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

This book explores the ways in which socio-technical settings in medical contexts find varying articulations in a specific locale. Focusing on Japan, it consists of nine case studies on topics concerning: experiences with radiation in Hiroshima, Nagasaki, and Fukushima; patient security, end-of-life and high-tech medicine in hospitals; innovation and diffusion of medical technology; and the engineering and evaluating of novel devices in clinical trials. The individual chapters situate humans and devices in medical settings in their given semantic, pragmatic, institutional and historical context. A highly interdisciplinary approach offers deep insights beyond the manifold findings of each case study, thereby enriching academic discussions on socio-technical settings in medical contexts amongst affiliated disciplines. This volume will be of broad interest to scholars, practitioners, policy makers and students from various disciplines, including Science and Technology Studies (STS), medical humanities, social sciences, ethics and law, business and innovation studies, as well as biomedical engineering, medicine and public health. Series Editors’ Preface 7 Preface and Acknowledgments 10 Contents 12 Editors and Contributors 15 List of Figures 18 List of Tables 20 Part I Introduction and Theoretical Reflections 22 1 Introduction 23 1 Prologue: Background and Purpose 23 2 Shortcomings in Current STS Scholarship 27 3 Defining Devices in Medical Contexts 29 4 Approaching the Sociocultural Context 31 5 Overview of the Chapters 33 References 38 2 Theoretical Reflections on Medical Devices and the Sociocultural Context in the Locale of Japan 41 1 Background 41 2 Technological Complexity and Clinical Workplaces 42 3 Subjectivity and Standardization of Bodies 45 4 Patients, Nurses and Physicians in Japan 47 5 User Needs and Device Development 52 6 Clinical Trials, Approval and Evidence-Based Judgement 56 7 Manufacturing and Diffusion 59 8 Hospitals and the Public Health System in Japan 61 9 Conclusion 65 References 66 Part II Experiences with Radiation 72 3 Knowledge and Culture Behind the Dosimetry System: Japanese Scientists, Radioactive Disasters and the Technologies for Measuring Radioactivity in the Twentieth Century 73 1 Introduction 73 2 The Birth of Radiology and the Dose Evaluation System 77 3 Visualizing Technologies of Radioactivity in Prewar Japan 80 4 Cyclotrons and Wartime Research 82 5 Scientific Investigations in Hiroshima and Nagasaki 85 6 The Bikini Incident and the Activity of Japanese Scientists 88 7 The Survivors of the Atomic Bombs and Dosimetry Systems 92 8 Conclusion 96 References 97 4 Monitoring Disaster: 3.11, Radiation Measurement and Public Health in Fukushima 102 1 Introduction 102 2 Radiation Monitoring and Human Health 106 3 The Limitations of Radiation Monitoring 111 4 Communicating Scientific Literacy 114 5 Conclusion 118 References 120 Part III Patient Safety, End-of-life and High-tech Medicine 127 5 Standardized Brain-Death Diagnostic Procedure: The Japanese Controversy of the 1980s and 1990s 128 1 Introduction 128 2 Background to the Brain-Death Problem 132 3 Three Concepts of Brain Death 133 4 Articulation of the New Brain-Death Diagnostic Standard 136 4.1 Problematization of the Japan Society of EEG Criteria (1982–1983) 136 4.1.1 The Impact of Proponents of the Brainstem Approach (1983–1987) 138 4.2 The Brain-Death Research Council Conclusion (1985) 141 4.3 Problematization of the Takeuchi Criteria (1986–1992) 143 4.4 From Cultural Arguments to the Original Voice 147 5 Discussion 149 6 Summary 152 References 153 6 Medical Technology, Terminal Care and Criminal Law: Court Cases from Japan 157 1 Introduction 157 2 Active Euthanasia 159 2.1 The Tokai University Hospital Case 160 2.2 The Judgement of the Court 162 3 The Cessation of Medical Treatment (Death with Dignity) 166 3.1 The Kawasaki Kyodo Hospital Case 167 3.2 The Judgement of the Court 170 4 Legislative Perspectives 176 5 Conclusion 179 References 179 7 The Role of Incident-Reporting Systems in Improving Patient Safety in Japanese Hospitals: A