Barriers to Innovation in the Field of Medical Devices

WH0/HSS/EHT/DIM/10.6

MedicAl devices: MAnAging the Mismatch An outcome of the Priority Medical Devices project

Barriers to innovation in the field of medical devices

Background Paper 6 August 2010

Contents

Preface 2 Introduction 3 Literature review of innovation diffusion: nature, stages, trends 4 Diffusion of innovation in health care 4 Unpacking the concept of innovation diffusion 5 Critique of the linear model of innovation diffusion 7 The changing composition of the users of new medical devices 8 Trends in medical device development and barriers to innovation 10 Imported versus locally produced medical devices 11 Barriers to medical devices 11 Barriers to innovation in high-resource countries 14 Model for the analysis of barriers to innovation in priority medical devices 16 Several perspectives from the literature 16 Outcomes of the literature review 19 Towards a new model of medical device innovation 21 References 22 2 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project

Preface

In 2007, at the request of the Government • projections of future burdens of These problems, challenges, and failures of the Netherlands, the World Health disease and disability in the context of amount to a mismatch, rather than a Organization launched the Priority Medical demographic trends; gap, that prevents medical devices from Devices (PMD) project to determine • cross-cutting issues, such as the training achieving their full public health potential. whether medical devices currently on of medical device users, medical device the global market are meeting the needs design, contextual appropriateness The PMD project also produced a report of health-care providers and patients of medical devices, and regulatory Medical Devices: Managing the Mismatch throughout the world and, if not, to propose oversight; aimed at achieving two objectives: the ﬁ rst, remedial action based on sound research. • catalysts of, and barriers to medical to inform national health policy-makers, device innovation and research. international organizations, manufacturers The project gathered the information and other stakeholders of the factors required by conducting literature reviews The original objective of the PMD project preventing the current medical device and surveys, and by convening meetings was to identify gaps in the availability community from achieving its full public of specialist consultants. of medical devices. The findings of health potential; the second, to provide a the project showed that gaps in the basis on which all players in the medical The project addressed various availability of medical devices is not the device scene can together use the ﬁ ndings complementary issues: primary issue, but rather a number of and recommendations of the PMD project • the global burdens of disease and shortcomings spanning several facets of to make public health the central focus of disability; the medical device sphere. This result their activities. • guidelines on clinical procedures for prompted a change of direction in which the management of diseases and the project shifted its focus onto the many disabilities; shortcomings related to medical devices.

This paper is part of a series of documents produced as background material for the PMD project report. The following papers are available as part of this series: 1 A stepwise approach to identifying gaps in medical devices (Availability Matrix and survey methodology) 2 Building bridges between diseases, disabilities and assistive devices: linking the GBD, ICF and ISO 9999 3 Clinical evidence for medical devices: regulatory processes focussing on Europe and the United States of America 4 Increasing complexity of medical devices and consequences for training and outcome of care 5 Context dependency of medical devices 6 Barriers to innovation in the ﬁ eld of medical devices 7 Trends in medical technology and expected impact on public health 8 Future public health needs: commonalities and differences between high- and low-resource settings

This document was developed under the primary authorship of Hristina Petkova. Her work is gratefully acknowledged. Thanks are also due to Benjamin Schanker and Dima Samaha for providing valuable contributions in editing, writing, and research.

This publication was produced under the direction of Josée Hansen.

The named authors alone are responsible for the views expressed in this publication. Barriers to innovation in the ﬁ eld of medical devices—Background Paper 6 3

Introduction

This paper forms a background contribution • What are the barriers to innovation? likely to impact on the innovation process. to Medical devices: Managing the • Who are the stakeholders in innovation? This paper offers examples from several Mismatch. Its objective is to locate the empirical studies in order to substantiate factors that explain the absence of priority Consideration is given also to the similarities theoretical claims from the literature about medical devices from certain markets, their and differences between innovation how innovation occurs in the biomedical inappropriate use where they are present, processes in high-resource settings on sector. The focus is then narrowed to and the lack of invention and subsequent the one hand, and in low- and medium- the concrete conditions that inhibit or diffusion into clinical practice in cases where resource countries on the other. The accelerate innovation in medical devices. the need exceeds availability. Questions the purpose is to understand what prevents Following this is a more detailed account paper aims to address include the following: innovation from occurring domestically of the barriers to use in medical devices • What defines innovation in medical within low-resource countries, and what and a review is offered of models by which devices? What are the stages of the hinders the optimal use in poorer countries innovation takes place. This supplies the innovation process? of devices manufactured by technically analytical framework of the current study. • What are the trends in the development advanced countries. The paper concludes with a comparative of medical devices? What are the model of innovation in priority medical barriers reported in the literature? These goals are pursued in several ways: devices for high-, medium- and low- • Why are medical devices available on ﬁ rstly through a search of the literature resource settings, which views innovation the market not being used in health including the terms ‘medical devices’, as a process comprised of separate stages care? What are the barriers to diffusion? ‘biomedical innovation’ and ‘diffusion’. The and which captures the disparities between • Would innovation close the gap in purpose of this is to explain the nature of different economies in terms of the way the availability, appropriateness and innovation in medical devices, to identify in which innovation occurs. The model acceptability of medical devices in the the stages of the innovation cycle, and to reflects the empirical findings from the management of high burden diseases? report trends in their development that are Priority Medical Devices Project survey (1). 4 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project

