used to estimate the amount of internal dose to which prefectural residents were exposed—a roughly 16-fold increase from the 3 WBCs that had been installed before 3.11 (Miyazaki et al. 2014, 95–96). Two months after 3.11, Fukushima residents started having the option to receive individual health check-ups conducted by the FHMS. Since May 2011, this survey has been conducted by the medical and research staff of Fukushima Medical University, the prefecture’s flagship medical education institute. The FHMS is a project to monitor the health of

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prefectural residents with two broad aims: to facilitate their well-being and to investigate the potential health effects of chronic exposure to lowdose radiation. The FHMS, which targets all residents of and visitors to Fukushima on or after 3.11, comprises a basic survey and a 4-part series of detailed surveys. The former is a self-administered questionnaire where respondents provide information about their location and their daily activities from 11 March onwards, from which the survey administrators calculate external exposure dose. The latter consists of a thyroid ultrasound examination for children, a comprehensive health check-up and a survey on mental health and lifestyle for evacuated residents, and a pregnancy and birth survey for expectant and new mothers. As of 2015, about 27% of the 2 million eligible subjects have voluntarily taken the basic survey (Kumagai and Tanigawa 2018, 31).

3

The Limitations of Radiation Monitoring

There is a broad consensus in the studies published by Japanese researchers that the 3.11 disasters did not expose the general public to high levels of radioactivity (Kurihara 2018). However, the question of negative effects to human health caused by chronic exposure to low levels of radiation persists (Nomura et al. 2017a; Normile 2011). Radiation exposure is a complex issue that concerns not only the question of health risk but also the perception of that risk. Participation in monitoring practices, whether carried out by public or private agencies, can help to mitigate anxieties about radiation (Kimura 2016, 107–111). But monitoring practices mobilized to serve the normative end of reassuring people have their limits. These limitations are manifest in the technology available to radiation surveyors, the systems of radiation measurement and protection, as well as the nature of scientific studies needed to interpret radiation data’s potential impact on human health. Uncertainties are inherent in all these areas. Radiation measurement devices, like all machines, can only be used effectively under certain conditions. Individual scintillation detectors, for instance, are designed to detect one specific type of radiation: sodium iodide (NaI) detectors measure gamma radiation, while zinc sulphide

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(ZnS) detectors sense alpha radiation (Birks 1964). GM counters and other gas-filled detectors also have their limitations. Gas-filled devices are often calibrated to measure the radiation dose from a specific radionuclide, such as caesium-137. This means that while the device is useful for measuring levels of radiation contamination, it cannot be effectively used to measure radiation dose rates (Steinhauser and Buchtela 2012). In the early phase of 3.11, moreover, uncertainties accumulated with the late collection of and communication on radiation emission levels immediately following the accident (Morris-Suzuki 2014, 341). Subsequently, monitoring effectiveness was further hampered by the inadequate placement and limited availability of the monitoring posts, detection devices and laboratories needed to analyze the samples and process the data (Higuchi 2016, 121). Another issue lies in the dose reconstruction process: monitoring devices can measure with reasonable accuracy (i.e., with a low margin of error), but they measure the dose to the device itself as an intermediate step in calculating the dose to an individual. This device reading is taken as a valid practical estimate of the actual dose received, but unavoidable indeterminacies arise when converting these measurements to figure out the amount of radiation dose to a body or a particular organ (IAEA 1998, 12–13). As Takahashi (2014) explains, the presence of multiple routes of exposure in air, soil, water and food complicated the process in which experts sought to create an accurate assessment of residents’ radiation exposure, complicating the assessment of risks to individuals’ health. In the early phase of 3.11, efforts to implement environmental monitoring of air dose rates and the degree to which radionuclides had contaminated living environments overshadowed the monitoring of radiation doses to individuals. Large-scale surveys by public organizations thus remain the main tool used to estimate the actual radiation doses received by residents (Takahashi 2014, 10). In short, the parameters within which experts utilize radiation data to extrapolate risk in 3.11 tend to produce indeterminate and conflicting interpretations. Kurihara (2018, 15–16) argues that significant uncertainty remains despite the success of prompt protective measures in 3.11 in reducing both internal and external doses of radiation to Fukushima residents. In a recent study, he highlights unresolved issues in initial

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efforts to calculate the internal doses to residents: assumptions made about the conditions of radiation ingestion, coupled with the short-lived characteristics of radionuclides including iodine-131, led to a possible over-estimation in the calculation of internal dose for children. Technical factors in data collection and the methodologies used to interpret that data have generated controversy even within the community of researchers investigating radiation’s health effects in 3.11, most prominently over the results of the first round of thyroid ultrasound examinations conducted as part of the FHMS. Four major studies conducted to assess the potential link between thyroid cancer and radiation exposure in 3.11 generated disagreement on whether the actual doses were high enough to cause cancer, or whether the presence of a “screening effect” (over-diagnosis) required factoring into the results (Takahashi 2018). The issue of representativeness also occurs for studies of individuals monitored through their voluntary participation. To what extent can studying one particular group effectively represent the actual state of a community with diverse groups of sub-populations? Nomura et al. (2017b, 2–3) note that representativeness critically affects the ability to generalize a self-selected group of individuals’ monitoring data to an entire population, and thus also the extent to which that same data can be used to inform policy measures. The voluntary nature of radiation monitoring practices after 3.11 has produced a sampling bias linked to subject self-selection factors including age, sex, evacuation status and ability to participate in the monitoring activity (Nomura et al. 2017a). Monitoring radiation’s impact on health, meanwhile, cannot resolve what physicians term “lifestyle-related” or “secondary” diseases caused by individuals’ everyday habits, activities and social environments. These include conditions linked to increased alcohol consumption and weight gain, which increase the likelihood of diabetes, cardiovascular disease, hypertension and other ailments (Ohira et al. 2018; Tsubokura 2018). Oikawa Tomoyoshi, vice-director of the Minami-soma Municipal General Hospital, has noted an increase in stroke, diabetes and mental health issues reported in his institution’s local patients (Oikawa 2016). Many evacuees and residents experience a loss of emotional health and well-being through multiple stressors that induce post-traumatic stress

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disorder, including forced relocations, the loss of loved ones, or intrafamilial conflicts over changes in living conditions. Stress and depression easily breed isolation, alcoholism and an inability to maintain social networks and healthy interaction with others, particularly in mothers of young children (Goto et al. 2015). In sum, anxiety and stress stemming from fears of radiation, including the unravelling of local communities and social infrastructure, have injured survivors’ well-being (Maeda et al. 2018, 54). For these local medical practitioners, the risk of injury to locals’ health from such lifestyle-related diseases linked to socioeconomic difficulties in post-disaster reconstruction is far greater than that from radiation exposure. The low-income, contingent labour force that comprises decontamination workers is especially prone to suffering this type of health risk (Tsubokura 2018, 79–80). A 2018 study on the health effects induced by radiation exposure in Fukushima, which draws comparisons with those suffered by survivors of natural disasters, concludes that there is a complex mix of individual psychiatric conditions, including depression and post-traumatic stress disorder, with psychosocial issues such as public stigma and discrimination against survivors (Maeda et al. 2018). Women, particularly expectant mothers or those with young children, are vulnerable to these psychosocial effects, due to concerns about the potential impact of radiation exposure on their children’s health and well-being. Despite the FHMS’s conclusions that, thus far, radiation has had no obvious effects on children’s health, the stigma linked to radiation exposure strains mothers’ mental health (Ito et al. 2018; Maeda et al. 2018, 54). In short, the wealth of data generated by radiation monitoring practices fails to adequately promote psychological well-being amongst the general public, and may even heighten the psychosocial effects of radiation stigma and discrimination.

4

Communicating Scientific Literacy

The previous section underscores how monitoring devices and networks of machines are necessary but insufficient tools to facilitate recovery from 3.11. If they address the objective aspect of anzen, I now turn

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to an area that addresses the subjective dimension of anshin: scientific literacy programmes. These programmes fall under the umbrella category of “science communication” and are of two main genres: (1) educational activities that explain “health literacy” and “radiation literacy”, which seek to impart scientific information to local residents and the general public on radiation-related issues; and (2) programmes on “risk communication” that aim to inform the same constituencies about potential health risks from radiation exposure. These attempts to facilitate literacy rely on “literary technologies” that complement other kinds of monitoring programmes for public health and environmental safety. I borrow this term from historians of science Steven Shapin and Simon Schaffer (1985), who use it to discuss how Robert Boyle produced scientific credibility for his invention of the air-pump in seventeenth-century England. In the 3.11 context, risk communication programmes are linguistic tools applied to manage persistent public anxieties about radiation exposure (Tanigawa and Hasegawa 2014, 44). The creation of such literary technologies is not a new phenomenon. Japan’s post-war industrialization prompted the creation of guidelines on risk communication decades before 3.11. These earlier programmes were devised by various government ministries, including the Ministry of the Environment (MoE) and the Ministry of Health, Labour and Welfare (MHLW), to address issues of consumption and exposure in areas ranging from food safety to chemical exposure (Yamaguchi et al. 2018, 94–95). Post 3.11, radiation exposure became a focus of such risk communication programmes, whose conveners and authors now include government agencies as well as medical institutions and individual researchers (Murakami et al. 2017). It had not entered the agenda of such programmes before 3.11, despite the growing number of nuclear power plants and radiological facilities in Japan from the 1960s onwards, perhaps due to the “safety myth” (anzen shinwa) that framed nuclear power (Kuroda et al. 2012). The health practitioners I personally interviewed, all emergency personnel on the frontlines of radiation medicine in 3.11, agreed that one’s knowledge of radiation can be increased by self-study. The implication is that doing so helps people to view radiation rationally instead of emotionally, and that people are capable of assessing personal risk

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from empirical evidence. Shigetomi Sh¯uichi, the former director of the now defunct Futaba K¯osei Hospital, which lies in the mandatory evacuation zone roughly four kilometres from the Dai-ichi plant, explained that, although personally exposed to radiation in the evacuation process, he possessed the scientific knowledge and training to understand that its levels were low enough to make human health risk unlikely (Shige¯ tomi 2016). Okubo Reiko, an emergency physician at FMU’s hospital, said that studying the radiation data publicly available had led her to conclude that the risk of raising a child in Fukushima is now “about the ¯ same as elsewhere” (Okubo 2015). However, the scientific understanding of radiation risk requires learning complex technical information about measurement units, exposure types and formulas, as even primers to the subject show (United States Nuclear Regulatory Commission 2017). Hasegawa Arifumi, chief of emergency medicine at FMU’s hospital, has spoken frankly about the difficulty of evaluating radiation exposure for his staff and patients due to his own lack of prior knowledge about radiation: “Even if we had been given those complicated numbers and units [about radiation exposure], at the time we didn’t have the knowledge to evaluate them” (Hasegawa 2016). This means that radiation levels and corresponding risk, or lack thereof, cannot be easily explained in a limited number of educational sessions. According to one journalist, a team of experts who held a seminar for evacuees from Iitate Village in Fukushima Prefecture initially reported success in communicating to their audience that radiation posed no major health risks to them. However, a follow-up survey conducted several months later showed that many evacuees retained little to none of the information, or interpreted it in ways contrary to the experts’ intentions (Ishido 2017). Laypeople’s struggles to understand and accept scientific explanations about radiation also relate to controversies and ambiguities in research on its effects at low levels (Perrow 2013, 57–64). Clinical studies on non-cancer health problems (e.g., thyroid diseases) in atomic-bombing hibakusha found no direct relationship between radiation exposure and disease occurrence (Imaizumi et al. 2006). Longitudinal scientific studies require the long-term shadowing of a population in order to collect valid data. But the health effects of radiation exposure also take a similarly

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long time to show up, and when they do show up, it may not be scientifically possible to prove that they were caused by radiation (Kamiya et al. 2015, 470). Yoshida K¯oji, a registered nurse and emergency radiation medical specialist at Nagasaki University, emphasizes that “it will take several years, decades even from now, to conduct thyroid gland examinations to see if there is any actual impact from radiation [on thyroid gland problems in children], which is why FMU must continue conducting thyroid gland screenings to properly understand the situation” (Yoshida 2016). Epidemiologically speaking, health problems which appear after a nuclear accident often cannot be clearly correlated with radiation exposure. Communication programmes and the availability of radiation monitoring data to the public also present potential problems of facilitating resident understanding, in the face of partially released numbers. For instance, a study of internal radiation exposure conducted by testing approximately 10,000 subjects with WBCs in the early phase of 3.11 yielded the conclusion that the majority of subjects received less than 1 mSv of exposure from radioactive caesium, which was within the annual dose limit for the general public established by international regulatory bodies (Miyazaki et al. 2014, 95–96). Nonetheless, this positive finding has proved challenging to explain to the study’s subjects. People receive their test results without adequate information on how to interpret the figures, and no channel is available for seeking explanations from relevant experts. In addition, not all the test data is released to the subjects, making it impossible for them to understand how their individual exposure results relate to the broader landscape of radiation exposure in Fukushima Prefecture (Miyazaki et al. 2014, 99). The opacity of these processes of data collection and presentation points to a “delusion of neutrality” in how Japanese experts have tried to communicate with the public (Shineha and Tanaka 2018, 108). Although the experts that run these “communication” and “literacy” sessions prioritize imparting accurate scientific knowledge, Shineha and Tanaka (2018, 109) point out that members of the public are more invested in gaining practical information about their immediate situation, including knowledge of specific welfare schemes. They thus call for programmes that are better attuned to popular needs and sensitivities,

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where experts engage the public with greater transparency and humility. Whether or not it is truly feasible for non-scientists or medical practitioners to adopt these attitudes, it is reasonable to assume that laypeople will face difficulties in accepting and adhering to professional norms of understanding. This conundrum recalls what Beck (2006, 336) terms “tragic individualization”, a state in which expertise alienates individuals yet compels them to live within their definitions and judgement. Assessments of communication programmes should also consider the challenges involved in preparing the experts who run them. Health practitioners testify to the difficulty of running these sessions with staff who are themselves struggling to fully comprehend and accept information about radiation risk. Local public health workers must deal with their own anxieties or uncertainties in facilitating communication sessions with their fellow residents. As public health specialist Got¯o Aya says in an interview for the documentary film Healing Fukushima, “They have to apply the words to explain something to themselves first, before they can communicate it to someone else. This makes their role very difficult” (Amir 2016, minute 51:25 to 51:30). Got¯o’s comment is suggestive of the general point that there is an affective dimension to expertise, particularly when it involves direct interactions between expert and lay communities. Public health practitioners must manage their own emotions and psychological states when wielding literary technologies of radiation monitoring. How communication programmes can be conducted to bring about the best possible outcomes for both experts and laypeople is an ongoing question, as well as an ongoing quest, for medical and public health practitioners in 3.11 Japan.

5

Conclusion

In a disaster context, monitoring is an essentially reactive project that seeks to document the effects of accidents, collecting data to form a scientific basis that local policymakers and citizens can use to make decisions. They are also normative projects that are intended to foster a sense of security amongst monitored subjects that scientific knowledge is being actively deployed to guard their health and well-being (Boudia

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2007). Yet the case of 3.11 shows that radiation monitoring may not effectively achieve such a goal due to the chronic indeterminacy which marks its findings. Radiation monitoring studies possess a characteristic common to all longitudinal scientific studies: namely, they require both the participation of an adequately large and representative group of subjects, and take years, sometimes decades, to yield significant conclusions. Yoshida K¯oji thus cautions that the health effects of radiation exposure from 3.11 will have to be re-evaluated after accumulating more years of observation and data (Yoshida 2016). In the context of 3.11 Japan, while radiation monitoring plays a critical role in assessing and maintaining public health in Fukushima, it is but one set of tools and programmes for safeguarding the overall wellbeing of local residents. Radiation monitoring might be understood as a necessary but insufficient mode of recovery for Fukushima: science and technology cannot substitute for the losses in community and family that many residents have suffered; equally, science and technology cannot ameliorate the damage to livelihoods and sources of income to local farmers. Finally, on the broader issue of socio-technical settings, the 3.11 context of radiation monitoring in Japan reinforces that, while science and technology may produce measures of anzen, those are insufficient to provide anshin. No matter how sophisticated monitoring technology becomes, human interpretation and communication of its data remain critical for finding a way through fears and uncertainties around radiation. Radiation monitoring comprises a technological apparatus that enables the extraction and compilation of social and biological data on human bodies. Gathering, storing and using this information involves a variety of normative assumptions and equally normative ends (Hogle 2008, 843). This observation recalls the longstanding arguments of STS scholars against technological determinism, or the belief that technology is the most important factor in shaping society and in solving social problems. The successful collection of data from radiation monitoring measures cannot negate the highly political and contested dimensions of what those numbers mean, and what steps people should take in response.

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System for Measurement of Radioactive-Cesium Concentration. Radiation Safety Management 14 (1): 1–8. https://doi.org/10.12950/rsm.14.1.

List of Interviews Hasegawa, Arifumi, emergency medicine radiation physician. Fukushima City, 3 March 2016. Kumagai, Atsushi, emergency medicine radiation physician. Fukushima City, 3 March 2016. Oikawa, Tomoyoshi, assistant director of Minami-soma municipal hospital. Minami-soma City, 27 February 2016. ¯ Okubo, Reiko, emergency medicine radiation physician. Fukushima City, 12 December 2015. Shigetomi, Sh¯uichi, former managing director of Futaba K¯osei Hospital. Futaba City, 27 February 2016. Yoshida, K¯oji, nurse practitioner, radiation emergency medicine. Fukushima City, 4 March 2016.

Part III Patient Safety, End-of-life and High-tech Medicine

5 Standardized Brain-Death Diagnostic Procedure: The Japanese Controversy of the 1980s and 1990s Kaori Sasaki

1

Introduction

This chapter explores ways in which the then novel standardized diagnostic procedure for brain death was articulated in Japan between 1982 and 1997. The articulation process developed through the public controversy over the definition of brain death, known as the “braindeath problem” (n¯oshi mondai), which emerged around 1982–1985 and, arguably, was settled in 1997. Among the earliest issues to be raised was the question of how brain death could be accurately diagnosed. Many medical professionals favoured the application of electroencephalogram (EEG), auditory brainstem response (ABR) and/or cerebral angiography for brain-death diagnosis; however, others refused to accept any of these methods. Consequently, there was a dispute as to what medical technology should be adopted. K. Sasaki (B) Center for Medical Education, Sapporo Medical University, Sapporo, Japan e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Brucksch and K. Sasaki (eds.), Humans and Devices in Medical Contexts, Health, Technology and Society, https://doi.org/10.1007/978-981-33-6280-2_5

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This analysis offers a case study of what Linda F. Hogle (2008) considers the role of Social Studies of Science and Technologies (STS) in medical contexts. As was discussed in Chapters 1 and 2, Hogle shows the importance of examining medical technologies that can produce changes in diagnostic procedure, conceptual boundaries between what is normal and disordered in human health, and decision-making regarding diagnosis and treatment. Specifically, she notes that: Diagnostic and research data from instruments are essential to such determinations…. [T]echnologies may change what constitutes evidence of both the presence of disorder and of the utility of certain therapeutic approaches. Medical technologies, in conjunction with concepts of disease, can categorize individuals into culturally constructed states of normality or pathology and have become a central part of decisionmaking about managing health problems in certain ways…. Diagnoses can determine treatments (how and where people will or will not be treated) and prognosis (probabilities and what is to be done). For these reasons, STS researchers have become interested in new forms of subjectivity as technologies affect peoples’ lives and work in tangible ways. (Hogle 2008, 842)

In this chapter, therefore, I examine how interlocutors with different perspectives argued for or against the adoption of EEG, ABR and/or cerebral angiography, which could “change what constitutes evidence of… the presence of disorder” of the brain when diagnosing brain death, and thus become “a central part of decision-making about managing” the brain-dead/dying. During 1968–1982, countries such as the UK, US, Taiwan, Sweden and Germany had been engaged in efforts to establish an authentic brain death diagnostic procedure. This process encompassed contestation over not only how to diagnose brain death, but also whether to change the definition of the end of human life from cardio-respiratory failure to brain death, a question inextricably linked with the religious and ontological significance of human life (see Giacomini 1997; Haupt and Rudolf 1999; Lock 2002; Pernick 1999; Russell 2000; Singer 1994). However, the debate was largely confined to professional circles. The one exception was the UK, where on 13 October 1980, the television

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programme Panorama triggered controversy over the credibility of the British approach, focusing in particular on the omission of the EEG test in the diagnosis of brain death; nevertheless, this issue was resolved within a couple of years. The situation in Japan unfolded in a very different manner. Intensive public debate over the brain-death problem began over the issue of which medical technologies should be adopted for brain-death diagnosis. Meanwhile this public debate reignited the legal controversy over whether brain death should be the end of human life or “the interim period between life and death”, the latter of which had been originally proposed by Bai K¯oichi in 1968. According to Bai (1968, 19), brain death could be interpreted as such, comparable to the legal status of “an embryo and foetus”. During this “interim period”, a brain-dead body should be respected as a living entity, like a foetus, whilst life support and organs could be removed only if both the brain-dead person and his or her bereaved accepted this, as in an abortion case. Later, during the 1990s, the focal issue within the brain-death problem shifted to the ontological significance of a brain-dead entity for their family and friends with reference to the issue of deathbed care for the brain-dead/dying, called mitori. This question can be juxtaposed with international mainstream bioethical consideration over the ontology of the brain-dead entity per se, which was contested in the 1970s and settled by the 1980s. Throughout the brain-death problem, mitori was defined as receiving and acknowledging the life of the brain-dead person through the giving of deathbed care by their loved ones together with medical staff. Because it entailed a sort of ritual of death, the right to mitori gained considerable public attention. Furthermore, the ongoing legal debate was rearticulated with this mitori agenda: seeing brain death as “the interim period between life and death” was regarded as protecting the right to mitori in contrast to seeing it as “the end of human life”. Hence, in the 1990s, the public debate over the brain-death problem converged on the legal definition of brain death with reference to the right to mitori. These diverse considerations regarding brain death, organ transplantation and deathbed care had invited cultural political argumentation from the late 1980s. Specifically, as Lock (2002) and Yoshino (1997) pointed

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out, whilst debating the brain-death diagnostic procedure, legal interpretation of brain death and mitori, public controversies over brain death had been contesting whether respect for Japan’s culture and traditional values should take precedence over following the so-called Western way and modern scientific approach. These controversies in Japan give an indication of how sociocultural arguments can be entwined in the development of new medical practices and the application of medical technologies. I have already examined the matter of mitori elsewhere (Sasaki 2006b, 2019); in this study I focus upon the controversy surrounding the brain-death diagnostic procedure. Specifically, I explore Japan’s attempt to establish a reliable brain-death diagnostic procedure with reference to the cultural arguments that were employed in the controversy over this attempt. This chapter offers a case study vis-à-vis such features of the brain-death problem as mentioned above, demonstrating how the semantic dimension of the sociocultural context might impact the pragmatic and institutional dimension of applying specific medical technologies in the locale of Japan (see Chapter 1). Given the context outlined above, this chapter illuminates how the brain-death diagnostic procedure to be authorized in Japan, with particular reference to the relevant medical technologies, was articulated in tandem with such cultural argumentation. I begin by sketching the background to the brain-death problem. I then detail three different concepts of brain death, which entail the application of three different medical technologies. This is followed by an exploration of the development of the brain-death problem in relation to its diagnostic procedures, focusing on the significance placed on specific medical technologies whilst also exploring and illuminating how cultural arguments were inscribed in its process. Next, I discuss the development process of the contestation over brain-death diagnostic procedures vis-à-vis the role of cultural arguments, in the hope of locating them within not only Hogle’s analytical framework but also the Japanese socio-historical context, both of which reflect the aim of this anthology. The concluding section sums up the findings of the case study.

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Background to the Brain-Death Problem

The origin of public controversy over the brain-death problem is often ascribed to Japanese traditional values and/or mistrust of medicine in Japan. However, as I have already argued elsewhere (Sasaki 2006a), it owed much to the medical and legal precedents of the first Japanese heart transplant case and the attempt to adopt and/or match AngloAmerican transplant medicine, which I explain below in detail. Shortly after the first ever heart transplant operation, which took place in South Africa in 1967, the first such operation in Japan was performed in August 1968. This became known as the Wada case, and the resulting row, which played out in the legal, medical and public spheres, eventually produced two official outcomes. First, leading brain specialists studied and then defined a standardized brain-death diagnostic procedure, the Japan Society of EEG Criteria. Second, a legal precedent was created as to the medical procedure for declaring human death, namely cardio-respiratory failure. Consequently, given that heart transplantation requires the extraction of a still beating heart from a brain-dead donor, for heart transplantation to be permissible, the legal definition of the end of human life would have to be amended. The above two outcomes were questioned during the years 1978– 1982. As heart transplantation became an established medical procedure in the US and UK, various Japanese policy makers and specialists wished to alter the legal and medical framework to follow the Anglo-American model of transplant medicine. Accordingly, there were cases in which nephrectomy (extraction of the kidney) was performed on a brain-dead patient for the purposes of transplantation, where the donor patient’s death was declared at the moment of cardio-respiratory failure, after the nephrectomy. In 1982, media coverage of these cases brought the issue of brain death to the centre of public attention. The following year saw several forums on brain death, to which medical ethicists, lawyers, neurologists and transplant surgeons were invited. As Bai indicates (1989), these professionals formulated a tacit consensus on a necessary agenda for authorizing heart transplantation: (1) to establish a more reliable medical diagnostic procedure, because the EEG Criteria had some weaknesses; and (2) to construct a public consensus on the

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legal definition of brain death in terms of authorizing organ donation from brain-dead donors. Against this backdrop, in 1983 the Ministry of Health and Welfare established the Brain-death Research Council (BD Council). This was charged with the task of reviewing and amending the EEG Criteria, in order to resolve the first of the two items on the agenda stated above. However, matters did not proceed as expected. In 1985, the BD Council proposed a diagnostic procedure, the Takeuchi Criteria, named after its Chair Kazuo Takeuchi. This triggered an intense public debate over the reliability of the procedure, leading to the emergence of what became known as the brain-death problem. Meanwhile, the various stances adopted towards the Takeuchi Criteria were articulated using cultural positions alongside scientific arguments in order to strengthen their position and gain legitimization within Japanese society. The debate became so heated and entangled that many researchers regarded the controversy of the brain-death problem as “deadlocked” or “chaotic” (Lock 2002, 5; Nakatani 1988, 52; Yonemoto 1988, 228). In the 1990s, argument over the Takeuchi Criteria expanded into other issues surrounding brain death, especially in terms of its legal status and the clinical treatment of brain-dead patients, in particular mitori, the deathbed care of the brain-dead/dying. These arguments were finally resolved only during the course of parliamentary debates that resulted in the Organ Transplantation Act of 1997. The 1997 Act produced a consensus on the brain-death diagnostic procedure and legal and clinical treatment for the brain-dead. As such, it arguably settled the brain-death problem.

3

Three Concepts of Brain Death

At the time when the BD Council commenced its research, internationally there were three different approaches to brain death: brainstem death, whole-brain death and total brain infarction, each of which reflected a different diagnostic procedure. The different approaches and procedures are summarized in Table 1.

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Table 1 Three different approaches to brain death Brainstem death Investigation of cause of deep comma Testing for brainstem function

Examination of other brain parts

Philosophy

Country example

Whole-brain death

Total brain infarction

Image analysis via X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) – Apnoea test (absent lung function) – Absence of brainstem reflexes (e.g., corneal, cough, pupillary light reflex) None

– Bedside, clinical observation – No need for advanced medical devices for diagnosis UK

– Apnoea test – Absence of brainstem reflexes – If necessary, absence of auditory brainstem response (ABR)

– Apnoea test – Absence of brainstem reflexes – If necessary, absence of ABR

Absence of Absence of either brainwaves both cerebral (EEG) blood flow or cerebral and brainwaves blood flow Clinical Pathological

US

Sweden

Source Author’s compilation

In each case, the diagnostic procedure for brain death should be applied only for patients who have fallen into deep coma. It comprises two or three steps, depending upon the concept of brain death. First, the cause of brain damage and subsequent coma is investigated through an image analysis of brain condition. The second step is to determine whether brainstem function is absent. The third step, where applied, checks the absence of other brain functions by monitoring brainwaves using an EEG and/or carrying out a cerebral angiography through X-ray or CT to establish whether there is blood flow to the brain.

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According to proponents of the brainstem death approach, the absence of brainstem function is sufficient to prove brain death, because without brainstem function—such as the control of the cardio-respiratory system—a human cannot biologically survive. The philosophy of this diagnostic procedure is distinct from the other two because it values careful clinical observation over technology, and does not use any diagnostic medical devices, apart from the imaging analysis. In the countries that adopted this stance, notably the UK, medical professionals were required to prove the absence of lung function and brainstem reflex through bedside clinical observations in order to declare brain death. Given the emphasis on clinical observation, the brainstem death approach could not easily accept the value of the then novel medical technology, ABR, which distinguishes between the absence and presence of brainstem response to sound stimuli via electric wave forms, in the form of either flat or complex waves. ABR differs from EEG because, although both show electric wave forms, EEG detects cerebral responses, whilst ABR checks one of the brainstem functions. In other words, although not part of the brainstem death diagnostic procedure, the purpose of ABR is to examine brainstem function. In contrast, both whole-brain death and total brain infarction use permanent loss of entire brain function as the criterion to diagnose brain death. In clinical terms, total loss of brain function is regarded as wholebrain death, whilst in pathological terms irreversible absence of cerebral blood flow (CBF) is understood to cause brain death because blood flow is vital for all organs—including the brain—to survive. Accordingly, if absence of CBF were to be proven, then in principle brain death could be declared. CBF is checked through X-ray or CT cerebral angiography, which provides images of blood flow in the brain. Whilst the reliance on image quality means that there is no device that can prove absolutely the absence of CBF, its presence can prove that the brain is alive. The impossibility of proving absence of CBF is reflected in the differences between the concepts of whole-brain death and total brain infarction. The whole-brain death concept takes a more clinical approach, demanding proof of the absence of brainstem functions and brain parts other than the brainstem through either brainwaves or CBF. At the time of the Japanese controversy, many countries had already adopted this

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approach. Total brain infarction, on the other hand, takes a more fundamental and pathological approach, which requires proof of absence of CBF. However, as explained above, only the presence of CBF, and not its absence, can be verified beyond doubt. Consequently, this approach requires the examination of brainwaves to augment the test for brain parts other than the brainstem, using not only cerebral angiography but also EEG. This approach was supported by Sweden, among other countries. Unlike the brainstem death approach in the UK, both the whole-brain death and total brain infarction approaches adopt advanced medical technologies. Consequently, there has never been any obstacle to recommending the application of ABR—which examines brainstem functions—in cases where medical specialists consider it necessary. However, it is not a compulsory requirement. In the following section, I show how these disparities impacted upon the brain-death controversy in Japan.

4

Articulation of the New Brain-Death Diagnostic Standard

4.1

Problematization of the Japan Society of EEG Criteria (1982–1983)

In the period immediately before the emergence of the brain-death problem, there was agreement among leading brain surgeons and neurologists in Japan on the necessity to revise the existing diagnostic procedure used to determine brain death, the EEG Criteria. This situation, as I will demonstrate, influenced and was inscribed in the development of the public debate. The EEG Criteria adopted the whole-brain death concept; however, questions from experts converged upon the examination of brainstem functions. Among those raising concerns, Masato Shinohara was the pioneer, whilst other medical specialists such as Katsurada et al. (1985), Itoh (1985), Sasaki et al. (1984) and Handa et al. (1984) later confirmed or developed his view. I hence consider Shinohara (1983) as representative.

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Shinohara raised three queries. First, the EEG Criteria were applicable only in cases of deep coma due to acute brain damage, such as stroke or car accident. Shinohara stated the necessity for criteria that “could apply to almost all clinical” cases (Shinohara 1983, 43–44) because other causes, such as asphyxia, could also trigger deep coma. Second, whereas the EEG Criteria required acute reduction in blood pressure to indicate the loss of brainstem function, Shinohara (1983, 50–51) argued that this could be difficult to detect, “thanks to the development and widespread application of anti-hypotensive (low blood pressure) drugs to patients in a critical condition”, which prevented “a sudden drop in blood pressure”. Third, he demanded that proper consideration should be given to ABR. Shinohara demonstrated the usefulness of ABR by using the case of a patient in deep coma due to muscular atrophy, i.e., caused by non-acute brain damage. The patient’s condition met the EEG Criteria for brain death in every respect other than the cause of coma. Shinohara then carried out another brainstem reflex test, pharyngeal reflex (response to some stimuli to the throat) on the patient and found it slightly positive. This reflex was listed in the US criteria, but not in those used in Britain. Therefore, the patient could be declared to be brain-dead according to the British criteria, alive by the American and in an undetermined condition by the Japanese. Subsequently, Shinohara (1983, 50) employed ABR and the result was clearly positive. Accordingly, he maintained that ABR “was helpful [especially] in difficult cases to diagnose a patient”. A research team at Osaka University reached a similar conclusion regarding the application of ABR when they independently revised the EEG Criteria (Sawada et al. 1985). According to the Osaka team, ABR should be used in cases of non-acute brain damage or for patients who did not show blood pressure reduction, both circumstances that the EEG Criteria could not cover. Thus, ABR was considered the crucial means to overcome the limitations of the EEG Criteria. Furthermore, medical professionals advocated ABR as more practical, objective, ethical, convenient and feasible than other diagnostic methods to check brainstem functions, such as brainstem reflexes and apnoea test. With regard to practicality, Katsurada et al. (1985) and Masaru Sasaki et al. (1984) argued that ABR offers clear objective evidence of the presence or absence of one brainstem reflex, whereas

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Table 2 Major Japanese neurologists’ view on the Society of EEG Criteria 1. Wish to expand its application to patients suffering from ‘non-acute’ brain damage 2. Difficulty in observing the point of sudden blood pressure reduction due to the development of drugs 3. The potential of ABR to resolve the above two issues 4. Recommend ABR as it is ethical, useful, helpful and feasible for brain-death diagnosis Source Author’s compilation

other brainstem reflexes are difficult to detect, in part because they rely on medical specialists’ observation. Mii (1992, 81–82) emphasized that many neurologists considered ABR “more ethical” than apnoea test because the latter involves “a serious risk of patient death”. Katsurada et al. (1985), Itoh (1985), Handa et al. (1984), Takeshita et al. (1985) and Shinohara (1983) all considered ABR both more practical and more ethical because it employs a tiny device placed inside a patient’s ear to test hearing responses at the bedside. Meanwhile, Azuma (1985, 509) and Itoh (1985, 1874) indicated that adopting APR for brain-death diagnosis would be feasible because the majority of hospitals already routinely applied ABR for brain-damaged patients. Consequently, Japanese brain specialists requested that the EEG Criteria should be revised to include ABR. Their request and recommendation comprised four points, as summarized in Table 2. I hence argue that in the early 1980s, there was a consensus of medical opinion on the high potential of ABR for application in the then novel standardized brain-death diagnostic procedure, and on the need to change the official stance on establishing evidence of brain death and achieving a decision about managing the brain-dead/dying. However, as shown below, subsequent events unfolded rather differently.

4.1.1 The Impact of Proponents of the Brainstem Approach (1983–1987) In response to the specialists’ recommendations, in 1983 the Ministry of Health and Welfare referred the matter to the BD Council. However, it

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appears that the Ministry itself had predetermined that it would adopt the British brain-death concept. Their preference was incompatible both with the specialists’ recommendation and with Japan’s common clinical practices for brain-death diagnosis, which adhered to the whole-brain death approach. The result was turmoil. The BD Council research protocol distributed to all research participants reflected the points made in the request from Japanese brain specialists. It asked all research participants to apply the EEG Criteria, except in cases of non-acute brain damage or those that could not be observed to be the result of sudden drop in blood pressure, and stated that both ABR and cerebral angiography could be added to the diagnosis process, if appropriate. However, the fact that the protocol recommended as a reference guide Dr C. Pallis’s ABC of Brainstem Death, a handbook for the British brain-death diagnostic procedure, suggested that the BD Council was subject to pressure from the Ministry, which favoured the UK concept of brain death. Indeed, as Takeuchi (1985, 1949), the BD Council Chair, recollected, the introduction of the brainstem death concept threw the research into confusion. Whilst two-thirds of the research participants followed the EEG Criteria, the remaining third apparently adopted the British criteria, since they omitted the EEG test that was compulsory for the former but not listed in the latter. Consequently, the results comprised two different clinical cases, which might force the BD Council to choose between them. In this situation the application of EEG became the central issue, and it seemed that the debate could lead to the change referred to by Hogle as “what constitutes evidence of… the presence of disorder”: in this case, a new definition of brain death. Meanwhile, cultural political voices emerged for the promotion of the brainstem death concept. For example, in 1984 Yomiuri, a major Japanese newspaper, published a series of articles beginning with an interview with Christopher Pallis, the British authority on brainstem death, under the headline “Brainstem Death, ‘100% reliability on its Diagnostic Procedure’ British Confidence” (1985, 50). It also covered a speech made by Uemura, the main actor promoting the British criteria, in which he introduced the British standard as an embodiment of “progress and advance in medicine” (Yomiuri 1985, 155–156). These articles, and

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others on the same topic, were collected and published in book form in 1985. Further, Yomiuri (1985, 52) employed cultural arguments, as the following three examples show. First, it highlighted Pallis’s call for the global medical trend to shift from whole-brain death to brainstem death. This implied that the British brain-death concept was more advanced than that of the US, not to mention the Japanese. Second, it underlined this point by quoting Tsuyoshi Sugimoto’s statement that: The worldwide trend was adoption of the concept of brainstem death. It is a serious problem that the [revised] Japanese one would be left behind this trend. (Yomiuri 1985, 53)

Third, it portrayed Kazuo Takeuchi, the chair of the BD Council, as outmoded. Yomiuri (1985, 46) reported that Takeuchi was allowing Japan to “lag behind” the world medical trend, a rhetorical pattern that can be observed in many other political discourses at that time. Thus, the support for the British brainstem death discourse adopted cultural argumentation. Subsequently, political intervention enhanced the position of the proponents of the British criteria. In 1985, at a symposium held by the Japan Society for Transplantation, Member of Parliament Kentaro Takagi gave a speech in which he disclosed that the parliamentary group promoting organ transplantation, of which he was leader, intended to adopt the brainstem death definition (quoted in Todai PRC 1985, 91– 92). This move gave a clear signal that there was political support for the British criteria. Those who supported the British approach argued the uselessness of medical technologies. They criticized the value of EEG, ABR and/or cerebral angiography, one or more of which could be necessary or appropriate for brain-death diagnosis under the whole-brain death and total brain infarction approaches. For example, Yutaka Maki (1985, 452–454) asserted that all three of these technologies were irrelevant to a diagnosis of brainstem death. Whilst EEG and cerebral angiography are unrelated to its definition, ABR does examine brainstem function, but was not adopted under the British procedure. As in the Fujiwara case mentioned

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above, ABR could give a positive result in some cases that fulfilled the British criteria for brain death. Because this could deny the reliability of the British criteria, the proponents directed their harshest criticism towards ABR. Uemura (1987, 225), for instance, maintained that two of the six types of waves in the ABR test “did not derive from brainstem responses”, and that those who diagnosed brainstem death by the British criteria “would not show the presence of ABR”, apart from those two waves. Thus they condemned the value of evidence produced by ABR. Furthermore, the proponents of the British criteria contended that the application of these medical technologies triggered confusion in clinical practice, on the grounds that many hospitals did not have the necessary equipment. Their voice can be deduced from a round-table discussion among brain specialists held by the Japan Medical Association in 1985. Participants questioned why some specialists condemned their use of devices such as EEG and ABR and expressed their puzzlement “considering such devices were prevalent amongst Japanese hospitals” (Takeuchi and Abe 1985, 1892). This statement revealed the lack of knowledge on the part of the critics. So immersed were they in the British idea that they took the British contingencies as reflecting the then Japanese situation. Tachibana (1986, 269) thus asserts that they argued against adopting EEG in Japan because it was found in “only 10 percent of hospitals in the UK”. In the light of Hogle, whilst the proponents of the British criteria refused the value of ABR in terms of providing evidence for a certain brainstem function, by arguing that the EEG test should be abandoned they supported the change in the method of establishing evidence to confirm brain death. Therefore, they favoured the possibility of significant change in the then common clinical practices and decision-making processes for the treatment of the brain-dead/dying in Japan.

