Humans and Devices in Medical Contexts: Case Studies from Japan

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.

• Language: English
• Publisher: Palgrave Macmillan
• Release date: Jun 19, 2021
• ISBN: 9789813362802

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© The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2021

S. Brucksch, K. Sasaki (eds.)Humans and Devices in Medical ContextsHealth, Technology and Societyhttps://doi.org/10.1007/978-981-33-6280-2_1

1. Introduction

Susanne Brucksch¹   and Kaori Sasaki²

(1)

German Institute for Japanese Studies (DIJ), Tokyo, Japan

(2)

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

1 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 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 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 socio-technical 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 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; 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.

2 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 socio-technical 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 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 Itō (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, 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.

3 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 iryō kiki tō-hō). As such, they are 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, their relationships to the clinical workplace and their embeddedness in the sociocultural context, which is clarified in the next section.

4 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 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 robot-friendly 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) 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 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 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 self-recognition 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 incident-reporting 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 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 built-in 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 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 socio-technical 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