Literature review of innovation diffusion: nature, stages, trends

Knowing is not enough; within which to explore the development of the fi nancing and delivery of health care, we must apply. Willing is technology for several reasons. They can including the level of reimbursement that be grouped under three broad assertions. new interventions will be able to obtain (6). not enough; we must do. For example, percutaneous transluminal 1. Medical innovation frequently occurs coronary angioplasty (PTCA),1 first GOETHE in ways different from other fi elds due assigned to a surgical Diagnosis Related to the emotional factors attached to the Group (DRG),2 provided a much higher The WHO Commission on Intellectual concept of health and illness and the compensation than the procedure itself Property Rights, Innovation and Public political commitment to offer citizens the cost. This stimulated rapid adoption of the Health views innovation as a “process cycle latest advances in medicine (11). method, and a high level of incremental of three major phases that feed into each innovation in PTCA catheters. On the other other: discovery, development and delivery” 2. Novel biomedical technologies have hand, cochlear implants3 were placed (2). Within the innovation cycle, a public two aspects – on the one hand, they in a DRG that covered only a fraction of health need creates a demand for products stand for promises for better health the cost of the device. This led to under- of a particular kind, suited for the particular and improved quality of life, and on diffusion but also to reduced subsequent medical, practical or social context of a the other, they are associated with research and development. Therefore, group, and feeds into efforts to develop new higher cost of services. In the context by limiting payment for sophisticated or improved products (2). of scarce resources and attempts to technologies, some of which are based reduce expenditure, health policy- and on the latest advances in science, cost- decision-makers have to prioritize. As reducing mechanisms such as DRGs can Diffusion of innovation in health a result, some technologies diffuse disincentivize innovation. care whereas others do not. The ‘innovation diffusion’ literature spans Cost is not the only contextual factor that a number of academic disciplines – 3. A perceived gap exists between impacts innovation. Social forces and from sociology, to medicine, psychology, ‘best evidence’ and ‘evidence-based contingencies (accidents) also shape new communication studies, economics, practice’. Technologies with reported technology. This includes cases where political science, information and clinical validity often fail to integrate robust evidence may confi rm (or reject) the communications technology – with each into medical use, and thus prevent need for an innovative approach, however realm conceptualizing the topic differently, patients from benefi ting from scientifi c it is not suffi cient for diffusion without the and articulating it in a different language, progress (12). This raises the question context of innovation. An example is the use such as ‘dissemination’, ‘implementation’, of why clinical evidence alone is of trastuzumab- a drug for the aggressive ‘adoption’, ‘adaptation’, ‘use’, ‘reach’, insuffi cient to ‘push’ forward innovation, Her2 form of breast cancer – in the UK ‘uptake’, ‘spread’, ‘translation’, or ‘transfer’ and what other factors may exist, that and Northern Ireland. This particular type of new ideas and knowledge. Each of these hinder the diffusion process. of cancer affects about 20– 30% of breast areas also uses different criteria to judge the cancer patients (14). The case attracted ‘success’ and ‘quality’ of diffusion, or the Fitzgerald and colleagues (7) assert that numerous media headlines due to a series extent to which a technology has ‘diffused’ health care is an interesting and complex of legal contestations and appeals over the into practice. domain, populated by a diverse set of restricted availability of the drug through groups, of which the medical profession the National Health Service (NHS). At The mechanisms by which innovations have retained primacy, particularly in the fi rst, the medication was licensed for the spread are sometimes differentiated decisions to adopt an innovation at the treatment of advanced breast cancer that between diffusion (passive adoption by local level. This is achieved mainly via had spread in the breast or to another individuals and organizations), and inter-professional alliances and networks dissemination (active attempt to infl uence for change, which may facilitate or inhibit 1 A surgical investigation based on inserting a small catheter in the femoral artery with the help of a camera, with the specifi c aim to clear up and bypass acute the rate and success of adoption) (3). diffusion. pathological obstructions affecting the arteries. 2 Diagnosis-related groups (DRG) have been introduced in the hospital sector of many health-care systems over the past 10 years, as a cost-containment There is a specifi c body of literature on A health-economics study exploring the measure based on the expected costs of inpatient treatment as a fixed fl at-rate (4–10) tariff for hospital services, as opposed to previous per diem charges. By limiting innovation diffusion in health care , impact of technological change on rising expenditure in a certain ‘group’ of conditions to a pre-calculated lump sum, which builds upon various models. Health health-care spending shows that the rate covering standard basic procedures, DRGs encourage less diagnostic testing, shorter lengths of hospital stay, and outpatient care (7,13). care is a particularly interesting domain of innovation is sensitive to changes in 3 Surgical implantation, into the mastoid cavity of the ear, of an electrical transductor that transmits sound to the brain Barriers to innovation in the fi eld of medical devices—Background Paper 6 5