4.2

The Brain-Death Research Council Conclusion (1985)

Under the circumstances outlined above, in December 1985 the BD Council announced its decision. The concluding remarks of its

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announcement indicate the Council’s concerns regarding both condemnation by the proponents of the British criteria and the risk of declaring death prematurely: Whereas some would critique our choice of whole brain death as outmoded in comparison to the [British] brainstem death concept,… we try to avoid committing medical professionals to declare death prematurely. (MHW 1986, 247)

Clearly, the BD Council faced a dilemma. How, then, did they seek to resolve it? The preface to the BD Council’s report was symbolic. It stated that the Council’s objective was a revision of the EEG Criteria, with the proviso that such a revision should be “internationally acceptable” (MHW 1986, 235). It then introduced the major differences between diagnostic procedures in different countries to show that “the concept of whole brain death is now widely accepted internationally” (MHW 1986, 235). By drawing on the “international trend”, they were able to defend themselves against criticism from their opponents. In fact, when referring to the international context, the BD Council was looking mainly to the United States, as is clear from its mobilization of the American President’s Commission Report. Published in 1981, this was among the most recent research reports at that time. As demonstrated above, the proponents of the British criteria disparaged the adoption of the whole-brain death concept in Japan with specific reference to the application of medical technologies. In response, the BD Council chose the whole-brain death concept, which requires either EEG or cerebral angiography, both of which were already in use in the US. The BD Council’s Takeuchi Criteria specified EEG as essential, and cerebral angiography as supplemental (see Table 3), a choice that owed much to the previous Japanese brain-death diagnostic procedure, the EEG Criteria and the prevalence of EEG devices in Japan. In citing ABR only as a supplementary test, the BD Council was also following practices established in some countries in Europe and North America since, as Uozumi and Oki (1985) point out, no model from such countries

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Table 3 Takeuchi criteria for diagnosing brain death in Japan Concept

Tests for brainstem

Tests for other brain parts

Whole-brain death

1. Apnoea test 2. Absence of brainstem reflexes 3. If appropriate, ABR

1. EEG 2. If appropriate, cerebral angiography

Source: Author’s compilation

specified ABR as an essential diagnostic item and its adoption as a necessary diagnostic procedure would therefore not be seen as “internationally acceptable”. The Takeuchi Criteria were therefore comparable to their American counterpart. Nevertheless, unlike Lock (2002, 136–138), who explains this similarity as a direct reaction to the demand to adopt US transplant medicine, I argue that the choices made can be attributed to the BD Council’s search for “international” credibility to refute criticism from the proponents of the British criteria. Otherwise, it could have diverged from the US criteria by adopting ABR, in line with the initial request by many brain specialists (see Table 2). With regard to Hogle’s framework, introducing the Takeuchi Criteria to the clinical domain in Japan would bring no official change to the decision-making process for diagnosis and treatment of brain death in terms of the use of medical technologies. The international trend hindered the medical authority from legitimating their own formally constructed innovative approach to the brain-death diagnostic procedure.

4.3

Problematization of the Takeuchi Criteria (1986–1992)

Despite the BD Council’s efforts to escape the harsh judgement of the proponents of the British criteria, in 1985–1986 it came under serious criticism. A notable journalist, Tachibana Takashi, cast doubt on the credibility of the Takeuchi Criteria and proposed an alternative standard (see Table 4), prompting intensive public debate over the choice of a reliable brain-death diagnostic procedure.

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Table 4 Tachibana’s recommendation on diagnosing brain death in Japan Concept

Tests for brainstem

Tests for other brain parts

Total brain infarction

1. Apnoea test 2. Brainstem reflexes 3. ABR

1. EEG 2. Cerebral angiography

Source Author’s compilation

Tachibana questioned the way in which the BD Council had ignored the data that indicated the importance of ABR and cerebral angiography for brain-death diagnosis. Amongst cases that met the Takeuchi Criteria, “17.3 per cent… showed positive” to ABR and “16.7 per cent maintained cerebral blood flow” (Tachibana 1986, 329–338). In other words, around 17% of patients defined as brain-dead according to the Takeuchi Criteria might be judged as alive if taking into account evidence yielded from the use of these medical technologies. For Tachibana, the BD Council’s negligence on these points was a result of political intervention to promote the brainstem death approach. His criticism was therefore equally applicable to the proponents of the British criteria who rejected the use of ABR, cerebral angiography and EEG. Tachibana (1986, 400) proposed that Japan should adopt the total brain infarction concept, which he regarded as consistent with the braindeath concept since permanent loss of CBF causes brain death. In the light of the aforementioned evidence, he argued that the use of EEG and CBF would reinforce the credibility of the diagnostic procedure. Similarly, drawing on the above finding, he maintained that ABR “should be added” to the procedure. Tachibana’s proposal encompassed a significant change in “what [would constitute] evidence of… the presence of disorder” of brain function and condition. ABR and cerebral angiography could provide evidence of the presence of brainstem response or blood flow in the brain, neither of which would be detected through the conventional methods. Consequently, those technologies could bring an official alteration to clinical decision-making on brain death in Japan. What, then, was the response to Tachibana’s criticism? A journal organized a panel discussion, under the striking title “Sakoku policy on ‘brain death’ shames Japan’s dignity: Medical doctors’ refutation of

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Tachibana Takeshi’s ‘brain death’” (Miyata et al. 1987). Many panellists were famous medical professionals, whilst the journal was a widely circulated popular magazine that supported the policies of the ruling Liberal Democratic Party. Consequently, the event had a particular impact on public and professional opinions. Sakoku refers to the policy of closing doors towards foreign countries, which had been abandoned during Japan’s nineteenth-century modernization, and implied that Tachibana’s claim would prevent Japan from simply adopting criteria used in other countries (Miyata et al. 1987, 110–111). The critics demanded the “emancipation” of Japan from Sakoku and an opening up to the concept of “Western enlightenment” (Miyata et al. 1987, 110). They also condemned Tachibana’s proposal regarding technological equipment (Miyata et al. 1987, 106), just as they had attacked the BD Council on the same issue. In his later writings, Tachibana (1991) referred in particular to the Swedish approach, i.e., total brain infarction, and to its requirement for cerebral angiography. To refute the brainstem proponents’ critiques, he also referred to Germany, whose authorities recommended the application of ABR (Tachibana 1986, 319–330). Accordingly, as Miyata et al. (1987, 106) note, Tachibana’s voice was recognized as representing the Swedish or continental European approach, which also exemplified the diversity of practices among various countries in Europe. Meanwhile, the Council members used the Takeuchi Criteria in conjunction with the US authority as means to defend themselves. This can be seen from the response of two Council members when, in 1987, they were asked by the Japan Medical Association to provide an explanation for the confusion around establishing a standardized braindeath diagnostic procedure (Takeuchi and Takeshita 1987). Indeed, the approach of the BD Council reflected the attitude of many brain specialists. Whilst a majority of them wished to adopt the whole-brain death concept, some were reluctant to employ cerebral angiography. The latter group, including Shinohara (1983, 55–57), worried about “the usage of radioactive products for angiography” and the reliability of the images produced. Conversely, they were keen on ABR, but on that issue they faced objections from the proponents of the British criteria, who doubted its value and pointed to the fact that no other countries employed ABR as

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an essential test. To find a balance between these positions, it appears that the BD Council decided to maintain one steady position by following the US approach. As the focus of debate shifted to the question of what technology could offer appropriate evidence to confirm brain death, this also entailed a contestation of the national prestige of Britain, the United States and Sweden in terms of their different brain-death concepts. Meanwhile, Yonemoto (1988) argued that the brain-death debate in Japan was a dispute over the value surrounding science. The result was a chaotic controversy. During the years 1988–1997 the debate came to encompass not just discussion on clinical criteria, but also arguments of national identity. For instance, a famous brain specialist, T¯oru Uozumi (1989), claimed that his research had revealed that among some of his patients who fulfilled the Takeuchi Criteria, brain functions had not actually ceased. Supporting Tachibana’s proposal, he made the following observation: Some have criticised that our approaches to brain-death caused Japan to be an underdeveloped nation…. However, I do not think so…. we have applied advanced medicine for [brain-dead patients] to grasp their medical condition. Such data is used for these public debates… democratically. It is rather a civilised way in comparison to other countries. (Uozumi 1989, 49)

As this remark indicates, the Japanese application of various medical technologies for brain-death diagnosis and the contestation of the scientific value of each technology was articulated with “democratic” and “civilized” values, and this was contrasted with practices in other countries. It also shows that the brain-death problem, and in particular the debate around Tachibana’s stance, was eventually rearticulated in conjunction with cultural arguments. Subsequently, those who supported Tachibana’s idea and/or refused the British and US approaches to brain death juxtaposed their stance with an independent Japanese approach. Here I would like to draw particular attention to two reports produced in 1991–1992 by the ad

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hoc Cabinet Advisory Committee for Brain Death and Organ Transplantation, to which the Japanese government had submitted questions on brain death and transplant medicine. One group within the committee proposed to authorize the Takeuchi Criteria and define brain death as the end of human life. The other group, led by the philosopher Umehara Takeshi, supported Tachibana’s approach, which defined brain death as an interim period between life and death and was intended to support the aforementioned right to mitori and the independent Japanese approach (see Sasaki 2006a for more details).

4.4

From Cultural Arguments to the Original Voice

As has been argued elsewhere (Sasaki 2006b, 2019), during the years 1989–1997 the issue of mitori, deathbed care for the brain-dead/dying, arose out of the brain-death problem alongside cultural arguments. Here, the focus of debate was the exact legal status of the brain-dead entity, and the appropriate clinical treatment. These questions were initially settled through the Organ Transplantation Act 1997, which, as pointed out by Cho (2003) and Lock (2002), was said to embody (so-called) Japanese cultural and traditional values, thereby arguably gaining more public support. Indeed, the legal and clinical treatment of the brain-dead/dying was taken as parallel to the cultural argumentation that was articulated within the brain-death problem—namely the legal definition of brain death as the “interim period between life and death” that was so important in the matter of mitori for brain-dead/dying patients. Accordingly, those who supported an independent Japanese approach were satisfied with the legislation, whereas some elites who favoured the British or American approach, such as Machino et al. (2004), problematized it and then demanded its amendment to bring Japanese practice into closer alignment with that of other countries. Yet despite its reputation as respecting cultural and ethical accounts in Japan, in fact the Act adopted the Takeuchi Criteria for the brain-death diagnostic procedure, thus endorsing the US position. This was passed over almost without comment. Why?

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A review of the code of practice and guidelines contained within the Act reveals that the Takeuchi Criteria were in practice revised, in line with the original recommendations made by leading specialists. Although ABR was listed as a supplementary test, and the Takeuchi Criteria were not formally revised, the fact that the guidelines strongly recommended that “ABR should be used and checked if possible” (MHW 1997a, b) meant that it was treated as if it were an essential and obligatory item in diagnosis (see Fig. 1). In this respect, the format resembled what major Japanese neurologists had been demanding in the early 1980s. In practice, therefore, the Act endorsed the domestic clinical experience. In other words, it actually recognized the voice of medical specialists in Japan. In Japan, the adoption of ABR for brain-death diagnosis was finally authorized in practice after a decade and a half of controversy. Taking Hogle’s account into consideration, specialists could have adopted ABR data as evidence of the absence or presence of normality of brainstem function as early as the mid-1980s, and changed their decision-making on the treatment of brain-dead/dying patients at that time. Instead, this

Lists ABR here in the same way as other necessary diagnostic points. In contrast, other ‘supplementary tests’, such as cerebral angiography, are not listed on this officially provided Brain-death Diagnostic Report Form.

Fig. 1 Brain-death diagnosis checklist (Source Author’s compilation based on MHLW 1997a, Appendix for Art. 5/1)

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case study from Japan has demonstrated that clinical experience may not be sufficient to acknowledge new medical technologies, because any evaluation of the practices and technologies originating in other countries inevitably involves cultural argumentation.

5

Discussion

The brain-death problem in Japan emerged from the question of how a legitimate brain-death diagnostic procedure should be constituted. From that starting point, it developed to address several related issues. The debate included (dis)agreement over the application of three medical technologies for diagnosing brain death, namely ABR, EEG and cerebral angiography. At the beginning of the 1980s, Japan’s first attempts to revise the brain-death procedure arguably paralleled what Hogle would consider an STS model case. Specifically, experts’ clinical expertise, accumulated through their adoption of a novel technology, ABR, prompted them to change “what constitutes the evidence” for brain-death diagnosis and “decision-making about” the treatment of the brain-dead/dying. However, in Japan, the debate proceeded along a different path. This study has cast light on the discourse in which the cultural arguments were inscribed. The initial dispute arose from the political intervention inspired by British practice, which challenged the experts and their desire to adopt the brainstem death concept rather than the previous whole-brain death concept. In Hogle’s terms, the proponents of the British criteria tried to avoid one change in clinical decision-making, namely the adoption of evidence provided by ABR, and to make their own change by abandoning the diagnostic value of EEG. Despite the political power they wielded, they did not achieve their desired result. Instead, their influence led to the formulation of other positions that invoked similar cultural arguments. First, some Japanese mainstream specialists, represented by the BD Research Council, mobilized another authority, the “international”, considered a synonym for the US standard, to defend their conventional approach. Seen through the lens of Hogle, the BD Council’s decision would bring little change to the evidence used for brain-death diagnosis

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because there would be no change in terms of the adoption of the three disputed medical technologies. Second, another group of experts coalesced around Tachibana’s criticism of the BD Council and proponents of the brainstem approach. They adopted the total brain infarction approach, which gave particular significance to cerebral angiography. When their claim was condemned by those who were keen to adopt the British brainstem death concept, who perceived Japan as lagging behind the UK, they explicitly mobilized the Swedish authority, pointing to that country’s use of total brain infarction, which required the use of both EEG and cerebral angiography. The stance of this second group entailed a change in the evidence and decision-making of brain-death diagnosis in Japan through the official adoption of a medical technology—cerebral angiography—other than the conventional one, EEG. Third, the so-called Swedish position was redefined and developed into an independent Japanese approach. The proposal made by this group encompassed the adoption of not only EEG and cerebral angiography but also ABR, and was thus novel among approaches existing at that time. This produced a significant change in establishing evidence for brain-death diagnosis and decision-making about the treatment of brain-dead patients in Japan. The course of this contestation might reflect Japan’s specific sociohistorical context. Since the Meiji restoration of 1868, elites in Japan had tried to overcome the lack of parity by adopting and then adapting models from Europe and North America. The political slogan adopted at that time, datsua-nyu¯o (leaving Asia and entering Europe), was symbolic; it meant that Japan intended to adopt a modernity common in various European countries. This process can be seen as analogous to what Homi Bhabha (1994, 89) calls “mimicry”. Focusing on the historical example of India under British colonial rule, Bhabha shows how elites in India wanted to take a some modern things from European and North American countries as far as they could. This behaviour was an attempt to overcome a perception of Asian countries as “primitive”, “underdeveloped” and “uncivilized”, a rhetorical argument present in Japan’s brain-death controversy as demonstrated in the quote by Uozumi (1989) above.

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Some academics may disagree with this understanding, mainly because Japan did not share the colonization experiences of most other Asian countries. However, their standpoint fails to take account of the overall (post)colonial influence, which, as Said (1995) and Fanon (2005) argue, has been embedded in official discursive practices, including academic discipline and the mentalities of the elites from Asia, Africa and South America. Indeed, as Komori (2001) demonstrates, datsua-nyu¯o had been a sort of mission for Japanese elites, which arguably contributed to Japanese pre-war imperialism and post-war economic development. This practice, as Morris-Suzuki (1995, 764) shows, was evident from the 1920s onwards, when the media and academia in Japan began to employ cultural arguments. There were also attempts to find an alternative approach to that of the modernization models observed in several European countries and North America, notably kindai-no-ch¯okoku-ron, the theory of overcoming the limitations and boundaries of modernity, elaborated in 1942 (Clammer 1999; Hiromatsu 1989; Sakai and Isomae 2010). This trend continued in the post-war era in both popular and academic discourse through “theories of Japaneseness”, known as nihonjin-ron (Aoki 1990; Mouer and Sugimoto 2015; Yoshino 1997). In line with the cultural argumentation infusing the brain-death controversy, the Japanese differencing strategy and search for an independent Japanese approach were reflected in the quest for a way to adopt all three of the aforementioned medical technologies for brain-death diagnosis. The outcome was that Tachibana’s stance on the brain-death diagnostic procedure, now redefined as more “scientific” and “civilized” than its rival approaches, arguably prevailed. As noted earlier, from the late 1980s onward, cultural argumentation played a growing role in the brain-death problem; indeed, the overall closure to the debate, the Organ Transplantation Act of 1997, was considered an embodiment of “cultural appropriateness” in Japan. Yet whilst the Act realized the legal and clinical treatment of the brain-dead, the brain-death diagnostic procedure did not reflect sufficient cultural appropriateness; instead, it accepted the Takeuchi Criteria, referring to the US criteria, as an appropriate international standard. This aspect of the legislation begs an explanation of its acceptability.

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137

Summary

This study has illuminated how the de facto Japanese authentic braindeath diagnostic procedure was constructed through a process that encompassed various contestations and cultural arguments. It has shown how, in practice, the guidelines and code of practice for the 1997 Act added ABR to the Takeuchi Criteria, thus meeting the demands of almost all of the debaters, apart from the proponents of the British criteria. The majority of brain specialists were satisfied, because the de facto version was extremely close to their original request shown in Table 2. Those who had supported an independent brain-death procedure did not raise objections because their main interest, as I have demonstrated elsewhere (Sasaki 2006a, 2019), had moved to the legal and clinical treatment of the brain-dead/dying, mitori, which was realized through the 1997 Act. Meanwhile, those who supported the Takeuchi Criteria were content because, without the political intervention from their opponents, they would have agreed to the original demand from the specialists. Thus, a consensus was established. This outcome invited almost all clinicians to adopt ABR for their brain-death diagnosis. To summarize, my examination has demonstrated that the clinical experience and expertise already existing in Japan played a significant role in the foundation of a code of practice for brain-death diagnosis. The controversy encompassed a course of cultural argumentation ranging from support for the adoption of approaches established in the UK, to calls for the development of an independent approach in Japan, confirming Japan’s original clinical experience. My conclusion, therefore, is that whilst the Japanese clinical domain had originally taken a similar approach to what Hogle might have anticipated, the official and political approval process of the change to “what constitutes evidence” for braindeath diagnosis and the associated “decision-making” on the treatment of brain-dead/dying patients followed a distinctive trajectory, strongly influenced by cultural argumentations.

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6 Medical Technology, Terminal Care and Criminal Law: Court Cases from Japan Yuji Shiroshita

1

Introduction

Medical devices, such as mechanical ventilators or artificial heart-lung machines, are integral components of terminal care. They have enabled physicians to ease patients’ pain or prolong their lives. However, the role of medical devices does not always comply with patients’ wishes. In certain cases, the use of life-support systems amounts to “overtreatment”. Medical machines for nerve block sometimes fail to remove patients’ pain. These situations also evoke certain legal problems. In the field of criminal law, these issues are generally divided into two categories. The first is “active (direct) euthanasia”, and the second is the cessation (i.e., withdrawing or withholding) of medical (i.e., life-sustaining) treatment at the request of the patient. Even with the development of Y. Shiroshita (B) Graduate School of Law, Hokkaido University, Sapporo, Japan e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Brucksch and K. Sasaki (eds.), Humans and Devices in Medical Contexts, Health, Technology and Society, https://doi.org/10.1007/978-981-33-6280-2_6

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palliative medicine, some patients might request that a physician kill them using lethal drugs or the like so that they can be released from irremovable pain. The precedent in Japan (Yokohama Dist. Ct., 28 Mar 1995) is that this type of euthanasia may be legal (as homicide with consent) if the act is performed under the following circumstances: (1) the patient is suffering from unbearable physical pain; (2) the patient’s death is unavoidable and the time of death is imminent; (3) the physician has tried every possible means to remove or relieve the patient’s physical pain and there are no alternative measures; and (4) there is an explicit expression of the patient’s wish to accept the shortening of their life. However, are these requirements enough to justify active euthanasia? The second category is the cessation (withdrawing or withholding) of life-sustaining treatment at the request of the patient (“death with dignity”). The Supreme Court (Sup. Ct., 7 Dec 2009) has not provided theoretical grounds for justifying such an act. However, it appears dependent on the district courts’ view (Yokohama Dist. Ct., 25 Mar 2005) that the physician’s act needs to be justified by both “the limit of physician’s duty to perform the medical treatment” and “the right to selfdetermination of patients”. Are these principles appropriate for justifying such acts? In other words, both acts are common in “evoking a patient’s death artificially” at their request. From the perspective of criminal legal theory, it is a question whether these acts constitute the crime of homicide or homicide with consent, and what requirements are needed to justify them if they are committed.1 In Japan, this issue has been mainly left to legal interpretation according to literature and judicial precedent (Kai 2009, 1) unlike in other countries where legislative solutions tend to be

1The

Penal Code of Japan states as follows: Article 199 (Homicide) A person who kills another shall be punished by the death penalty or imprisonment with work for life or for a definite term of not less than 5 years. Article 202 (Inducing or Aiding Suicide; Homicide with Consent) A person who induces or aids another to commit suicide, or kills another at the other’s request or with the other’s consent, shall be punished by imprisonment with or without work for not less than six months but not more than seven years.

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sought.2 While the Japanese situation seems roundabout at first glance, it has the advantage of building a logical basis for the problem. Many discussions have taken place on this issue for over 50 years, and there are also a fixed number of cases. In this chapter, accordingly, these topics are examined from the viewpoints of (medical) criminal legal theory, and some conclusions are drawn on the legality/illegality of acts evoking death in terminal care. Although legal discussions only present one point of view on this issue, they do provide a stable and logical solution in a constitutional country. It is natural that legal discussions seeking to produce more accurate legal theories should also obtain suggestions from other fields of study, including interdisciplinary research. This chapter is divided into three parts: in the first, the legality/illegality of active euthanasia is examined; in the second, the justification of the cessation of medical treatment is discussed; and in the third, the legislative perspective on such acts is considered.

2

Active Euthanasia

Although “euthanasia” (anrakushi) is not originally a legal term, it generally implies an act to relieve or remove the acute physical pain of a patient, whose time of death is imminent, at their request. The aim of euthanasia is to allow the patient to achieve their own peaceful death. There are several ways of classifying euthanasia. In Japan, a classification deriving from a theory proposed by Karl Engisch (1889–1990), a well-known German criminal law scholar who has had a great effect on Japanese criminal law theory, has been used since the 1950s. It is as follows: 1. Pure euthanasia. This is a type of euthanasia where removing or relieving pain does not hasten the time of the patient’s death. This kind of act is widely justified as “an act performed in the pursuit of lawful business” (Article 35 of the Penal Code). 2 For

example, The Netherlands (2001), Belgium (2002) and Luxembourg (2009) legalized active euthanasia by physician, while the US (1985), France (2005) and Italy (2017) legislated for the rights of the terminal patients including the cessation of medical treatment.

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2. Indirect euthanasia. This is a type of euthanasia where giving an analgesic drug hastens the time of the patient’s death as a side effect. This act is justified by a variety of reasoning. One explanation is that it comes into the category of medical treatment because its main purpose is to remove or relieve the patient’s physical pain and because the act fulfils medical adequacy (lege artis). 3. Passive euthanasia. This is a type of euthanasia where the physician releases the patient from physical pain by withdrawing life-sustaining measures in accordance with their request. This act (i.e., omission) does not violate the physician’s legal duty because the physician does not compel the patient to receive life-sustaining measures against their will. 4. Active (or direct) euthanasia. This is a type of euthanasia where the physician or close relatives remove the patient’s physical pain by actively killing them with lethal drugs or the like in accordance with their request. This type of euthanasia has been the most controversial in the field of criminal legal theory due to its directness in causing the patient’s death.3 Accordingly, this chapter elaborates on the most debated type of euthanasia: active euthanasia. Seven criminal cases are reported in which the illegality of active euthanasia has been discussed (see Table 1). However, the seventh, known as the Tokai University Hospital case, is the only case involving criminal responsibility by a physician (see Yokohama Dist. Ct., 28 Mar 1995).

2.1

The Tokai University Hospital Case

In this case, the patient, a 58-year-old man, had been hospitalized because of multiple myeloma. The accused, a 35-year-old physician, had joined the medical team as the patient’s attending physician on 1 April 3 In

addition to these types, there is a view that a new type of euthanasia, physician-assisted suicide (PAS), should be added (Kai 2009, 3). With this the type of euthanasia, the physician assists the suicide of the patient by providing a lethal drug or the like. PAS derives from legislation in the US, especially that in the states of Oregon, Michigan and California. This type could be classified as a variation of active euthanasia.

29 October 1975 30 November 1977

Physician/Patient

Husband/Wife

Son/Father

Homicide consent Homicide consent Homicide consent Homicide Homicide consent Homicide consent Homicide

Charge

with

with

with

with

with

2 years (2 years)

3 year (1 year)

3 years (4 years) 1 year (2 years)

1 year (2 years)

1 year (3 years)

1 year (2 years)

Sentence: Imprisonment with hard labour (suspension)

Source Author’s compilation based on Tokyo Dist. Ct., 14 Apr 1950 (58 Saibansho jiho¯ 4); Nagoya App. Ct., 22 Dec 1962 (15 Kokeish ¯ u¯ 674); Kagoshima Dist. Ct., 1 Oct 1975 (808 Hanrei jiho¯ 112); Kobe Dist. Ct., 29 Oct 1975 (808 Hanrei jiho¯ 113); Osaka Dist. Ct., 30 Nov 1977 (879 Hanrei jiho¯ 158); Kochi Dist. Ct., 17 Sep 1990 (1363 Hanrei jiho¯ 160); Yokohama Dist. Ct., 28 Mar 1995 (1530 Hanrei jiho¯ 28)

Yokohama District Court

17 September 1990 28 March 1995

Son/Mother Husband/Wife

01 October 1975

Kagoshima District Court Kobe District Court Osaka District Court

Kochi District Court

Husband/Wife

22 December 1962

Nagoya High Court

Accused/Victim

Tokyo District Court

Son/Mother

Date

14 April 1950

Court

Table 1 Cases of active euthanasia in Japan

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1991. On the 13 April, the patient was in the sixth grade of consciousness and showed no reaction to pain stimuli. He was also in a critical condition and breathing with difficulty, snoring loudly. The eldest son of the patient believed that the life-sustaining measures were a burden to his father and that it would be better for him to pass away naturally without such measures. The son requested that the physician withdrew the intravenous drip injection and catheter. The physician finally ordered the nurse to remove the above-mentioned equipment and then removed the airway (respirator). As there was no change in the patient’s condition, the son again asked the physician to make his father comfortable. The physician injected the patient with twice the normal amount of diazepam and haloperidol, both of which have the side effect of restraining breathing. However, the situation did not change after an hour. Persuaded by the angry son, the physician decided to help the patient die. The physician then injected twice the normal amount of verapamil hydrochloride and 20 mL of undiluted potassium chloride (KCL), and the patient passed away as a result. To summarize, this case is special because the first act involves passive euthanasia, the second act relates to indirect euthanasia and the last act constitutes active euthanasia. All of these acts were performed within the space of only nine hours.

2.2

The Judgement of the Court

The public prosecutor charged the physician with homicide in respect of the last act (Article 199 of the Penal Code). The court found the physician guilty of homicide, and sentenced him to two years’ imprisonment with hard labour, with the sentence suspended for two years. This case was confirmed at the first trial. This was the first case of active euthanasia where a physician was the accused, and the court’s judgement is particularly remarkable because it stipulated four requirements for the performance of lawful active euthanasia by physicians. The requirements are as follows: 1. the patient is suffering from unbearable physical pain;

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2. the patient’s death is unavoidable and the time of death is imminent; 3. all possible treatment and care to remove or relieve the patient’s physical pain have been provided and there are no alternative measures; and 4. there is an explicit expression of the patient’s wish to accept the shortening of their life at the time of active euthanasia. The Yokohama District Court stated that requirements (1), (3) and (4) were lacking in this case. As to requirement (1), the patient was not suffering from unbearable physical pain, because he was in the sixth grade of consciousness and had no reaction to pain stimuli. Therefore, there was no premise for requirement (3). Moreover, it is clear that he could not express his wish to accept the shortening of his life, as noted in requirement (4). Only requirement (2) was fulfilled in this case. In fact, these requirements were derived from the revised edition of those in a case presented before the Nagoya Court of Appeal in 1962, which have been adopted in criminal cases in Japan for over 30 years (see Nagoya App. Ct., 22 Dec 1962).4 These four new requirements apparently presuppose that the act of euthanasia should be performed only by physicians. There are several criticisms of these requirements. In particular, the incompatibility of requirement (3) with (4) is clear, because a patient for whom there are no alternative measures except active euthanasia to

4 In

this case, the accused poisoned his father who had been paralyzed following cerebral haemorrhage. The Nagoya High Court ruled that active euthanasia could be justified if each of the following requirements were fulfilled: 1. The sick person suffers from an incurable disease according to modern medical knowledge and technology and the time of death is imminent. 2. The pain of the sick person is so extreme that it is unbearable for everyone to witness his or her state. 3. The act is performed only for the purpose of relieving the death pains of the sick person. 4. The sincere request of the patient is given when they are clearly conscious and able to express their wishes. 5. The act must be performed by a physician in principle. If this is impossible, there should be special reasons for asking other persons. 6. The method must be ethically appropriate.

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relieve their pain cannot usually express their wishes. From the viewpoint of practical medicine, there is a very low possibility that all of these requirements will be fully satisfied. However, the most important contribution of this judgement is that it clearly provided the theoretical grounds for justifying active euthanasia, which are the right to self determination and averting present danger. This case was thus the first time that judges had explained the grounds for the justification of active euthanasia. The right to self-determination is a well-known principle for justifying euthanasia. The Yokohama District Court considers this right in requirement (4). However, if the right to self-determination provides the independent grounds for euthanasia, the range of justifications will be limitless. At the same time, using it as a single basis for justifying euthanasia may be inconsistent with the purpose of the Penal Code, which punishes homicide with consent. Therefore, it seems that the Yokohama District Court applied the principle of averting present danger together with the right to self-determination in order to properly restrict the range of justifying euthanasia. Averting present danger, which is generally known as “necessity” in Anglo-American criminal statutes, is regulated in the Penal Code of Japan as follows: Article 37 (Averting Present Danger) (1) An act unavoidably performed to avert a present danger to the life, body, liberty or property of oneself or any other person is not punishable only when the harm produced by such act does not exceed the harm to be averted.

In this article, three elements are prescribed: (a) the existence of a present danger to life and the like; (b) the unavoidability of the act of averting; and (c) a lack of excess of the produced harm. Here, the “unavoidability of the act of averting” means that the act was the one and only way to avert the danger, and the “lack excess of the produced harm” is also called “weighing of harms”. It is clear that the judgement adopted “unbearable physical pain” and “unavoidable and imminent death” with respect to (a) the existence of a

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present danger to life and body”, and “there are no alternative measures” with respect to (b) the unavoidability of the act of averting. How, then, was (c) the lack of excess of the produced harm, treated? In this judgement, the substance of “the lack of excess of the produced harm” is not clear. We can guess that “harm produced” means causing death and that “harm to be averted” means continuous physical pain. The point of this judgement is that this balancing test depends on the patient’s self-determination. However, for the purpose of concluding that this inequality is true, we have to admit that the removal of continuous physical pain is an “interest” of the patient. In many situations (such as surgeries performed by physicians), we can say that the removal of continuous pain is an “interest”. It is based on the premise that the patient is able to be alive after the removal of pain. In contrast, with respect to euthanasia, removal of continuous pain clearly entails depriving the patient of life and we cannot conclude that it is an “interest” in the normal sense. The judgement seems to admit that the removal of continuous pain in exchange for life could be an “interest” based on the self-determination of the patient. Hence, a terminal life with physical pain could reduce the necessity of protection. However, this thought includes a risk that the qualitative aspect of life could be a critical element of the balancing test. As a matter of criminal law, it is questionable whether we can consider quality of life in discussing protection of life (Shiroshita 2012, 2013, 104). Thus, there are some difficulties justifying active euthanasia, and it has been suggested that recent developments in palliative care would reduce the necessity of active euthanasia. Even if we can explain the justification for active euthanasia, legislating or creating guidelines on its requirements as a code of conduct for physicians would be in conflict with their professional ethics. The “Guidelines on the Decision-Making Process for the End-of-Life Medical Care” issued by the Ministry of Health, Labour and Welfare of Japan (MHLW 2018), which will be addressed subsequently, clearly explains that it does not treat active euthanasia.

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As a matter of substantive criminal law, a defendant of active euthanasia will be exculpated not by general theory of justification, but only by an excuse considering individual circumstances.5 The next problem is another act that evokes a patient’s artificial death in terminal care, the cessation of medical treatment.

3

The Cessation of Medical Treatment (Death with Dignity)

“Death with dignity” (songenshi) is not a legal term either, nor is it a neutral term because of its affirmative expression. Therefore, many scholars describe it as “withdrawing or withholding of artificial medical (or life-sustaining) treatments by complying with a request of the patient” or shortly, “cessation of treatment”. This terminology is the same in interdisciplinary research (Hogle 2008, 849). This concept seems to be similar to “passive euthanasia”. It is true that both acts have in common that they are mainly performed by omission. However, each should be distinguished because “passive euthanasia” requires the existence of acute physical pain, and it aims to remove the pain. By contrast, death with dignity does not require the existence of physical pain, and the aim is to allow the patient to achieve his or her own natural death. In Japan, there are two precedents concerning the legality/illegality of the cessation of medical treatment. The first is the Tokai University Hospital case, but as mentioned above, the prosecutor did not charge the accused with withdrawing medical treatment. The court stated the requirements of permissible cessation of medical treatment, only in its obiter dictum. According to the dictum, the cessation of medical treatment is permissible under the requirements based on the theory of “the right to self-determination of patients” and “the limit of physician’s duty 5 According

to the theory of exigibility, culpability is negated when the actor cannot be expected to have alternatively performed a legal act in light of individual circumstances. This is because culpability is based on the presumption that there is a reasonable expectation that the actor could have acted legally (it derives from German nineteenth-century criminal legal theory). It is possible that the situation of active euthanasia comes under such “individual circumstances”.

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of medical treatment”. First, the patient should be suffering from an incurable disease, and be in a terminal state where there is no possibility of recovery and where death is unavoidable. Second, the patient should provide a manifestation of their intention requiring the cessation of medical treatment at the time of cessation. In the case that there is no such manifestation, the presumed wishes of the patient may be considered. The presumption can be based on (1) the patient’s living will or advanced directive or (2) the manifestation of the patient’s family. Third, the object of the cessation of medical treatment may include all measures such as drug administration, chemotherapy, artificial dialysis, artificial respiration, transfusion, nutrition and hydration.

3.1

The Kawasaki Kyodo Hospital Case

The second case is the Kawasaki Kyodo Hospital case. In this case, the Supreme Court stated that a physician’s act of removing an endotracheal tube, which had been inserted in order to maintain the airway, from a patient who had been hospitalized after suffering a severe bronchial asthma attack and was in a coma at the time of the removal of the tube, cannot be regarded as a cessation of treatment that is legally permitted under the given circumstances. The developments until the removal of the endotracheal tube are as follows (see Supreme Court of Japan 2009; this summary is based on the English homepage): a. On 2 November, 1998, the patient concerned (a 58-year-old man) had a severe attack of bronchial asthma (status asthmaticus) in his car on the way home from his office. The patient was in cardiopulmonary arrest when he was brought into Hospital A about 7.00 p.m. on that day. Although his cardiopulmonary functions were restored as a result of first-aid treatment, the patient did not regain consciousness, and it was decided that he should be taken to the intensive care unit (ICU) to receive medical treatment, while being kept on a respirator. Owing to hypoxaemia during cardiopulmonary arrest, the victim suffered serious after-effects in not only cerebral functions but also brain-stem functions, and remained in a coma until he died on 16 November.