Comparative Perspective 181 1 Introduction 181 1.1 Concepts of Safety 184 1.2 The Japanese Context 185 1.3 Analytical and Methodological Framework 187 2 Incident-Reporting Systems as Tools for Organizational Learning 189 2.1 Incident Data Collating Processes in Japanese Hospitals 190 2.2 Feedback from Incident Data in Japanese Hospitals 195 3 Varieties of Incident-Reporting Systems in Europe 196 3.1 Comparing Incident-Reporting Systems Across Europe and Japan 197 3.1.1 Denmark 197 3.1.2 Germany 199 3.1.3 Ireland 200 3.1.4 Netherlands 201 4 Conclusion 203 References 205 Part IV Innovation and Diffusion of Medical Devices 211 8 The Postwar Medtech Industry in Japan: A Business History Perspective 212 1 Introduction 212 2 A Macroeconomic Overview of the Japanese Medtech Market 216 3 Innovative Companies in a Global Perspective 218 4 Concentration and Transnational Expansion 221 5 The Competitive Advantage of Olympus and Toshiba 224 6 Foreign Companies in the Japanese Medtech Industry 228 7 Conclusions 231 References 233 9 Close Collaboration Between Medical Professionals and Engineers in Medical-Device Innovation: The Commons for Medicine and Engineering Japan Liaison Platform 237 1 Introduction 237 2 Disciplinary Barriers Between the Medical and Technological Fields 239 3 The Significance of Clinical Needs for Innovation 241 4 The Case of Commons for Medicine and Engineering Japan 248 4.1 The Establishment of the Liaison Platform 248 4.2 The Mission and Activities of Commons 250 4.3 The Mediator-Initiated Partnership Model 251 4.4 Identifying Clinical Needs 254 5 Discussion and Conclusions on the Ecosystem in Japan 255 References 260 Part V Engineering and Evaluating Medical Technology 264 10 Empowering Patients in Interactive Unity with Machines: Engineering the HAL (Hybrid Assistive Limb) Robotic Rehabilitation System 265 1 Introduction 265 2 Socio-Technological Human–Machine Relations 268 2.1 Developmental Framework: Society 5.0 271 2.2 Cybernics as an Approach to the Implementation of Society 5.0 272 3 HAL as Interactive Unity and Empowerment Technology 273 4 Built-in Ethics 278 4.1 Safety Issues 279 4.2 Cyborgization 281 5 Conclusion 283 References 285 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 291 1 Introduction 291 1.1 Defining Health 294 1.2 Overall Research Strategy 295 2 Voluntary Movement Disorders and Their Treatment 297 3 Clinical Trials and the Establishment of Evidence 300 3.1 Code E6 300 3.2 Investigator-Initiated Trials 302 3.3 Patient-Oriented Trials 303 4 The Case of the Cyborg-Type Robot HAL 306 4.1 HAL and the Cybernics Principle 306 4.2 HAL as a Medical Device 308 4.3 Clinical Evaluation, Combined Therapy and Patient-Reported Outcome 309 5 Conclusions 314 References 315 Part VI Conclusions 321 12 Conclusions on Socio-Technical Settings in Medical Contexts from the Locale of Japan 322 1 Background 322 2 Semantic Dimension 324 3 The Pragmatic Dimension 326 4 The Institutional Dimension 328 5 Conclusions for STS Research 330 References 333 This book explores the ways in which socio-technical settings in medical contexts find varying articulations in a specific locale. Focusing on Japan, it consists of nine case studies on topics concerning: experiences with radiation in Hiroshima, Nagasaki, and Fukushima; patient security, end-of-life and high-tech medicine in hospitals; innovation and diffusion of medical technology; and the engineering and evaluating of novel devices in clinical trials. The individual chapters situate humans and devices in medical settings in their given semantic, pragmatic, institutional and historical context. A novel interdisciplinary approach offers deep insights beyond the manifold findings of each case study, thereby enriching academic discussions on socio-technical settings in medical contexts amongst affiliated disciplines. This volume will be of broad interest to scholars, practitioners, policy makers and students from various disciplines, including Science and Technology Studies (STS), medical humanities, social sciences, ethics and law, business and innovation studies, as well as biomedical engineering, medicine and public health