organ. Based on clinical evidence of the often insuffi cient to achieve widespread research), which then moves in a linear drug’s effi cacy, the British National Institute translation. progression from the laboratory to animal for Clinical Excellence (NICE) issued models and applied research, to select guidance stating that health trusts had to Fitzgerald and colleagues (7) explored populations (targeted development), to provide trastuzumab only for advanced- the process of diffusion of eight different manufacturing and marketing, and fi nally to stage patients. As a result, many patients innovations in the United Kingdom, which adoption and use at the patient’s bedside, in the early stages of this type of breast were considered within two major sectors of as depicted and critiqued by Gelijns and cancer were refused the medication, health care – acute and primary admissions Rosenberg (6). even in circumstances where their cancer – and upon which the strength of the specialist had recommended it. Cancer scientifi c evidence varied. The aim was to While some technologies may follow this charities criticized this restrictive policy, see whether scientifi c proof would guarantee linear trajectory, this is not a predominant and the postcode lottery provision of the diffusion and if so, to what extent. The model of diffusion in medicine. There is a drug, which was given to 90% of early- study found that there was little correlation substantial body of literature that supports stage Her2 breast cancer individuals in between strong scientific evidence and the contrary – the idea that innovative some areas of England and only to 10% opportunities for widespread translation biomedical technology is assimilated in a in others. Under sustained pressure from of medical innovation. For example, even complex, non-linear, dynamic pattern, often clinical professionals, patients patient though there is much evidence concerning contingent upon a mix of factors. These groups, politicians and the public, NICE Heparin use following orthopaedic surgery, factors can originate from the attributes issued its fi nal guidance on trastuzumab this has resulted in continuous controversy. of the technology itself, from the context in 2006, approving the drug not only for Its diffusion has remained at what Fitzgerald within which the new procedure is meant advanced-stage patients, but also for use and colleagues (7) call the “debated” stage. to operate, or from the interaction between in early-stage breast cancer. the specifi c technology and the context (9) Another instance of an innovation that failed in which the device operates (5,6,8,9). This example reinforces the view that to diffuse widely based on the strength of medical innovation can be a highly evidence alone is the use of the computer Everett Rogers’s work since the 1960s and contested area of decision-making, where support systems for treatment of diabetes in notably his 1995 publication Diffusion of clinical evidence, technical attributes of the primary care (7). The St. Vincent Declaration Innovations is a recurrent reference point technology and data on cost-effectiveness of 1989 set out a guideline delineating a for diffusion studies at large (7,9,16,17). only partially influence implementation. standard of care for diabetes, a directive Rogers offers a framework for considering Diffusion is affected also by its broader supported with evidence, but many general innovations as new ideas or practices context, such as stakeholders’ interests, the practitioner’s were not convinced that the adopted over time by members in a social political climate, and public expectations. evidence was relevant to their patients in system. The author defines diffusion Only some technological innovations primary care, and felt that the standards as a process by which an innovation is accomplish their intended use, as originally were appropriate mainly for acute cases communicated through certain channels meant by the designer and others “drift”1 of diabetes. As a result, the innovation did over time among the members of a social into alternative applications. (14) not fi nd wide acceptance. It illustrates that system, following a fi ve-step process (18): new knowledge can be ambiguous and • Knowledge Other empirical studies identify multiple interpreted according to particular contexts, • Persuasion cases where validated evidence fails to which can affect the degree of translation • Decision achieve widespread implementation. Lang, into daily use. • Implementation Wyer and Haynes (12) report the case of • Confi rmation the Ottawa Ankle Rules, fi rst derived in the If robust scientifi c evidence is not enough The ‘successful’ spread of an innovation early 1990s, as a highly sensitive bedside to guarantee that a novel medical technique follows an S-shaped curve (Figure 1). diagnostic method for appropriate referral will disseminate into widespread use, this According to Rogers, people are infl uenced for X-ray. Despite systematically reported raises the question of which other factors by many factors in their decision about diagnostic accuracy of the Ottawa Ankle come into play to determine the future of whether to adopt an innovation or not. Rules, i.e. 98% sensitivity, 32% specifi city, an innovation. In the next section, several Determinants include the utility of the and high acceptance by patients and perspectives are presented that reveal innovation, any disruptions that it may health care staff, the clinical uptake of the factors affecting the dynamics of the cause to existing habits, personal or social the method is inconsistent, and its use in innovation process. values, social status of opinion leaders, clinical practice remains relatively low (11). and the cultural propensity of individuals This suggests that evidence-base alone is to innovate (tolerance or resistance towards Unpacking the concept of change culture) (17,18). innovation diffusion 1 “Drift” is a concept originating in the fi eld of evolutionary biology (particularly in the sense of genetic drift), which has been adapted to other fi elds such as A popular way of thinking about medical Within a defined population, there are health services research, (e.g. the use of a leprosy drug to treat dementia). innovation is one in which a group of several sub-populations with different The concept is employed to denote a situation in which a technology is used differently from the designer ’s intent, implied in the original prescription, so scientists has a new idea (original basic ability and willingness to adopt. Individuals that the innovation might develop in unanticipated ways. 6 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project