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b. The accused worked as a physician at Hospital A and held the post of Director of the Department of Respiratory Medicine. She directed the course of medical treatment for the victim from 4 November. Although the victim’s blood pressure, pulse and the like were stable, his airway was inflamed, and Staphylococcus aureus and Enterococcus were found in his sputum. On the said day, the accused met with the patient’s wife and children who explained how the patient had been brought into the hospital. On this occasion, the accused informed them of the patient’s condition, including her view that it would be difficult for the patient to regain consciousness and that it was highly likely that he would fall into a vegetative state. c. Subsequently, on 6 November, since the patient was found to have spontaneous respiration, the respirator was removed and the endotracheal tube was left attached in order to prevent glossoptosis and suck phlegm. On 8 November, the patient’s limbs started to show contractures. The accused, having determined that there was no hope for the recovery of the patient’s brain functions, informed the patient’s wife and children of the his condition, and obtained their consent to the effect that a respirator would not be attached to the patient again even when his respiratory condition deteriorated. The accused also notified them that the endotracheal tube could not be removed immediately because it would cause the risk of suffocation. d. On 11 November, mainly because the endotracheal tube attached to the patient needed to be replaced with a new one, the accused wondered whether it would be possible for the patient to survive without an endotracheal tube after the old one was removed. When the accused tentatively removed the tube in the presence of the patient’s wife, the patient’s breathing quickly slowed. Therefore, the accused inserted a new tube into the patient’s trachea, stating to his wife that “he would not be able to survive without a tube in his current condition”. e. On 12 November, the accused moved the patient from the ICU to a single room on the South Second Floor Ward, which is a general ward, instructed the nurse to reduce the oxygen supply and perform a transfusion, and notified her of the decision not to perform cardiopulmonary resuscitation in the event of a sudden deterioration in the

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patient’s condition. On 13 November, the accused informed the patient’s wife and family that the patient had been moved to the general ward, and also informed them that there would be a higher risk of a sudden turn for the worse after the move to the general ward. She confirmed with them that cardiopulmonary resuscitation would not be performed in the event of a sudden deterioration in his condition. f. The patient had a bacterial infection complicated with septicaemia. During the period between the patient’s hospitalization following the severe bronchial asthma attack and the removal of the tube in question, no electroencephalogram or other test was performed as needed for determining the expected length of the remaining life of the patient. It is unknown how the patient himself wished to be treated at his terminal stage. g. On the afternoon of 16 November, the accused met with the patient’s wife and was told by her, “We would like to ask you to remove the tube. This is the decision of our family. We all gather here tonight, so please do it”, and the like. Hearing this, the accused decided to remove the tube. At about 5.30 p.m. on that day, the patient’s wife, children and grandchildren gathered in the patient’s room, and at about 6.00 p.m., the accused came into said room with an assistant nurse. Having confirmed that all family members were there, the accused, at the request of the patient’s family members who had given up hope of the patient’s recovery, removed the tube, which had been inserted into the patient’s trachea through his nose in order to maintain the airway, while recognizing that this could cause the death of the patient, and took no measures to help him breathe. h. Contrary to expectations, the patient started to gasp for breath, arching backward. The accused administered Cercine and Dormicum to the patient by intravenous injection and took other measures, but was unable to calm him down. Then, the accused asked for advice from another physician working at the hospital, and obtained Mioblock, a muscle relaxant, from the nurse station of the ICU based on said physician’s advice. Then, at about 7.00 p.m. on the same

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day, the accused instructed the assistant nurse to administer three ampoules of Mioblock to the patient by intravenous injection. The patient stopped breathing at about 7.03 p.m., and his heart stopped at about 7.11 p.m.

3.2

The Judgement of the Court

The public prosecutor charged the physician with homicide following this chain of events. Hence, the act of removing the endotracheal tube in combination with the act of administering Mioblock was considered to constitute homicide. In 2005, the Yokohama District Court found her guilty of homicide, and sentenced her to three years’ imprisonment with hard labour, suspended for five years (63 Keish¯u 2057, Yokohama Dist. Ct., 25 Mar 2005). As a matter of fact, the court found that the patient’s family had not asked the defendant to remove the patient’s tube. The court explained the guilty verdict as follows, based on, not explicitly, obiter dictum of the Tokai University Hospital case: 1. Cessation of medical treatment in terminal care is permissible on the grounds of respect for the self-determination of the patient and the limit of duty of medical treatment based on a medical decision. 2. Respecting the self-determination of the terminal patient does not imply admitting suicide or accepting the right to die. It should be positioned as a reflective effect of allowing the patient to decide how to achieve his or her death, which derives from the right to human dignity, or the right to the pursuit of happiness. 3. Self-determination requires that there is no prospect of recovery for the patient, whose death is imminent. The patient should have an ability to understand the above condition. The patient must be well informed regarding his or her condition, prospect of recovery, or possible measures of treatment. He or she must decide voluntarily and express his or her intention sincerely. If the physician cannot directly identify the patient’s real intention because of the progress of his or her condition, it is desirable to search his or her real intention with

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clues such as a living will, or a presumption by the patient’s family or person who knows their thoughts on life well. When the real intention is unknown despite these efforts, the physician should consider the principle of in dubio pro vita and give priority to the protection of the patient’s life by means of continuing the most suitable measures. 4. In a case where the physician has tried all possible medical treatments and where the limit of medically effective treatments has been reached, there is no legal duty to continue or provide treatment that is considered to be medically harmful or meaningless, even if the patient requires it. At the same time, the judgement of the physician should be limited to the validity of medical treatments and so forth. Although the physician may advise the patient regarding how to lead to death, such advice should be given as a reference opinion. It is not appropriate for the physician to make a value judgement of how to die on behalf of the patient. 5. In this case, it is clear that no test for determining the possibility of recovery or the length of the remaining life of the patient was performed. The possibility that the patient would recover from a coma or a vegetative state remained to a certain degree. There was no circumstance presuming the patient’s request for the cessation of medical treatment. The physician’s act of removing the endotracheal tube was not legally permitted because the duty of medical care had not reached its limit. Thus, the act of removing the endotracheal tube constituted homicide, and it also constituted homicide in combination with the act of administering Mioblock. The defendant appealed to the Tokyo High Court, which sentenced her to 18 months’ imprisonment, suspended for three years (the lightest sentence for homicide) in 2007 (see 63 Keish¯u 2135, Tokyo High Ct., 28 Feb 2007). As a matter of fact, the Tokyo High Court found that the patient’s family asked the defendant to remove the patient’s tube. This is the main reason that the court reduced the sentence passed by the lower court. At the same time, the court noted that it was somewhat cruel for the physician to be blamed because she was forced to make a decision at the request of the patient’s family in a situation for which no legal norm or medical ethics on the cessation of treatment that medical staff should

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follow had been established. This circumstance also seems to have been considered a mitigating factor. Initially, the Tokyo High Court noted the following problems with (1) the “self-determination of the patient” approach and (2) the “duty of medical treatment approach” in the Yokohama District Court judgement: (1-1) It is questionable that the patient’s decision to determine his or her own treatment policy falls under the category of the constitutionally guaranteed right to self-determination. (1-2) If we admit the cessation of treatment is legally permitted, we have to consistently explain the existence of the Article 202 of the Penal Code which prohibits aiding and abetting suicide. (1-3) In case that a patient who suddenly lost consciousness cannot execute self-determination, a substituted judgement or assumption of their wishes can be considered. If we deny these means, it will be against the right of self-determination because medical treatment that may be contrary to the patient’s wishes can be continued or the situation will be left to the physician’s discretion. However, the substituted judgement is nothing other than the self-determination of the family itself, and there is a danger that the assumption of the patient’s wishes tends to be fictitious. (2-1) The duty of medical treatment approach is applied in extremely terminal and limited situations in which medical treatment is meaningless. Hence, it is unreasonable from a viewpoint of interpretation to apply the approach broadly. There is also a problem regarding the stage at which the care should be considered meaningless. (2-2) The question whether the physician has a duty to continue treatment if there is any little possibility of recovery has not been solved. (2-3) According to this approach, it is presumed that the cessation of treatment should be principally interpreted as an “omission”. However, there is a possibility that the cessation of treatment may partly include an “act” such as administering Mioblock, just as in this case. This is not necessarily sufficient as a way of understanding terminal care.

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Thus the Tokyo High Court criticized the validity of the two approaches and concluded that legislation or guidelines should be provided in order to resolve the “death with dignity” problem entirely. On the other hand, the court admitted that it was possible to postulate the two requirements to the extent necessary to solve the specific case, and found that the physician’s act of removing the endotracheal tube could not be justified because the patient’s wishes were unconfirmed and the physician has not been released from the duty to medical treatment. The defendant finally appealed to the Supreme Court. The Supreme Court dismissed the final appeal of the defendant and provided the following reasoning (see 63 Keish¯u 1899, Sup. Ct. 7 Dec 2009; in this judgement, “the victim” means “the patient”): The defence counsel argues that the accused, who took charge of the victim at his terminal stage, removed the endotracheal tube at the strong request of the victim’s family members from which the victim’s wishes can be presumed, and therefore the removal of the tube in question can be regarded as cessation of treatment that is legally permitted. However, according to the developments of the facts mentioned above, during the period from when the victim had a severe bronchial asthma attack and was hospitalized until the removal of the tube in question was performed, no electroencephalogram or other test was performed as needed for determining the expected length of the remaining life of the victim among other aspects. In addition, in light of the fact that the removal of the tube was performed only two weeks after the victim had developed the disease, it can be found that at the time of the removal, it was impossible to make an accurate determination as to the possibility of the victim’s recovery or the expected length of his remaining life. At the time of the incident, the victim was in a coma, and the removal of the endotracheal tube in question was performed at the request of the victim’s family members who had given up hope of the victim’s recovery. As it is found from the circumstances described above, the victim’s family members did not make such request after being properly informed of the victim’s condition, etc. Nor can it be said that the aforementioned act of removing the tube was performed based on the presumed wishes of the victim. Taking into consideration all of these factors, we should say that the aforementioned act of removing the tube cannot be regarded as cessation of treatment that is legally permitted.

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According to this reasoning, the determination of the court of prior instance is justifiable in that it ruled that the act of removing the endotracheal tube in combination with the act of administering Mioblock constitutes homicide.

This is the first and only judgement of the Supreme Court of Japan regarding the criminality of cessation of treatment. The Supreme Court stated that the act of removing the endotracheal tube constituted homicide, but it did not clearly present the general requirements for justifiable cessation of treatment. However, it refers to “the possibility of the victim’s recovery or the expected length of his remaining life” and “the presumed will of the victim”. It may safely be assumed that the court considered the two requirements presented by the Yokohama District Court in 1995, the self-determination and the duty of medical treatment. According to the Supreme Court’s judgement, if the victim’s family members had made a request after being properly informed of the victim’s condition and the like, and if the act of removing the tube had been performed based on the presumed wishes of the victim in this case, cessation of treatment would have been regarded as legally permitted. It is also noteworthy that the Supreme Court interpreted an act (not an omission) of removing an endotracheal tube as a kind of “cessation of treatment”. This justification can basically be supported from the viewpoint of substantive criminal legal theory. However, there are some issues to consider regarding the two requirements. As to the self-determination, patient consent is generally a requirement for the commencement of medical treatment. Hence, a patient is not legally compelled to be treated against their will. Accordingly, the most important requirement of cessation of medical treatment is theoretically the patient’s self-determination. This should be distinguished from self-determination in the case of active euthanasia. With respect to active euthanasia, self-determination is the right to abandon one’s own life directly. In the case of cessation of medical treatment, it means the right to refuse treatment and accept a natural death, so-called “defensive self-determination”. When the patient’s present wishes cannot be determined, the presumptive wishes should be considered depending on their living will or advanced directive. As the Tokyo High Court noted,

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denying these means would be against the right to self-determination. Information from the patient’s family also constitutes important evidence of the patient’s presumptive wishes. It is important to note that this should be distinguished from the “substituted judgement” by the family, which ultimately means the family’s self-determination, not the patient’s. Regarding the duty of medical treatment, when it is lacking, the physician is not legally obliged to continue medical treatment. Naturally, a physician does not need to give life-sustaining treatment to a patient who has no possibility of recovery. However, the Supreme Court judgement of 2009 mentioned “the possibility of the victim’s recovery or the expected length of his remaining life”. The relationship between “the possibility of the victim’s recovery” and “the expected length of his remaining life” is not clear. Theoretically, the impossibility of the patient’s recovery is the most crucial point for judging the absence of the duty of medical care. Therefore, the expected length of the patient’s remaining life needs to be considered as one element determining the possibility of the victim’s recovery. Evidence of determination will also include the burden of the medical treatment for the patient, the specialty or exceptionality of the medical measures, and so forth. It is surely difficult to accurately determine the impossibility of the patient’s recovery. With modern medicine, the time of imminent brain death will be one criterion. Moreover, the relationship between the right to self-determination and the duty of medical treatment is controversial. According to the judicial research official of the Supreme Court, the meaning of the above judgement is that both the right to self-determination and the duty of medical treatment should be at least considered for justification (2013, 580). In contrast, the Yokohama District Court stated that the legal duty to continue or provide treatment could be denied even if the patient required it. This suggests that the absence of duty could be the sole basis for the cessation of treatment. However, the right to self-determination embodied in a patient’s “informed consent” is one of the necessary conditions for justifying the performance of medical treatment. Therefore, it should be still stated as a requirement for the cessation of treatment. At the same time, the self-determination of the patient cannot justify the cessation independently, since the Penal Code proscribes homicide with consent. The duty of treatment needs to be released in order to withdraw

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life-sustaining measures. Therefore, both the right to self-determination and the duty of medical treatment should be considered requirements for justifying cessation of treatment. There is also a prevailing view that both requirements should be integrated under the perspective of “the best interests of the patient” (Machino 2007, 52–53). This view asserts that the irrational self-determination of the patient should be fine-tuned with their best interests, towards the affirmation of a duty of medical treatment. This would lead to the same results as the above understanding, which postulates the fulfilment of both requirements. Another critical and realistic issue concerns the concrete delineation of these abstract requirements in the face of terminal care. This point relates to making an official rule for the cessation of medical treatment.

4

Legislative Perspectives

The MHLW and some professional societies, such as the Japan Medical Association (JMA), Japanese Association for Acute Medicine and Japan Geriatrics Society, have issued guidelines on terminal care. Although they do not directly treat cessation of medical treatment and are not legally binding, they may offer some suggestions. For example, in March 2018, the MHLW issued the “Guidelines on the Medical Decision-Making Process in the Terminal Stage of Life”, which were revised from the previous 2007 guidelines (MHLW 2018). These guidelines state that end-of-life medical care should be performed on the basis of the patient’s decision-making after being provided with adequate information and explanation by medical professionals and fully consulting with the multi-disciplinary medical care team. The guidelines stipulate that the definition of “end of life” should be determined on the basis of the appropriate and reasonable judgement of the medical care team, in consideration of the patient’s condition. They also incorporate the concept of advanced care planning (ACP), which entails discussing the patient’s future end-of-life medical care repeatedly in advance with their family or medical care team. The main part of the concrete contents is given in Table 2.

Source MHLW (2018)

1. In cases where the patient’s wishes can be confirmed; I. In deciding the medical care plan, the medical professionals including physicians should provide and explain adequate information after expert medical scrutiny in accordance with the patient’s condition In addition, the patient’s decision-making should be based on sufficient consultation towards consensus building between the patient and the medical care team, and the plan should be decided by the multi-disciplinary medical care team II. The medical care team should provide and explain adequate information and support the patient expressing and conveying his or her wishes each time, as the patient’s wishes tend to change with the passage of time, changes in the patient’s condition, changes of medical evaluation and so forth At that time, the consultations need to be repeated with the family, as the patient may become unable to express his or her wishes III. The content of consultation in this process should be documented each time 2. In cases where the patient’s wishes cannot be confirmed; In cases where the patient’s wishes cannot be confirmed, the medical care team should determine it carefully according to the following order I. Where the family presumes the patient’s wishes, it is fundamental that the presumed wishes should be respected and that the best plan is adopted II. Where the family cannot presume the patient’s wishes, it is fundamental that the medical care team fully consults with the family as an alternative to the patient and that the best plan is adopted. This process should be repeated depending on the passage of time, changes in the patient’s condition, changes of medical evaluation and so forth III. Where the patient has no family or the family entrusts the judgement to the medical care team, it is fundamental that the best plan of medical treatment for him or her is adopted IV. The content of consultation in this process should be documented each time

Table 2 Extract from the “Guidelines on the Medical Decision-Making Process in the Terminal Stage of Life” 6 Medical Technology, Terminal Care and Criminal Law …

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These guidelines respect the patient’s wishes in principle in the following order of importance: (i) the patient’s actual wishes, (ii) the patient’s wishes as presumed by the family and (iii) the patient’s best plan of medical treatment. This direction will also be consistent with the above-mentioned theory. The guidelines suggest not only the substantive requirements of justifying cessation of treatment but also the procedural requirements of performing it correctly. “The medical care team consisting of multi-disciplinary specialists” seems to be especially important for preventing errors and improving the quality of judgement. In September 2018, it was reported that the Liberal Democratic Party (LDP) of Japan had begun to consider legislating a new law on endof-life care. The nonpartisan assembly federation drafted a “bill on the respect of the patient’s wishes in end-of-life medical care” in 2012, which was not presented to the Diet. The draft in 2012 justified the cessation of medical treatment under the condition of the patient’s advanced directive. The LDP also decided to reconsider the draft with the concept of ACP, encouraging the transparency of decision-making in clinical practice. As noted above, the decision of the Tokyo High Court in 2007 has already emphasized the necessity for legislation or guidelines on this issue. There is also a view that legislation is the most suitable way of ¯ justifying acts concerning the life and death of patients (Oya 2018, 141). Legislation would surely be desirable for the sake of legal stability. However, legislation without legal grounds is highly reckless (Kai 2009, 8). As the content of the requirements remains controversial in both theory and practice, it is questionable whether legislation would put an end to the present debate. First and foremost, it would not be an easy task to come to an agreement that can be legislated upon. The discussion should be further extended by an interdisciplinary approach. At the same time, preparation of a patient’s living will or advanced directive is exceptional in Japan. It is necessary to foster a “culture in the medical front” (Ida 2018, 112) that respects the patient’s self-determination in end-oflife medical care as planned by the guidelines issued by the MHLW. It is not too late to start legislative work even after confirmation of these prerequisites.

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Conclusion

From the viewpoint of (medical) criminal legal theory, active euthanasia is not justified. On the other hand, the cessation of treatment could be justified under the requirements of the patient’s self-determination and (the lack of ) the duty of medical treatment. However, there remain some issues in both theory and practice to consider regarding the two requirements before legislative work can start. Although medical progress often results in “unintended consequences” (Lock 2008, 882), it is ironic that developments in medical devices have promoted discussions on the justification of evoking a patient’s artificial death. In the cases of active euthanasia and cessation of medical treatment, medical devices might function not only as physical means of prolonging patients’ lives but also as psychological incentives to shorten them. The role of medical devices in terminal care should be reconsidered in the context of the physician–patient relationship as befits the new era.

References Hogle, Linda F. 2008. Emerging Medical Technologies. In The Handbook of Science and Technology Studies, 3rd ed, ed. Edward J. Hackett, Olga Amsterdamska, Michael E. Lynch, and Judy Wajcman, 841–874. Cambridge, MA: MIT Press. Ida, Makoto. 2018. Chiry¯o ch¯ushi wo megutte [On the Cessation of Medical Treatment]. Hanrei jih¯o 2374: 108–113. Irie, Takeshi. 2013. Case Comment. Saik¯o saibansho hanrei kaisetsu keijihen, Heisei 21-nendo [Commentary on the Supreme Court Judgements of 2009], 557–583. Kai, Katsunori. 2009. Euthanasia and Death with Dignity in Japanese Law. Waseda Bulletin of Comparative Law 27: 1–13. Lock, Margaret. 2008. Biomedical Technologies, Cultural Horizons, and Contested Boundaries. In The Handbook of Science and Technology Studies, 3rd ed, ed. Edward J. Hackett, Olga Amsterdamska, Michael E. Lynch, and Judy Wajcman, 875–900. Cambridge, MA: MIT Press.

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Machino, Saku. 2007. Kanja no jiko-kettei-ken to ishi no chiry¯o gimu [The Right to Self-Determination and the Physician’s Duty of Medical Treatment]. Criminal Law Journal 8: 47–53. MHLW (Ministry of Health, Labour, and Welfare). 2018. “Jinsei no saish¯udangai ni okeru iry¯o no kettei purosesu ni kan suru gaidorain” no kaitei ni tsuite [About the Revision of the “Guidelines on the Medical Decision-Making Process in the Terminal Stage of Life”], 14 March 2018. https://www.mhlw. go.jp/stf/houdou/0000197665.html. Accessed 15 June 2019. ¯ Oya, Minoru. 2018. Ripp¯o mondai to shite no sh¯umatsuki iry¯o [End-of-Life Care as a Legislative Problem]. Hanrei jih¯o 2373: 136–142. Shiroshita, Yuji. 2012. Sh¯umatsuki iry¯o (anrakushi/songenshi) [End-of-Life Medical Treatment: Euthanasia/Death With Dignity]. In Lecture Seimei-rinri to h¯o [Lecture on Bioethics and Law], ed. Katsunori Kai, 90–101. Kyoto: H¯oritsu Bunkasha. Shiroshita, Yuji. 2013. Sh¯umatsuki iry¯o wo meguru keih¯oj¯o no sho-mondai [Criminal Law Issues on End-of-Life Medical Care]. Criminal Law Journal 35: 103–110. Supreme Court of Japan. 2009. Judgements of the Supreme Court. Keishu 63/10 (2007 (A) 585), 7 December 2009 (Date of the Judgement). http://www. courts.go.jp/app/hanrei_en/detail?id=1037. Accessed 15 June 2019.

7 The Role of Incident-Reporting Systems in Improving Patient Safety in Japanese Hospitals: A Comparative Perspective Naonori Kodate, Ken’ichiro Taneda, Akiyo Yumoto, and Yoshiko Sugiyama

1

Introduction

At the turn of the century, patient safety was ensconced in the policy agenda of many English-speaking countries (Kohn et al. 1999; Department of Health 2000; Runciman and Moller 2001). The then UK Secretary of State for Health, Alan Milburn, wrote in the foreword of the government report An Organisation with a Memory as follows: Advances in knowledge and technology have … immeasurably increased the complexity of health care systems. Their unique combination of N. Kodate (B) School of Social Policy, Social Work and Social Justice, University College Dublin, Dublin, Ireland e-mail: [email protected] K. Taneda Department of International Health and Collaboration/Department of Health and Welfare Services, National Institute of Public Health, Wako, Japan e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Brucksch and K. Sasaki (eds.), Humans and Devices in Medical Contexts, Health, Technology and Society, https://doi.org/10.1007/978-981-33-6280-2_7

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processes, technologies and human interactions means that modern health care systems are among the most complex in the world. With that complexity comes an inevitable risk that at times things will go wrong. And in health care when things go wrong the stakes are higher than in almost any other sphere of human activity. (Department of Health 2000, v)

As Faulkner (2009, 2) states, “[h]ealth hazards and the societal apprehension of ‘risk’ have assumed an extraordinarily large place in the analysis of contemporary healthcare systems and public health”. While technology carries increased safety risks, it is also seen as offering part of the solution by monitoring the situation and providing timely alerts and the like. Incident-reporting systems have therefore been seen as a technological aid to tackling safety risks. Information and information exchanges are essential to the delivery of care, and in this chapter, incident-reporting systems, as part of information technologies, are considered as one key component of infrastructure and medical technology in a broader sense. Before incident-reporting systems were introduced in healthcare, they had already been a feature of many safety-critical industries such as nuclear power plants and offshore oil exploration, as well as transport sectors (Benn et al. 2009; Reason 2016; Stemn et al. 2018; Van der Schaaf and Wright 2005). This safety information system usually relies on voluntary reports submitted by frontline staff, and contains data regarding near-misses, adverse events (AEs) and safety concerns. The idea is to use the systems for organizational learning so that the delivery of care becomes safer. With the introduction of such a tool, socio-technical settings within organizational and societal contexts have become increasingly important. A. Yumoto Graduate School of Nursing, Chiba University, Chiba, Japan e-mail: [email protected] Y. Sugiyama Technology Division, Paramount Bed Co. Ltd., Tokyo, Japan e-mail: [email protected]

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Internationally, the concept of the “risk society” proposed by the German sociologist Ulrich Beck was published in 1992 (Beck and Ritter 1992). It outlines the uncertainty of safety in post-industrial economies, and was later expanded to include major incidents and disasters that could affect a large proportion of the world, if not all of it (Beck 1999; Cantelli et al. 2011). As demonstrated by the concept of the “precautionary principle” (Beck 2006, 334), preventive measures, supported by tools such as incident-reporting systems, were sought to mitigate levels of risk in organizations and society at large. The arrival of the concept of the risk society was observed in the healthcare sector, including in Japan. In 1999, two patients having surgery at the Yokohama City University Hospital were mixed up. In the same year, another AE took place at Tokyo Metropolitan Hiroo Hospital, and its Chief Executive (CEO) was prosecuted and convicted of deliberately concealing the event and violating the duty to notify it to the police. The turn of the century, therefore, also marked the beginning of a plethora of safety improvement initiatives and policies in Japan (Kodate 2012; Leflar 2009, 2012; Tahara 2007). As this chapter will show, Japan introduced national and local incident-reporting systems in the 2000s. Nationally, the third-party organization Japan Council for Quality Health Care (JQ) has been managing the web-based reporting system since 2004, and collects data associated with serious untoward events and incidents on a voluntary basis. Certain types of hospitals (e.g., national and teaching hospitals) are mandated to report. While the JQ collects incident data at national level, many healthcare providers use its reporting and learning systems at local (hospital) level (Hirose 2016). Each hospital has also been internally collating such information and using the data to address safety issues and concerns. However, despite the emphasis on incident reporting as a source of learning, there has been little research regarding how healthcare practitioners and hospitals utilize the system and data to address weaknesses in their processes. Therefore, the key questions are (i) how incident-reporting systems in the Japanese healthcare sector work, and (ii) how they are structured and function in comparison to those in other European countries. This chapter addresses these questions by tracing the development of reporting systems in Japan

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and comparing them with others in Europe. It focuses on the operationalization of incident-reporting systems within organizations and a broader country context. The chapter first outlines different concepts of safety, and the context in which patient safety policy has led to the development of incident-reporting systems in Japan. The method used to conduct the study reported in this chapter is then described, followed by the findings and a discussion.

1.1

Concepts of Safety

Safety has been defined as “the condition of not being in danger or of not being dangerous” (Cambridge Academic Content Dictionary 2009). In medical contexts, patient safety is concerned with “the prevention of errors and adverse effects to patients associated with health care” (WHO n.d.). In both cases, safety has long been considered to be an absence of some negative thing (e.g., obstacle), conditions (e.g., danger and risk) or consequences (e.g., harm and damage), rather than the presence of favourable conditions, things or results. Incidents in healthcare settings mean events that have or could have resulted in unintended serious harm. They may include near-misses, AEs and safety concerns. An AE, on the other hand, is defined as “an unintended injury to a patient, as a result of healthcare management rather than the disease process, sufficiently serious to prolong hospital admission or to cause disability persisting after discharge or to contribute to death” (Neale et al. 2006, 158). In Japan, there are two concepts of safety: anshin and anzen. Anzen broadly corresponds to the word safety, while anshin signifies a subjective sense of security and comfort (Kamide et al. 2015). Patient safety in Japanese is kanja anzen (patient safety), or iry¯o anzen (medical safety). Anshin, if it is used in the context of healthcare, would encompass personal and public trust in the delivery of care by healthcare practitioners and organizations such as hospitals and clinics. The combined term anzen-anshin is widely used as a set phrase in Japan (Kamisato 2017), applying to public security, food, infectious diseases, cyber security and natural disasters (MEXT 2004). The phrase became pervasive

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from the mid-1990s onwards following the Kobe earthquakes (Tanaka 1996) and the Sarin gas attack on the Tokyo subway (Taneda 2005). Subsequent events, most notably the Great East Japan Earthquake in Kobe and the Fukushima nuclear disaster, further heightened public awareness of safety and security. In the area of safety science, in 1997 the British psychologist James Reason (2016) presented an accident causation model used in risk analysis and safety management in a wide range of safety-critical domains such as aviation, nuclear plants and healthcare. At around the same time, also in Japan, a prominent scholar in the philosophy of science coined the term anzen-gaku (Safety Studies) (Murakami 1998). However, in Japan, there was a greater focus on the dwindling trust in social systems within healthcare delivery, and restoring a psychological sense of security (anshin) was therefore the priority. While the technology used for incident reporting was therefore not in itself new in safety-critical domains, incident reporting in healthcare had to be adopted in several stages. There have been challenges in the process of embedding systems so that reporting and learning from incident data takes place effectively in healthcare (Waring 2005, 1932). Over the last 20 years, reforms have been introduced, and in some countries, the system and procedure for licencing, registration and monitoring healthcare practitioners’ fitness to practice have been reviewed. The various performance measurements for both healthcare practitioners and service delivery organizations include the reporting of AEs and publication of safety records (Archer et al. 2017; European Commission 2014; Kodate 2018; Kovacs et al. 2014; Møller et al. 2016). Japan is no exception, although the degree of stringency of regulation and enforcement has been relatively modest (Hirose et al. 2003; Kodate 2012), as will be explained in the next section.

1.2

The Japanese Context

In Japan, the issue of how to handle and report “unnatural deaths” became the primary public policy matter for patient safety (Kodate

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2018, 218). Article 21 of the Medical Practitioners’ Law in Japan stipulates that, when an unnatural death occurs, a doctor is required to report the case to the police. The definition of “unnatural death” was understood to mean deaths from non-medical causes, criminal activity, sudden accidents, suicides, epidemic infections and so forth. However, the Japanese Society of Legal Medicine (Nihon H¯oi Gakkai) broadened the scope of interpretation in its guidelines, published in 1994. The definition of notifiable unnatural deaths included those possibly caused by medical management (Leflar 2009, 22–23). When the Hiroo Hospital case occurred, the connection was made and the lacuna in public policy became apparent (e.g., inadequacy of professional self-regulation, administrative oversight, governance of health service providers at that time). As a result of subsequent discussions and deliberations, two parallel national reporting systems have emerged in Japan. Governance of healthcare delivery in Japan is characterized by a centralized bureaucracy with weak political representation compared with the UK or the Nordic countries (Kodate 2018, 210). One of the reasons is that acute care in Japan is provided primarily through private hospitals (58%). National hospitals and regional hospitals (i.e., those managed by municipalities and prefectures) account for 8 and 12% of total bed provision respectively. In terms of ownership, private hospitals account for 69% of the total number of facilities (MHLW 2018). Under these arrangements, the healthcare system in Japan is not as politically charged as that in some other countries, and elected officials in the Diet (kokkai ) are not held accountable for delivery issues, including patient safety. These issues are not contested during general elections at national level, although the situation is different for publicly funded hospitals at regional level (Takaku and Bessho 2018). However, the national government is responsible for the registration of medical practitioners, with the Ministry of Health, Labour and Welfare (MHLW) administering a national licencing examination (Kodate 2018, 210). Regionally, prefectures provide licences for hospitals and monitor their legal compliance, benchmarked against guidelines laid down by the MHLW. In addition, the Ministry of Education, Culture, Sports, Science and Technology (MEXT) has overall responsibility for national university

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hospitals (Kodate 2018, 210). Japan’s incident-reporting systems have been implemented gradually under this complex web of accountabilities. Following major AEs in 2001, the MHLW internally established the Patient Safety Office (PSO) and the National Council for Patient Safety, consisting of experts who would review patient safety measures (Kodate 2018; Taneda 2019). In 2003, new requirements were introduced by the government for “advanced treatment hospitals” (tokutei kin¯o by¯oin), and these led to the appointment of medical safety management personnel, the establishment of a patient safety management department and patient consultation services in these hospitals (Taneda 2019). In the following year, mandatory reporting was introduced for advanced treatment hospitals only, and other types of hospitals were encouraged to take part on a voluntary basis. The MHLW amended the Ministerial Ordinance, obliging accredited health providers (including all national and national university hospitals) to ensure safety measures by reporting medical errors. This was enacted in October 2004. These hospitals began reporting patient safety incidents to the national AE reporting and learning system operated by the JQ, as previously mentioned. Two of the major functions provided by the JQ are: hospital accreditation (which is not mandatory, and is independent of the government) and adverse/near-miss event data collection and analysis (approved by the government) (Kodate 2018, 213). Since 2009, the Japan Obstetric Compensation System for Cerebral Palsy (JOCS-CP) has also been managed by the JQ. The JOCS-CP is a no-fault compensation and investigation/prevention scheme (Taneda 2019, 56).

1.3

Analytical and Methodological Framework

The analytical framework used for the study combines the sociotechnical approach with new institutionalism. The former has been used to examine the implementation of health information technologies such as electronic health records (e.g., Aarts et al. 2010; Carayon et al. 2011; Craig and Kodate 2018). The successful execution and running of such technologies require a good understanding of organizational structure, socio-technical settings and the processes where these technologies are

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embedded (Hogle 2008). Understanding the way in which the information is interpreted and used, and by whom, are also important factors if an organization is to maximize the benefits of such technologies (e.g., Hewitt and Chreim 2015; Hewitt et al. 2017; Sanne 2008). The latter framework, new institutionalism, looks at the ways in which social institutions (e.g., rules, norms, conventions) shape the behaviours of actors. The framework also emphasizes the stabilizing nature of institutions (Pierson 2001, 251). In order to answer the key questions, four semi-structured interviews were conducted with two hospital-based safety managers (one acute care hospital and one mental health hospital in the Greater Tokyo Area), and one Director of a PSO in a large teaching hospital outside Tokyo. Another interview was conducted with a representative who oversees the national reporting system (see the list of interviewees). These interviews were conducted between December 2016 and June 2018 in the Greater Tokyo area. The acute care (AC) hospital is a privately run, not-for-profit JCIaccredited teaching hospital with around 500 beds, whereas the university hospital is a national teaching hospital (TH) with more than 1000 beds. The mental health hospital (MH) is publicly run, and has 200 beds. Although it was difficult to select a representative sample in a country with more than 8000 hospitals and clinics, three different sizes (ranging from 200 to 1000 beds), types of ownership (public, private and national) and two types of care (acute care and mental health) provide a balanced view. In addition, all three hospitals have standardized incident-reporting structures, and take part in JQ’s reporting system. The lead author (Kodate) also conducted 12 interviews in four European countries (see the list of interviewees). The inclusion criteria for the interviewees were expertise in or a high level of familiarity with incident-reporting systems in their own countries. The interview guide included roles in, responsibilities for and experiences with incidentreporting systems and perceptions of the effectiveness of the systems. Usability, the level of standardization in the use and dissemination of the systems, the level of public involvement and the emphasis on systems learning were also queried. A similar guide was used for the interview with the representative of the national reporting system in Japan.

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It is worth noting that a similar study was conducted in England, where the lead author collated and analyzed the data in two English hospitals together with a UK-based human factors expert (Anderson et al. 2013; Anderson and Kodate 2015). In other words, where relevant, references will be made to similarities and differences between the Japanese and English hospitals in the next section.

2

Incident-Reporting Systems as Tools for Organizational Learning

As previously mentioned, each hospital sets up its own local reporting and learning mechanisms and processes in Japan. Depending on the type of provision (national, regional, teaching or private) and the resources available, the arrangements can vary. The following simplified schematic diagram offers one such example (Fig. 1).

Departments and Wards Nursing; Surgery; Psychiatry; ME; Pharmacy; ER; ICU; HCU, etc. Serious Untoward Incident to be reported immediately

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Grade 1: Mild Adverse Event 2: Moderate Adverse Event 3: Severe Adverse Event 3a: Severe AE which required simple treatment 3b: Severe AE which needed intensive treatment 4: Life-threatening or disabling Adverse Event 5*: Death related to Adverse Event * When unanƟcipated deaths occur and appear to be caused by inappropriate medical care or management, all healthcare providers are required by law (since 2015) to report them to the Japan Medical Safety Research OrganisaƟon, which is a third-party independent body.

To be inves gated and reported within 45 days of the AE occurring

Nursing Pa ent Safety Commi ee (PS reps from each Ward)

Pa ent Safety Commi ee

Pa ent Safety Conference

(Reps from Department/Unit. e.g. pharmacist, AHPs, radiographer, etc.)

(Clinical Leads + Head of Nursing PS CommiƩee)

Fig. 1 Reporting processes in a Japanese hospital (Source Kodate et al. 2019)

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Incident Data Collating Processes in Japanese Hospitals

When personnel witness or discover an incident, including AEs, they report it online, using a software package. The PSO consists principally of the Director, who is a medical doctor/senior consultant, and the Safety Manager (SM, registered nurse, seconded to PSO), supported by a few administrators. The size of the PSO team was more or less the same across the three hospitals that we examined. In the interviews, all three SMs referred to the limited manpower available to them for handling the great amount of data (interviews, AC, MH and TH). Compared with the study conducted in two teaching hospitals in England, the difference was stark, particularly between acute care and teaching hospitals (AC/TH). In the acute care teaching hospital in England, a risk manager was assigned to each clinical department and worked closely with the department’s risk lead who was usually a medical doctor (Anderson et al. 2013, 143). In the Japanese acute care hospital (AC), as mentioned above, there was only one registered nurse, seconded to the PSO, to act as a full-time SM. The administrators who work alongside SMs were neither dedicated to patient safety matters, nor trained as risk managers, unlike their counterparts in the hospital in England. The Safety Manager in Japan reports directly to the Chief Executive, and may not necessarily return to their original nursing post. The SM accesses the database directly, and each morning reviews incidents that have occurred during the previous night, checking the seriousness of each case. Here AEs are classified into six grades: Grade 1, Mild AE; Grade 2, Moderate AE; Grade 3a, Severe AE which required simple treatment; Grade 3b, Severe AE which needed intensive treatment; Grade 4, Life-threatening or disabling AE; and Grade 5, Death related to AE. It is worth noting that a standard classification in Japan is that defined by the Committee of the National University Affiliated Hospital Safety Management. When a relatively serious incident (graded as 3b or higher, for example, a bone fracture due to a fall) is reported, the SM checks the medical record of the patient involved, and visits or calls the ward to speak to staff. In parallel with this process, a head nurse in each unit

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is required to know what incidents took place on the previous day, and has to respond. The SM liaises with head nurses before officially accepting a report. In the nursing group, there is a lead nurse, designated as someone who is in charge of patient safety. While frontline personnel can input data into the software system (e.g., CoMedix, Cybozu, SafeMaster), people who have access to the database are limited to the SM, Medical Director, Deputy Medical Director and the Patient Safety Head Nurse. The Medical Director, in theory, can see the database, and the SM puts together the list of AEs in hard copy. A reporter decides on the seriousness, and also fills out the recommendations in the report via the software. Therefore, it is crucial that the SM checks each report, assessing the appropriateness of the grade and the recommendations. There is a column for the SM to type in the feedback, although this may not be seen by the reporter unless they check the system. The SM occasionally receives queries via email from a reporter with regard to the actions resulting from their report. The SM responds to such queries individually by email. It is entirely at the SM’s discretion and depends on their capacity (interviews, AC and TH). In order to share the information, many hospitals use collaborative software (groupware). Information regarding critical incidents and remedial actions is shared through the software systems mentioned. When critical incidents occur (Grade 3b and higher), these cases are brought up with selected committee members at a weekly early morning meeting (called Patient Safety Conference). The meeting may not be held if there have been no serious cases reported in the previous week. For more serious incidents (Grade 4 and higher), an emergency meeting is called, which clinical leads from relevant units are required to attend (interviews, AC and TH). To sum up, the first step is to report, grade and classify the seriousness of the incident. Sometimes the same incident is reported multiple times by different practitioners, or by those from different professional healthcare groups (e.g., nurses, pharmacists and medical device technicians), or an incident that is discussed had not been reported by anyone. In such cases, the SM coordinates any action so that the case will be recorded in a consistent manner.

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At this initial stage, the challenges include the poor quality of the original reports and lack of clarity regarding what to report, although a manual on how to report is normally provided by PSOs in hospitals. This issue was raised both in England and in Japanese hospitals (Anderson et al. 2013, 146). Safety managers must oversee quality, and need to go back to reporters, which highlights the significance of integrating how incident-reporting systems are used into induction and training sessions for new entrants and trainees. In both countries, some resistance towards or reluctance to engage with the reporting activities was mentioned, particularly among medical doctors, as opposed to nurses, pharmacists and medical device technicians (Anderson et al. 2013, 147). However, in the case of Japanese hospitals, underreporting did not feature as prominently as in the study conducted in England. All three SMs emphasized the increase in reporting activities in recent years. Nevertheless, the SM in TH admitted that challenges still exist when dealing with clinicians who try to refute the argument that reporting will lead to safety and better quality of care. He mentioned that the PSO team have created a pocket-sized manual in which recommendations for selected incidents are written. The members of the team carry it on them, and show it to clinicians to convince them that reporting contributes to learning (interview, TH). In other words, the “no blame” attitude prevailing in Japan appears to be embedded in the participating hospitals, too. Infrastructure (e.g., easy access to software on desktop computers available on wards) serves the purpose, and some improvements in user-friendliness in recent years have also been noted (interview, AC). The perspective on “senior” (senpai ) and “junior” (kohai) was an additional sociocultural dimension, typical of Japan. For example, a senior nurse, reflecting on her own learning journey, felt responsible for errors reported by a junior nurse. There is also a strong sense of reporting verbally to senior members of staff, particularly among nurses, before they use the reporting system. Overall, the SMs carry a great share of the responsibility, as they oversee the entire set of incident reports, and are the lynchpin of the whole reporting and communication process. It is worth noting that SMs in Japan are mostly nurses seconded from their clinical duties, unlike in

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English hospitals, where SMs are full-time managers who may not even be clinically trained. The process for reporting to the external body (JQ) is an entirely separate one. Online reporting is open to registered hospitals, clinics and dental care providers. There are two categories, medical accidents and near-misses. Medical accidents include: (1) death or physical or mental disability persisting as a result of evident errors in medical care or management, or care requiring unanticipated or greater care and treatment; (2) similar to (1), where errors are not evident but suspected and unanticipated; (3) other than (1) and (2), with cases that contribute to prevention of medical accidents (Fig. 2). Near-misses include: (1) an error that was committed in medical care but was detected before it caused any harm to a patient; (2) an error that was committed but did not have any impact on a patient or had a slight impact that required minor treatment (e.g., disinfection, moistening, administration of analgesics, etc.); and (3) an error that was committed, with the impact being unknown (Fig. 3).

Nursing care

33.9 %

Treatment / procedure

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9.4 %

Drainage tube etc.

7.7 %

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Blood transfusion

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Other

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Fig. 2 Medical accidents, by type, reported from 274 healthcare facilities with mandatory reporting obligations (Total number of accidents reported: N = 4030; January to December 2018) (Source JQ 2019, 15)

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Drug

31.7 %

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Medical device etc.

3.3 %

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100,000 150,000 200,000 250,000 300,000 350,000

Fig. 3 Near-misses, by type, reported from 514 healthcare facilities with mandatory reporting obligations (Total number of near-misses reported: N = 921,140; January to December 2018) (Source JQ 2019, 18)

This voluntary reporting system at national level provides the JQ with an overview of safety and quality in 1502 hospitals, clinics and dental care facilities across Japan (as of December 2018, JQ). As previously mentioned, in the Japanese healthcare system, only a small proportion of hospitals within the total provision are legally required to report. 274 hospitals (containing a total of 140,188 beds) are mandated to report medical accidents, while the rest (797 hospitals) voluntarily engage with the reporting process. This amounts to 12.8% of the total number of hospitals (8365, according to MHLW 2018). Between January and December 2018, 4565 medical accidents and 31,073 near-misses were reported, and the number is on the increase each year (JQ 2020). The voluntary nature of the system, and the patient safety alerts which the JQ communicates by facsimile and on the website, incentivize care providers to engage with the system (Fig. 4). There is also scope for exchanging information internationally and learning from each other. The JQ has teamed up with the Canadian Patient Safety Institute, and now disseminates safety alerts and information internationally. It also sends out SMS alerts nationally (interview, JP).

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40,000 35,000 30,000 25,000 20,000 15,000 10,000 5,000 0 2010

2011

2012

2013

Medical Accidents

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Near-Misses

Fig. 4 Number of medical accidents and near-misses reported to JQ, 2010–2018 (Source JQ 2018, 7; JQ 2019, 18)

2.2

Feedback from Incident Data in Japanese Hospitals

Japanese hospitals have several committees set up to discuss and analyze the incident data and decide on remedial actions (Fig. 1). Some senior members sit on all the committees at different levels within an organization, hearing the same cases (Grade 3b and higher) several times. The SMs believe that this is an important, iterative process of feedback for learning. In the acute care hospital in this study, there is a monthly plenary meeting which every healthcare staff member is invited to attend, and where a list of serious incidents from each department is presented. At this meeting, apart from anonymization of patients’ identifiable information, the original reports are presented to the whole plenary meeting. The SM stresses the importance of an “open culture”, raising awareness of reporting incidents and cascading the information to frontline staff. As a feedback mechanism, the online system alone can be unreliable, because the information can easily pass unnoticed. Providing feedback effectively from incident-reporting systems is one of the major challenges, as the key aspect of reporting and learning systems is this “output” (e.g., lessons from incidents) and “outcome” (e.g., safer care and quality

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improvement). This challenge has been noted by many other studies (Anderson et al. 2013; Benn et al. 2009; Møller et al. 2016). The timing of the feedback to frontline staff is also very important, as some remedial actions may need to be taken (interviews, AC, MH and TH). As the feedback is centrally provided through the online platform, actions tend to be decided and implemented in a more decentralized manner (e.g., ward, professional groups), particularly in large-scale acute care settings. For hospitals and clinics, another source of feedback can be found in safety alerts and recommendations from external bodies such as the JQ. However, in the two hospitals (AC and MH), the resources did not appear to be systematically used, whereas in TH the catalogue of safety alerts was regularly circulated and shared within the organization by its SM. The following section compares the link between national and organizational reporting systems, based on the data from expert interviews.

3

Varieties of Incident-Reporting Systems in Europe

In 2017, the Organisation for Economic Cooperation and Development (OECD) published a commissioned report entitled “The economics of patient safety: strengthening a value-based approach to reducing patient harm at national level” (Slawomirski et al. 2017). The report states: Learning from AEs is a key part of any quality and safety improvement strategy at institutional level. This is based on sound reporting systems that are usually voluntary in nature. Reducing cultural and legislative barriers to do so plays an important role …. A reporting systems [sic] also ensures that incident reports are reviewed and investigated when necessary to establish the root causes of the incident and to generate learnings. (Slawomirski et al. 2017, 58)

However, according to the overall findings from the survey, the least favourably rated interventions were “mandatory reporting of specific AEs typically called sentinel events” at macro/national level. Although this

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was favoured in several jurisdictions of different European countries, the JQ’s reporting and learning system in Japan is operated on a voluntary basis (except certain types) (interview, JP). This section reviews semistructured interviews conducted with policy experts from four European countries (Denmark, Germany, Ireland and the Netherlands) between January and December 2017. The background and basic structure of the country’s reporting systems are provided at the beginning of each section (European Commission 2014).

3.1

Comparing Incident-Reporting Systems Across Europe and Japan

3.1.1 Denmark In Denmark, with its mandatory reporting system, the data are shared across different levels—national, organizational and clinical. One expert describes the reporting process, and the role of an SM in a hospital: When the data is submitted to the risk manager, the risk manager sends it to the department. And the department usually have a number of safety representatives, typically a mixture between the disciplines that are represented, you know nurses or doctors who have responsibility for certain areas or specialties at the department. And it’s actually their job to kind of transform this incident report to learning. … after the local learning process has happened … the safety representative has written kind of an answer, conclusion. The incident report is anonymized and then sent to the Danish Patient Safety Authority. (DK-1)

This coordinated approach in Denmark can be partially explained by the protection from penalties: “I think that having the reporting system is very valuable … one of the main values in this is that it’s, you cannot be punished for reporting AEs in this system” (DK-2). However, the nonpunitive aspect of the system can attract criticism from elected officials and the police, as the reporting system can be accessed from community care settings.

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Another noteworthy characteristic is that the Danish system is open to reporting from patients and relatives (Table 1), and from nursing homes. “But the reports from patients and relatives are very limited and what Table 1 Outline of incident-reporting systems of examined countries (acute care) Country

Characteristics of national incident-reporting systems

Japan

– Agency: Japan Council for Quality Health Care, JQ (third-party organization) – Mandatory reporting: Yes (advanced treatment hospitals only) – Reported content: All serious AEs and near-misses – Law: Ordinance of the Ministry of Health, Labour and Welfare (Heisei-16-nen Kosei-r ¯ od ¯ o¯ shorei ¯ dai-133-go), ¯ 2004 – Agency: Danish Society for Patient Safety, PS (third-party organization) – Mandatory reporting: Yes – Reported content: All serious AEs – Law: Act on Patient Safety (Lov om patientsikkerhed i sundhedsvæsenet), 2003 – Agency: Agency for Quality in Medicine, AQuMed (third-party organization) – Mandatory reporting: No – Reported content: Primarily near-misses – Law: Patient Rights legislation (Gesetz zur Verbesserung der Rechte von Patientinnen und Patienten, Bundesgesetzblatt [BGBl]), 2013 – Agency: Health Information and Quality Authority (third-party organization)/State Claims Agency (government body) – Mandatory reporting: Yes – Reported content: All serious AEs – Law: Patient Safety (Notifiable Patient Safety incidents) Bill, 2019 – Agency: Health and Youth Care Inspectorate IGJ (government) – Mandatory reporting: Yes – Reported content: All serious AEs – Law: Healthcare Quality, Complaints and Disputes Act (Wet kwaliteit, klachten en geschillen zorg), 2015

Denmark

Germany

Ireland

The Netherlands

Source Compiled from interview data

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we know so far about that is that most patients or relatives that report are people who have a professional background in health care.” (DK-2) A greater number of incidents is reported from community care settings, primarily associated with medications and the ageing population. As a way of overcoming the lack of timely feedback, some initiatives were taken in care homes, moving away from the electronic reporting system. “We made a piece of paper for them. Because they had a lot of falls, a lot of patient falls at nursing homes. And a lot of patients didn’t get their medicine, so … they just have to fill one line and that’s it and it’s just on the table in the middle of the nursing home, they have a small office usually. And we had a pilot project on this in about 10 municipalities and they were very, very happy with it because it was so easy to make this reporting” (DK-3).

3.1.2 Germany In Germany, the emphasis is on learning from near-misses and learning at clinical/local level (Table 1). The fragmented system at national level was portrayed as problematic by the experts interviewed. “One Regional Chamber of Physicians provides one reporting system, a regional one for hospitals. But there are others, such as a national reporting system for the intensive care and anaesthesiology departments. There is another one in the region. And this is both for the ambulatory care and patient care. There is a national reporting system for hospitals. Then there is the commercial one for hospitals as well …” (DE-1) Where there is no standardization, the quality of information can be questioned and its validity decreases. “As with most systems if they are local or paper based or electronic trans-national, whatever, the level of analysis, the quality of the analysis depends on the quality of the reports. So often you can’t really analyse the cases properly” (DE-2). Also in Germany, AEs are not shared. “[L]ike the society of surgeons or internal medicine and so on, they view the serious incidents and some of them will be reported like in professional journals and so on. But it’s not a systematic way.” (DE-2) “The clinicians would be very interested in changing something at local level. And for some incidents if it goes

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through the central Risk Management Department and then comes in top down … then they will build up resistance” (DE-1). However, the law mandates each hospital to use these incidents, analyze them, “derive recommendations for future practice and so on. And they have to report in the yearly quality report about some results from the incident reporting. These quality reports are an obligation, they have to publish it on their website” (DE-2).

3.1.3 Ireland Ireland is an interesting case. In response to a national scandal involving medical errors, the government’s Health Service Executive set up a serious incident management team in 2008. However, the National Incident Management System (NIMS), hosted by the State Claims Agency (SCA), had already been established as an incident information system. A hospital has an obligation under NIMS information to ensure that incidents are notified to the SCA. In 2015, a single standard incident report form was introduced under the upgraded NIMS. There needs to be a transitional period before national and local reporting systems are reconfigured and standardized. [W]ell not everywhere has electronic. A lot of places are still evolving ok. So in the HSE [Health Service Executive, a government body responsible for the provision of health and personal social services in Ireland] they have the HSE steering group, and NIMS steering group. Which is trying to enhance NIMS, make it easier to report. And the ideal is to have each unit report their own incidents. At the moment the risk manager gets all the incidents on a paper form. And they have to input it into the national incident management system (IE-1).

This means a duplication of work, and variations in quality. “It is really inefficient and it is a big problem because the quality and safety teams in the hospitals are very small. I mean I think there is about 4 to 6 in each site of people and they are just spending most of their time physically inputting and recording data” (IE-2).

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There is also an issue with the fact that the primary purpose of the NIMS is to deal with claims. From the point of view of the SCA, learning is entirely up to each local hospital, however hospitals are mandated to report. “I suppose it’s up to each hospital to take responsibility and to decide how they’re going to manage those risks that have been identified you know” (IE-3). The Irish government recently passed the Patient Safety (Notifiable Patient Safety Incidents) Bill 2019, making reporting mandatory.

3.1.4 Netherlands In the Netherlands, all care providers are mandated by law to report serious AEs (sentinel events) to the Dutch Health Inspectorate (Inspectie Gezondheidszorg en Jeugd, IGJ, part of the Ministry of Health) within 3 days. The IGJ collates, analyzes and assesses the quality of AE reports coming from hospitals, primary care and nursing homes. While hospitals and providers use electronic reporting systems for their own learning, there is now a great focus on learning at national level in the Netherlands, particularly in the acute care sector. One expert stressed the evolutionary step of the reporting systems in the country. “In the hospitals in the Netherlands we are now at the stage that they’re all reporting and that they are all able to do an adequate incident analysis with an internal team … I think the next step in our country for the hospitals is to focus on the quality of the safety recommendations, the improvement recommendations” (NE-1). Contrasting the Dutch system with the fragmented reporting situation in Germany, one interviewee, who had worked in acute hospitals in both countries, commented that the “unscientific” aspect of incidentreporting systems has been raised as a reason for doctors’ lack of support and enthusiasm for a more integrated reporting system at national level. “If we do something it must be scientifically proven, must be perfect. Otherwise we don’t. And the Dutch are more pragmatic, they say ok we have to do something so let’s do it and we will improve it along the way …” (NE-2).

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Like Denmark, the Netherlands has a relatively “open” reporting system. Trust is an important issue in society more broadly, and for the reporting systems to work, because tension exists between open disclosure for the public and a safe space for using such sensitive information (i.e., AE data) for improving care. While the Inspectorate is reluctant to share the AE data that they collect with the public, elected officials or other public authorities can put pressure on them to release it. “When you share this information on how many incidents are taking place you need to also manage the way in which you communicate this because you don’t want there to be panic” (NE-3). In addition, careful judgement and assessment of data based on professional knowledge and expertise is essential to maintaining healthcare professionals’ trust and engagement. There is “a very clear distinction between complications, incident and calamities. A complication means we have an unwanted result but the processes leading to this were ok. And that’s what can happen if you perform surgery, you can have a re-bleed …” (NE-2). The Japanese (JQ) approach to incident-reporting systems resembles Denmark’s non-punitive approach, which is arguably essential for engaging and increasing the number of participating organizations (interview, JP). However, it differs greatly from the Danish system’s high level of standardization and openness towards the general public. In this sense, the Japanese system works more like those of the Netherlands and Germany (Table 2). In terms of dissemination to wider society, the JQ regularly holds a press conference and explains reported incidents in detail as part of its outreach and public engagement activities. The Irish system is a peculiar case of having an old, firmly established reporting system (NIMS), which may take a while to be replaced by a new system. In the case of Japan’s other reporting system, established to handle unnatural deaths, it is hoped that the creation of a separate system will lead both to better understanding of each episode and to preventive measures.

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Table 2 Summary of incident-reporting systems of the examined countries

Usability Level of standardization Level of public involvement Dissemination and support Emphasis on systems learning

Japan

Denmark

Germany

Ireland

The Netherlands

High High

High High

Low Low

Low Low

Mixed High

Low

High

Low

Low

Low

Strong

Strong

Mixed

Mixed

Strong

Mixed

Strong

Limited (nearmisses only)

Mixed

Strong

Source Authors’ own data Notes The scores of low, mixed and high were given based on the interviews

4

Conclusion

This chapter has described how incident-reporting systems work in Japan, primarily at national and local (organizational) level. Although patient safety had been seen as being on the “margins” of care delivery, the mainstreaming of the issue has been gradually achieved in many advanced economies. Safety management is embedded in their organizational processes and daily clinical practices. Incident-reporting systems are now an essential part of the infrastructure and tools in clinical settings. Incident-reporting systems represent an interesting case of human– system interactions in medical contexts. First and foremost, they serve as a repository of information on what went wrong and how. They can also be used as a communication tool to share information about their environment. How the data itself is used for learning depends mainly on local resources and organizational processes. In the case of incident reporting, other human-to-human interactions such as discussions, socialization (senior–junior staff relationships) and professional group boundaries are very influential. Given that this safety information system relies on reports submitted by frontline staff and contains very sensitive data, a high level of trust and perceived usefulness are necessary conditions for it to work efficiently.

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The incident-reporting systems in Japan (especially in acute care hospitals) have been developed organically and embedded in local settings over time. Reporting to the JQ is on the increase, and the principle of voluntary reporting, with its proactive alert system, enhances its perceived usefulness. Although the synthesis of information derived from local and national systems occurs haphazardly and is relatively weak, both the infrastructure and a strong commitment to patient safety at organizational and clinical (micro) level facilitate reporting activities. Our examination of the local (hospital) and national (regulatory) nexus associated with incident-reporting systems in four European countries shows clearly that there are marked differences in the way systems are set up and used across countries. Whilst there is a broad consensus that incident-reporting systems can be a useful tool, legal requirements for reporting, regulators’ remit, professional groups’ engagement with reporting and methods of reporting (paper based/electronic) all appear to be variables. This demonstrates that incident-reporting systems at macro level are shaped by social institutions and how they have evolved in each national jurisdiction. One of the common themes to emerge was trust and confidence building among stakeholders and the general public. Learning from errors can be shared widely across hospitals and even countries, but trust in social institutions must first be established and their usefulness proven to practitioners, frontline staff and patients. Overall, the term anshin appeared to be prioritized over anzen in Japan, both at societal and organizational levels, particularly in Japan’s approach to the adoption of safety science. Unlike in several European countries, a more general idea of risk management, as suggested by Beck’s risk society concept, had not permeated the highly professionalized healthcare sector in Japan. Future challenges will include limited resources (in particular, understaffing in the PSO and insufficient investment in technologies and devices) committed to the patient safety and quality improvement domain in Japan, and how to create an environment that supports learning both locally and nationally. Staff shortage in the sector more broadly is also worth noting. Applying socio-technical and institutional perspectives to the analysis of incident-reporting systems will further help highlight the strengths of current practices and enhance collective learning for more robust implementation of safer practices.

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List of Interviews Japan AC (Interview ID), Safety Manager in an acute care hospital, 10 January 2017. MH (Interview ID), Safety Manager in a mental health hospital, 26 December 2016. TH (Interview ID), Director of Patient Safety Office in a teaching hospital, 22 June 2018. JP (Interview ID), Representative, national incident-reporting centre, 22 June 2018. Denmark DK1 (Interview ID), Representative, non-governmental body for the promotion of patient safety, 5 July 2017. DK2 (Interview ID), Representative, national incident-reporting centre, 7 July 2017. DK3 (Interview ID), Researcher in patient safety, 30 August 2017. Germany DE1 (Interview ID), Safety Manager, university hospital, 21 July 2017. DE2 (Interview ID), Manager, region-based incident-reporting centre, 11 September 2017. Ireland IE1 (Interview ID), Government official in charge of patient safety policy, 25 January 2017. IE2 (Interview ID), Researcher in patient safety, 20 February 2017. IE3 (Interview ID), Representative, state-funded regulator in charge of quality and standards of care, 15 March 2017.

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IE4 (Interview ID), Representative, state-funded regulator in charge of incident reporting, 12 May 2017. The Netherlands NE1 (Interview ID), Representative, third-party national regulator in charge of patient safety and incident data, 1 March 2017. NE2 (Interview ID), Researcher in patient safety, 16 March 2017. NE3 (Interview ID), Safety Manager/doctor in university hospital, 15 September 2017.

Part IV Innovation and Diffusion of Medical Devices

8 The Postwar Medtech Industry in Japan: A Business History Perspective Pierre-Yves Donzé

1

Introduction

The exploration of the conditions of the emergence of medical technology in the Japanese socio-technical settings context addressed by this volume provides an excellent opportunity to offer a business history perspective. The STS literature has demonstrated that medical technology does not develop autonomously as a mere outcome of the progress of science, but must be approached in relation to “other aspects of daily life, commerce, and governance” (Hogle 2008, 841). However, although few works have emphasized that the development of medical technology should be understood within the context of what Reiser This work was supported by a Grant-in-Aid for Scientific Research, (C) 17K03839. I wish to express my utmost gratitude to Raphaël Imer (Enovating, Neuchâtel, Switzerland) who developed the global medtech patent database.

P.-Y. Donzé (B) Osaka University, Suita, Japan e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Brucksch and K. Sasaki (eds.), Humans and Devices in Medical Contexts, Health, Technology and Society, https://doi.org/10.1007/978-981-33-6280-2_8

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(1978) called the medical-industrial complex, the business history of medicine is still an emerging field (Donzé and Fernandez Perez 2019). Yet, research and development (R&D) carried out by medical device companies is highly influenced by their relations with other organizations like universities and hospitals, and by external factors such as the way doctors practice medicine and the structure of medical markets. The major characteristic of Japan in an international comparative perspective is the presence of a hospital system based on a large number of small private hospitals, while hospital systems in Europe and America are rather based on a lower number of large (often public) hospitals. Unlike other countries, the Japanese government did not intervene to organize the hospital system, nor did it concentrate high-tech equipment in a small number of establishments (Donzé 2018). In 2000, there were 73 hospitals per million population in Japan, far more than in Germany (44.2), the US (20.6) and the Netherlands (13.1) (OECD 2018b). Moreover, due to the competition between hospitals to attract patients, they usually acquire the newest technology (Ikegami 2014). Independent doctors working in private surgeries do the same. The competitiveness and the high fragmentation of the Japanese hospital system are driving forces for the diffusion of technology. In 2014, Japan was the country with the highest density of medical equipment. It had 107.2 CT scanners per one million population, against 41 for the US, 35.3 for Germany and 13.3 in the Netherlands (OECD 2018c). As for MRI, Japan was also number one in 2014, with 51.7 scanners per million population against 38.1 for the US, 30.5 for Germany and 12.9 for the Netherlands (OECD 2018d). While the high competitiveness of the hospital system is a major driving force of the diffusion of medical technology, at the same time hospitals have less capital to invest in equipment than hospitals in Europe or the US, due to their smaller size. Hence a major issue for discussion is the conditions under which foreign medical technology can be applied to the Japanese socio-medical context, and how Japanese firms can supply their goods to other countries. Looking at the development of medical technology by private companies makes it possible to highlight the specificities of the Japanese medtech industry in particular and the socio-technical settings in Japan more generally.

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Literature on the Japanese medtech industry is sparse and focuses mostly on specific cases. Three major topics have attracted the attention of scholars. First, several works in social science and business history have emphasized the importance of small and medium-sized enterprises (SMEs) in this sector. Takeuchi (1974) demonstrated the presence, during the high-growth years, of a cluster of small manufacturers of medical instruments in Tokyo, explaining this by the proximity of customers (medical doctors, hospitals and medical schools). Similar clusters can also be observed in Osaka and in Kyoto since the Meiji period. The manufacturers of medical instruments not only imported and copied products from Germany and the US, but also adapted them to the requirements of Japanese doctors and to the specificities of the Japanese medical market (Donzé 2016). The ability to co-develop medical equipment together with doctors increased the competitiveness of Japanese SMEs. Shimadzu, for example, was able to dominate the market for Xray devices against the multinational Siemens during the interwar years (Donzé 2018). Moreover, after World War II, some specialized SMEs, like the producer of syringes Mani, expanded in foreign markets on the strength of high-quality goods developed for niche markets (Sakai 2018). However, Oshita and Ikeno (2016) argued that a major problem for medtech SMEs in Japan is that neither are they frequent targets of a merger by large companies, nor do they have the ambition to become listed. In the US and in Western Europe, mergers and acquisitions (M&A) and initial public offering (IPO) are important ways of supporting the growth of medtech SMEs in the global market, but in Japan, their owners prefer to follow the traditional model of gradual development of a small and independent company. The second topic of research is large multinational corporations, especially firms engaged in the field of diagnostic imaging devices (X-ray, computed tomography [CT] scanners and magnetic resonance imaging [MRI]). Japanese giants of the electronics industry, like Toshiba and Hitachi, dominate the domestic market, together with a few foreign companies like General Electric (GE) and Siemens (Nishimura 2010; Onuma 2010). Gelijns and Rosenberg (1999) argue that this competitiveness has relied on continuous investment in research to improve

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this technology since the early decades of the twentieth century. Consequently, research shows that both SMEs and large companies have a competitive advantage in the Japanese medtech industry. This is, however, not a contradiction, as the two types of firms have developed distinct products and equipment (Donzé and Imer 2020). The third issue is regulation. The Japanese authorities do not recognize trials and safety regulations adopted by foreign governments but maintain their own standards that act as non-tariff barriers to protect local manufacturers (Altenstetter 2014; Tamura 2013). According to Foote and Mitchell (1989), measures adopted by Japanese authorities in the 1970s and 1980s (import approval, prices fixed by the authorities, non-recognition of foreign safety tests and information) led to a trade deficit for the US medtech industry from the mid-1980s and gave way to an investment strategy in sectors in which American companies had a technology lead, for example in pacemakers. However, as I will discuss below, the overall presence of foreign firms is very low. Moreover, although regulation has recently been eased (for example, the reform of the Pharmaceutical and Medical Devices Act in 2014 expanded thirdparty certification in order to facilitate the access of Japanese markets to foreign companies), as yet there has been no noticeable effect on the presence of foreign firms and devices in Japan. Consequently, literature on the Japanese medtech industry focuses essentially on case studies of successful firms and on regulation. The position of these companies in the global medtech industry is not discussed. Hence, the objective of this chapter is to offer a general understanding of the dynamics of the Japanese medtech industry from the 1960s until today. The main research questions addressed here are: What are the characteristics of Japanese medtech companies in an international comparative perspective? How have they changed over time? How do Japanese firms expand on global markets? What presence do foreign medtech firms have in Japan and what is their role? This research is based on the methodological approach of business history and the analysis of data from various databases (Thomson One on M&A and PATSTAT for global patents). The chapter is in six sections. Following this introduction, Sect. 2 gives a general overview of the medtech market in Japan. Section 3 discusses the innovativeness

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of Japanese medtech firms, based on an analysis of patent applications. Section 4 uses M&A data to shed light on the transformation and globalization of the medtech industry. Next, Sect. 5 focuses on two important case studies (Olympus and Toshiba) and Sect. 6 discusses the presence of foreign medtech companies in Japan. General conclusions are drawn in Sect. 7.

2

A Macroeconomic Overview of the Japanese Medtech Market

The major characteristics of the medtech sector are emphasized in statistical data giving a macroeconomic overview of its evolution. First, one must stress that the Japanese market for medical devices experienced rapid growth between the 1970s and the mid-1990s (see Fig. 1). The value of national production, which was under 100 billion yen from 1955 to 1969, went from 119 billion in 1970 to 720 billion in 1980 and 1,337 billion in 1995. In regard to gross domestic product (GDP), 1 800 000

0.80

1 600 000

0.70

1 400 000

0.60

1 200 000

0.50

1 000 000

0.40

800 000

0.30

600 000 400 000

0.20

200 000

0.10 0.00 1955

1960

1965

1970

1975

1980

1985

Production in current yen

1990

1995

2000

2005

2010

As a % of GDP

Fig. 1 Production of medical devices in Japan (in million yen and as % of GDP) (Source Based on Yakuji kogy ¯ o¯ seisan dotai ¯ tokei ¯ nenpo, ¯ Tokyo: MHLW, 1955–2010)

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1,200,000 1,000,000 800,000 600,000 400,000 200,000

1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

0

Import

Export

Fig. 2 Import and export of medical devices in Japan (in million yen) (Source Based on Foreign Trade Statistics, 1985–2010)

the growth was particularly important in the 1970s (from 0.06% in 1970 to 0.25% in 1980). Consequently, the growing domestic market represented a good opportunity for growth for Japanese companies. On the other hand, the expansion of the Japanese market for medical devices attracted many foreign companies. Although few of them invested directly in Japan (see below), they accessed this market through exports. Figure 2 shows a continuous increase of imports, which multiplied by five between 1985 and 2010. The market share of imported goods went from 19.9% in 1985 to 45.6% in 2000, then stagnated at an average of 46.5% in 2001–2010.1 It means that about half of the market is dominated by foreign devices. As for exports, they show a similar level to imports until the early 1990s, then a general slow growth during the following two decades. However, as there was also a slow increase in production during this period, export represent a slightly growing share of production: 19.7% in 1985, 24.4% in 2000 and 26.5% in 2010. This statistical overview highlights two successive phases in the development of the postwar Japanese medtech industry. First, until 1990, the market experienced rapid expansion and was dominated by domestic 1The

size of the market was measured as production + import – export.

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firms, which did not particularly expand abroad. Second, from 1990, the domestic market entered a phase of slow expansion but with a growing importance of foreign products. The relaxation of accreditation regulations for foreign medical devices since 2000 has obviously contributed to this growth. With strong competition from foreign firms, Japanese medtech companies had difficulties expanding equally rapidly in foreign markets.

3

Innovative Companies in a Global Perspective

Patents are commonly used in economic theory and economic history to estimate the level of innovation of a firm or a country (Cantwell 1995; Chang 2001; Fontana et al. 2013). The focus in this chapter is on patent applications for medtech innovations (International Patent Classification code A61B) made between 1960 and 2014 by individuals and organizations based in Japan. This includes all patents applied for throughout the world (including in Japan) by assignees whose addresses were in Japan. Such a selection makes it possible to include both multinationals applying for patents in the US, and individuals or small organizations only doing so domestically. The database used, constructed with the intelligence company Enovating, served for a general analysis of the dynamics of innovation in the global medtech industry (Donzé and Imer 2020). Between 1960 and 2014, a total of 521,365 patents were applied for by 647,399 assignees. Japan is the world’s second largest holder of patents (23.2%), after the US (23.8%), for assignees. This larger number appears surprising considering that the number of substantial innovations in the medtech industry was not high. However, in practice enterprises use patent applications to protect each major step of the development of a new technology. Moreover, not all patents lead to the market launch of a new device. These data are, however, an excellent proxy for discussing the nature of innovation in a given industry. The general feature of innovation in the Japanese medtech industry is its domination by large enterprises. They hold a total of 82.9% of applications, well ahead of individuals (14.2%), universities (2.2%) and

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government agencies (0.7%). Moreover, the concentration of research in few large firms is striking. The 10 largest firms have a share of more than half of all applications (54%) and nearly two-thirds of applications made by companies (65.2%). Of course, these data do not give any information about the size of the firms but a look at the average number of patents applied for by firms suggests that these are large organizations: the 10 largest firms had on average more than 8,300 applications through the entire period, a huge level of activity requiring specialist research facilities. The average number of applications for all firms is 21.2, while it is 1.7 for individuals and 7.4 for universities. Despite the domination of the Japanese medtech industry by large companies, a more qualitative analysis of the largest innovators highlights major changes over time. Table 1, showing the 10 largest firms from the 1960s to the years 2010–2014, clearly illustrates the lasting Table 1 Top 10 largest Japanese firms for patent applications in the medtech industry, 1960–2014 1960−1969

1970−1979

1980−1989

1990−1999

2000−2009

2010−2014

Olympus (34)

Toshiba (797) Olympus (467) Hitachi (293) Canon (195) Panasonic (184) Shimadzu (140) Nippon Electron (79) Fujitsu (61) Omron (58) Aloka (57)

Toshiba (4156) Olympus (4253) Hitachi (2165) Panasonic (1120) Shimadzu (1021) Yokogawa Electric (877) Canon (716) Fujitsu (598) Mitsubishi Electric (469) Fujifilm (385)

Olympus (4666) Toshiba (3846) Hitachi (2893) Shimadzu (1610) GE Yokogawa (1158) Panasonic (1116) Canon (1071) Pentax (1059) Fujinon (957) Topcon (720)

Toshiba (6749) Olympus (6418) Hitachi (3469) Fujifilm (2532) Pentax (2294) Panasonic (1917) Konica Minolta (1612) Canon (1475) Shimadzu (1077) Fujinon (913)

Toshiba (5284) Olympus (3275) Fujifilm (2433) Canon (1715) Hitachi (1652) Terumo (976) Seiko Epson (694) Konica Minolta (690) Hoya (664) Panasonic (580)

Toshiba (10) Hitachi

(6)

Nikon

(6)

Panasonic (5) NEC (4) Kowa (3) Omron (3) Feather (2) Terumo (2)

Notes (1) The number of applications is displayed in brackets. (2) Grey cells represent specialized medtech companies. (3) Data are incomplete for the 1960s because Japanese companies did not fully use the International Patent Classification system at that time Source Based on PATSTAT

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domination of large companies from the electronics (Toshiba, Hitachi, Panasonic, etc.) and optical instrument industries (Olympus, Canon, Nikon, etc.). The competitive advantage of these firms in medtech relies on their continuous investment in R&D. It strengthens their position and contributes to make it difficult for newcomers to enter the medtech market with similar devices and equipment, as emphasized by Gelijns and Rosenberg (1999). The giants of the electronics industry were able to maintain their dominance for over half a century. The next section analyzes the acquisition strategy pursued by Toshiba. The second feature of the Japanese medtech industry is the enduring presence of specialized medtech companies, i.e., companies whose core business is related to medtech or which started in this industry before diversifying. Most of these firms were founded before World War II and developed by improving their core technology and diversifying gradually to related products. For example, the company Terumo was founded in 1921 by a group of scientists—including the famous bacteriologist Shibasaburo Kitasat¯o, who was involved in research at Charité in Berlin with Robert Koch and was nominated for the Nobel Prize in Medicine— to manufacture and distribute thermometers. It focused on measuring instruments and expanded in the 1970s to disposable goods (plastic syringes, catheters), drugs and heart-lung machines. Hence, R&D and diversification enabled the company to gradually reposition itself into technology-intensive products, while keeping its core competence in the development of devices for bedside patient care (Terumo 1982). Terumo exemplifies the development path that can be observed in other specialized companies. The third characteristic of this industry is the very low presence of foreign companies. Only one firm in the top 10 rankings has some foreign capital, GE Yokogawa Medical Systems, a joint venture founded in 1982 by GE and Yokogawa Electric, specializing in X-ray and MRI equipment. It was ranked the fifth largest patent applicant in the 1990s but disappeared from the rankings after 2000. In addition to private companies, there were a large number of individuals but most of them only applied for one or two patents, and it is not possible to gain a statistical overview of their profile on the basis of

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the patent application database. A qualitative survey of the largest innovators highlights the variety of innovators and the general change over time from medical doctors to private companies.2 In the 1970s, only eight individuals applied for more than five patents. Four were independent medical doctors, two were engineers at Toshiba and Hitachi, one was unknown but applied patents for endoscopes for Olympus and Pentax, and the last is completely unknown. Over the following decades, applicants working in academia (engineering or medicine) accounted for 50% (1980s) and 60% (1990s) of the 10 largest individual innovators. However, after 2000, engineers from the largest firms represented the largest share of individuals (100% from Fujifilm in 2010—2014). As for universities, they rarely applied for medtech patents before 2000. This change results from the enactment of the Bayh-Dole Act in 1999, which facilitated the patent commerce by universities. It led to the opening of several technology transfer offices in universities (Takenaka 2005). Prior to this date, none of them had more than 10. In 2010–2014, the three largest applicants were the University of Tokyo (78), Osaka University (66) and Tohoku University (63). It is difficult to estimate joint research or technology transfers between academics and firms on the basis of patent applications. The opening of 26 technology licensing organizations in Japanese universities between 1998 and 2002, however, shows that the buying and selling of patents from/to private partners had become a major activity in Japanese universities (Takenaka 2005).

4

Concentration and Transnational Expansion

The domination by large companies of innovation in the Japanese medtech industry since the 1960s, and the relative absence of newcomers, can be explained as the result of either in-house research and development (R&D), or of M&A. This section analyzes M&A in 2The sources for this analysis are patent applications and online databases for research papers CiNii (https://ci.nii.ac.jp/ja) and research funding KAKEN (https://kaken.nii.ac.jp/ja/).