Figure 1. The S-curve, cumulative distribution of adopters over time who are more than two standard deviations earlier than the mean in adopting an innovation (‘innovators’ comprising 2.5% of the population); those between two and one standard deviation earlier (‘early adopters’ ‘Saturation point’ comprising 13.5% of the population); those with one standard deviation on either side of the mean (‘early majority’ and ‘late majority’, respectively 34% each); and those beyond one standard deviation from the mean (‘laggards’ making up 16%) (3, 18) Adopters (cumulative) (Figure 2). ‘Take-off’

Lag Three points are worth noting. Firstly, phase that categories, such as “innovators” or “early adopters” are not a reflection of Source: Greenhalgh et al (3). Time personality features of individuals, but are mathematically defined cut-offs for the adopters of any particular innovation by Figure 2. Distribution of new adopters of an innovation against time a population (3). Secondly, the classical S-shaped curve, which shows the pattern Early Late of innovation adoption, is the combined majority majority 34% 34% curve of the subpopulations of adopters (i.e. ‘early adopters’, ‘late majority’, etc.). If separated, the sub-groups of adopters would each have a respective S-shaped diffusion curve with a longer or shorter Early lag phase and a greater of lesser part of adopters the population that ultimately adopts (3). Adopters 13.5% Laggards Thirdly, different innovations introduced into 16% different populations produce a cumulative adoption curve of the same basic shape Innovators (S-curve) but with different slopes (rates 2.5% of adoption) and intercepts (proportion of people adopting) as demonstrated in Figure 3. According to Greenhalgh and colleagues Time X-2SD X-1SD X X+1SD (3), curve D (discontinuation) is the most Source: Greenhalgh et al (3). common diffusion curve of all types, and the challenge is to explain the different adoption curves – (A) rapid and complete Figure 3. S-curves for different innovations and populations adoption, (B) longer lag phase, (C) slower A = rapid and complete adoption by a population adoption and incomplete coverage, and (D) B = similar pattern following a longer lag phase adoption followed by discontinuation (3). C = slower adoption and incomplete coverage D = adoption followed by discontinuance The purpose of the diffusion model is to describe the step-wise increases in the number of adopters and predict the development of a diffusion process. In the A B C product innovation context, for example, the model provides forecast of ﬁ rst-purchase sales of innovations, where the number

Adopters (cumulative) of adopters deﬁ nes the unit sales of the product and its growth (19). D Leadership from those whose opinions are

Source: Greenhalgh et al (3). Time Barriers to innovation in the ﬁ eld of medical devices—Background Paper 6 7