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the Japanese medtech industry between 1986 and 2017, based on the Thomson One database, accessed in April 2018. Data related to M&A before 1986 are not available. Figure 3 shows the general evolution of M&A between 1986 and 2017, from the perspective both of Japanese companies that acquired another company or company’s division (in Japan or abroad), and hence extended their scope of activity (buyers), and of Japanese companies that were taken over by another company (Japanese or foreign), and hence disappeared (targets). A total of 769 cases were identified over the whole period: 443 buyers and 326 targets. Both proxies present a similar general trend, with a low number of cases until 1997, then an important development. There were only 59 cases in 1986–1997, just 7.7% of the total. This trend is not specific to the medtech industry and can be observed for the rest of the Japanese economy. Change of corporate governance and liberalization of finance made M&A easier from the late 1990s onwards (Miyajima 2007). A detailed analysis of the buyers demonstrates that these Japanese firms mostly took over other Japanese companies (70.7% of cases). When they acquired foreign firms, it was especially companies based in the US (14.7%) and in Europe (8.1%). Japanese medtech companies aimed to

45 40 35 30 25 20 15 10 5 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

0

Targets

Buyers

Fig. 3 Number of mergers and acquisitions in the Japanese medtech industry, 1986–2017 (Source Based on Thomson One Database)

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develop their technology and knowledge through the takeover of specialized small firms. Moreover, the acquisition of foreign firms occurred early. The 22 companies purchased up till 1991 were all based abroad and more than half of all foreign M&A were realized before 2007. Since the mid-2000s, the acquisition of other Japanese companies has become more important. For example, Terumo acquired a total of 12 foreign firms between 1997 and 2017, including seven based in the US: Olson Medical Sales (1997), Micro Vention (2006), Caridian BCT (2011), Kalila Medical (2016), as well as some divisions of 3M (1999), St Jude Medical (2016) and Bolton Medical (2017). It made also three acquisitions in Japan (Ikiken in 2001, the heart and lung division of Edwards Life Science in 2005, and Clinical Supply Co. in 2008). As for Olympus, one of the largest innovators in the medtech industry, it made three acquisitions in Japan (Sumitomo Osaka Cement BSM in 2005, Terumo Collagen Business in 2006 and Iwaken Co. in 2009) and took over Flemming in Germany (1990), PamGene International in the Netherlands (2000), as well as Cytori Therapeutics (2006), Asthmax (2007), Small Bone Innovations (2010) and a division of Stryker (2010) in the US. This was rather exceptional, as Japanese medtech companies usually merged a smaller number of foreign firms. Toshiba, the largest innovator of the industry, took over only one firm in South Korea (Comed Medical Systems, in 2012). This case shows that M&A was not the only way to remain innovative and competitive. Next, the Japanese targets were mostly acquired by other Japanese companies (89.3%), a very high level in international comparisons, with foreign firms representing only 10.7% of acquisitions. During the same period, the rate of acquisition of medtech companies by foreign firms amounted to 51.3% in Germany and 66.9% in Switzerland. Even the United States, where the merger of domestic firms is exceptionally high due to the large number of start-ups, has a rate of foreign takeovers higher than Japan: 13.4%. It is no exaggeration to describe the Japanese medtech industry as deeply closed to foreign companies. Only 35 firms were taken over by foreign firms, mostly American (13 cases) and European (8 cases). One can conclude that Japan is not a major source of knowledge for global companies of the medtech industry—or that these firms have difficulties accessing Japan through

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M&A, but the result is the same. It is remarkable that the global medtech leaders realized only very few acquisitions in Japan. General Electric (US), with a joint venture in Japan since 1982, purchased only Tanaka X-Ray Manufacturing in 1993 and a division of NEC Medical Systems in 1999. As for Siemens and Medtronics, they did not acquire a stake in any Japanese medtech company. A second interesting finding is that most of these Japanese companies were taken over by relatively small firms. The 10 largest innovators from Table 1 had only a tiny share of these M&As (19 cases, or 8.1%). The purchase of Japanese companies was hence not a way of strengthening the domination of large enterprises through diversification. Their organizational in-house R&D capability and the merger of foreign companies were the basis of their lasting domination. Small specialized companies preferred to use domestic M&A to expend the scope of their activities and to internalize new knowledge. This is, for example, the case for Nipro Co., a company based in Osaka and founded in 1954, which specialized during the 1960s as a manufacturer of small glass products, in particular for medical use (Nipro 2017). It was listed on the Tokyo Stock Exchange in 1996 and realized several acquisitions that supported its diversification: the mechanical hearts division of Toyobo (2009), the cardiology products company Goodman Co. (2013), the medical division of the synthetic rubber maker Unitika (2015), the producers of surgical appliances and supplies NexMed (2017) and, recently, Machida Endoscopes, a producer of a broad range of medical instruments (2018). These various takeovers allowed Nipro to establish itself as a general medtech company. Consequently, the sales of Nipro’s medical division grew from 64.7 billion yen in the fiscal year 2000 to 132.8 billion in 2010 and 300 billion in 2017 (Nipro 2000–2017).

5

The Competitive Advantage of Olympus and Toshiba

Olympus and Toshiba have been the most innovative medtech companies in Japan since the 1960s. They are also among the largest today in terms of production value (see Table 2). How have they managed to keep

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Table 2 Top 10 largest manufacturers and importers of medical devices in Japan, 2012 (in billion yen) Manufacturer Toshiba Medical System

Value

Importer

227.5

Johnson & Johnson

Value 200.0

Terumo

246.2

Philips Electronics Japan

83.2

Olympus Medical System

192.4

Siemens Japan

78.3

Nipro

145.0

Boston Scientific Japan

74.2

GE Healthcare

98.1

Nihon Alcon

61.7

Panasonic Healthcare

98.1

Nihon Medtronic

59.4

Hitachi Medical

87.2

Covidien Japan

58.0

Sysmex

87.1

Nihon Stryker

53.9

Nihon Kohden

87.1

St Jude Medical

45.0

Nikkiso

72.1

Nihon Becton Dickinson

33.4

Note Foreign companies are displayed in grey Source Based on R&D 2014

their competitive advantage over more than half a century? This section discusses the development of these two firms with a special focus on their ability to internalize new resources to maintain their competitiveness in a fast-changing environment. The roots of Olympus date back to 1919, with the creation of a small firm specialized in the development of instruments and optical products (Olympus 1969). It became famous during the 1930s for the production of cameras, and launched after World War II in the field of endoscopy. The development of Olympus relied on its core competence in optical technology applied to medicine. It designed and improved endoscopes through collaboration with medical doctors and engineers from public research institutions. For example, the world’s first gastrocamera was unveiled by Olympus in 1951 but required five more years of joint research with the Department of Internal Medicine at the University of Tokyo before being launched on the market. Then, in the 1960s, Olympus moved to optical-fibre technology through joint research with Osaka Institute for Industrial Technology (Osaka k¯ogy¯o gijutsu shikenjo) (Yamaguchi and Shimizu 2015). These relations between industry, medicine and public research facilities demonstrate that joint research was being carried out in the medtech business just as it was

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in other Japanese manufacturing industry sectors at that time (Sawai 2012). This kind of cooperation has continued to this day. Since 2000, Olympus has been using its cooperation with renowned medical doctors in particular to publicize its innovation in its annual reports to investors (Olympus 2017). Olympus pursued its growth in this core competence. In 1991, it held over 75% of the world market for flexible endoscopes (Gelijns and Rosenberg 1999). It diversified gradually on this technical basis. Endoscopy itself was improved by the adoption of ultrasound and video technology in the 1980s. Moreover, Olympus applied its knowledge beyond the field of diagnostics, notably through the development of cameras and video systems for surgery. The company was reorganized in 2004, with the main division separated into autonomous subsidiaries. The medtech division became Olympus Medical Systems. The growth of Olympus relied on in-house R&D and on the internalization of knowledge. The two sources of innovation were, however, interrelated. Olympus invests large amounts of capital in R&D. In 2014, it was the world’s sixth biggest R&D spender, with a total of 425 million USD, and the top non-American firm. This sum represented 8.4% of gross sales (Medical Design & Outsourcing Design 2016). Research was not only being carried out at headquarters in Japan. The global organization built by Olympus has had an important impact on R&D globally. For example, in 2010–2014, Olympus Surgical Technologies America (OSTA), a subsidiary that brings together research facilities in the US, applied for 96 patents, while the German subsidiary Olympus Winter IBE applied for 184 patents over the same period (Centredoc 2018). Hence, Olympus benefits from local knowledge developed by its subsidiaries around the world. External knowledge comes both from the cooperation itself and from the takeover of companies (Thomson One database). In Japan, notably, Olympus took over the bone substitute business of Sumitomo Osaka Cement (2005) and the company Telos (medical equipment for surgery, 2007). In 2001, Olympus signed a contract with Terumo on technical cooperation. Collaboration with Sony began in 2013. The electronics giant received 11% of Olympus’ capital and became its largest shareholder (5% and third shareholder in December 2018). In the same year

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the two companies created a joint venture, Sony Olympus Medical Solutions (SOMED). The goal is to use Sony’s high-tech digital imaging capability and Olympus’ expertise in medical technology for surgery (Nikkei BP 2017). Outside Japan, Olympus has acquired Human Group (automated blood-analysis instruments, Germany, 1990), Flemming (diagnostic equipment, Germany, 1990), Celon (medical instruments, Germany, 2004), Gyrus Group (surgical devices, UK, 2007), Spiration (respiration equipment, US, 2010), Innov-X Systems (portable X-ray devices, US, 2010), Spirus Medical (endoscope insertion assistance devices, US, 2010) and Image Stream Medical (surgical image management solutions, US, 2017). These different partnerships have enabled Olympus to consolidate its position in endoscopy and to diversify to other areas of the medtech industry. As for Toshiba, its beginnings are very different from those of Olympus. The firm was founded in 1939 using capital from General Electric as the merger of two electrical appliance companies, Tokyo Electric and Shibaura Works. It is a general electrical equipment manufacturer and one of the largest companies in Japan. The cooperation with GE enabled Tokyo Electric to be one of the largest manufacturers of X-ray devices in Japan during the interwar years. It adapted American equipment to the structure of the Japanese hospital market (i.e., smaller, simpler and cheaper devices) through cooperation with medical doctors, in particular Koichi Fujinami, a promoter of radiology in Japan (Donzé 2018). After 1945, Toshiba’s competitive advantage in the field of medical technology relied mostly on diagnostic devices. The company continued working together with professors of medicine from the most renowned universities in the country (Toshiba Medical 1998). It diversified gradually into other fields. However, the growth pattern of Toshiba is very different from that of Olympus. It is characterized by a lower level of internationalization, little diversification, and a stronger focus on in-house R&D. The major takeovers realized by Toshiba have aimed at strengthening its position in the field of medical imaging diagnostic systems (CT scanners and MRI). It merged, notably, the foreign firms Diasonics Magnetic Resonance (MRI systems, US, 1989), Applied Superconectics (MRI systems, US, 1990), Barco-NV Advanced (imaging solutions, UK, 2008) and Comed Medical Systems (radiation devices,

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South Korea, 2012). All these companies are involved in MRI technology. Moreover, patent application statistics show that Toshiba engaged far less than Olympus in R&D abroad. In 2010–2014, it had only nine patent applications in the US and none in Germany. Hence, the core competitive advantage of Toshiba remained medical imaging diagnostic systems. It established itself as the most important producer of CT scanners in Japan, but was behind in MRI. In 2007, it had a 50% share of the Japanese market for CT scanners, but was only fourth for MRI, with 15% (Nishimura 2010). This competitiveness relied on the development of numerous small and cheap CT scanners for specific segments of the market, rather than the multipurpose equipment developed by European and US-American companies. Foreign equipment needed to be adapted to the specificities of the Japanese hospital market, so Toshiba focused its R&D on this technology and set up a financial organization specifically to support the acquisition of large equipment by medical doctors and hospitals. The subsidiary, Toshiba Medical Finance, was founded in Tokyo in 1970. As this field is the largest and most profitable of the medtech industry, the company could maintain its number one position in Japan. It experienced important growth, the number of employees rising from 309 in 1960 to 1,281 in 1995. Sales were less than 10 billion yen until 1967, then passed the 90 billion mark in 1986 and the 120 billion in 1988 (Toshiba Medical 1998). Toshiba Medical Systems was acquired in 2016 by Canon amidst Toshiba’s heavy financial losses.

6

Foreign Companies in the Japanese Medtech Industry

The annual survey of the Japanese medical industry compiled since 1988 by the service company R&D Co. highlights the presence of foreign companies in specific areas of the medtech business (R&D Co. 2014). In 2013, for example, foreign multinational enterprises dominated the market for MRI equipment, which represents high-tech in this industry. GE was number one with 28.5% of sales, followed by Siemens (27.9%)

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and Philips (17.2%). Another field controlled by foreign-owned companies is artificial implants, where the largest players were Japan Stryker (19.6%), Johnson & Johnson (17.3%), Zimmer (14.2%), Medtronic (8.7%) and Biomet Japan (7.6%). However, in the general medtech industry, foreign companies only occupied second place, with the notable exception of GE. Table 2 shows clearly that the American multinational is the only one within the top 10 largest manufacturers in 2012, ranked fifth. In contrast, all major importers of medical devices were foreign companies established in Japan, mostly from the US. This clear divide demonstrates the two different ways of carrying out innovation. Japanese companies focus on R&D in their home country, hence do not import devices manufactured in their foreign plants. As for foreign companies, they are not really engaged in R&D in Japan, as we have seen, but import their high-tech products to Japan. This trade has developed rapidly since the early 1990s. During the 1980s, there was a balance between import and export of medical devices in Japan (slight deficit since 1987), but a great change began in 1992, with the fast growth of imports and the slow increase of exports, so that the balance of trade in this industry became largely negative (Kimura 2012). Moreover, this feature of the contemporary medtech industry in Japan is not new, as highlighted by the Centredoc medtech patent database. During the 1970s, apart from Hewlett Packard Yokogawa, no foreign company or joint venture with foreign capital applied for more than five patents. Similarly, in the 2000s, there were hardly any foreign firms within the 385 companies that applied for at least five patents, with the exception of GE Yokogawa, ranked 41st with 97 patents. This lack of engagement of Japanese companies can be explained by general factors regarding foreign direct investments (FDI) in Japan and particular factors linked to the medtech industry—which are both related. First, one must bear in mind that Japan is one of the most closed countries for inward FDI (Hoshi 2018; Mason 1995). Regulation, the distinctiveness of the Japanese market and high costs have prevented many foreign firms from investing in Japan. Hence in 2017 Japan had the lowest level of inward FDI stock among OECD countries, amounting to only 4.1% of GDP, against 24.1% for China, 40.5%

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for the US and 57.4% for the EU (OECD 2018a). Second, in the field of medical devices, Altenstetter (2014) in particular has demonstrated that regulation, for example the lack of recognition of foreign standards and trials by Japanese authorities, was a major obstacle to foreign companies’ investment in Japan. Moreover, the characteristics of the Japanese medical market (high competition between numerous small private hospitals) require companies to develop specific devices or to adapt their equipment. In the field of X-ray machines and MRI equipment, Japanese hospitals tend to purchase smaller, simpler and cheaper products. For example, most of them acquire head-unit CT scanners, while US hospitals purchase whole-body machines (Foote 1992). However, light instruments and implants do not represent an investment in equipment for medical doctors and hospitals. Hence the structure of the Japanese medical market has a lower impact on their sales. This is undoubtedly the reason why the field of medical implants is dominated by foreign firms. GE is an exception and deserves special attention. This company has been a promoter of X-ray devices since the early twentieth century (Janssen and Medford 2009). In Japan, it transferred production to its subsidiary Tokyo Electric (Toshiba since 1939) during the interwar years and established itself as a major competitor of Shimadzu until the war (Donzé 2013). After 1945, although GE restarted technical cooperation with Toshiba in the early 1950s, medical devices were not included in the new agreements. Between 1945 and 1980, GE focused its healthcare business on the US market and accessed overseas markets through exports. In 1961, the export of medical X-ray devices amounted to only 30% of sales.3 For the American multinational, the internalization of knowledge related to CT scanners represented an opportunity to expand its healthcare business on the global market. This technology had been developed by the British firm EMI in the early 1970s. Its medical electronics division faced financial losses and was merged in 1979 with Thorn Electrical Industries (Blume 1992). GE began CT scanner development in 1976 and took over Thorn EMI’s scanner division in 1980. 3Taniguchi

1961.

Collection (TC), copies of General Electric archives, World Market Opportunities,

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It became established as one of the most competitive companies in this field, alongside Siemens and Philips. In 1976, GE signed an agreement in Japan with Yokogawa Electric for the sale of CT scanners (Nishimura 2010). Japan was the second largest market in the world for this equipment, with high potential for growth, so that GE wanted to become established as a leader in this country. However, a major challenge for GE was the local competitors (Hitachi, Toshiba and Shimadzu) which had “products that challenged the partnership [with Yokogawa]. Designed specifically for the Japanese market, those products were smaller, less expensive to operate and cheaper to buy.”4 Hence, in 1982, GE engaged more deeply in Japan with the foundation of a joint venture with Yokogawa for the production and sales of MRI and CT scanners, and related devices: Yokogawa Medical Systems (YMS; renamed GE Yokogawa Medical systems in 1994, and GE healthcare Japan in 2009). The role of Yokogawa changed from a distributor of GE’s goods to a co-developer of new products (such as the CT Max System), which are sold to other countries, including the US (small hospitals and clinics). GE’s annual report for 1986 mentions that “the price and performance of this new CT scanner [CT Max System] make GE the first supplier to place advanced CT capabilities within the reach of smaller hospitals and clinics”.5 The partnership with Yokogawa made it possible for GE to acquire knowledge about the development of smaller and simpler devices for the middle and entry markets (Nishimura 2010). This strategy enabled the US corporation to strengthen its presence on global markets. In Japan, GE Yokogawa had the largest market share for MRI in 2007 (25%), ahead of Philips (24%), Siemens (23%) and Toshiba (15%) (Nishimura 2010).

7

Conclusions

This chapter has used various databases and sources to highlight the dynamics of the Japanese medtech industry. The general conditions of 4TC, 5TC,

Alliances: RX for business, 1987, no. 65, vol. 1. General Electric, annual report, 1986.

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the market for medical instruments, devices and equipment are characterized by rapid development since the mid-1970s and the increasing presence of foreign imported goods since the 1990s. Hence, Japanese companies have faced increasing competition on their home market since the end of the twentieth century. Despite these changes, the rankings of the most innovative firms (based on their number of patents) have remained very stable since the 1960s. The industry is dominated by a few large companies from the electronics industry and some specialized medical firms. In particular, the absence of foreign firms is striking. Remaining competitive for several decades requires an upgrade of technology and the internalization of knowledge. Numerous Japanese medtech firms have enlarged their learning base through M&A since the 1990s. The acquisition of other companies, abroad and particularly in Japan, has enabled them to diversify to new fields of the medtech industry, as demonstrated by the case of Olympus. Some other companies did not engage actively in M&A but were able to maintain their position by focusing on their core competences. This is particularly the case for Toshiba, a large electronics conglomerate that specialized in diagnostic imaging technology. Another characteristic of the Japanese medtech industry is the low presence of foreign companies, in contrast to the situation in Western Europe. A paltry 10% of all Japanese medtech firms acquired since 1986 belong to foreign companies. Rather than investing in Japan, global medtech firms prefer to export their goods to Japan. Most of them are disposables, instruments and implants, rather than equipment. The specificity of the Japanese hospital market, characterized by a large number of small private hospitals, requires the adaptation of foreign medtech equipment—which is not being realized by most foreign firms. General Electric is an exception, having co-developed with Yokogawa Electrics during the mid-1980s small and cheap CT scanners suitable for Japanese hospitals that made it possible to develop new markets elsewhere in the world. This exceptional case highlights what a foreign firm can learn from investing directly in R&D in Japan. The business history approach proposed by this chapter contributes to a better understanding of the influence of market conditions on the formation of medical technology in the context of socio-technical

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settings. Although this dimension is often overlooked by STS scholars, it is important to discuss technological development in specific social and cultural contexts. Japan has developed a very competitive industry in medical imaging devices and endoscopy alongside the strong diagnostic tradition of Japanese physicians, but also because the specific nature of its hospital market required it. The presence of a large number of small private hospitals in a competitive environment made it necessary to adapt foreign equipment. The methodology followed here has, however, some limitations. Databases and statistics do not facilitate detailed discussion of the patient–doctor–manufacturer relationship and how it impacts on the development of medical devices. More qualitative case studies would be necessary to shed light on this dimension. Similarly, studies of these aspects from an STS and medical sociology standpoint could benefit the field of business history.

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Nikkei, BP. 2017. “Geka shujutsu” ni idomu Son¯ı [Sony Challenging “Surgery”]. Nikkei bijinesu, 10 February 2017, 17. Nipro. 2000–2017. Annual Report. Retrieved from: https://www.nipro.co.jp/ en/ir/library/. Accessed 5 December 2018. Nipro. 2017. Sano Minoru to Nipuro no 70-nen [Minoru Sano and 70 Years of Nipro]. Osaka: Nipro. Nishimura, Shigehiro. 2010. Gurobaru keiei to chiteki zaisan manejimento [Global Business and the Management of Intellectual Property]. In Gurobaru keizai ni okeru keiei to kaikei no kenky¯u [Research on Management and Accounting in the Global Economy], ed. U. Okura, K. Suyama, and K. Ito, 95–134. Osaka: Kansai University Press. OECD (Organisation for Economic Co-operation and Development). 2018a. FDI Stocks (Indicator). OECD. https://doi.org/10.1787/80eca1 f9-en. Accessed 12 December 2018. OECD (Organisation for Economic Co-operation and Development). 2018b. Hospitals (Indicator ). OECD. Retrieved from: https://stats.oecd.org/Brande dView.aspx?oecd_bv_id=health-data-en&doi=data-00541-en. Accessed 12 December 2018. OECD (Organisation for Economic Co-operation and Development). 2018c. Computed Tomography (CT) Scanners (Indicator). OECD. https://doi.org/10. 1787/bedece12-en. Accessed 12 December 2018. OECD (Organisation for Economic Co-operation and Development). 2018d. Magnetic Resonance Imaging (MRI) Units (Indicator). OECD. https://doi. org/10.1787/1a72e7d1-en. Accessed 12 December 2018. Olympus. 1969. 50-nen no ayumi [50th Anniversary]. Tokyo: Olympus. Olympus. 2017. Annual Report. https://www.olympus.co.jp/ir/data/pdf/ir_ medical_2017_04.pdf. Accessed 25 June 2019. Onuma, Masaya. 2010. Shin-ky¯u “sumi-wake” wo jitsugen suru seihin tenkai [New and Old “Compartmentalization” Resulting from Product Evolution]. In Nihon kigy¯o kenky¯u no furonteiya 6-g¯o [Frontier of Japanese Business Studies, Vol. 6], ed. Tsuyoshi Numakami, Masaru Karube, and Minoru Shimamoto, 47–63. Tokyo: Yuhikaku (Hitotsubashi University). Oshita, Hajime and Ikeno, Fumiaki. 2016. Iry¯o kikai kaihatsu to bencha kapitaru [Venture Capital and the Development of Medical Devices]. Tokyo: Gentosha Media Consulting. R&D Co. 2014. Iry¯o kiki y¯ohin nenkan [Yearbook of Medical Devices and Supplies]. Tokyo: R&D Co. Reiser, Stanley J. 1978. Medicine and the Reign of Technology. Cambridge: Cambridge University Press.

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9 Close Collaboration Between Medical Professionals and Engineers in Medical-Device Innovation: The Commons for Medicine and Engineering Japan Liaison Platform Kazuo Tanishita

1

Introduction

Many medical devices used in Japanese medical institutions are imported. Imports of medical devices have exceeded exports over the past few decades (see JFMDA 2018) due to the weakness of the medicaldevice industry in Japan, which is inhibited by a lack of communication between medical and technical experts. In the sales rankings of the top 30 global medical-device companies in 2018, the Japanese companies Olympus and Terumo ranked 19th and 21st respectively (MPO 2018). The highest-ranking company in terms of sales was Medtronic, one of the world’s largest medical-device corporations, located in the United States and Ireland. One reason for Japan’s weakness in this area is that the development of medical devices is often based on technological priorities, without K. Tanishita (B) Keio University, Tokyo, Japan e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Brucksch and K. Sasaki (eds.), Humans and Devices in Medical Contexts, Health, Technology and Society, https://doi.org/10.1007/978-981-33-6280-2_9

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sufficient consideration of clinical needs1 (Editorial board of WEDGE 2012, 30–32). As a result, the final products often do not meet clinical needs and cannot be used in clinical settings. Thus, medical professionals and clinical technicians face difficulties when looking for suitable devices made in Japan, and instead employ usable devices produced in the United States and other foreign countries. Voices within Japan, concerned about dependence on imports from abroad, are calling for a strong domestic medical-device industry to facilitate acquisition of the devices required for diagnostics and treatment in clinical settings, in order to ensure the country’s medical security. To foster a strong medical-device industry in Japan while also ensuring that the development of medical devices meets clinical needs, more opportunities for close collaboration between medical and technology professionals are required. However, disciplinary differences between medical and technology professionals in Japan create something of a barrier to communication and collaboration which needs to be overcome. This leads to the question: What boundaries exist between physicians and engineers in Japan? Moreover, how can these barriers be overcome to enable collaboration between the medical and engineering fields? This chapter introduces a case study of a liaison platform called Commons for Medicine and Engineering Japan (hereafter Commons). The concepts of boundaries and user-led innovation are used to reflect on a way to cross disciplinary barriers and spur medical-device development. The purpose of this case study is to elaborate on the potential for close collaboration that is envisioned as a result of overcoming these barriers through the Commons platform, particularly for small and mediumsized enterprises (SMEs). In other words, this case study provides a valuable opportunity to reflect on how it has become possible to overcome disciplinary barriers to medtech partnerships in a society such as Japan, where hierarchical structures prevail. The manifold activities of

1 According

to the definition of Zenios et al. (2010, 37), the clinical needs represent the change in outcome or practice that is required to address a defined clinical problem. They are the bridge between problems and solutions and they play the most important part in the development of devices.

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Commons have resulted in many sophisticated technologies proving the innovativeness of this liaison platform. This chapter is organized into five sections. The first identifies the disciplinary barriers in Japan that restrict the transfer of information, such as clinical needs, in the innovation process of the development of medical devices. The second explains user-driven innovation, which is the preferred way for medical-device development to take place, and considers the importance of clinical needs. The third reflects on the significance of clinical needs in the innovation of usable medical devices against the backdrop of prevailing disciplinary barriers. The fourth introduces a way of overcoming interdisciplinary barriers through the Commons liaison platform and outlines its outcomes. The fifth draws brief conclusions on a desirable ecosystem for medical-device development and the necessary changes in Japan.

2

Disciplinary Barriers Between the Medical and Technological Fields

The consideration of needs in clinical settings has been crucial for securing the development of many medical devices. Medical professionals encounter various difficulties during their daily clinical practices and in their technology-dense working environment. These circumstances provide a strong incentive for the development of clinically usable devices. However, disciplinary and organizational barriers between the medical and technological professions cause stagnation in the flow of information about the demand in clinical settings. “Disciplinary barriers” means boundaries between different disciplines. More specifically, Ferlie et al. (2005, 128–130) noted the presence of an impermeable boundary between different professionals that impedes the spread of innovation. This boundary comprises social and cognitive dimensions. The social boundary is created by well-developed professional roles and identities, as well as traditional work practices. Individual professionals tend to defend their established professional roles, identities, work priorities and “jurisdictions”, and, thus, they sometimes seal themselves off. What is more, cognitive boundaries are

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created by the different knowledge bases, agendas, questions and research cultures of different professions. Thus, professionals in different fields may interpret the same subject differently and lose opportunities for productive dialogue and collaboration for joint research. Abe et al. (2016, 20–22) criticized the notion of Ferlie et al. (2005, 128–130), pointing to possible factors in addition to disciplinary boundaries that can affect the diffusion of innovations and to which Ferlie et al., in their view, did not pay sufficient attention. In addition, Hogle (2008, 845) pointed out that the transfer of knowledge from a non-medical domain to medicine requires consensus among diverse groups of the clinical or medical profession, engineering and physics, as well as negotiations across professional, technical and institutional domains. This implies the presence of barriers between different disciplines. Consequently, the coordinating and negotiating activities that take place across disciplines and professional domains have become a key aspect of the analysis of innovation and knowledge production. In Japan, similar boundaries between the medical and technological fields restricting the flow of ideas and information prevail. In particular, small businesses developing technologies are not motivated to participate in the medical-device sector, due to the lack of necessary information about clinical settings. Increasing access to this information and knowledge transfer is critical for small businesses, because many have developed cutting-edge technologies but have not utilized them to stimulate the medical industry in Japan. Nevertheless, crossing these boundaries is difficult in Japanese society, because, traditionally, individuals have tended not to become involved in different disciplines and professional domains but to confine their activities to their own discipline (Tanishita 2013, 8–17). Furthermore, the medical and clinical worlds are generally organized as closed communities to ensure the privacy of patients as well as of medical professionals. Consequently, information on the usability or poor functioning of medical devices does not filter back to manufacturers and developers. Since the medical-device innovation process requires the production and transfer of knowledge and experience from the clinical workplace to the manufacturing setting, such disciplinary barriers pose a serious problem for efforts to spur medical-device development in Japan.

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Moreover, we should note the educational background of medicaldevice professionals. Most leading universities in the US have curricula and graduate programmes for biomedical engineering. US News and World Report evaluated the best biomedical engineering programmes in US universities in 2019, including the highest-ranked programmes at Johns Hopkins University, the Massachusetts Institute of Technology (MIT) and Duke University (Morse and Martin 2019). There, university students who have majored in disciplines unrelated to medicine, such as engineering, have the opportunity to join a medical school. They enter the graduate school of biomedical engineering and acquire exactly the same knowledge of medicine in their curriculum as do those in medical school. This produces a great pool of skilled biomedical engineers. Understanding of the engineering field equips them well to talk to engineers and medical professionals, based on the shared knowledge acquired during their university curriculum. This is one reason for the strength and innovativeness of the medical-device industry in the US, where disciplinary barriers between the medical and engineering fields have been bridged due to shared knowledge and joint training. In Japan, in contrast, the education system for medicine and biomedical engineering differs considerably from that in the US. Disciplinary barriers exist due to the autonomy and separation of each discipline and faculty at Japanese universities. Only a few graduate schools at Japanese universities have biomedical engineering programmes comparable to those in the US, such as Tohoku University and Okayama University (see Tohoku University, n.d.; Okayama University, n.d.). These factors contribute to the significant disciplinary barriers that exist between the medical and technological fields in Japan, hampering medical-device development.

3

The Significance of Clinical Needs for Innovation

Not only manufacturers but also clinical staff express a desire for medical devices that better serve the needs of clinical workplaces. In a report on clinical needs and ideas produced by the Japanese Government’s Kinki

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Bureau of Economy, Trade and Industry (Kinki Bureau of Economy, Trade and Industry 2017), a survey conducted in cooperation with the JSES (Japan Society for Endoscopic Surgery) received 660 responses from JSES members. These responses indicated that about 90% of medical professionals working in clinical settings were dissatisfied with conventional medical devices and wanted devices that are more practical. Specifically, respondents noted the following issues: inconvenience (72%), high cost (65%), limited functionality (61%), unsatisfactory basic performance (50%), and inappropriate device shape (45%). Additionally, 72% of the respondents reported having had ideas for improvements, and 58% had come up with ideas for new devices. The results of the questionnaire survey highlight the importance of clinicians’ demands for functionally improved and better designed medical devices to solve problems encountered in clinical settings and suggest an urgent need to meet this demand. According to the user-innovation studies carried out by Eric von Hippel, users have innovated new devices in the fast-changing scientific instrument industry (von Hippel 1986, 796–798). He proposed the notion of “lead users” of a new product or process. According to von Hippel, lead users are a group of people whose present strong needs are an indicator of innovations that will become a general demand in a marketplace months or years into the future. In their study on the user–technology relationship, Oudshoorn and Pinch (2008, 554–556) similarly emphasized that the creative capacity of users shapes technological development in all phases of innovation, and the boundary between design and use is actually blurred. Hence, the notion of user-led innovation in clinical settings should also be effective for medical-device development. For instance, Higashi (2016, 31–37) discussed the development of care robotics in Japan based on sharing knowledge and skills among users and manufacturers to achieve devices that better meet user needs in healthcare. Accordingly, many technology professionals in Japan have recognized that the initiation of medical-device development should be based not on seeds of technology, but rather on clinical needs (Editorial board of WEDGE 2012, 30–32). This insight was the reason why the late Masaki Kitajima emphasized the importance of clinical needs for medical-device development and initiated the Commons

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liaison platform, which pursues a need-driven approach to innovation in its activities (Kitajima 2013, 2–3; see below). Clinical needs covers various topics, ranging from incremental improvements (simple needs) to radical innovations (major needs) or mixed needs (see Fig. 1). Accordingly, measures addressing clinical needs range widely from simple improvements to major innovations (Zenios et al. 2010, 46–47). An incremental need is focused on addressing issues by making improvements and refinements to an existing solution and has relatively easy goals to accomplish in a short time span. i.e., a few years. Often, the costs of such devices are low and high profits are not anticipated. Measures addressing clinical needs that are simple improvements on the status quo are highly visible and thus easily identified in a clinical setting.

High

Visibility

Stickiness Mixed

Easy to identify Final product within a few years Low-cost products

Matching meetings of

Low the Commons

Improvements, Refinements Basic needs

Difficult to identify 5 –10 years High-cost products

Biodesign programme at Stanford University

Innovative and tacit needs

Clinical needs stored in the minds of clinical professionals Fig. 1 The range of clinical needs producing varied outcomes. Notes The abscissa shows the rate of innovation in clinical needs. The ordinate shows the rate of matching of achievements with seeds of technology. Stickiness is a concept defined by von Hippel as the necessary expenditure required to transfer information in a form that is usable by an information seeker (Source Based on Zenios et al. 2010, 46)

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The Biodesign educational programme at Stanford University is based on a concept that determines clinical needs as the most crucial step in medical-device development (see Zenios et al. 2010, 1–55). The programme promotes the identification of needs in a clinical setting via careful and systematic observation, which is referred to as “clinical immersion”. The programme was launched in 2001 and many graduates have become entrepreneurial innovators of medical devices (Ikeno 2013, 43–54). As a result of the positive outcomes, the fundamental concept of the Biodesign programme was published in Japanese and has become widely recognized in the field of biomedical engineering and the medical-device industry (Ikeno 2013, 43–54). The approach of Thomas J. Fogarty, a cardiovascular surgeon, talented inventor and innovator of several medical devices in the US, provides a further example of need-driven innovation as a way of achieving practical devices for clinical settings (Omoe and Tanishita 2013, 55–61). Fogarty launched a research and development facility, the Fogarty Institute of Innovation (FII), at the El Camino Hospital near Stanford University (see FII, n.d.). The proximity of this institute to the hospital expedites feedback on the safety and effectiveness of device development from clinical to technological settings—two key criteria for receiving approval for new devices. Fogarty also emphasizes the importance of patient opinion and strongly suggested that device development should proceed based on the “patient-first” concept (Omoe and Tanishita 2013, 55–61), as such innovation responds best to users’ needs. In other words, the experiences from the Biodesign programme and the Fogarty Institute support the basic insights of von Hippel as well as those of Oudshoorn and Pinch on the significance of users for successful innovation; they became an inspiration for several activities of the Commons liaison platform (see below). Major needs, on the other hand, require innovative solutions that represent a major departure from currently available technology and more radical innovation. Producing a market-ready device that addresses a major need takes up to 10 years, and the costs are naturally high (Zenios et al. 2010, 46–49). Nevertheless, for both incremental and major needs, more innovative requirements to strengthen the medical industry have to be discovered through extensive discussion with medical

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professionals. The reason is that innovative needs are concentrated on the processes of curing, eliminating and preventing various disease states and on medical science and mechanisms of action rather than on improving existing treatments or solutions (Zenios et al. 2010, 20–47). At present, medical professionals in Japan consider clinical needs the core of achieving satisfactory clinical experiences for patients. However, observing innovative needs in a clinical setting is far from simple; rather, they are discovered through substantial discussion with medical professionals, ideally evolving through the following steps. The significance of clinical needs must be reconsidered, as it determines the entire development process and the ultimate success of devices. Clinical needs with clear clinical significance remain crucial for the development of innovative medical devices; they have potential as intellectual property, and thus should not be disclosed without careful consideration. Clinical needs comprise low- and high-specificity needs (see Fig. 2; Tanishita 2019, 56–59). Low-specificity needs include background and basic problems. They can be disclosed without any intellectual property issues, because their requirements are too ambiguous to provide clear ideas for device development. Conversely, high-specificity needs require

Release of clinical needs

Background

Low- specificity basic problem

Refinement of clinical needs

Concrete identification & generalization

Solution

Matching

Forecasting of the goal

Intellectual priority

Seeds of Technology

No intellectual property priority

Increased intellectual property priority

Fig. 2 Clinical needs comprising low-specificity needs and refinement of highspecificity needs (Source Tanishita 2019, 54)

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more specific tasks and problem-solving procedures; they are therefore valuable as potential intellectual property and should not be disclosed. Because medical professionals are not trained to be entrepreneurial innovators, they do not tend to consider the intellectual property aspect when it comes to high-specificity clinical needs. What is more, they frequently miss vital opportunities to acquire valuable patents when these needs are announced without a non-disclosure agreement (NDA), which is essential for companies to generate a return on their R&D investment. Recently, the Japan Agency for Medical Research and Development (AMED) proposed a system for presenting clinical needs, drawing attention to the issue of intellectual property in publications and introductory seminars (see AMED 2017). For entrepreneurs, a disclosed clinical need should have low specificity and provide an indication of an idea for medical-device research and development. The next step is to identify low-specificity needs that are too roughly conceived and too ambiguous for the planning of device development. That is, vague clinical needs should be clarified to form ones that are more specific. Here, we should note that refinement processes must be conducted only in closed meetings held with NDAs. These processes consist of gutaika (concrete identification) and fuhenka (generalization) (Tanishita 2019, 56–59). The concrete identification of clinical needs is usually achieved by focused discussion among core members. These members should not avoid friction, conflict or criticism during the discussion, as these processes are most important in determination of the subject of development. All questionable and ambiguous aspects must be discarded through focused and critical discussion, which can determine the achievement of development. The focused and critical discussion must be carried out between the core members of the development team, which consists of medical and technology professionals and additional experts such as mediators. The core members should be at best fewer than three in number to avoid the non-disclosure of sensitive information (Tanishita 2019, 56–59). The next step is the generalization of clinical needs, which can help to ensure the usability and applicability of the device in a clinical setting. This step requires cutting-edge information from various disciplines,

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including medicine, science, engineering, information technology, regulatory science, intellectual property and business management. This step also requires the concretely identified clinical need to be reviewed by multidisciplinary experts to confirm its adequacy, an important aspect when judging whether to move the discussion forward to complete the final planning stages of development. At this point, technologies matching the clinical need should be identified. The most important factor in the latter step is to identify why the proposed design is needed in a clinical setting and how it will help medical professionals perform diagnoses and treatments that could not be done using conventional methods. For instance, Verganti (2009) outlined the significance of innovation by emphasizing the importance of “knowing why”, rather than “knowing how”. This idea applies to the development of medical devices. Devising new means of diagnosis and treatment leads to new discoveries of medical significance and contributes to the advancement of medicine, as illustrated by previously invented devices and modalities such as the X-ray machine, electrocardiograph, diagnostic ultrasound, computed tomography and magnetic resonance imaging. These well-known medical devices met clearly identified innovative clinical needs. Thus, the medical significance of a device must be understood in order to achieve sophisticated and practical innovation in clinical settings. To sum up, the purpose and medical significance of the entire planning process of medical-device development must be evaluated thoroughly in the final step of generalizing a clinical need. The measures that can be taken to promote close collaboration and disclose clinical needs for better medical-device development in a society such as Japan, where disciplinary boundaries prevail between the medical and technological fields, is demonstrated by the case study of the Commons liaison platform.