trusted – “opinion leaders” or “change means adopters have an active role in dramatically reduced the incision size for agents” – is important in innovation the dissemination process, rather than the lens and necessitated the development adoption as a mechanism to influence the “passive” function (as mere receptors of smaller, folding lenses. others through conformity, so that the of ideas from opinion leaders) ascribed spread of ideas among individuals occurs to them earlier by Rogers. Therefore a Over the next 30–40 years the technology by imitation (16). linear model that takes little account of evolved in a step-wise pattern, structured contextual influences in technology around a co-evolution between the invention Given the importance of “opinion leaders” in implementation, such as the presence of devices, medical practice and industrial this model, particularly at the early adoption of multiple professions in the health-care participation in a mutually constitutive stage, any attempt to infl uence diffusion arena, with different value systems applied way. This was a systematic, distributed would need to address the attitudes of to the credibility of evidence, seems fl awed. process where problems were solved opinion leaders fi rst. This could be achieved Fitzgerald and colleagues (7) maintain by the engagement of multiple actors, through mass media and persuasion, or strongly that knowledge is ambiguous, and such as specialist consultants, university what emerges as a more effective approach, a contested phenomenon. Acceptance departments, fi rms and state regulators, through strong interpersonal ties, such of such knowledge has to occur prior at the interface of what Blume (4) calls the as exchanges about the innovation with to changes in practice, and only after a “inter-organizational structure”. What this, peers. These are regarded as more trusted process of debate in local contexts. and other examples (e.g. the incremental ‘channels’ to deal with resistance or apathy improvement of the oral contraceptive pill to towards a novel idea, and to influence Consoli and colleagues (5) also largely reject reduce estrogenic risk, and the refi nement strongly held attitudes (18). the linearity of innovation diffusion and of endoscopes through fi bre-optics) show deem the model “laboratory bench” to is that it is a misconception to make a The assimilation of innovation is complex, “patient bedside” an under-representation clear distinction between research and iterative, and frequently beset by shocks, of a much more complex process. Diffusion development, and the adoption of medical setbacks and surprises (3). is a dynamic process through problem innovation as implied by the linear model. sequences (5). This places knowledge The development of an innovative technique translation on a trajectory of change, which often continues well after its introduction Critique of the linear model of involves identifying clinical problems and in medical use. Clearly, adoption is the innovation diffusion fi nding answers by generating innovative beginning of a prolonged process of The linear model of innovation diffusion ideas. Paradoxically, these ideas can pose redesign, feedback and adaptation to users’ has been critiqued on several grounds. problems to existing modes of practice demands (6). Fitzgerald and colleagues (7) express and can therefore have a destabilizing, concern that the simple, stage-like design even disruptive effect on established It may also be the case that the technological offered by Rogers presents the innovation- order, e.g. pre-existing clinical practice, or innovation itself does not originate decision process as essentially one of fi nancing and organization of services (8). within the medical sphere. Gelijns and choice between accept and reject, which The problem–solution rationale for Rosenberg (6) assert that a high percentage does not explain why or how the knowledge initiating innovative strategies ties in of medical devices have emerged not from or evidence is accepted. The authors query with Hughes’ concept of innovation as a clinical research, but through importing a common premise in health policy – that pattern of “reverse salients”, which affect of technologies developed elsewhere (e.g. for many conditions there is one optimal technological developments by driving effort lasers, ultrasound, magnetic resonance solution, based on science; a position towards corrections of technical problems spectroscopy and notably, the computer), conveyed also through agencies such as in an incremental way (20). which are then modifi ed to suit the needs NICE in the United Kingdom, which is of the medical sector, thus strengthening supposed to disseminate evidence and The innovation of the intraocular lens for the capacity to perform ‘upstream’ guidance in a top-down pattern to clinical cataracts articulates this logic well (5). biomedical research. Magnetic resonance staff (assuming that there is a single unifi ed The technology has diffused into practice imaging (MRI) for instance, a technology body of facts). becoming one of the most frequently that originated from basic research on the performed routine operations in the structure of the atom was later transformed An objection to this vertical model of industrial world today. However, it has into a major diagnostic tool, which has in knowledge translation can be forged on gone through a trajectory of problem– turn improved the ability to research various the grounds that there is rarely agreement solution sequences, with an initial lack of internal organs, highlighting the non-linear among professionals on one optimal acceptance of cataract replacement, with nature of the innovation process (6). solution. As a consequence, a single preference being given only to removal. solution is unlikely to be implemented; Two events shifted the diffusion process: Despite the shortcomings of the linear and further, interpretations and priorities a community of practitioners enthusiastic model, two concepts are particularly among those who adopt an innovation (so- about intraocular lenses, who developed valuable. One is the delineation of phases called ‘adopters’) affect their willingness shared norms concerning their use, and in the innovation process, upon which to subscribe to innovation diffusion. This the adoption of a new technique which subsequent research has built, including the 8 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project