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The Case of Commons for Medicine and Engineering Japan

According to the Medical Technology Innovation Scorecard published in a report by PwC (see Wasden 2011), Japan has the weakest score when it comes to adapting to the changing nature of medical technology innovation, including medical devices. In general, small companies, amounting to 99.7% of all corporations in Japan, fulfil an important role in innovation, because many of them own original technological resources capable of supporting the development of industry in Japan. Their potential to introduce these technological resources for the development of innovative medical devices is therefore extremely important. However, disciplinary and organizational barriers between the medical and technological fields hamper the smooth introduction of these seeds of technology. That is to say, medtech partnerships (ik¯o renkei) have not been well established in Japan. This is the main reason for the low score in the PwC report and the major motivation for establishing the Commons for Medicine and Engineering Japan liaison platform.

4.1

The Establishment of the Liaison Platform

In 2009, the late Masaki Kitajima, a widely known surgeon, professor and president emeritus of the International University of Health and ¯ Welfare (Otawara, Japan), proposed launching an “unclosed common land” platform, which anyone could join to exchange opinions and to share information for medical-device development (Kitajima 2013, 2–3). This platform was expected to offer anyone the opportunity to establish medtech partnerships, regardless of their background, and to initiate a new medtech partnership movement. After repeated discussion with experts from different disciplinary backgrounds, the liaison platform became an effective means of crossing disciplinary and organizational barriers by starting an academic liaison organization cooperating with many medical and technological academic societies. This organization was named Nihon ik¯o mono-zukuri komonzu (Commons for Medicine and Engineering Japan) and provides manifold opportunities to link

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medical and technology professionals who are eager to promote medicaldevice development within their disciplines, as well as the advancement of medicine and social welfare (Commons, n.d.). The mission of the organization is to integrate academic societies. Thus, the members of Commons (individual academic societies) have the joint motivation of alleviating or eliminating patient distress by providing innovative medical devices for clinical use. The academic societies associated with Commons include medically oriented societies, such as the Japan Society for Endoscopic Surgery, the Japanese Society for Artificial Organs, the Japan Society of Computeraided Surgery, the Japanese Society of Biorheology, the Japanese Society for Medical and Biological Engineering, the Japanese Society of Dental Materials and Devices, and the Japanese Society of Medical Instrumentation. On the engineering side, members include the Japan Society of Mechanical Engineers, the Institute of Electrical Engineers of Japan, the Japan Society for Precision Engineering, the Society of Instrument and Control Engineers, the Robotics Society of Japan, the Society of Life Support Engineering, the Japanese Society for Biomaterials and the Japan Society for Technology of Plasticity. Over the past decade, Commons has led several activities to facilitate the crossing of barriers between medical and technology professionals (see Table 1 for an outline of Commons activities). These activities Table 1 Outline of Commons Mission:

Founder: Chief director: Structure: Budget: Source of income: Year of foundation: Range of activities:

To construct a platform for medtech partnerships, where anyone who wishes to develop medical devices can participate at any time Prof. Masaki Kitajima Prof. Kazuo Tanishita 213 members 10 million yen Membership fees, contract business, donations 2009 Medtech partnership seminars, R&D seminars, medical needs exhibitions, matching events between medical needs and seeds of technology, symposium on recent topics relating to medical devices, etc.

Source Compiled from author’s own data

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have contributed to a rapid increase in the flow of information from the medical to the technological field (Tanishita 2013, 8–17). In addition, the foundation of AMED (Japan Agency for Medical Research and Development) in 2015 offered an additional source of R&D funding for medical devices developed by interdisciplinary research groups. These developments led to a boost in R&D activities and a rise in medtech partnerships in Japan.

4.2

The Mission and Activities of Commons

The most significant achievement of Commons has been the provision of opportunities for the exchange of ideas between medical and technological experts at medical society meetings. Many medical professionals were already members of medical societies for their own specialties and attended annual medical society meetings. The annual meetings of these specialist societies provided the best opportunity for the exchange of ideas. Sumio Matsumoto, director emeritus of Tokyo Medical Centre and an expert in digestive surgery, initiated a programme of this kind (Tanishita 2016, 151–152). More specifically, he suggested a programme for the exchange of ideas at the 2012 JSES annual meeting. Physicians presented various clinical needs and engineers displayed new designs and materials with possible applications for new medical devices. This programme proved successful because many medical professionals attended the meeting, eager to discuss collaboration with engineers over the development of future medical devices, which had until then been a rare occurrence. Owing to this positive outcome, the JSES decided to continue this programme at its annual meetings (Tanishita 2016, 151–152). The exchange of ideas at the JSES meetings represented the first attempt associated with a medical society meeting in Japan. Thereafter, the programme’s concept has spread to other medical societies, including the Japanese Association of Cardiovascular Intervention and Therapeutics, the Society for Nursing Science and Engineering, the Japanese Society for Neuroendovascular Therapy, the Japanese Orthopaedic Association, the Japanese Orthopaedic Society of Knee, Arthroscopy and

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Sports Medicine, and the Japanese Society of Fracture Repair. Subsequently, these medical societies have conducted similar programmes for the exchange of ideas at their annual meetings and many participants in these programmes have had the opportunity of finding collaboration partners for R&D of medical devices. All these medical societies have expressed their intention to continue the programmes and have provided society members with opportunities for collaboration on medical-device development. At present, Commons is cooperating with all these programmes through meetings in the medical societies (Kinki Bureau of Economy, Trade and Industry 2017). This outcome implies that most medical professionals have developed a stronger awareness of the significance of information exchange from their daily clinical practice, which is essential for the achievement of successful medical-device development. They have also become increasingly inspired by and open to collaboration with technology professionals in development based on clinical practice (Kinki Bureau of Economy, Trade and Industry 2017). Additionally, programmes for the exchange of ideas have provided opportunities, not only to medical professionals, but also to technology professionals. Technology professionals have usually had few opportunities to approach medical professionals to obtain information about clinical practices. The implementation of programmes for the exchange of ideas at annual meetings of medical societies has helped to overcome disciplinary barriers between medical and technology professionals. Commons also offers other types of programmes for medical and technology professionals to exchange ideas, including seminars, medical technology seminars, hospital seminars and hospital visits (see Table 2). We should note that many types of programmes for the exchange of information and ideas are available to foster the advancement of medical-device development.

4.3

The Mediator-Initiated Partnership Model

Another way of overcoming barriers that is practised at Commons is the use of a mediator between two disciplines. The mediator must be able

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Table 2 Types of interaction between medical and technology professionals Type of interaction

Examples

Exchange events for medical and technology professionals at clinical society meetings

• Japan Society of Endoscopic Surgery • Japanese Association of Cardiovascular Intervention and Therapeutics • Society for Nursing Science and Engineering • Japanese Society for Neuroendovascular Therapy • Japanese Orthopaedic Society of Knee, Arthroscopy and Sports Medicine • Science and Technology seminar at Kanagawa Academy • Tokyo Metropolitan Government events for medical technology meetings • NCGM (National Centre for Global Health and Medicine) and Commons • Medtech laboratory at Iizuka Hospital, Kyushu • Medical technological seminars, etc.

Hospital seminars and tours Exchange seminars at hospitals

Medtech laboratories built in hospitals Seminars to learn the practice of medicine in clinical settings Source Own data

to understand the medical and technological disciplines and play the roles of interpreter and coordinator. Among the most promising candidates for this role are biomedical engineers, who are educated in biology and medical science in addition to their technological specialization, such as mechanical engineering, electrical engineering, chemical engineering or information science. In some countries, graduate schools at various universities offer biomedical engineering programmes of specialized training in a technological discipline and medicine (see above). One reason for the strength and innovativeness of the medical-device industry in the US is the presence of numerous biomedical engineers with a specialized training and education in the field of medical-device engineering. In Japan, however, the lack of specialized curricula at universities and the resulting shortage of biomedical engineers and limited number of

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graduates from this discipline prevents extensive collaboration between the two disciplines. Hence, rapid progress in the medical industry is not expected and alternative approaches are needed. Although employees of medical-device companies in Japan have not necessarily been educated in biomedical engineering, they acquire considerable medical knowledge and skills via on-the-job training. Usually, medical-device companies have to have special licences for medical-device warranties and are permitted to sell their devices to hospitals. In Japan, a company with a licence to produce and sell medical devices is called a marketing authorization holder (seiz¯o hanbai-gy¯o ) (Kashino 2014, 27–42). Employees of marketing authorization holders are fully informed on how medical devices are used in clinical settings. Thus, they have similar abilities to biomedical engineers to act as mediators between medical and technology professionals. Toshihiko Kashino, an expert in medtech partnerships and the managing director of Commons, has suggested an approach to medicaldevice development in which marketing authorization holders function as mediators, promoting close communication between medical and technology professionals (Kashino 2014, 27–42). The model is illustrated in Fig. 3. Kashino pursued this approach by establishing an exhibition in the Hongo District of Tokyo, which has long been well known for its dense concentration of medical-device companies and close communication with medical professionals in proximity to the University of Tokyo Hospital. This district was thus a convenient place for an ideas-exchange exhibition. The Hongo Exhibition has been held Smooth communication

Smooth communication

Clinical Site

Marketing authorization holder

Manufacturing company / Academia

Clinical needs

Product design

Manufacturing

Fig. 3 Marketing authorization holders as mediators (Source Kashino 2014, 35)

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14 times a year since 2016, attracting numerous technology professionals and manufacturers from many areas of Japan. These professionals display their devices and materials to marketing authorization holder companies to discuss possible collaborations on medical-device development. According to Kashino, authorization holder companies are able to provide specialized advice on the feasibility of device development and knowledge of how medical devices are used in clinical settings. With many technology companies participating in the exhibition to seek collaboration on medical-device development, the Hongo Exhibition has become a model for further Commons activities.

4.4

Identifying Clinical Needs

The Iizuka Hospital in Fukuoka Prefecture, Kyushu, is a recent example of how to achieve clinical immersion to promote the establishment of clinical needs. The hospital started to collaborate with the Fogarty Institute of Innovation in 2014 and built a medtech laboratory inside the hospital (Igeta et al. 2017, 207; Iizuka Hospital, n.d.)—the first facility of its kind to be built in a Japanese hospital. In this laboratory, medical professionals such as physicians, nurses and clinical engineers can exchange ideas and opinions, discuss problems, and present clinical needs to the hospital director. Hospital administrators and patent attorneys provide specialized advice on the regulatory and organizational requirements relevant to the proposed clinical needs. Eight companies and a university R&D group participate in the laboratory to explore clinical needs for medical-device development. The idea of this clinically centred development provided a template for consideration by other hospitals in Japan. For example, in 2017 the National Cancer Centre Hospital East (NCCE) in Chiba Prefecture launched the NEXT Medical Device Innovation Centre, which provides state-of-the-art medical care to patients and develops medical devices and technologies, especially in surgery and endoscopy (see NCCE, n.d.). Six companies and two university groups participate in the NEXT Centre to enable close collaboration with medical professionals from the National Cancer Centre.

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To summarize, the activities of Commons have resulted in many sophisticated technologies demonstrating the innovativeness of this platform and have broadened the variety of approaches to overcoming disciplinary boundaries to achieve close collaboration and the disclosure of clinical needs for innovation in medical devices. What is more, the environment for the development of medical devices has changed considerably over the last decade. A programme to foster medtech partnerships was launched in 2010. The Japan Agency for Medical Research and Development (AMED) and local governments such as those of Tokyo and Saitama started to provide funding for the development of medical devices. Since 2015, the number of R&D teams receiving these funds has increased, and several of them have succeeded in achieving market-ready devices. AMED’s 2014 progress report listed 920 proposals, of which 107 were accepted; 19 teams produced commercialized devices (see MRI 2014). Thus, about 2% of total proposals yielded final products. It is not certain whether this figure is satisfactory. What is safe to say is that there is a need to expand the initial planning phases, including the identification of clinical needs, to produce excellent and clinically effective devices. The success rate of the development of medical devices meeting clinical needs may then increase further.

5

Discussion and Conclusions on the Ecosystem in Japan

Based on the insights contained in this chapter, and as suggested already elsewhere, I propose the creation of an ecosystem of clinically centred medical-device development in Japan based on close collaboration between medical and technology professionals (Tanishita 2019, 56–59). Figure 4 illustrates the four steps required to produce innovative and market-ready medical devices. The first step is to create opportunities for encounters between medical and technology professionals. Normally, these professionals do not interact unless a route is intentionally installed to connect them. During the past decade, various channels have been devised to create opportunities for encounters; however, opportunities

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Shared motivation to relieve patient distress

Coordination of access to clinical field Matching events between medical and technological professionals at clinical society meetings Medical technology seminars Interchange seminars at hospitals Hospital visits HongoExhibition

Continual and sustainable collaboration

Common motivation

Creation of useful medical devices

Collaboration Mediator-initiated collaboration Translational research promoted by the government Japan Biodesign programme

Innovation

Some final products are now approved by PMDA.

Mentorship and Education

Fig. 4 Schema of a desirable ecosystem for medical-device development. Notes: The translational research is a project led by the Japanese government. It means the effective transfer of basic research to clinical application (Source Tanishita 2019, 52)

alone do not suffice to accelerate medical-device development. Therefore, there is the further need to increase opportunities for encounters of a kind that make it easier to overcome organizational boundaries. The Commons liaison platform conducts such activities, creating and increasing opportunities, including exchange events at clinical society meetings, medtech seminars and exchange seminars at hospitals, as outlined above. The second step is to have a joint motivation for medical-device development. The most important motivation is the alleviation of patient distress, as suggested by Fogarty (Omoe and Tanishita 2013, 55–61). However, medical-device development is still different from that of industrial devices. For instance, some technology professionals are only interested in the specifications of device design, materials, industrial processing and other technological aspects, and not in how devices are used in clinical settings. In other words, technology professionals only pay attention to the production of devices in line with the requests of medical professionals. This passive attitude has led to deviations from the original aims of the medical professionals and has often resulted

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in development failure. On the other hand, many medical professionals are so devoted to and occupied with their daily clinical duties that they sometimes omit to communicate precise instructions to technology professionals (Tanishita 2013, 8–17). There is therefore a need to increase opportunities for the exchange of ideas and to raise awareness of the need for close collaboration to disclose clinical needs. Commons has provided several such joint activities designed to change mindsets in the interests of better device development. Furthermore, medical professionals have sometimes failed to clearly explain the inadequacies of conventional methods and devices in clinical settings, which raises the risk of failure and less practical device development. In other words, technology professionals have started an R&D process with limited or biased knowledge of clinical settings. This approach should be avoided through meaningful discussion of clinical needs between medical and technology professionals. More specifically, it is extremely important that professionals from both fields not only share a joint motivation but also achieve a joint understanding of the development of the envisioned medical devices through two-way communication. Hence the need for mediators to assist and to interpret across disciplinary barriers. In the model suggested by Toshihiko Kashino, marketing authorization holders function as mediators for medtech partnerships in Japan as a response to the shortage of trained biomedical engineers from domestic universities. The third step is continual and sustainable collaboration. Some medical and technology professionals have falsely assumed that development would proceed automatically without discussion during the intermediate stage, once the content of the development had been determined. However, the intermediate research and development process always involves trial and error, as well as corrections and adjustments to planning (Tanishita 2013, 8–17). Medical professionals need to participate in the development process from the beginning, as they are the main users of these devices. They need to participate in the technological development as much as possible. Thus, continual and sustainable discussion and exchange of ideas may be regarded as key to achieving satisfactory final products. The importance of continual and sustainable

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collaboration was also emphasized in the study by Higashi (2016, 31– 37), who pointed out that lead users play a crucial role in co-creation in the development process, as they help to specify the appropriateness and acceptability of new devices in a continuous feedback loop process. The last step is the creation of the market-ready device. This final product must be approved by the regulatory agency in Japan, the Pharmaceuticals and Medical Devices Agency (PMDA 2019). This regulatory process is essential for clinical application of a final product. The consideration of regulatory issues during the last step often comes too late; these issues affect the safety and efficacy of the device and therefore must be taken into account from the initial steps in development (Yoshikawa 2013, 151–157). This requirement is one of the more difficult aspects of medical-device development. As such, it needs to be addressed by experts at the outset to avoid unnecessary consumption of time, human and financial resources. To summarize, disciplinary differences between medical and technology professionals in Japan create barriers that hamper communication and collaboration between them. However, it has been demonstrated that disciplinary barriers can be overcome by various activities conducted by Commons, which acts as a liaison platform for various medical societies and research groups. Through the platform, multidisciplinary experts have been able to share their motivation to establish and maintain medtech partnerships. The medtech partnerships generated play an important role in the development of medical devices based on innovative clinical needs, continuing in close collaboration toward the accomplishment of final devices that meet user needs in clinical workplaces. These manifold activities of Commons have resulted in many sophisticated technologies proving the innovativeness of this liaison platform. In addition to the activities of Commons, some universities and hospitals in Japan have begun to hold exchange events for medical and technology professionals. Recently, some hospitals in Japan have started to allow clinical immersion to allow research groups from technological fields to explore clinical needs. This trend will promote medtech partnerships and generate further progress in Japan’s medical industry. It has also been shown that the study of social factors during technological innovation helps to identify factors in the success or failure of

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medical-device development, or why the circumstances differ between countries such as the US and Japan. In particular, the concept of disciplinary boundaries, as outlined by Ferlie et al. and Hogle, allows us to identify social and cognitive factors that hinder smooth communication between the medical and technological fields. These barriers can encompass professional roles and identities, and work practices, as well as different knowledge bases, agendas, questions and research cultures. In addition, the notion of user-led innovation, as outlined by von Hippel, Higashi, Oudshoorn and Pinch, is essential to reflection on the medicaldevice development situation in Japan. To explore incremental or major needs in clinical settings, the most important initial step remains close collaboration based on medtech partnerships. In other words, medical professionals can play a part as lead users, based on sharing knowledge with users and manufacturers through close collaboration, and marketing authorization holders can function as mediators between the different fields. Finally, it has been shown that the ecosystem of Japan differs widely from that of the US. This implies that there is a need to reflect, not only generally on the human factors, but also on the country-specific factors regarding innovation which might lead to different responses to similar problems. For example, we observed that crossing the boundary between medical and technical fields is difficult in Japanese society, because, traditionally, professionals have tended not to get involved in different disciplines and domains but to confine their activities within their own discipline. The medical and clinical worlds are generally closed communities, in contrast to those in the US. In addition, the medicine and biomedical engineering education systems differ considerably due to the autonomy and separation of each discipline and faculty at Japanese universities and the lack of integrated programmes like those prevalent in the US. This context poses not only a serious problem for medicaldevice development in Japan but also leads to different responses, such as the model where the mediation function between medical and technology professionals is carried out by marketing authorization holders, rather than biomedical engineers as in the US.

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Part V Engineering and Evaluating Medical Technology

10 Empowering Patients in Interactive Unity with Machines: Engineering the HAL (Hybrid Assistive Limb) Robotic Rehabilitation System Patrick Grüneberg

1

Introduction

In the wide field of rehabilitation robotics, the exoskeleton robot HAL (Hybrid Assistive Limb) in Japan presents a specific case of human–

This case study draws on my long-term collaboration with the Cybernics group since 2011 and was supported by JSPS KAKENHI Grant Number JP 18K00035. As a visiting researcher at the Center for Cybernics Research, my work concerns cognitive models of voluntary initiation of gait movement (Grüneberg et al. 2015, 2018). In addition to this work on the cognitive analysis of the HAL system, another research project concerns the norms and values underlying the design and implementation of an interactive unity in HMR. In the course of this latter project, I conducted interviews with two robotics engineers at the Center for Cybernics Research about their views on HMR, the HAL system, and related social and ethical issues. Both interviewees are aware of the research purpose and gave their informed consent to the anonymous citation of their statements. Each interview lasted 50 minutes, followed semi-structured guidelines and was analyzed using qualitative content analysis (Gläser and Laudel 2013).

P. Grüneberg (B) Kanazawa University, Kanazawa, Japan e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Brucksch and K. Sasaki (eds.), Humans and Devices in Medical Contexts, Health, Technology and Society, https://doi.org/10.1007/978-981-33-6280-2_10

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machine relations (HMR), in that it autonomously takes over certain impaired functions of its human user during the execution of forward gait. In this interactive unity of HAL and human, HMR and the ethical framing of the HAL system are understood as an empowerment technology (ET). However, more detailed attempts to clarify the approach to HAL in Japan beyond its technical and clinical applications and in an intercultural perspective are still awaited. The problem is that much research about robotics in Japan builds on certain cultural stereotypes (Nakada 2019) of enforced “exoticization”. As Wagner critically points out, studies on “the” Japanese approach to robotics often proceed within a set of essentialist stereotypes turning on mentality, religion and popular culture (Sabanovi´c 2014; Wagner 2014), according to which the Japanese are supposed to welcome robots. While some scholars express doubts over the alleged particularly high acceptance rate of robots within Japanese society (e.g., Bartneck et al. 2005; Bartneck 2008), the government, mass media and popular cultural media frequently reinforce this image, promoting the validity of these common stereotypes. In the end, these stereotypes and corresponding attempts at “self-orientalization”, i.e., the emphasis on a “unique Japanese approach” and attitude towards robotics by Japanese actors, tell more about “the desires, dreams, reactions to, and needs of a society at certain times” (Wagner 2009, 514) than about the actual practice of robotics in Japan. Studies that go beyond the common stereotypes do, of course, exist, such as Robertson (2018) on gender and family issues, Sabanovi´c (2014) on sociocultural values and images underlying social robotics or Matsuzaki (2013) on human–robot relations. The limited informational content of exoticizing accounts is particularly reflected in the sociocultural bias of the ontology underlying HMR. This view, according to which the human agent is prioritized over the machine, usually departs from an individualistic conception of human and machine. Ethical assessment builds on this hierarchy so that the machine is considered a potential threat to human superiority and integrity. In contrast, in the Cybernics approach to HAL, which departs from a relational understanding, the machine is designed as an agent that integrates into human agency for the sake of human empowerment so that it can hardly be considered an ethical risk. However, such a different

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view could easily be disregarded as less relevant because it is considered merely a specific cultural view, as opposed to (alleged) scientific and objective standards. These subtle tendencies towards exoticization could even be reinforced if the methods for comparing different approaches (here, cultural-anthropological and sociological methods) follow the same rationale as the dominant view. To the extent that conventional conceptions prevailing in countries in Europe and America are the standard approach to HMR and related ethics, there is thus always the risk that underlying sociocultural differences could impede recognition of an alternative, equally valid, approach. This case study attempts to show that the HAL scenario in Japan provides a capability-oriented approach to medical HMR with builtin ethics. This approach differs from the prevailing view by a relational ontology that allows the integration of machines into human agency for the sake of fostering human integrity. In order to avoid exoticizing this alternative approach and to come to a systematic understanding of its ethical framing, this case study departs from a cognitive-design viewpoint that asks “what particular kinds of subjects are being created by the way augmentations are conceptualized and executed” (Hogle 2008, 854). This focus on the cognitive implementation of HMR allows the underlying conceptions of the engineers to be explicated as functional resources for creating HMR and thereby addressing the questions of first, how ET are constructed and legitimized in Japan, and, second, what relationship between humans and machines is envisioned in the context of healthcare. Following Hogle, the approach to HAL practised by a group of Japanese engineers is not seen as a specific cultural approach, but as one possible functional approach to HMR beside other possible approaches practised in other places. At the same time, the intention is not to exclude the notion of cultural and social embedding, because any approach is embedded in its environment. The point rather is that the cultural difference is not seen as a cultural difference per se, not as an idiosyncratic one, but as one in the functional design of HMR. Methodologically speaking, functional concepts do not build on opaque concepts of mentality or “exotic” practices, so that the cognitive-design viewpoint comes as a tertium comparationis that allows different approaches to HMR to be conceptualized, compared or even cross-fertilized.

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The remainder of this chapter is divided into three parts. Section 2 sketches the developmental framework of the HAL system in Japan. For this purpose, the government vision of a Society 5.0 and its implementation in the Cybernics programme are characterized as a sociotechnological approach that builds on intrinsic HMR compared to the techno-technological approach prevailing in many countries in Europe and America, which builds on a strict distinction between human and machine. Based on the Cybernics approach, Sect. 3 provides a cognitive analysis that classifies HAL as an instance of ET and shows how the HAL system creates an interactive unity with its user in order to complement their impaired forward gait capability. Based on the results of the previous sections, Sect. 4 provides an ethical assessment of the Cybernics approach as a capability-oriented approach with built-in ethics. In contrast to dichotomic HMR, the HAL system implements a conception of HMR that overcomes the dichotomy of human and machine by integration into human agency. This intrinsic or built-in empowerment fosters human agency and lays the foundation for patient-centred HMR complementing common risk-based scenarios. The validity of this relational conception of HMR is evaluated by considering it against the ethical issues of safety and cyborgization. Methodologically speaking, this ethical assessment meets a desideratum according to which STS studies too often abstain from taking a normative stance (Johnson and Wetmore 2007, 567). In contrast, the cognitive-design approach assigns STS concepts a constitutive role in the normative analysis of the design and implementation of medical HMR.

2

Socio-Technological Human–Machine Relations

From a cognitive-design viewpoint, two approaches towards HMR can be distinguished. The standard approach and related ethical considerations build on autonomous agents (Sabanovi´c 2014, 356; Suchman 2007, 226–240) and individual moral agency based on specific properties of an agent, such as the capacity to act for reasons, behavioural autonomy, understanding, consciousness or responsibility (Floridi and

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Sanders 2004; Misselhorn 2013). Ascribing moral agency to human individuals comes with a strict division of agents as individuals.Humans are prioritized over machines in terms of their ethical significance. It is, then, the individual human that enters into a relation with an individual machine so that the individual relata “human” and “machine” forego the relation of interaction. In this vein, the standard cognitive-design approach could be characterized as a techno-technological approach, in that it takes technology as a mere technological phenomenon as distinct from the human being. The design task, then, is to enable interaction between the two. During interaction, the hierarchic order that prioritizes the human renders machines a potential threat to human autonomy and integrity. Accordingly, ethical assessment aims at identifying and resolving the inherent conflict between human autonomy and machine automatization, so that the techno-technological approach fosters an ethical orientation to the risks of HMR for humans. In contrast to this standard view, the socio-technological approach departs from a relational ontology. While the well-known concept of the socio-technical system (Ropohl 1999) provides a general conception of the embedding and intertwining of human and machines, the sociotechnological design approach particularly concerns the engineering process (design, development and implementation). More specifically, following the idea of Clark’s Natural -born Cyborgs, Matsuda proposes a non-essentialist definition of the human in terms of Plessner’s homo absconditus, according to which a presumed essence of the human cannot be specified (Matsuda 2016, 69). This open view places humans in line with non-human entities and implies a relational formation that builds on a heterarchic order of human and machine. A heterarchy “may be defined as the relation of elements to one another when they are unranked or when they possess the potential for being ranked in a number of different ways” (Crumley 2008, 3).1 Thus, as opposed to a hierarchy with a fixed vertical order of unequal elements, a heterarchy allows for basically equal elements to be arranged in varying horizontal 1 McCulloch

first introduced the term in the context of describing the neural behaviour of reflexes. He concluded that an organism has a “heterarchy of values, and is thus internectively too rich to submit to a summum bonum” (McCulloch 1945, 92; for a logical foundation see Günther 1971).

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and vertical orders. The simultaneity of both types of orders means that heterarchy and hierarchy are not mutually exclusive. Rather, a heterarchy can contain hierarchies or form a part of a hierarchy. Opposed to the individualistic conception of the techno-technological approach, the socio-technological approach develops HMR based on the intrinsic, or horizontal relation of human and machine. Horizontally speaking, there is no substantial difference between them, so that technology comes as an inseparable part of human development. Tools and machines are considered human counterparts. This conception can be traced back to relational notions of the self (Lennerfors 2019, 61–63; Robertson 2010, 14) and is also implemented in kansei engineering, a way of translating users’ subjective experience into a design (Levy 2013; Sabanovi´c 2014, 355). While humans are considered dependent on their intrinsic relations with other human and non-human entities, a specific vertical order can come into effect if it appears to be necessary to prioritize either human or machine. In the case of medical HMR, this applies to vulnerable humans who ask for protection due to their fragile condition. Compared to, for example, HMR in manufacturing, where the robot is made to act independently of humans in order to accomplish its task in the most optimal way by using its technical capabilities, which often exclude any human interference, medical HMR is expected to respect and adjust to the condition of the human subject. Accordingly, human agency has to be prioritized, which implies a vertical order in favour of the human. A heterarchy combines both the horizontal and vertical orders in one complex relation and allows for different configurations of human and machine. In the case of medical HMR, the horizontal interdependence is combined with a vertical prioritization of the human. Such a heterarchic relationship does not imply a substantial gap between human and machines as in a merely hierarchic conception, nor does it invoke what Matsuzaki (2013, 370) critically identified as “the shadow view of ‘robots as servants to humans’”. The socio-technological conception rejects such unilateral relations in favour of more complex heterarchic relations that reflect the simultaneous need of interdependence and of control instances in specific HMR scenarios.

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Developmental Framework: Society 5.0

With the initial development of the HAL system dating back to the 1990s (see below), HAL anticipated the current approach to HMR in Japan: the vision of a Society 5.0. This is no coincidence, considering that Yoshiyuki Sankai, a well-known roboticist in Japan, was the inventor of HAL and one of the initiators of the government’s vision of Society 5.0. However, unlike the historical genesis, the following overview begins with the current developmental framework. To begin with, the Japanese government diagnosed an “era of drastic change” (CaO 2016, 1) of social and economic conditions due to advances in information and communication technologies (ICT). In order to not only meet the upcoming challenges, but to shape the new course of technological development and to finally let Japanese society benefit from the outcomes of disruptive innovations, the government introduced the 5th Basic Science and Technology Plan for the period 2016–2020 (CaO 2016). The basic plan suggests numerous measures for supporting future industries and related social transformation, addressing economic and social challenges, and reconsidering the principles of science, technology and innovation. In terms of “techno-social design”, all aspects of the 5th Basic Plan envision the implementation of a “new possible future” (Fujimura 2003, 192) that conceives human–machine integration as the central measure of scientific and technological innovation: the so-called “super-smart society” or Society 5.0 (CaO 2016, 12–15). More precisely, the plan states that this is “a society that is capable of providing the necessary goods and services … that is able to respond precisely to a wide variety of social needs; a society in which all kinds of people can … overcome differences of age, gender, region, and language” (CaO 2016, 13). For this purpose, the government aims at “merging the physical space (real world) and cyberspace” (CaO 2016, 13). In this vein, the 5th Basic Plan goes beyond the industrial focus on manufacturing and logistics of Industry 4.0, a political campaign originating in Germany. The far-reaching vision of a fusion of human and technology provides nothing short of a total view of a society encompassing all relevant scientific, economic and social domains, such as education, healthcare, public services, transportation and finance.

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Nevertheless, the basic plan seems like a highly prescriptive government programme that “manipulate[s] culture as another tool to produce or reorder worlds in alignment with both national economic priorities and ideals of Japanese society” (Hogle 2008, 863). Accordingly, this vision may evoke an instrumentalistic idea of the technological controllability of society. For the current purposes, this comprehensive focus on society is seen from a cognitive-design viewpoint and, in this view, reflects the socio-technological approach to the extent that Society 5.0 aims at robotic and AI technologies that will “coexist and work” (CaO 2016, 13) with humans: “The important thing is how society can be changed and how society can be advanced by using technology. … It is not only the technology, it is not only the people – together with the people and technology, how we can form society in the future” (interview, 12 December 2018). In sum, the vision of Society 5.0 promotes a socio-technological framework for understanding HMR.

2.2

Cybernics as an Approach to the Implementation of Society 5.0

The University of Tsukuba operates the Center for Cybernics Research (CCR), which uses the Cybernics approach as one of the basic methodologies for implementation of Society 5.0. The term “Cybernics” denotes a framework for R&D that uses a wide variety of methods in order to achieve “the fusion of human, machine and information systems” (Sankai 2014a, 3). Central methods include cybernetics, mechatronics and informatics, complemented by robotics, neuroscience, ergonomics, kansei engineering, physiology, social sciences and ethics. Accordingly, Cybernics denotes not a specific technology, but an interdisciplinary academic field that includes the entire spectrum of actors ranging from engineers, and devices to users and decision makers, and therefore provides an environment for R&D ranging from basic concepts to practical applications. The programme implements the socio-technological approach to the extent that it aims at “coexistence and interdependence between technology and humankind” (Sankai 2014a, 4) in that it “is mainly not only focusing on the production and the function of … robots but also

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on their implementation in society” (interview, 11 November 2018). In this view, machines are considered counterparts that support humans. So far the vision. The next section narrows the socio-technological approach down to the HAL system and clarifies in particular the heterarchic order of HMR.

3

HAL as Interactive Unity and Empowerment Technology

At present, the actual development of market-ready products based on Cybernics is, with some exceptions, limited to the exoskeleton robot HAL developed by Cybernics and realized as a product by Cyberdyne Inc. Development began in 1992 with motion support for the upper and lower limbs, the latter being used for rehabilitation purposes (see Fig. 1). Currently, HAL is distributed as a single- and double-leg version and can be used for rehabilitative treatment (HAL for Medical Use) or for supporting a wearer in chronic stages (HAL for Well-being). This case study concerns the former. The HAL system obtained CE marking (CE 0197) in 2013 as the first robotic medical device and is in accordance with the EU Medical Devices Directives, while Cyberdyne Inc. adopted the international standard ISO13485 (Medical Device) in 2012 as the first robotic medical device manufacturer (Sankai 2014b; TÜV Rheinland 2013). With 291 units for lower-limb rehabilitation in use by March 2019, HAL treatment is currently available in Japan as well as in Bulgaria, Germany, Italy, Malaysia, Philippines, Poland, SaudiArabia, and the US; approval as a medical device has been obtained in Europe, Japan and the US, enabling cover by public health insurance schemes (Cyberdyne Inc. 2019). While for example the German scheme mainly covers spinal cord injuries, the Japanese scheme additionally includes neuromuscular diseases and stroke-related diagnoses. The fact that approval occurred earlier in Germany and for different diagnoses may imply a different understanding of health/disease and risk/benefit assessment. Without going into a full comparison of the German and Japanese approval procedures, it can be stated here that the stronger German focus on recovery contrasts with the broader Japanese focus

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Fig. 1 Patient wearing HAL in a walking device (side view) (Source Grüneberg et al. [2015])

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on life support. Also addressing rare diseases (nanby¯o ) such as gradually progressive neuromuscular diseases, the Japanese scheme is in line with rehabilitative palliative care that “aims … to enable them [people] to live as independently and fully as possible … within the limitations of advancing illness” (Tiberini and Richardson 2015, 2). Clinical studies of HAL-assisted therapy provide data regarding the beneficial effects on gait therapy (Nakajima 2018; Wall et al. 2015) so that, depending on the diagnosis, the ability to walk is restored or improved, or its decline is slowed. Compared to other exoskeletons, HAL is not worn continuously, but at certain time intervals in rehabilitation therapy in hospitals under the supervision of a medical specialist. HAL was developed to support patients to execute movements that they can no longer (fully) execute themselves, using robotic systems for upper (Maciejasz et al. 2014) or lower-limb therapy (Díaz et al. 2011). Since most exoskeleton robots (as well as traditional physiotherapy) affect the neural system by acting on the (distal) physical level, they do not take the patient’s voluntary resources into account, and leave him passive: the impaired limbs are being moved (Belda-Lois et al. 2011). Advances in the field of robot-assisted therapy, however, suggest that the active participation of the patient in the therapeutic process has positive effects on motor recovery (Hogan et al. 2006). In order to fully exploit the active participation of the patient, the interactive biofeedback (iBF) hypothesis (Matsuda 2016, 67–68; Nakajima 2018, 37; Sankai 2014b) proposes an active control strategy that builds on biosignals (Belda-Lois et al. 2011) within the proprioceptive loop of movement initiation, execution and feedback to the brain (see Fig. 2). Following the iBF hypothesis, the patient enters into an interactive unity with HAL. This unity is a heterarchic relation that unfolds in the course of movement. After the patient has been equipped with HAL, he voluntarily initiates forward walking. Even in the case of severely impaired patients, efferent electromyography (EMG) signals of neural muscle activity often remain in the leg muscles, but no longer result in sufficient joint movement. By means of EMG sensors attached to the flexor and extensor muscles of hip and knee, HAL detects and interprets these biosignals (Almeida Ribeiro et al. 2013) as the patient’s intention to move their body voluntarily (Kawamoto et al. 2010). Accordingly, the

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Fig. 2 Interactive unity of patient and HAL. Notes In the HAL rehabilitation scenario, voluntary initiation of forward gait (1) begins with the efferent active neural signal (2) which originates in the brain based on voluntary attempts of the patient to move. The exoskeleton robot detects the signal of the intended motion and is activated in order to assist the leg motion. The execution of leg movement (3) releases an afferent signal of consequential sensation that goes back to the brain and signals that a motion has been executed successfully (4). The proprioceptive loop of gait initiation, execution and feedback is closed (5) with assistance of the robot acting as a part of the patient’s agency (Source Author’s compilation)

patient’s voluntary efforts to move work as a command to make the robot generate torque that facilitates leg movement and hence supports walking motion. In the horizontal order, patient and HAL work as interaction partners, with HAL integrating in the human execution of movement— in other words, becoming a part of the patient’s agency and body, thereby supplementing the actual implementation (actuation) of leg movement. The patient relies fully on the robot. In the vertical order, the patient

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controls HAL based on his volitional attempts to walk forward. The human is fully in control of the robot, i.e., HAL will not move unless the patient attempts to walk. Finally, after the leg movement is executed, an afferent signal of consequential sensation is reported back to the brain and closes the proprioceptive loop. According to the iBF hypothesis, this process supports neurorehabilitation and motor learning (for a detailed cognitive analysis of the patient–HAL interaction, see Grüneberg et al. 2015; for subjective control strategies of HAL, see Grüneberg et al. 2018). Based on the cognitive analysis of the HAL system, the type of technology suggested by the socio-technological approach can be defined as empowerment technology (ET). In the healthcare context, ET in general and HAL in particular can be classed as medical devices because they can be used for rehabilitation (Cheng 2003, vii; Hogle 2008, 841). Furthermore, ET form a subgroup of assistive technologies. While the umbrella term “assistive technologies” comprises numerous technologies for supporting the elderly, there is no standard definition (Brucksch and Schultz 2018, 13). Thus, first, ET extends to anyone in need of support, regardless of their age. Second, the specific type of assistance is the result of the functionality of ET as hitherto implemented in the HAL system. Conventional devices are reactive (passive) in the sense that they employ their function as a mechanical reaction to the user’s action, such as a wheelchair. While ET also acts on behalf of the user (vertical asymmetry), the system, once activated, moves with a certain degree of autonomy, i.e., conducts action as an agent in relation to the human (horizontal reciprocity). In this way, ET preserves human autonomy in that it integrates into and supports the physical and volitional exercise of the patient. This type of assistance comes as a form of empowerment, in that it aims at “the capacity of individuals … to take control of their circumstances, exercise power and achieve their own goals … to maximize the quality of their lives” (Adams 2008, xvi). Referring to the definition of ET provided by the PhD programme in Empowerment Informatics at the University of Tsukuba, the medical application of HAL falls under the first category “Supplementing reduced physical, sensory or cognitive functions” (PhD Program in Empowerment Informatics 2014). Both general and medical definitions of empowerment reflect a relational

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concept of health as “the ability to adapt and self manage” (Huber et al. 2011) and imply a dynamic conception that relates a healthy state to the particular situation of an individual. Thus, in contrast to the WHO definition that suggests “complete” states of health and well-being that are unattainable for certain group of patients (Matsuda 2016, 58–60), health is correlated to the inherent capabilities of humans (Robeyns 2017, 38– 41) so that medical ET, such as HAL, can be characterized as medical assistive devices that enter into an interactive unity with the care recipients and supplement impaired functions in order to restore or maintain their capability of an independent way of life as much as possible. Based on this definition, medical ET can be distinguished from enhancement technologies because the former are applied according to a diagnosis of an impairment of daily activities and not to the desire for non-therapeutic enhancement of existing capabilities such as in sports or lifestyle applications (Grüneberg 2012). There does exist a concrete therapeutic need in terms of the limited agency that ET are supposed to mitigate or to overcome. This therapy-related definition of ET must of course be distinguished from the non-therapeutic use of the same technology.