criticism that the neat stages misrepresent users (e.g. physicians, regulators, payers, secondary effect of the division of tasks, a much more complex reality. The other is insurers) – which gradually reduces the based on the use of advanced techniques, the idea of interpersonal infl uence through uncertainty associated with new treatment is an ascended status of doctors over non- social networks, opinion leaders and change options. clinicians, such as the nursing profession, agents, as the dominant mechanism for and the establishment of certain hierarchies diffusion (18). According to Greenhalgh The role of expert users is traditionally in the medical profession. and colleagues (16), adoption decisions associated with physicians, acting on behalf occur via patterns of friendship, advice, of their patients, not only as sources of The changing composition of the communication and support existing among information but also as specialists in the users of new medical devices members of a social structure, where fi eld with the skills and tacit knowledge While medical professionals still hold an different groups have different types of necessary to turn new ideas into applicable essential position as users of innovative social networks. Doctors, for example, often solutions. While the medical profession, clinical methods, other participants in the operate in informal, horizontal networks, and particularly specialists, are indeed diffusion process are important. These effective in spreading peer influence. a key driving force behind innovation, include patients, health economists, Nurses, however, are observed to have the reciprocal relationship – innovation government offi cials, managers, insurers more formal, vertical networks, better driving forward specialization – is also and regulators, all of whom are increasingly placed for “cascading” information and worth considering. In fact, Blume (4) important in identifying demands for new passing on authoritative decisions (16). suggests precisely that new technologies technologies, as well as which services will foster specialization (division of labour) be integrated into mainstream care, and With these provisions in mind, translation in medicine, an example of which is the how they will be used, distributed, paid for, of knowledge into practice can be invention of the thermometer, pioneered evaluated and monitored. This has shifted understood as a long-term learning process by Hermann Boerhaave in the 1700s, the balance of determinants of innovation – characterized by a constant exchange of which permitted delegation of the practical from factors such as clinical evidence and feedback between the developers of medical part of diagnosis to assistants, leaving decisions made principally by doctors technology (e.g. research and development the physician to apply diagnostic skills to and scientists, to cost-efficiency and laboratories or clinical practices), and its the interpretation of the data obtained. A sociopolitical considerations, such as equity of access, and involving non-clinicians in the decision-making process of adoption. Figure 4. Stakeholders involved in the innovative process What once could be called “an extreme information asymmetry between physician and patient” (6), which gave clinical Users Other stakeholders professionals unlimited power to determine the demand for novel techniques, is now Medical professionals Manufacturers mostly outmoded, with patients now active participants in decisions about health and General practitioners Vendors/distributors access to state-of-the-art services. Specialists International regulators (e.g. surgeons, anaesthetists) In spite of the increasing role of social and National/domestic regulators Allied health professionals economic factors in the innovation adoption (e.g. nurses) Health ministry process, medical practitioners retain their “medical mode of control” (4) and still have Professional societies powers to facilitate or block innovation.

Patients For many physicians, innovation is seen Individual patients as a symbol of higher quality of care, but also as a source of prestige, status and Patient organizations distinction. It attracts research grants to hospitals, particularly in public care Family members systems such as the British NHS, but also in private in-patient sectors where in order Caregivers to attract a greater market share, managers Academic researchers aim to offer potential ‘customers’ a wider range of state-of-the-art technologies. In Biomedical engineers addition, new technologies give a certain status to specialists in terms of availing Medical students clinicians of powerful instruments to Biomedical control, through which they can revalidate engineering students Barriers to innovation in the ﬁ eld of medical devices—Background Paper 6 9

their profession: “by inventing technologies isolation from the fi nancial implications of and contextualized feedback mechanisms which need highly specialized medical their decisions. This has been changing that operate to influence technological expertise to operate, physicians are over the past 10 years, with increasing development in medicine. Furthermore it securing a role for themselves” (4). This costs, shared by patients in the form was argued that scientifi c evidence is not ‘protectionist’ policy by clinical specialists of co-payments, and a reduction of the suffi cient to ‘push’ through assimilation on through “inventing” methods whose use number of reimbursable services as part its own; rather, there is an interplay between relies on certain expertise becomes even of compulsory care. Figure 4 captures the the technological and social systems so more evident against the backdrop of main stakeholders involved in the innovation that diffusion engages multiple actors prospects for replacement of surgical work process as potential benefi ciaries of the at an interface of “inter-organizational with robots (21). current report. structure”(4). Finally, diffusion can result from relatively stable organizations and processes Finally, an important determinant of In summary, this section has considered the (‘regularities’) but can also be infl uenced by the innovation process is the payment literature on the translation process from unpredictable events (‘contingencies’) that mechanism for medical services in different a critical stance. It has been shown that make it neither an entirely random, nor a health care systems. In countries such as although the linear model (18) has some predictable process. The next section will Germany, where insurance companies act merits, for example, in its conceptualization start to unpack the implications of these as third-party payers of services, patients of opinion formation within peer groups, its conclusions in more detail. and medical practitioners can be seen in linearity does not do justice to the complex 10 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project

Trends in medical device development and barriers to innovation

The purpose of this section is to identify at the core of public health interventions people thought this goal was within reach barriers to innovation in medical devices for the prevention of death or disability, and was because the technologies needed to for the developing world as part of the WHO for managing the diseases of poverty (23). perform key interventions (such as oral publication Medical devices: Managing rehydration solutions, food supplements, the Mismatch. It examines perspectives These traits are recognized by the WHO antibiotics, vector control agents, water from the existing literature on obstacles publication Medical devices: Managing the pumps and latrines) were inexpensive, to the effective adoption of medical Mismatch, which uses the term “priority” to well-known and effective (25). The logic devices. Problems meeting the needs denote gaps in the availability of appropriate ran that if these technologies were of low-income countries by technologies medical devices for the prevention, successful in targeting causes of disease designed elsewhere are also considered. diagnosis and treatment of high-burden in developed countries, they must be In this respect, the paper identifies a diseases in selected low- and middle- equally effective in helping the developing considerable gap in current innovation income countries. world. Although some early success was work. Much attention is focused on factors registered, the campaign was largely a that hinder the adoption of devices in Populations in industrialized countries failure (26). One example of a failed attempt low-resource settings (acquired through often take for granted modern medical to ‘transplant’ technology from advanced import or donation) that have already technology and expect to be treated with to less-developed countries is the case been designed outside their domestic state-of-the-art equipment, whereas people of malaria, which was eliminated in the context (typically in developed countries). in financially-disadvantaged countries developed world by the application of Little is said, however, about why there is frequently experience shortages of essential engineering techniques (draining swamps, limited domestic innovation in low-income supplies, such as syringes or oxygen masks. salt fl ats, and contained sewer systems) countries in the fi rst place, and how to The stark contrast between these realities is and pesticides. Substantial investments tackle its absence. What are the barriers not diffi cult to explain, but extremely hard by WHO and others to apply these same to local development of medical devices? to tolerate from humanistic, medical and technologies in the developing world ethical points of view. Indeed developing have been generally unsuccessful, and A mismatch in design for different contexts countries, which are often exposed to the malaria remains one of the largest killers is not limited to separate countries. There pressing circumstances of food crises, civil of children and pregnant women in sub- are examples within high-resource settings wars, or severe infringement of human Saharan Africa (25). where innovative solutions designed for one rights, can hardly make their health care context (e.g. a hospital) do not address the systems a fi rst priority. They can neither Explanations for the failure amounted need in another (e.g. home-care). consistently spend to bridge gaps in health- largely to mistrust in the government by care provision, nor match the high level local communities, expensive installation The verifi ed answers to these questions of material and human resources that and maintenance of engineering solutions, may only be possible with input from advanced economies deploy, which is and high levels of emigration of health empirical work. However, the purpose at needed to develop and introduce missing professionals, all of which disincentivize present remains to offer insights into trends medical devices or maintain those already large public projects (25). Clearly a number and barriers to innovation identifi ed in the provided from donor countries. of factors in the local context of developing literature from a critical stance, but also countries infl uence technology diffusion to try and anticipate possible reasons why There is an obvious need to seek ways of in unanticipated ways, and expectations priority medical devices are not generated or closing the gap between what is needed that familiarity with the equipment, its appropriately used in certain environments. and what is available in terms of medical affordability, and effective application devices in financially-disadvantaged alone would be suffi cient to guarantee their Medical devices cover a wide range of societies. successful use did not live up to reality. instruments, from weighing scales to sophisticated implants, imaging systems In response to this challenge, governments, Within the narrower domain of medical and laboratory equipment, that are used industry and charities have shown a devices, such factors apply as well, which at all levels of health services as inputs to willingness to invest in or donate medical reinforces the argument that ‘transplanted’ patient care and as tools in medicine for devices to developing countries, as part of equipment from high-income countries the prevention of disease, disability and an overarching aim to achieve “Health for to middle- and low-income ones rarely death (22). According to the World Health All by 2000” as set out in a WHO project translates appropriately. While devices Organization (WHO), medical devices are from 1979 (24). One of the reasons some brought in from abroad might offi cially be Barriers to innovation in the fi eld of medical devices—Background Paper 6 11