4

Built-in Ethics

When it comes to the basic ethical question of whether or not to use HMR for medical purposes, the socio-technological approach departs from the fundamental decision in favour of human–machine interaction. In contrast to techno-technological frameworks that also propose the widespread dissemination of ICT (Floridi et al. 2018), but that (despite the fact that the use of ICT itself is not questioned) include an ethical justification for implementing AI-based technologies (see for example the EU’s Ethics Guidelines for Trustworthy AI [High-Level Expert Group on Artificial Intelligence 2019]), neither Cybernics nor Society 5.0 consider that the actual use of HMR involves issues of particular ethical consideration. This prominent lack of an explicit discourse in Japan about ethical issues could evoke the above-mentioned instrumentalistic idea of the technological controllability of society or stereotypes

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of Japan as a robot-affine society. However, despite the lack of a general ethical justification of medical ET (and human–machine interaction in general), an ethical assessment of the cognitive design of the HAL system and the approach to Cybernics shows that an implicit ethical framing is employed. To assess whether and to what extent ethical issues are addressed in this socio-technological approach, Cybernics is confronted with the ethical problems of safety and “cyborgization”. Both problems reference the HAL case directly, whereas more complex issues such as human dignity exceed the scope of this case study. To cover all relevant ethical considerations of safety and cyborgization within the Cybernics approach, two related ethical perspectives are distinguished. First, safety in HMR involves questions of standardization and legislation, and therefore a formalized approach to ethics leading to technical standards. Second, (medical) HMR also raises ethical issues regarding the impact of HMR on the human lifeworld. Both perspectives also apply to cyborgization in the sense that it is considered a safety issue to be regulated and a broader societal question. Within the Cybernics approach, both ethical perspectives are intertwined and occur implicitly, so it is taken for granted that the use of machines is a viable option and ethical considerations are embedded in R&D processes.

4.1

Safety Issues

Safety issues are a general topic within technology-related ethics and form a basic component of engineering ethics (Poel and Royakkers 2011, 217–244). In Japan, safety is also a standard criterion for the approval of medical devices alongside efficacy and quality (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices 1960). In this vein, the discourse in Japan promotes safety in terms of standardization and legislation with the goal of producing safe machines that secure user acceptance and providing reliable liability standards for manufacturers (Matsuzaki and Lindemann 2015, 510–513; Hasebe et al. 2014, 300 for the Cybernics programme). Accordingly, the HAL system is equipped with a number of electromechanical safety mechanisms that protect the human user (Sankai et al. 2011). In this

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traditional sense, the discourse in Japan meets the traditional ethical requirements of safe devices. In recent years, the focus on technical safety has been broadened. There are numerous aspects of the impact of human–machine interaction on human relations that integrate further requirements (Bekey 2014). Honda (2013, 26–30) stresses that a mere focus on technical safety issues is insufficient and that safety issues extend equally to the social impact of robotic technologies. How is this situation handled in Cybernics? The focus is on the protection of personal information, also a particular concern in the operation of HAL which collects personal health data. While such data are generally treated as clinical data with the same disclosure requirements as other patient data, Cyberdyne Inc. explains that HAL data is processed anonymously and that it has established regulations for protecting personal information (Cyberdyne Inc. 2019). The 5th Basic Plan also attempts to extend the technical focus to the integration of ethical, legal and social issues in the implementation process of future technologies. This includes an investigation of the “possible impact such technological developments will have on humans and society” (CaO 2016, 18). In practical terms, however, no institutionalized discourse in policy-making on these issues exists comparable with, for example, the SIENNA approach to stakeholder-informed ethics in the European Union (The SIENNA Project 2019). This situation might be perceived as a substantial ethical shortcoming in the course of implementing ET in Japan. In contrast, interview data suggest a distinction between a narrow (traditional) and an extended sense of safety. In terms of traditional device safety, a member of the Cybernics group states that “[i]n Japan, the important thing is comfort rather than safety” (interview, 12 December 2018) because the user perception of safety (anzen-sei) builds on the comfort (ansei-ji) that a technology provides. While this relation between comfort and safety implies a specific sense of device safety prevailing in Japan, the meaning of safety is also extended to social safety: AI and robotic technologies are designed to “help us to make decisions by ourselves” (interview, 12 December 2018) and therefore aim at human empowerment so that the human ultimately remains the measure of all HMR. In this light, ethical concerns appear rather to be embedded in

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the socio-technological approach, to the extent that the primary focus is on the human being and human society rather than on the technology. Because the imperative of human autonomy guides the cognitive design of HMR in Cybernics and the societal implementation of ET, the assessment of the social impact of machine interaction already forms a part of the engineering process itself and therefore receives considerable attention. In sum, the approach to Cybernics does not suggest a principal lack of ethical concerns. Compared to the explicit ethical assessment that is applied in many countries in Europe and America and that is conceptually distinct from the technological development process and then integrated into R&D under the headings of “technology assessment” and “ethical guidelines” (Floridi et al. 2018, 690–695), Cybernics and Society 5.0 more generally demonstrate an implicitly ethical attitude: first, the formalized safety standardization and safety legislation requirements are met; second, and most likely comparable with “design ethics” (Chan 2018; Verbeek 2008), the HMR design process is guided by a human-centred perspective.

4.2

Cyborgization

HAL raises the issue of “cyborgization”—“the phenomenon of technological restoration, augmentation and alteration of human natural capacities and functionality” (Zhao 2006, 403). More specifically, HAL physically supports human limbs and is supposed to modify neuronal structures (iBF hypothesis). Common ethical discourses about cyborgization primarily concern the “boundaries of the human” (Hogle 2008, 853), pointing out the problem of altering human identity based on the alteration of the body. Apart from transhumanist approaches that advocate cyborgization, the common ethical thread thus concerns the destabilization of identity in the sense that human–machine interfaces can “transform identities and disrupt received notions of what it means to be human” (Hogle 2008, 858). In this view, human–technology interfaces pose a substantial threat to people’s identity through the

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manipulation of their bodies. In particular, Robertson sees a “remarkable congruity” (Robertson 2018, 174) between the promotion of HAL by Cyberdyne Inc. and transhumanist ideas that enforce regulation of the human body. Fostering bipedalism, Robertson (2018, 168–174) regards exoskeleton robots as a means to normalize “nonstandard bodies” (Hogle 2008, 855) and hence to exclude these from the social sphere. In contrast to Robertson’s reservations, Sankai stresses the “peoplecentered way of thinking” (Sankai 2014a, 16) that underlies Cybernics. In other words, HAL implements patient-centred HMR concerning highly specific conditions of impairment that is not meant as a general measure adjusting gait behaviour (Matsubara 2011). Without doubting the need to establish and preserve diverse notions of the human body, the assessment of enforcing bipedalism appears unfounded in the case of HAL, particularly for patients who seek to restore their lost bipedal locomotion ability and who explicitly appreciate robotic walking support (Grüneberg et al. 2018). Due to the interactive unity established by HAL, these patients rather experience HAL as adjusted to match their bodies, as assisting their physical autonomy, and therefore as a part of their self. On the general issue of the boundaries of the human, a member of Cybernics explains, first, that cyborgization is principally a safety issue concerning the physical integrity of humans in HMR: technology may not harm the biological body (interview, 12 December 2018). Second, in line with Matsuda’s above-mentioned reference to Clark’s idea of natural-born cyborgs, which acknowledges various types of technology as cyborgization, ranging from implants and prostheses in the narrow sense to any kinds of technology such as screwdrivers or glasses (Zhao 2006, 403), the member promotes a conservative view according to which cyborgization has no effect on human identity because this has not changed fundamentally since “two thousand years ago” (interview, 12 December 2018). While “tools and society have changed” (interview, 12 December 2018), the member states further, the basic concerns and topics of human affairs remain the same so that cyborgization by means of exoskeletons or even implants would not change this situation significantly. Confronted with Foucault’s concept of bio-power and the instrumentalistic idea of technological controllability in the

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5th Basic Plan, the same member affirms the idea of shaping society through technology based on the assistive role of technology as long as it “foster[s] [the] human skill of decision-making by themselves” (interview, 12 December 2018). While the HAL technology can be used for different purposes, Cyberdyne Inc. commits itself to the assistive usage of HAL in “the areas of medicine, living support and disaster recovery”, thereby “preventing the ... technology from being used to harm people or to create military weapons” (Cyberdyne Inc. 2019). In this view, acceptable cyborgization stands and falls with the preservation of physical integrity and the assistance of human autonomy during HMR. To sum up, as well as considering the formal safety issues of cyborgization, a conservative view of human continuity joins an open view of what humans could become by using technology. However, such a general openness does not, as Matsuda (2016, 70) argues, imply an “anything goes” approach. Instead, the potential concerns about introducing cyborg technologies, such as distribution justice or solidarity, and a way to balance technological innovation and a “culture of mutual aid” need to be addressed. Compared to the prevailing ethical accounts, this tension between technological modification on the one hand and concern for human autonomy and physical integrity on the other is not resolved by referring to ethical guidelines centring around a universal valuation of the human. It is rather constantly negotiated in a process of “‘active incompleteness’” (Robertson 2010, 14) of artificial systems, according to which these can adapt and interact with variable human counterparts. Within the patient-centred approach, the technical design of such systems and consideration of their social impact is reflected in case-specific criteria that follow from the specific settings of users and that constructively guide R&D and the ET implementation process.

5

Conclusion

This case study of Cybernics and the HAL system in the context of Society 5.0 began with the questions, first, how ET are constructed and legitimized in Japan, and, second, what relationship between humans and machines is envisioned in the context of healthcare. In order to tackle

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these questions beyond common stereotypes, it was necessary to address the methodological issue of exoticization. For this purpose, Cybernics and HAL were analyzed from a cognitive-design perspective that departs from Hogle’s question of what kind of subjects are being created by cyborgization. Results point to HMR based on an interactive unity of human and machine for the sake of human empowerment. As regards the first question, medical ET are constructed as sociotechnological HMR implementing a capability-oriented approach to human agency; this technological intervention of ET into humans is legitimized according to two criteria: first, the interactive unity has to bring about human empowerment; and second, physical integrity has to be ensured. In contrast to an individualistic conception of agency, Cybernics considers the performance of human agency as being inherently coupled to human and non-human relata so that the integration of a machine into the course of human agency is not supposed to alter human identity. Replying to Hogle, human subjects are being created during cyborgization. Regarding the second question, the socio-technological approach implies a relational understanding of health. Based on the idea of health as the ability to adapt and self-manage that reflects the capability orientation of ET, Cybernics promotes patient-centred HMR. While the present case study has so far attempted to provide conceptual clarification of the approach to Cybernics and proceeded rather affirmatively, two issues remain unresolved. First, the underlying instrumentalistic idea of the technological controllability of society raises concerns regarding the range and feasibility of technical solutions to medical problems. Despite technological progress, the intrinsic focus on human society should also be taken into account in assessing whether a technological solution or additional other measures such as social care should be applied. Accordingly, Cybernics is required to ensure a selfcritical exercise of the socio-technological approach. Second, Cybernics stands and falls with the preservation of empowerment and physical integrity. Both demands impose a significant burden on the engineer who is required to negotiate the possible degrees of enabling empowerment in relation to the physical condition of the patient, both constantly and case by case. Thus, despite built-in ethics, ethical issues are not settled. At this point, common ethical resources that provide the conceptual means to

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assess the interests of vulnerable subjects could play out their strengths. In this way, the relational approach also applies also methodologically to the extent that distinct approaches, here to HMR and related ethics, are conceptualized as functional resources that should complement each other in order to handle complex problems such as those in healthcare.

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List of Interviews 11 November 2018, Tsukuba, robotics engineer at University of Tsukuba. 12 December 2018, Tsukuba, robotics engineer at University of Tsukuba.

11 Innovative Technology, Clinical Trials and the Subjective Evaluation of Patients: The Cyborg-type Robot HAL and the Treatment of Functional Regeneration in Patients with Rare Incurable Neuromuscular Diseases in Japan Takashi Nakajima

1

Introduction

Incurable progressive rare neurological/neuromuscular diseases for which there are no established treatments strongly compromise the social way of life of affected patients and their families. Many academic scholars have believed that medical treatment for the recovery of function in incurable and progressive neurological/neuromuscular diseases is of no significance or is in vain (Bagheri et al. 2006). This is based on the belief that the central nervous system, including motor neurons, once grown and developed, does not recover after it has been damaged (Ramón y Cajal 1968 [1928]). This belief has prevented researchers from promoting studies of T. Nakajima (B) National Hospital Organization, Niigata National Hospital, Kashiwazaki, Japan e-mail: [email protected] © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Brucksch and K. Sasaki (eds.), Humans and Devices in Medical Contexts, Health, Technology and Society, https://doi.org/10.1007/978-981-33-6280-2_11

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treatments to improve the symptoms of progressive neurological conditions other than curative treatments to normalize such conditions. In principle, rehabilitation medicine is the provision of support for a patient suffering from a serious illness, disability and ageing. With rehabilitation, patients develop abilities to overcome their hardships and make efforts to continue living proactively. In practice, however, rehabilitation medicine has tended to focus on trauma, stroke and disuse syndrome. Physical rehabilitation for incurable progressive rare neurological or neuromuscular diseases has been neither sufficiently practised nor adequately studied, resulting in a lack of medical evidence. Only a few physiotherapists specializing in disease are considered able to perform appropriate physical rehabilitation for such patients. Despite their efforts, in cases where innovative technology and devices are used, either medical futility concerns or neo-Luddite beliefs insist on the importance of the direct involvement of physiotherapists in rehabilitation. Moreover, some scholars perceive innovative technology for physical rehabilitation as less suitable and prefer to “coexist with nature” without becoming dependent on “artificial support provided by mechanical devices” (e.g., Glendinning 1990). In other words, the field of patient treatment and physiotherapy has been somewhat resistant to the adoption of innovative technology. This inherent resistance highlights the need for medical science and medical engineering to also conduct research on alternative approaches to providing new treatments. As there is a lack of clinical studies, public funding is necessary to enable clinical research in Japan.1 This is not only for research on rare diseases but also for exploring treatments that employ new types of innovative rehabilitation technology and in turn obtaining the relevant medical evidence to support them. At the present time, some high-tech devices are used in medical treatment of patients with incurable and intractable diseases. However, considering rehabilitation devices as alternative approaches should not prevent that innovative

1The Orphan Drug Act is a mechanism to support the development of drugs and medical devices for rare diseases with public funds. The act, adopted in the United States in 1983, was established to address the disparity in funding for rare diseases. An almost identical act was adopted in Japan in 1993, in Australia in 1997 and in the EU in 1999.

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technology from being critically studied. Moreover, innovative technology requires sufficient clinical proof for its adoption as a conventional medical treatment. Nevertheless, first and foremost, we need to ask what our basic understanding of the meaning of health is, as this will affect the nature of medical treatment, the employment of medical technology and clinical evaluation. Only after having answered this question, are we able to specify (a) how individuals are actually connected to medical devices and the purpose of using innovative technology, (b) what the influence of medical devices like HAL is on medical conditions, particularly for patients with gait impairment, (c) how the impact of these innovative devices in medical treatment should be assessed during clinical evaluation and (d) how we should evaluate the safety, efficacy and patient benefit of these medical devices. To answer these questions, appropriate clinical trials need to be conducted. Hogle (2008, 852) writes that production of scientific knowledge in clinical trials and data interpretation demonstrates that evidence “takes multiple forms to do what we ask it to do”. She also points to the “gap in Science and Technology Studies (STS) regarding the medical technology trials, the differences in cultural and scientific authority as part of medical technological systems” as well as “issues about the normalization of nonstandard bodies”, in particular on such a group of people “who may receive what kind of replacement device or therapy” (Hogle 2008, 852, 855). In other words, the case of the cyborg-type robot HAL and the treatment of functional regeneration in patients with rare incurable neuromuscular diseases provides a valuable example to study variations in a socio-technical setting in Japan. What is more, the outcome of this clinical trial also demonstrates variations in medicaldevice trials resulting from different concepts of health or consideration of patients’ subjective evaluation. For instance, our research team explicitly understands this clinical trial as going beyond the normalization principle by considering patient-reported outcomes (PROs). Below, we define the concept of health on which the clinical trial on HAL for Medical Use was based and explain our overall research strategy.

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Defining Health

The preamble to the Constitution of the World Health Organization (WHO), written in 1946, defines health “positively, as complete physical, mental and social well-being, not merely negatively as the absence of disease or infirmity” (Grad 2002, 981). It has been argued that in constructing the concept of health, the WHO has overlooked important dimensions. However, modifications in health management indicators and policies in accordance with other dimensions were not considered necessary by the WHO. Subsequently, the WHO did not modify their original concept of health in 1999 (Chirico 2016). So, this WHO definition of health as complete well -being, although criticized, is still widely accepted and most current health sciences are based on it. However, increasing criticism of the definition has arisen because of the difficulty of applying it in an operationalistic way during scientific analyses, and of applying it to incurable diseases and the increasing incidences in chronic illness in an ageing society like Japan (e.g., The President’s Council on Bioethics 2003; Matsuda 2012). More precisely, the WHO definition can be understood as a concept that “categorize[s] individuals into culturally constructed states of normality or pathology” that “have become a central part of decision-making about managing health problems in certain ways” (Hogle 2008, 842). Still, Hogle (2008, 849) points to the circumstance that “there are tensions between attempts to standardize, normalize, and unify bodies and technological practices and the diversity that bodies display under varying conditions”. Another proposal is to change the criterion of complete well-being rather than considering other dimensions. Accordingly, Huber et al. (2011) suggest an alternative concept of health in their article “How Should We Define Health?” in the British Medical Journal . The authors proposed changing the emphasis in the concept of health towards the “ability to adapt and self-manage in the face of social, physical, and emotional challenges”. In other words, medical treatment would be interpreted as the provision of support needed to help patients to adapt to ailments or to certain disorders/disabilities instead of efforts aimed at normalization. Based on this alternative concept of health, the definition

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of medical treatment used in this chapter is as follows. Medical treatment is supporting patients with various medical conditions using drugs and medical devices. Support is provided for patients in such a way as to encourage them to actively adapt to new physiological environments (internal/external conditions) and make further efforts to live. This type of medical treatment is expected to contribute to the mental and physical revitalization of patients. Against this backdrop, the dualistic and, therefore, problematic distinction between normal/abnormal in the WHO definition can be avoided during clinical trials, diagnoses and medical treatment processes (Matsuda 2015, 258).

1.2

Overall Research Strategy

Our research group, a multi-institutional research group based at Niigata National Hospital in Kashiwazaki City, performed a randomized clinical trial (NCY-3001) for gait treatment in patients with incurable and intractable rare progressive neuromuscular disease. This clinical trial and the resulting treatment with Hybrid Assistive Limb (HAL) as a new medical device for gait impairment are based on the alternative concept of health defined above. More specifically, this treatment aims at enhancing intention-based functional regeneration of the neuromuscular synaptic network. The research team believed that a combined therapy, that is motor learning with HAL combined with disease-modifying drugs, including antibody medicine, oligonucleotide medicine and stem cells, would help patients to adapt actively and intentionally to their medical conditions or disabilities. Accordingly, as part of the alternative definition of health, our research team argued that during the clinical trial, the patients’ subjective evaluations should be emphasized as evidence of adaptation and improvement of symptoms in the form of PROs as part of the alternative definition of health. This replaces the exclusive reference to standard criteria such as device safety and observed performance that was previously the case during the clinical evaluation process for new medical devices in Japan.

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This study responds to the gap in STS research by elaborating on the case of the cyborg-type robot HAL and the treatment of functional regeneration in patients with rare incurable neuromuscular disease. Faulkner (2009, 20) writes that, for case studies of medical devices it is common for medical practitioners to become involved as consultants or research partners during clinical evaluation to provide the required medical expertise during the engineering process. The author has headed a research project on “Measures for Overcoming Intractable Diseases: Implementation of an Investigator-initiated Trial on a New Medical Device for Inhibition of Progress or Treatment of Rare Intractable Diseases/Intractable Neuromuscular Diseases, Hybrid Assistive Limb (HAL-HN01) Voluntarily Controlled by Bioelectrical signals, etc.”, funded by the Ministry of Health, Labour, and Welfare (MHLW) of Japan and the Japan Agency for Medical Research and Development (AMED). Medical-device development for rare diseases as opposed to common diseases is generally considered to be at a disadvantage when it comes to reimbursement of development costs. However, our research team was convinced that this would not be the case. In the case of vulnerable patients with rare neuromuscular diseases and low and less frequent bioelectrical signals from their damaged neuromuscular system, the required efficacy can be achieved using high-performance HAL technology to drive HAL. This efficacy can be observed in the device performance data from patients with cerebrovascular disorder and severe spinal cord injury in the acute phase. The author’s research experience at the US National Institutes of Health (NIH) from 1987 to 1989 has been of great assistance in the design and implementation of further research projects. For instance, at the NIH it is usual for a medicine and health science research project to be conducted by a team comprising experts from various fields and to be based on strategic networks. The findings of recent decades have proved the innovative NIH approach to be the correct one (Stevens et al. 2011), and it has been successful in achieving advanced technologies (compare Faulkner 2009, 4). Our research team in Japan has worked in a comparable way, with experts from various fields, and there is a continuous exchange between scholars, practitioners and patient groups during the research process. More specifically, the technology and

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the innovative treatment require translation into established concepts and terminology in order to receive social and scientific approval. It is sometimes vital to adjust epistemology and methodology when evaluating the efficacy and safety of innovative technology. Therefore, we were convinced that researchers specializing in medicine, engineering and philosophy/humanities were needed for multidisciplinary teams capable of dealing with interdisciplinary research projects to develop new medical devices. This chapter aims to provide a critical evaluation of the use of wearable robotic technology as potential means of “enhancement beyond therapy”. The next section explains the basic body function of reacquisition of voluntary movement following impairment, on which the operating principle of HAL for gait treatment in patients with rare incurable neuromuscular disease is based. The third section describes the structure of clinical trials in general, the difficulties experienced in Japan and the need to integrate PROs in order to operationalize the alternative definition of health. The fourth section introduces the cyborg-type robot HAL (Hybrid Assistive Limb) for Medical Use and its clinical trial conducted by our research based at the Niigata National Hospital in Kashiwazaki City. The section also explains the difference between this medical technology and transhumanism.

2

Voluntary Movement Disorders and Their Treatment

Voluntary movement is an important body function that enables humans to maintain internal environments and to live independently. For example, if somebody is thirsty, they will voluntarily drink the required volume of water. However, if that person is physically unable to drink water voluntarily, they are not able to maintain their homeostasis and will not survive without support. A wide variety of medical conditions can cause disorders of voluntary movement (Flanders 2009) or the motor system (Knierim 1997). These conditions include almost all neurological and neuromuscular diseases, including cerebrovascular disease, spinal cord injury, Parkinson’s disease, alcoholic encephalopathy,

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multiple sclerosis, HTLV-1-associated myelopathy (HAM), spinocerebellar degeneration, amyotrophic lateral sclerosis (ALS), spinal muscular atrophy, muscular dystrophy and several other conditions. In addition to these medical conditions, the process of ageing can also be regarded as one cause of voluntary movement disorder (Seidler et al. 2010, 722). Voluntary movement disorders are thus becoming an issue of growing importance in ageing societies like Japan. Medical research has attempted to develop curative treatments for voluntary movement disorders, but these efforts have proved fruitless so far (Ramón y Cajal et al. 1991). Nursing care and social support are still recommended as the standard measures for these diseases because there is a lack of medical research on alternative approaches (Saraceni 2014). For instance, the currently available physiotherapy programmes for the recovery and learning of voluntary motor functions are the Brunnstrom movement therapy (Brunnstrom 1970), which is based on the stroke model and uses reflexes to develop movement, proprioceptive neuromuscular facilitation (PNF) based on the polio model (Knott and Voss 1956) and the Bobath method (Bobath 1970), which was derived from the cerebral palsy model. These therapeutic programmes are provided at rehabilitation centres in Japan, but they cannot be regarded as adequate because of a lack of medical research and, consequently, medical evidence. The latest neuroscience findings are not reflected in these physiotherapy programmes and no adequate clinical trials have been conducted to demonstrate their efficacy. More precisely, regeneration of neurons and reconnection of synapse networks of the motor system are vital for the recovery and learning of voluntary movement. For instance, Nikolai Aleksandrovich Bernstein, a neurophysiologist, demonstrated as early as 1967 that where the nervous system is not completely destroyed, recovery of function may occur through reconnecting the synapse network itself (Bernstein 1967). This is enabled by a biofeedback mechanism through an individual’s own proprioception. In other words, it would be valuable to study methods for improvement of functions such as voluntary movement, even if the diseases themselves could not be cured.

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A new repetitive facilitation exercise technique using this principle has recently been introduced by Kawahira et al. (2009) and tested by a clinical trial for the first time. The Kawahira method has been developed as a manual physiotherapy programme for motor learning or reconnecting synapse networks. The method repeatedly matches the intention of movement to the intended errorless movement phenomenon based on the latest developments in neuroscience. The previous methods were based on trial and error, eliciting a movement phenomenon corresponding to the movement intention. A reward was given for correct movement, and a punishment for incorrect movement. The Kawahira method is innovative because it completely denies such a trial-anderror method. However, it can only facilitate basic single-joint voluntary movement. Generally, voluntary movement in everyday living is bilateral multi-joint movement, and the intention of voluntary movement should be matched repeatedly to the entire range of complex multi-joint movement phenomena. However, it is difficult to facilitate such complicated voluntary movements manually using this method. Hence, some kind of medical device or assistive technology is needed. More specifically, according to Zehr et al. (2016), gait disorder can be improved by matching the bilateral hip-joint and knee-joint movements to the gait cycle. Motor learning in this complex multi-joint movement requires that the individual’s motor perception of the movement phenomena through their proprioception match their motor intention. In order to ameliorate gait disorder, the repetition of a combination of walking intention and corresponding correct multi-joint movements is necessary. Before our study, no treatment to improve impaired voluntary movements had been fully established. The conclusion of our clinical trial is that its precise methodology has been elucidated with the successful development of the medical device HAL for Medical Use (Nakajima 2017a, b). Our team assumed that HAL would be a medical device that could enable intention-based repetitive multi-joint movement in order to reconnect synapse networks from upper cortical neurons to the motor unit. The first randomized clinical trial of HAL as a medical device was to validate whether there was sufficient evidence that a reconnection of the synapse network and motor unit could be achieved. This was evaluated by a walking programme observable at the empirical level.

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Clinical Trials and the Establishment of Evidence

As Faulkner (2009, 1) correctly points out, innovation in health care technologies is shaped by a set of potentially controversial political, social, economic and medical interests. Hence, it is not surprising that “evidence-based” movements have been growing over the last few decades, particularly in the medical context, including the approval of pharmaceutical products and medical devices. This movement’s minimal requirement is to “produce comparable, quantifiable proofs of efficacy” in order to standardize clinical practices, to review new products and to determine device and drug approval procedures through clinical trials. This can be interpreted as an attempt “to increase the reliability of clinical judgments” (Hogle 2008, 848–849). A central part of this assessment is to evaluate the quality, safety and efficacy of medical devices (Faulkner 2009, 2).

3.1

Code E6

At present, clinical trials are conducted in accordance with guidelines and codes of practice that standardize the scientific and ethical procedures for pharmaceutical and medical-device approval. This interlinkage between evidence-based knowledge production and political regulation has become known as regulatory science in the field of healthcare (Faulkner 2009, 2). More specifically, the Global Harmonization Task Force (GHTF) has sought to harmonize regulatory systems (including medical-device regulatory systems) across European countries and also on the international level, its stated goal being the reduction of costs due to varying national regulatory requirements, the reduction of non-tariff trade barriers for the medical-device industry, the reduction of hurdles to access medical technologies, and the resulting best available treatment for patients (Faulkner 2009, 30, 36). The International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was initially founded as the International Conference on Harmonization of Technical Requirements for Registration of

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Pharmaceuticals for Human Use, incepted in 1990 and later incorporated under Swiss law. ICH was born out of the need to establish a single market for pharmaceuticals but now functions as the global platform for the “regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration for making common rules”. One of the ICH codes, ICH Code E6 on Good Clinical Practice (GCP), states in its introduction that it is an “international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects” (ICH n.d., 2016, 1). ICH code E6 GCP was also translated into Japanese and modified to conform with the Pharmaceutical and Medical Device Law. Once these central guidelines for clinical trials had been adopted in the regulatory framework of Japan, the Ministerial Ordinance on Good Clinical Practice (Ordinance of the Ministry of Health and Welfare No. 28) was enacted in 1997 (PMDA 1997). This ordinance specified the formal system for implementation of clinical trials in Japan from 1997 onwards. Ethical codes on clinical studies involving human subjects had been incorporated into the Nuremberg Code and the Declaration of Helsinki as a result of the experiences of medical experimentation and eugenics of National Socialist Germany, which insisted that persons including individuals with incurable and intractable diseases or the disabled were deemed “life unworthy of life” (lebensunwertes Leben) (see Kuntz and Bachrach 2004). These ethical codes are based primarily on the principle that individuals should be able to subjectively judge the appropriateness of taking part in a clinical study based on due consideration of the likely benefit to themselves of the medical experiment rather than on an exclusively scientific judgement of the benefit that the medical experiment might deliver to humankind. This basic principle does not change, even in the case where the subject is suffering from an intractable medical condition, is dying or is a prisoner sentenced to death. With the adoption of the Nuremberg Code, regulatory requirements and controls have been implemented for healthcare and the medical treatment of patients in Europe, North America, Asia and Australia (Lock 2008, 882, 886). Lock (2008, 888) points to the contested field of genetics, where the eugenics discussion of “poor genes” regarding the “reproductive lives of

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individuals designated as genetically unworthy and as a burden to society” can be observed even today, and where further adjustment of ethical guidelines might be required. Therefore, when the PMDA and the MHLW approve new drugs and medical devices, ICH Code E6 GCP must be implemented in Japan as an ethical procedure. Only the results of clinical trials conducted according to ICH Code E6 GCP can be used to apply for the approval of pharmaceuticals and medical devices. Prior to a clinical trial, the standard operating procedure (SOP), an investigator’s brochure detailing drugs and/or medical devices, and a clinical trial protocol need to be prepared. Then, these documents have to be approved by an institutional review board (IRB) and by the PMDA. An appropriate explanation of what is entailed must be given to participating patients. After their written voluntary consent has been obtained, a clinical trial undergoes not only monitoring but also auditing by a third party and regulatory authorities. These procedures, defined by ICH Code E6 GCP, enable the collecting of clinical data with sufficient scientific and ethical legitimization and need to be followed by manufacturers of pharmaceuticals as well as medical devices when applying for approval of their products for clinical use. In other words, production of clinical evidence has been extended to manufacturers’ R&D activities and the approval of innovative medical devices.

3.2

Investigator-Initiated Trials

In general, pharmaceutical and medical-device manufacturers in Japan take a hesitant view of costly clinical trials in the field of innovative technology and treatments for incurable and intractable rare diseases, and the associated R&D, as these might not generate a return on their investment. That is why the Japanese government gave consideration to the possibility of implementing publicly funded clinical trials, revising the Pharmaceutical and Medical Device Law in 2003 so that investigators could conduct clinical trials of their own volition (Ito 2016). Unlike industry-initiated trials, investigator-initiated trials are conducted by independent clinical investigators such as medical researchers in research

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hospitals. More specifically, an investigator needs to follow the GCP Ministerial Ordinance, or ICH code E6 GCP translated into Japanese, and prepare the necessary SOPs together with the clinical trial protocol. In Japan, the whole process is the same as for industry-initiated trials. The investigator submits the clinical trial protocol, investigator brochures and an informed consent form to the respective IRB and the PMDA. Clinical trial protocols for approving new medical devices or medicines should comply with ICH code E6 GCP and require IRB approval and PMDA review. The PMDA is the regulatory authority for clinical trials for this purpose; its activities are based on regulatory science and related laws and supervised by the MHLW. Once the PMDA has reviewed and approved the clinical trial plan, the investigator may begin the trial with patients. In the case of a multi-centre clinical trial, a coordinating investigator is appointed. Investigator-initiated trials similar in nature to NIHsponsored clinical trials in the US can be conducted in Japan, because they qualify for public funding. An investigator specializing in treating the target disease can select the clinical outcome sought by patients as the primary endpoint and prepare the protocol. These new types of clinical trial give the clinical investigator the freedom to initiate and conduct clinical trials that deal with rare diseases and their treatment (and that gain less attention in industrial research). Medical researchers also have more flexibility to integrate PROs into the clinical evaluation.

3.3

Patient-Oriented Trials

The standard criteria for the assessment of medical devices are nowadays established using a risk-based approach (Faulkner 2009, 37). Devices are classified according to their risk level. There are four risk categories for devices, ranging from “extremely low risk to the human body” (Class I), such as scalpels, to “highly invasive to patients and with life-threatening risk” (Class IV), such as pacemakers (PMDA 2019). For approval of new medical devices higher than Class II, the safety and efficacy/performance of the device needs to be assessed by clinical trials. “Post-marketing”

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surveillance through a vigilance system enables re-evaluation (Faulkner 2009, 36–37; PMDA 2019). Faulkner (2009, 36, 38) writes that patient aspects receive more attention in the regulatory regime of the EU but this does not necessarily imply that the devices perform “better in terms of patient outcomes” (comparative effectiveness), which seem to be dealt with primarily at the national or local level. Accordingly, “qualitative research methods associated with the social sciences” have gained greater attention and are influencing the theory and methodology of health technology assessment (HTA) in Europe, particularly as regards “patients’ experiences of healthcare and health technologies” (Faulkner 2009, 10). In the case of incurable and intractable neuromuscular diseases that cause voluntary movement disorders, a patient-oriented clinical trial could imply a special technology that helps the patients actively adapt themselves to medical conditions or disabilities. For the assessment of this type of medical technology, the purpose of a clinical trial is to demonstrate scientific evidence that such adaptations enable improvement of the patients’ subjective evaluations of symptoms. Previously, the patient’s subjective assessment was buried in the placebo effects and was thought to be unable to be scientifically evaluated. As psychometric methods have progressed, subjective evaluations, as represented by PROs, have gradually become available in clinical trials. These PROs can be used for the assessment of medical technology as well as for the clinical evaluation of all medical products (Cella et al. 2007). Based on the alternative definition of health as defined above, these approaches could support patients to adapt to ailments or disabilities rather than implementing measures for normalization. Unlike outcomes evaluated with biomarkers or device-based indexes by healthcare providers, PROs mean ultimate outcomes as subjectively evaluated by patients (Cella et al. 2007). The conventional concept of quality of life (QoL) can be classed as life-related PRO. Health-related QoL (WHO 1995) is now classified as health status-related PRO. In principle, in clinical trials, therapeutic effects can be evaluated according to PROs as well as to QoL instrument indexes. Subjective scientific evaluation of a clinical trial consists of the following scientific mechanisms concerning subjective evaluations produced over time: (a) recalibration (modification of the rating scale itself over the course of time); (b)

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reprioritization (modification of priority of value judgement); and (c) reframing (modification of the frame of recognition). This has previously been described as “the working definition of response shift that is a change in internal standards, values and the conceptualization of QOL” (Sprangers and Schwartz 2000, 14). As a result, the response shift phenomenon appears to be characterized by changes in the evaluation of the exact same event at different time points. For this reason, the potential use of PRO as the primary efficacy endpoint in clinical trials has not yet been sufficiently studied from a scientific perspective. For instance, the first known subjective assessment issue in clinical trials is the placebo effect. It should be understood as a kind of response shift phenomenon, but it has been considered as a subjective bias to be suppressed. Thus, subjective evaluation was previously not preferred (Evans 2010) or not accepted (Eisenhauer et al. 2009) because it was considered to be unreliable. In fact, most healthcare outcomes are not primarily based on biological criteria but relate to perceptions such as pain, numbness, discomfort or fatigue (Younger et al. 2009). Thus, the patients’ perception and experiences can be final indicators of whether healthcare approaches and treatment are successful. At present, evaluation of the quality of healthcare depends to a certain extent on patients’ perceptions, such as PROs. However, there remains a view within healthcare that PROs lead to an unreliable rating that generates less reliable and consistent data (Oehrlein et al. 2018). However, during the process of treatment and healing, some patients need to reorganize their perception and narrative of their health history over time, for example by actively adapting themselves to ailments and/or disabilities in order to continue living proactively. Conversely, they are in need of help when this ability to live proactively is declining. In the process of adapting their perception and understandings in their minds, they need to develop their resilience and try to continue living with incurable and intractable conditions and disabilities. First, then, treatments for patients are required to give appropriate control of basic physical symptoms including disability, pain, cardiorespiratory failure, malnutrition, etc. These treatments can restore patients’ ability to evaluate themselves. Second, the treatments are required to produce effects that cause a response shift so that the patients can

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live positively. The treatments may have not only biological, but also psychosocial effects. Our research team believes that treatments that can improve PROs share these characteristics.

4

The Case of the Cyborg-Type Robot HAL

Yoshiyuki Sankai (2010, 2014), a well-known cyborg-robot scientist in Japan at the Centre for Cybernics Research, University of Tsukuba, invented the Hybrid Assistive Limb (HAL) as part of a research project launched in 1991. His research is based on the concept of Cybernics. Later, he founded Cyberdyne Inc., a corporation to manufacture and marketize HAL as a medical device in various countries.

4.1

HAL and the Cybernics Principle

Norbert Wiener (1954, 1961) introduced the theory of cybernetics as an alternative approach to the widely quoted game theory of von Neumann, which is based on playing the best way through decisionmaking but without the possibility of implementing essential changes to the rules or the setting. In the cybernetics approach, participants may control or change themselves, remodel components or adjust the overall parameters. In other words, cybernetics is regarded as technology for controlling a mechanical system through the operator’s command. Yoshiyuki Sankai integrated informatics and mechatronics into Wiener’s cybernetics approach. Later, Sankai et al. (2014) developed the field of cybernetics, mechatronics and informatics further and coined the term Cybernics for their approach. The term Cybernics expresses the basic technological principle of HAL. Specifically, cybernetics requires humans to control devices/systems. In the case of cybernetics, even when a human is wearing a device that they are operating, they perceive themselves as being operated by a second party (i.e., a mechanical device). On the other hand, in Cybernics humans wear and become integrated with a device, which supports their movement based on their

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proprioception. Therefore, under the principle of Cybernics, neither a control stick nor a keyboard is used to operate the device. Instead, the individual will be wired directly to the device, and signals are exchanged on a real-time basis. In this sense, Cybernics aims at connecting this cyborg-type robotic device mechanically and electrically with a human. Thus, the individuals wearing the devices can move their own bodies based on their own intention and proprioception. Based on this Cybernics principle, Sankai invented the lower-limb type HAL for Medical Use in Japan. The European model of HAL (Cyberdyne n.d. (a)) and the Japanese model (Cyberdyne n.d. (b)) are the same device, HAL-ML05, but with different regulatory indications. Sankai has developed a range of models, such as the enhancement model, disaster response model, single-joint model, lumbar model, finger model, Cybernic prosthetic leg model and others. The lower-limb type HAL for Medical Use is characterized by simultaneous movements of bilateral multiple leg joints according to the wearer’s voluntary movement intention, as described above. It is a hybrid mechanism that enables the integration of a mechanical device with human capability. That is why this device was named “hybrid assistive limb” (HAL). HAL decodes the wearer’s voluntary movement intention from bioelectric signals on their skin, analyzes various types of sensor information and detects their movement intention. In other words, unlike other wearable robots, HAL is unique in that it has an important function of detecting a wearer’s movement intention from weak and sparse bioelectric signals on the skin surface. The mechanism that enables the integration of mechanical assistance and the power for the wearer’s own voluntary movement is incorporated within the HAL system. For this purpose, the following three control mechanisms are hybridized into the system: (a) bioelectrical signals-based Cybernic voluntary control (CVC), which works in accordance with the wearer’s movement intention; (b) Cybernic autonomous control (CAC), which refers to the normal database like supervisor on multi-joint voluntary movements (e.g., standing, walking, running, etc.) and completes voluntary movement even in the case of insufficient or erroneous bioelectrical signals; and (c) a Cybernic impedance control (CIC), which exempts the wearer from feeling the weight of HAL (now approximately 15 kg) so

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that the wearer is able to perceive the position and movement of their lower limbs with their own proprioception. More precisely, when the CVC detects that the wearer has started walking, the HAL power unit generates torque using the CVC. At the same time, HAL estimates the walk phase in real time from the measured values of each joint angle and force plate sensor. Using these data, CAC adjusts to the correct walking pattern by outputting the required torque. In addition, in the presence of CIC, the wearer perceives how much the leg movement is shifted from the correct movement pattern. Based on the wearer’s proprioception, the wearer can make their legs and HAL work in coordination to produce correct walking patterns. The power unit allows the wearer to walk long distances with the correct walking pattern without fatigue. In this way, in all walking phases, both feedback from the wearer’s proprioception to the motor system and feedback from the HAL sensor to the power unit, will occur. These feedbacks are called interactive biofeedback (iBF) because the wearer and HAL are fused, and the feedbacks interact simultaneously with each other. We believe that wearers can perform motor learning through iBF.

4.2

HAL as a Medical Device

In the medical field, the research team, together with Yoshiyuki Sankai, had assumed that HAL could be used as a medical device that can modify human functions and the microstructure of the nervous system, i.e., a medical device that promotes neuromuscular plasticity including reconnecting the synapse network from upper motor neurons to motor units that consist of lower motor neurons and those governing muscle fibres. When HAL is operational, it is expected that motor neurons minimize muscular activation and excessive or harmful activity is prevented in the affected neuromuscular system. Thus, HAL is supposed to protect affected motor neurons and/or muscles. Moreover, repeated treatment may contribute to improvement of those patients’ motor function. Initially, when patients with muscular dystrophy, spinal muscular atrophy or ALS wore a previous model of HAL, a welfare model that was developed for people with disuse syndrome, this model did not work

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for those diseases. The mechanism of analyzing the wearer’s bioelectric signals adopted in this previous model only functioned insofar as the wearer had a normal neuromuscular system. Therefore, its performance failed to meet the pathophysiological conditions of these neuromuscular diseases including muscular dystrophy, spinal muscular atrophy and ALS (Nakajima 2011). Thereafter, special efforts were made by Yoshiyuki Sankai’s team to develop a second medical device model (investigational name: HAL-HN01). It was hoped that this model would respond to weak and sparse bioelectrical signals in patients with neuromuscular diseases. As a result of these efforts, the HAL-HN01 was able to be used to support disabled motor functions of patients with neuromuscular diseases that affect various voluntary movements. HAL-HN01 was later renamed HAL-ML05.

4.3

Clinical Evaluation, Combined Therapy and Patient-Reported Outcome

In Japan, the regulatory agency PMDA and the MHLW required clinical trials to be conducted to approve the use of HAL as a new medical device in the clinical environment. Clinical trials are required not only to gain the approval of a medical device, but also to enable national health insurance to cover treatment with a new medical device such as HAL. We find similar procedures of clinical trials for health insurance coverage in many countries (Hogle 2008, 842). In Japan from 2013 to 2014, a clinical trial entitled “Investigator-initiated Clinical Study of Wearable Assistive Robot for Lower Limbs Controlled Voluntarily by Bioelectric Signals etc. (Hybrid Assistive Limb [HAL]-HN01) as a New Medical Device to Delay Progression of Intractable Rare Neuromuscular Diseases – Randomized, Controlled, Crossover Study for Gait Improvement as a Short-Term Effect” (NCY-3001)2 was conducted in patients aged 18 years or over (Nakajima 2013). These patients had been suffering from unsteady ambulation due to rare incurable and intractable neuromuscular disease mainly affecting the motor unit. These included spinal 2The author himself coordinated the whole clinical trial and functioned as principal investigator of the trial, NCY-3001, registered as JAM-IIA00156.

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muscular atrophy, spinobulbar muscular atrophy, amyotrophic lateral sclerosis (ALS), Charcot-Marie tooth disease, distal myopathy, congenital myopathy, muscular dystrophy and inclusion body myositis. In this clinical trial (NCY-3001), the research team based at the Niigata National Hospital in Kashiwazaki City examined whether a walking programme using HAL-HN01 (the investigational device name of HAL for Medical Use) Lower Limb Type, could show a short-term improvement effect in walking by evaluating the efficacy and safety of HAL in this walking programme. The hypothesis of our research team for the clinical trial and the subsequent standard medical treatment was that the intention-based errorless motor learning provided by this iBF with HAL may improve walking capability without HAL (that is, after treatment with HAL, walking capability would be improved even in the absence of HAL). We considered that this would be based on the motor learning principles of Hebbian theory (Hebb 1949) and Edelman’s neural group selection theory (Edelman 1987, 1993). The clinical trial (NCY-3001) yielded evidence to support the proposed hypothesis and a clinical study report was completed in 2015. In due course the PMDA and MHLW approved HAL as a medical device for the treatment of incurable and intractable rare neuromuscular disease. Accordingly, HAL for Medical Use was classified as a Class II medical device under the Pharmaceutical and Medical Device Law in Japan. According to the results of NCY-3001, national health insurance also covered the gait treatment with HAL in these rare neuromuscular diseases in Japan. Subsequently, the medical treatment programme with HAL was named “Cybernic treatment” by inventor Yoshiyuki Sankai and the author. A further successful clinical trial in patients with incurable neurological diseases affecting the descending pathways from cerebral cortex above motor unit (clinical trial NCY-2001) was conducted from 2014 to 2018. This group of diseases includes spastic paraplegia such as HTLV-1-associated myelopathy (HAM) and hereditary spastic myelopathy. Although Cybernic treatment with HAL has been evaluated as monotherapy according to the results of NCY-3001 and NCY2001, our research team assumed that its efficacy could be enhanced in

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combination with genome editing, gene therapy with adeno-associated virus vector, stem cells, and disease-modifying drugs such as antisense oligonucleotide drugs, antibody drugs, and so on (Nakajima 2017b). Theoretically, these drugs or gene therapy used in isolation are not thought to be able to easily regenerate nerve connections and functions. The basic purpose of the HAL research project is to work with these therapies and combine them with HAL to promote functional regeneration. Our research team has already started a walking treatment programme with HAL in combination with the anti-oligonucleotide drug Nusinersen for spinal muscular atrophy. There are other potential candidates to be combined with HAL. As Hogle (2008, 853) has already stated, with combined therapies it is important to revisit the increasing number of emerging medical technologies that appear to be “hybrids of computational, communications, mechanical, chemical-pharmaceutical, and biological elements” and therefore new configurations of “expertise, participants, and ways of defining the medical problem to be solved”. Instead of the WHO definition of health as “complete well-being”, Huber et al.’s (2011) alternative definition of health as the “ability to adapt and self-manage in the face of social, physical, and emotional challenges” appeared more appropriate to our research. We believe that Cybernic treatment with HAL is based on this alternative health concept as it helps patients actively adapt themselves to their diseases or disabilities. As evidence of such adaptation, in addition to scientifically demonstrated improvement of symptoms, our research team was convinced that we need to pay sufficient attention to patients’ subjective evaluations during the clinical evaluation of medical treatment with HAL. Therefore, we have included PRO measurements in the postmarketing long-term survey of Cybernic treatments. More specifically, we adopted the Japanese version of the Decision Regret Scale (DRS) that was translated and verified by Tanno et al. (2016), which shows patient perception of loss from the expected value as one of the PRO measurements. When treatments for advanced neuromuscular diseases are evaluated in the real world, it is not appropriate to just compare the efficacy of “before and after” assessments because these diseases always

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worsen over time. It is possible to use historical data for comparative evaluation, but that alone is not enough. So we considered PRO evaluation such as DRS to be necessary. Improving PROs is the basic and minimum goal of our research team. We believe that it is necessary to evaluate the treatment of incurable and intractable patients based on the health concept of Huber et al. (2011). We also believe that improving PROs encourages both the patient and their family to live actively again. In other words, medical care and treatment that allow desperate patients to rewrite their own stories is quality care. Such response shifts are caused by changes in a patient’s own evaluation criteria. For example, a patient participating in Cybernic treatment with HAL often shows a positive facial expression like a smile before their walking disability improves. Consequently, such a patient continues to undergo Cybernic treatment successfully and maintain/improve their walking ability. For the sake of completeness, we should mention that HAL is essentially intended to be developed as a medical device. However, it might also be reinterpreted by some scholars as technology for enhancing human physical strength by rewriting synaptic connections to higher levels of efficiency. In other words, HAL could be used for an approach that is beyond therapy. Therefore, there is a need to reflect on whether Cybernic treatment with HAL falls into the category of therapy or that of beyond therapy. For example, HAL was viewed from the transhumanism standpoint in the H + magazine (Vol 1/Fall 2008, 6). Therapy means recovering good health or normal state, while beyond therapy means producing a health condition beyond the normal state. Thus, enhancement technologies, healthcare for realization of human desires, and transhumanism and euphenics approaches are incorporated into the concept of “beyond therapy” (The President’s Council on Bioethics 2003; Matsuda 2012). In particular, the work of Donna Haraway and others has encouraged discussion and critique on the concept of transor post-humanism within the field of STS (Hogle 2008, 854). For our research team, however “therapy” with HAL for Medical Use must mean the provision of the support needed to help patients adapt to ailments or disabilities.

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Of course, assistive technologies have the potential to augment body function, to provide and/or maintain a certain degree of autonomy as well as to enhance selfhood in particular for disabled individuals and patients with incurable neuromuscular diseases. However, at the same time, these technologies may “suggest dependence and difference” (Hogle 2008, 854). Thus, some technologies have the technical potential to provide function that goes beyond therapies. To address this issue, medical technology beyond therapy may be regarded as a form of body modification to be strictly regulated. It is generally thought that individuals should not be allowed to receive therapy in the hope of exceeding normal voluntary function. However, it is very difficult for patients with neuromuscular disease to define operationally their normal voluntary function. It is thus difficult to clearly determine the range of normal function medically, so it is not easy to establish legal standards. Currently, under Japanese law, “beyond therapy” is not covered by health insurance, but the difficulty of defining normality and abnormality objectively are likely to create problems in the future. Therefore, we think that the health standard proposed by Huber et al. as “adapted or not” should be accepted as a medical standard, as opposed to “normal or abnormal”. HAL for Medical Use could also be perceived as a wearable cyborgtype robot because human and machine connect with each other mechanically and electronically. Clarke (2003) argues that “man is a natural-born cyborg”. As infants and children, as we enjoy playing with toys, we learn to move and think, and in doing so we develop our nervous and muscular system. Through the use of toys, humans learn early on to utilize and integrate tools with themselves and to carry out complex actions that cannot be achieved by manual power alone. This is particularly true for the technology-dense environments of medicine and hospitals. Our current idea is that when a damaged neural system regenerates, what is needed is a complex tool such as HAL. According to Hogle (2008, 853), the image of the cyborg or hybrid often appears in association with boundary-crossing technologies such as bioinformatics or assisted reproduction that are challenging “taken-for-granted categories of nature and culture”. However, we believe in the idea that humans have somehow been “cyborgs” in the sense of “tool-using animals” from

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the beginning, and that people live not only with nature but with tools and machines as an important part of their human existence.

5

Conclusions

The medical-device clinical trial for cyborg-type robot HAL was launched in Japan as a trial relating to incurable and intractable rare medical conditions. Of course, our research team has realized that this clinical trial for rare diseases is also important from a general healthcare perspective. The important points are as follows. Our project started with a study on treatments for these rare medical conditions that only actually affect a limited number of people. Because patients with neuromuscular disease are vulnerable and their health condition is severe, the performance levels required from medical devices in relation to such diseases is very high. As a result, these devices were also able to meet the performance requirements for common critical medical areas, including spinal cord injury and acute stroke. We are confident that our approach can also work for projects aimed at developing treatments for conditions prevalent among elderly people and can contribute to the resolution of other problems that affect many ageing societies abroad. At the same time, it is possible to conduct fundamental philosophical, ethical and sociological discussions. In particular, some socio-medical problems can be alleviated in their early stages when user acceptance of technology is widened by close discussion with individuals who are rarely found in society, such as those with rare intractable diseases. Basically, innovative technology has both benefits and risks in different contexts. To address these potential risks, we believe that medical devices should be shared in a range of different environments, sociocultural settings, regulation, bioethical norms and economic conditions. This would help to adjust and improve innovative devices later on, as well as to conduct development projects that would allow a medical system to become widely utilized abroad. In order for HAL to be used as a medical device in many regions and countries, approval by the regulatory authority in each country is required: such as the PMDA and the MHLW in Japan, EMA in Europe

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and FDA in the United States. Even though there are international standards such as ICH, it is important to accept local assessment for employment of a medical device in each region or country. In order for the medical device to spread widely in Japan, it must be covered by public medical insurance, because the medical insurance system affects local norms, values and economic conditions. Medical drugs and medical devices should be evaluated in each country. To that end, the experience of our research team is that a multidisciplinary research team, including researchers specializing in philosophy and humanities, is a promising way to achieve widespread acceptance of innovative medical technologies derived from different countries. Acknowledgements I would like to thank Andrew P. Wood for his Englishlanguage assistance.

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Nakajima, Takashi. 2011. Clinical trial of robot suit HAL technology for neuromuscular intractable rare diseases. Journal of the National Institute of Public Health 60 (2): 130–137. Nakajima, Takashi. 2013. Investigator-initiated Clinical Study of Wearable Assistive Robot for Lower Limbs Controlled Voluntarily by Bioelectric Signals etc. (Hybrid Assistive Limb [HAL]-HN01) as a New Medical Device to Delay Progression of Intractable Rare Neuromuscular DiseasesRandomized, Controlled, Crossover Study for Gait Improvement as a Short-Term Effect (Study NCY-3001). Clinical Trials Registry (JMACTR Detail), 26 December. https://dbcentre3.jmacct.med.or.jp/JMACTR/App/ JMACTRS06/JMACTRS06.aspx?seqno=3962. Accessed 26 November 2019. Nakajima, Takashi. 2017a. Assistive technology for supporting communication for patients with incurable and progressive neuromuscular diseases, including transparent character boards, a mouth-shape character method, and an advanced Cybernic Interface device. Journal of the National Institute of Public Health 66 (5): 491–496. Nakajima, Takashi. 2017b. Cybernic functional regeneration using Hybrid Assistive Limb (HAL) for the patients with neuromuscular and cerebrovascular diseases. Clin. Eval. 45 (2): 352. Oehrlein, Elisabeth M., Eleanor M. Perfetto, T. Rose Love, Yujin Chung, and Parima Ghafoori. 2018. Patient-Reported Outcome Measures in the Food and Drug Administration Pilot Compendium: Meeting Today’s Standards for Patient Engagement in Development? Value Health 21 (8): 967–972. PMDA (Pharmaceutical and Medical Device Agency) 2019. Basic concept for Approval and Certification for Medical Devices. http://www.std.pmda.go. jp/scripts/stdDB/pubeng/stdDB_pubeng_regulation.cgi. Accessed 9 August 2019. President’s Council on Bioethics (US). 2003. Beyond Therapy: Biotechnology and the Pursuit of Happiness. President’s Council on Bioethics (US). http://hdl. handle.net/10822/559341. Accessed 9 August 2019. Ramón y Cajal, Santiago. 1968 [1928]. Degeneration and regeneration of the nervous system. London, New York: Hafner Publishing Company; Facsimile of the 1928. Ramón y Cajal, Santiago, Javier DeFelipe, and Edward G. Jones. 1991. Cajal’s Degeneration and Regeneration of the Nervous System. New York: Oxford University Press.

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Part VI Conclusions

12 Conclusions on Socio-Technical Settings in Medical Contexts from the Locale of Japan Susanne Brucksch

1

Background

The case studies in this anthology have demonstrated that relationships between humans and devices in medical contexts not only vary in accordance with their professional, disciplinary or organizational surroundings, but also find various articulations in specific locales such as Japan. To address a locale systematically, I have suggested distinguishing between the semantic, pragmatic and institutional dimensions in Chapter 2 to examine socio-technical settings in the medical domain, as they are the modes of “how things are viewed differently, how things are done differently, and how these activities are institutionally arranged differently” (Rammert 2002, 175). Accordingly, this concluding chapter aims to shed light on aspects of the case studies in order to highlight significant variations. At the end, this chapter draws a conclusion for S. Brucksch (B) German Institute for Japanese Studies (DIJ), Tokyo, Japan © The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021 S. Brucksch and K. Sasaki (eds.), Humans and Devices in Medical Contexts, Health, Technology and Society, https://doi.org/10.1007/978-981-33-6280-2_12

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the field of STS (Science and Technology Studies) and the study of socio-technical settings in the medical domain. The case studies of this edited volume provide multifaceted insights into socio-technical settings in medical contexts. Specifically, medical devices and their agency are discussed as “artificial sources of radiation, and by building on these machine therapies, radiation therapies” (Nakao, Chapter 3), and as a “technology of knowledge production which mobilizes specific devices and practices to generate information about health” (Loh, Chapter 4). Furthermore, “radiation has been visualized, generated, measured and controlled with various instruments” (Nakao, Chapter 3), while “monitoring devices can measure with reasonable accuracy (i.e., with a low margin of error)” (Loh, Chapter 4). Similarly, “the adoption of EEG, ABR [auditory brainstem response] and/or cerebral angiography” functions as a means to measure “‘the presence of disorder’ of the brain when diagnosing brain death” (Sasaki, Chapter 5), whereas medical devices “such as mechanical ventilators or artificial heart-lung machines … have enabled physicians to ease patients’ pain or prolong their lives” (Shiroshita, Chapter 6). In addition, web-based incident reporting of medical incidents “serve[s] as a repository of information on what went wrong and how” and may act as “a communication tool to share information about their environment” (Kodate et al., Chapter 7). In contrast, the case studies also provide lessons on the medtech industry “improving their core technology and diversifying gradually to related products” (Donzé, Chapter 8), the “flow of information to manufacturers regarding clinical needs”, and engineers coming up with “new designs and materials with possible applications for new medical devices” (Tanishita, Chapter 9) or methods “of translating users’ subjective experience into a design”, while “machines are primarily regarded as a supplement […] to impaired humans” (Grüneberg, Chapter 10). Finally, we can also learn about the “production of clinical evidence […] extended to manufacturers’ R&D activities and the approval of innovative medical devices” (Nakajima, Chapter 11). Unfortunately, these insights cannot be elaborated on here due to space limits, but they have already been reflected on in further detail in Chapter 2. What is more, there may be further aspects of socio-technical settings in medical contexts that are not

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covered in this conclusion but certainly deserve more scholarly attention and may become subjects of future research and follow-up publications.

2

Semantic Dimension

The semantic dimension considers variations in valued signs, symbols and beliefs regarding relationships between humans and devices. Recurrent features in Japan that are widely referred to under the pretext of culture are specific values, national priorities and national identity in terms of self-positioning, often implemented in governmental programmes and politics. For instance, Sasaki (Chapter 5) perceives “cultural argumentation” at play referring to “modernization models” during the process of the introduction and legitimizing of the concept of brain death in Japanese legislation and clinical workplaces. Grüneberg (Chapter 10) mentions that a government programme such as the vision of a Society 5.0 “may evoke an instrumentalistic idea of the technological controllability of society” following economic priorities. Another variation can be observed regarding the emergence of discourses and certain issues on the agenda of academic communities in specific locales. For instance, Grüneberg (Chapter 10) observes a “lack of an explicit discourse in Japan about ethical issues”. Similarly, Shiroshita (Chapter 6) finds that the issue of “evoking a patient’s death artificially” at their request was “left to legal interpretation according to literature and judicial precedent” in Japan, unlike in other countries. What is more, academic discourses about technologies are usually shaped by limitations in findings, varying interpretations, ambiguities and controversies, which mean that the public struggles, for example, “to understand and accept scientific explanations about radiation”, as Loh (Chapter 4) writes. Therefore, she concludes, “[u]ncertainties are inherent in all these areas”. Such ambiguities and uncertainties can also be observed during the legitimization of evidence, which is also likely to show varying representations. For example, Sasaki (Chapter 5) perceives this difficulty regarding the controversy which “emerged from the question of how a legitimate brain-death diagnostic procedure should be constituted” and which was infused with arguments of self-assurance regarding a

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Japanese identity, influencing practices of brain death diagnosis in clinical workplaces. In contrast, some flexibility in the constitution of evidence is appreciated when it comes to the acknowledgement of patients’ perceptions of their state of health, which are widely infused by sociocultural constructions of normality and pathology. Nakajima (Chapter 11) demonstrates that the “consideration of patients’ subjective evaluation” matters and that there are “variations in medical-device trials resulting from different concepts of health”. Conversely, Loh (Chapter 4) shows findings from her case study on radiation in Fukushima Prefecture that self-study can increase the scientific literacy of individual citizens, which can help in “assessing personal risk from empirical evidence”. In these three cases, local variations in what constitutes evidence and risk assessment influence the final judgement and subsequent health-related procedures. Semantic variation is particularly prominent in the concepts of risk and safety. For instance, Loh (Chapter 4) emphasizes that there are “alternate modes of understanding, inflected by specific aspects of language and culture”, in how global risks are perceived in different localities. As pointed out in Chapter 2, in Japan, one can encounter the safety concept of anzen-anshin, which is a coupling of scientifically proven safety (anzen) with the societal expectation of “reassurance” (anshin). Kodate et al. (Chapter 7) specify that “anshin appeared to be prioritized over anzen in Japan, both at societal and organizational levels, particularly in Japan’s approach to the adoption of safety science”. Loh (Chapter 4) opines in her case study on radiation that, “while science and technology may produce measures of anzen, those are insufficient to provide anshin. No matter how sophisticated monitoring technology becomes, human interpretation and communication of its data remain critical for finding a way through fears and uncertainties around radiation”. Furthermore, Grüneberg (Chapter 10) finds in his case study on empowerment technology that, “‘[i]n Japan, the important thing is comfort rather than safety’ … because the user perception of safety (anzen-sei) builds on the comfort (ansei-ji) that a technology provides”, which is reminiscent of patient subjective evaluation as mentioned by Nakajima (Chapter 11). At present, the understanding of medical security also extends to a sufficient supply of crucial pharmaceuticals and

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medical equipment such as artificial ventilators and virus-proof gowns in Japanese hospitals during the pandemic caused by the novel coronavirus. More specifically, writing before the pandemic, Tanishita (Chapter 9) has already concluded that there were “voices within Japan, concerned about dependence on imports from abroad, … calling for a strong domestic medical-device industry to facilitate acquisition of the devices required for diagnostics and treatment in clinical settings, in order to ensure the country’s medical security”.

3

The Pragmatic Dimension

The pragmatic dimension pays attention to variations in practices, behaviour and interaction patterns in relationships between humans and devices. Regarding technology usage in clinical workplaces, Kodate et al. (Chapter 7) report that “socialization (senior–junior staff relationships) and professional group boundaries are very influential” during incident reporting in Japan through a web-based reporting system. More precisely, they refer to an example where a senior nurse feels “responsible for errors reported by a junior nurse” as well as “a strong sense of reporting verbally to senior members of staff, particularly among nurses”, influencing how effectively web-based reporting systems work. In addition, Nakajima (Chapter 11) mentions a particular pattern in physiotherapy programmes in Japanese rehabilitation centres for people with disabilities such as impaired voluntary movement. He emphasizes that these centres tend to follow certain therapeutic models without conducting sufficient medical research into their adequacy, and, therefore, to neglect alternative rehabilitation technologies. Similarly, in his study on the post-war medtech industry, Donzé (Chapter 8) sees a pattern where the “strong diagnostic tradition of Japanese physicians” contributed to the shaping of medical imaging devices. Accordingly, manufacturers were particularly successful in the past in developing “numerous small and cheap CT scanners for specific segments”, responding to user needs in clinical workplaces in Japan. There are several examples, dating back to the pre-war period, of manufacturers of medical instruments adapting them “to the requirements of

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Japanese doctors and to the specificities of the Japanese medical market”, according to Donzé (Chapter 8). For instance, the “company Terumo was founded in 1921 by a group of scientists—including the famous bacteriologist Shibasaburo Kitasat¯o, who was involved in research at Charité in Berlin with Robert Koch and was nominated for the Nobel Prize in Medicine”, underlining the importance of links between Japan and Germany among engineers and medical specialists in those days. In contrast, Tanishita (Chapter 9) points out that nowadays small companies in particular “fulfil an important role in innovation” but also have the tendency to focus on “technological priorities, without sufficient consideration of clinical needs”. Similarly, Nakajima (Chapter 11) indicates that “pharmaceutical and medical-device manufacturers in Japan take a hesitant view of costly clinical trials in the field of innovative technology and treatments for incurable and intractable rare diseases, and the associated R&D”, which became the major reason for legal revision to allow investigator-led clinical trials since 2003. To summarize, these case studies tell us about innovation practices and technology shaping influenced by the institutional environment, economic risk perception and personal linkages of developers, manufacturers and clinicians. Innovation activities in medical engineering and scientific instruments can also be perceived in the field of radiation research. More precisely, Nakao (Chapter 3) writes in her study on the history of radiation that the “IM fontactoscope (IM being Iimori’s initials) was invented in 1935 and made quantitative measurement of radon in water easy, enabling more systematic research in radiochemistry”. She points out that these R&D activities were closely related to “measuring technology of mineral springs and chemical analysis of radioactive elements developed in prewar Japan [that] were helpful to Japanese scientists in wartime nuclear weapons research”. According to Nakao (Chapter 3), this measuring technology later contributed to conducting “investigation of the atomic bombs in Hiroshima and Nagasaki”. In addition, Loh (Chapter 4) writes that innovation in technologies to measure radiation have their “evolutionary trajectory” after the nuclear catastrophe of Fukushima, which “has generated new tools for radiation monitoring, including a gamma-ray spectrometer built by Osaka University engineers in 2015 that detects radioactive caesium”. In other words, both authors

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give examples of innovations in measuring technology that are deeply rooted in historical precedence of experiences with radiation in the locale of Japan. Moreover, both Loh and Nakao point to the geographical and historical embeddedness of certain research activities particularly prominent in the locale of Japan. For instance, Loh (Chapter 4) stresses that “[r]adiation measurement devices, like all machines, can only be used effectively under certain conditions”. More precisely, “monitoring effectiveness [in measuring radiation in Fukushima] was further hampered by the inadequate placement and limited availability of the monitoring posts, detection devices and laboratories needed to analyze the samples and process the data”. The geographical and historical conditions become particularly clear in Nakao’s case study (Chapter 3), because several Japanese scientists “contributed to the development of a dosimetry system both as research subjects and as subjective agents”, being themselves atomic bomb survivors. Moreover, “different climatic conditions in Nevada and Hiroshima/Nagasaki” acting on materials brought from Japan to the US to simulate radiation effects led to high levels of inaccuracy in scientific results. To conclude, these findings lead to the consideration of a dimension of geographic-climatic conditions when studying socio-technical settings in a specific locale.

4

The Institutional Dimension

The third dimension tackles how socio-technical settings are institutionally arranged in specific locales, which encompasses the organizational, structural and regulatory aspects. For instance, Nakajima (Chapter 11) stresses that “[e]ven though there are international standards such as ICH, it is important to accept local assessment for employment of a medical device in each region or country”. In Japan, a prominent example is the regulatory handling of unnatural death. For many years, physicians were required to report cases to the police, which, therefore, “became the primary public policy matter for patient safety”, as Kodate et al. (Chapter 7) write. Advances in medical technology have also led to new issues in terminal care, medical interventions and patients’

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rights, matters which are regulated in Japanese criminal law. Shiroshita (Chapter 6) analyzes in depth the “cessation (withdrawing or withholding) of life-sustaining treatment at the request of the patient”. As no theoretical grounds have been provided, in Japan district court judgements have functioned as justification for “‘the limit of physician’s duty to perform the medical treatment’ and ‘the right to self-determination of patients’”. In addition, in the various court cases discussed, Shiroshita (Chapter 6) describes the importance of the family during end-of-life decisions in Japan, reflected in subsequent regulation and guidelines for cases of euthanasia. A number of characteristics of Japan’s hospital system affect the innovation and diffusion of medical devices. Donzé (Chapter 8) points to “a large number of small private hospitals” in Japan. He continues by stating that “[w]hile the high competitiveness of the hospital system is a major driving force of the diffusion of medical technology, at the same time hospitals have less capital to invest in equipment than hospitals in Europe or the US, due to their smaller size”; this also makes them “purchase smaller, simpler and cheaper products”. Interestingly, Kodate et al. (Chapter 7) repeat their conclusion that incident reporting in Japanese hospitals shows a lower level of “standardization and openness towards the general public” than the Danish system, working “more like those of the Netherlands and Germany”. Tanishita (Chapter 9) supports this observation in his study on medtech partnerships, as “the medical and clinical worlds are generally organized as closed communities to ensure the privacy of patients as well as of medical professionals”. He concludes, therefore, that, “[c]onsequently, information on the usability or poor functioning of medical devices does not filter back to manufacturers and developers”, a weakness that could be extended to organizational learning on patient safety. Tanishita (Chapter 9) explicates the closed nature of academic and professional communities in Japan, by employing the boundary concept. He writes that “crossing these boundaries is difficult in Japanese society, because, traditionally, individuals have tended not to become involved in different disciplines and professional domains but to confine their activities to their own discipline”. These “[d]isciplinary barriers exist due to the autonomy and separation of each discipline and faculty at Japanese universities”, which has resulted in a “lack

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of specialized curricula at universities and the resulting shortage of biomedical engineers”. In other words, these findings strongly suggest that professional, disciplinary or organizational surroundings themselves differ widely between different locales and emerge as a cause of variations in socio-technical settings in medical contexts.

5

Conclusions for STS Research

The case studies in this anthology give manifold examples of the ways in which socio-technical settings in medical contexts find varying expressions in specific locales. Consequently, Tanishita (Chapter 9) concludes from his study on medtech partnerships that “there is a need to reflect, not only generally on the human factors, but also on the countryspecific factors regarding innovation which might lead to different responses to similar problems”. Similarly, Nakao (Chapter 3) elaborates in her case study “how malleable evidence can be produced by different dosimeter methods or influenced by varying motivations, research techniques and environmental conditions”. Sasaki (Chapter 5) summarizes in her research on brain-death diagnostics that “clinical experience may not be sufficient to acknowledge new medical technologies, because any evaluation of the practices and technologies originating in other countries inevitably involves cultural argumentation”. Moreover, in his study on applied ethics for empowerment technologies, Grüneberg (Chapter 10) perceives a “sociocultural bias of the ontology underlying HMR [human–machine relationships]” and that there is “always the risk that underlying sociocultural differences could impede recognition of an alternative, equally valid, approach”. Conversely, Nakao (Chapter 3) draws the conclusion that “the history of radiation and dosimetry in Japan shows the importance of standardization that works beyond local conditions”. Alternatively, Nakajima (Chapter 11) infers “that medical devices should be shared in a range of different environments, sociocultural settings, regulation, bioethical norms and economic conditions”, to reduce the risks of novel medical devices intended for use in other countries as well. To sum up, the study of socio-technical settings in their local environment is needed, not only for the adoption of novel

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technologies, but also to achieve standardization feasible in the medical domains of many different countries. Furthermore, almost all the contributions to this anthology are considered by their authors as responses to lacunae in the field of Science and Technology Studies (STS), some in terms of specific aspects of sociotechnical settings in medical contexts, insufficient consideration of the locale or shortcomings in existing approaches. For instance, Nakajima (Chapter 11) responds with his case study to a desideratum regarding clinical trials of medical devices in STS research. Donzé (Chapter 8) acknowledges that “[t]he STS literature has demonstrated that medical technology does not develop autonomously as a mere outcome of the progress of science” and suggests an alternative, business history approach that “contributes to a better understanding of the influence of market conditions on the formation of medical technology”, as this “dimension is often overlooked by STS scholars”. Similarly, Grüneberg (Chapter 10) positions his contribution as an ethical assessment of empowerment technologies, where “STS studies too often abstain from taking a normative stance”. Loh (Chapter 4) takes a similar course, examining the monitoring of the long-term health effects of radiation in Fukushima and the “socio-technical ramifications in a historical context”, while Nakao (Chapter 3) enriches her case study on dosimetry by considering “the history of technologies for measuring and visualizing radioactivity to examine the historical context and cultural authority behind the production of knowledge about radiation exposure”. The analytical framework proposed instead by Kodate et al. (Chapter 7) for their case study on incident-reporting systems in hospitals “combines the socio-technical approach with new institutionalism” to understand the “organizational structure, socio-technical settings and the processes where these technologies are embedded”. In other words, the field of STS in Japan may benefit from previous studies on relationships between humans and devices, where there are still research gaps in scholarship on Japan. On the other hand, many affiliated disciplines would similarly profit from an enriched analytical framework provided by STS for studies on varying locales to achieve sophisticated research outcomes.

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A further proposition regarding the lacunae in STS research on medical devices and the consideration of various locales lies in interdisciplinary research. For instance, Nakajima (Chapter 11) reasons that “technology and the innovative treatment require translation into established concepts and terminology in order to receive social and scientific approval”, taking a medical science stance in his case study on the rehabilitation system HAL for Medical Use. He argues that “researchers specializing in medicine, engineering and philosophy/humanities were needed for multidisciplinary teams capable of dealing with interdisciplinary research projects to develop new medical devices”. Shiroshita (Chapter 6) supports this argument for the field of regulatory science, as it seems to be “natural that legal discussions … should also obtain suggestions from other fields of study”. He stresses that “legislation without legal grounds is highly reckless” and, therefore, the “discussion should be further extended by an interdisciplinary approach”, because the content of legal requirements can be “controversial in both theory and practice” and it is “questionable whether legislation [alone] would put an end to the present debate”. This means that interdisciplinary collaborative research can be an effective way of enhancing analytical frameworks and methodology for the study of emerging medical technologies. It also helps to “overcome the communication gap between the humanities and social sciences on the one hand and natural sciences and engineering on the other” (Brucksch and Wagner 2016, 15). As a final remark, it is worth noting that there are two other aspects of research of socio-technical settings in medical contexts in Japan that certainly require more scholarly attention. One is the decentring of research on medical technology from North American and European locales. The editors have contributed their share by compiling this anthology of case studies on Japan from various disciplines. The other aspect is the continuing need to deconstruct Europe and North America as imagined locales devoid of different sociocultural surroundings influencing socio-technical settings as well as an imagined “uniform” point of reference for scholars contrasting them with the locale of Japan. This is still partially true for some of the case studies in this anthology, while others go explicitly beyond that perception, e.g., Kodate et al. and Donzé (Chapters 7 and 8). The medical field in Japan is itself a convincing

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example demonstrating that it is shaped by domestic factors as well as Chinese, German and US influences, underlining the necessity of a systematic approach to similarities and differences in socio-technical settings. To conclude, then, let me stress once again that there is a need for further research on relationships between humans and devices in medical contexts in specific locales such as Japan, Europe and North America, as well as room for further adjustment of the methodology in STS and affiliated disciplines, since the suggested analytical framework should be understood as a starting point.

References Brucksch, Susanne, and Cosima Wagner. 2016. Introduction to the Technikstudien: Science and Technology Studies (STS) Research Initiative on Japan. ASIEN 140 (July 2016): 5–21. Rammert, Werner. 2002. The Cultural Shaping of Technologies and the Politics of Technodiversity. In Shaping Technology, Guiding Policy: Concepts, Spaces and Tools, K.H. Sørensen, and R. Williams, 173–194. Cheltenham: Elgar.