‘available’ in developing countries, they are addition, many multinational companies funded by international donors or foreign not always exploited to their full capacity, for have already established manufacturing governments (29). Assistance can take which there are certain barriers to blame. facilities in new destinations, such as China, different forms, such as corporations These are presented in more detail in the as a way of accessing the local market acting directly or through private voluntary following section. directly but also exploiting opportunities organizations, or governments providing aid for lower production cost. Some companies to other governments, while the intended relocate their business off-shore altogether beneficiaries can range from individual Imported versus locally produced and produce medical devices for re-export health-care facilities to entire health medical devices to the home country. systems (29). Medical technology in developing countries is often imported. China is a rapidly growing market, with a Despite considerable investments, a share of 34.4% of the Asia-Pacifi c market’s majority of developing countries do not seem Import, with reference to medical device value, and an estimated annual medical to recognize the management of medical movement, is used as a broad term in the device market growth rate of 14.9% in the devices as a public health priority, or lack literature to denote acquisition of equipment period 2002–2006 (28). In nominal terms, the capacity to do so. This often means that by developing nations from outside their the Chinese medical device market is worth equipment is procured in ways that do not own domestic setting. This includes devices around US$ 14 billion with a projected correspond to standards of effi cacy, quality that are sold (often at discounted prices value in 2011 of US$ 23.2 billion, which and safety (23). In sub-Saharan Africa, for but nevertheless to make a profi t) by the represents an increase of 69% since example, almost 70% of equipment is exporting developed countries. The term 2006. A factor that contributes to the found to lie idle due to mismanagement also refers to donated items through aid attractiveness of this market for foreign of the acquisition process, absence of user intervention. In this respect, several trends entrants is the limited number and small- training and lack of effective technical emerge: scale of local production and development support (29). Another study reported that • Developing countries represent new of medical equipment, which gives large over 50% of the medical equipment in market opportunities for the medical multinational corporations considerable developing countries is not functioning, not device industry. market advantage. used correctly or not maintained, with some • There is a strong degree of reliance being entirely unnecessary or inappropriate by low-resource settings on imports of The reality is that scarcely any large scale to fulfi l its intended purpose (23). In addition, medical equipment from developed local production of medical devices takes about 30% of the medical equipment that countries. place in the developing world, or where it the World Bank spent US$ 1.5 billion • A large number of medical devices does, it is under the control of multinational on between 1997 and 2001 was found acquired by developing countries remain companies for export purposes (25). to remain unused (22). Of the devices idle, suboptimally or inappropriately in use, 25 to 35% was not used due to used. Exports of medical devices by developed downtime (e.g. equipment breaks), often • Research attention focuses on barriers economies for profi t purposes constitute with an insuffi cient capacity to repair the to diffusion of imported medical devices, one possible channel of acquisition for technology. and on how industry in developed low-income countries. Other ways in countries can (re)design instruments which health-care equipment reaches the What other reasons are there that might for the developing world in view of local developing world include aid interventions, account for the failure of most medical defi ciencies. joint partnerships, and provisions of devices once they reach developing • There is sparse literature on barriers supportive systems, often the result of countries? Why does equipment known to invention of medical devices locally diplomatic initiatives funded by high- to be effective in advanced economies not within developing countries. income economies. work in low-resource settings? The following text provides some answers. The developing world – a growing potential In spite of changes in the global economic market for the medical device industry landscape by steep market growth in some It is estimated that developing countries countries (e.g. China and India), overall Barriers to medical devices altogether represent an immense potential there is still a large degree of dependence As illustrated earlier, technology diffusion market for medical devices in view of on donor assistance in the area of health in medicine is a complex, non-linear and the sheer size of their total population care. Reliance on aid for medical devices dynamic process. There are obstacles (4.9 billion), generating an aggregate gross is caused mainly by persisting fi nancial to the introduction of any innovative domestic product (GDP) comparable to problems in low-income nations, lack of method, procedure or piece of equipment, that of the developed nations (27). This resources in public health care systems, regardless of whether it takes place in a creates a strong incentive for high-income and a growing burden of disease. Donations developing or developed country. Common economies, notably the United States, usually include physical equipment and barriers to innovation do exist for both high- Europe and Japan to produce equipment spare parts, and in some countries, and low-resource settings, such as limited for export to the developing world. In nearly 80% of health-care equipment is staff training on how to use the new device, 12 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project

hostility on the part of established medical example, a single MRI scanner can cost have a credit card). practice and reluctance to admit the need more than a million US$ to purchase, and • Health staff members believe that for skill upgrade (as seen in the intraocular together with operating costs can take up purchase of spare parts is a poor use lens example in the United Kingdom). a signifi cant proportion of a developing of resources (e.g. requesting a new However, differences are observed in the country’s health-care budget. device altogether from a sponsor in a ways that countries are able to respond to developed country can be seen as a these challenges. The cost of capital, however, is only the better option than meeting the cost of tip of the proverbial iceberg, with many a spare part). An example of this can be seen in the case recurrent costs hidden underneath, such as • Technical staff members do not act due of invasive interventions such as cardiac service contracts, spare parts, depreciation, to frustration, lack of tools and manuals, pacing or blood pressure monitoring consumables (e.g. accessories such as and/or corruption. through electrodes, and catheters entering needles), training, etc. Such costs are the heart or great vessels. Used at fi rst in presented in Figure 5. However, the EWH study also found that the 1950s, these devices caused concern the lack of spare parts may not actually be in the 1960s and 1970s due to the risk of Spare parts a predominant barrier. Only 12.3% (120 out micro shock – a small electrical current The lack of spare parts for the repair of of 975) of the broken equipment actually not perceptible by normal human contact medical equipment can present a serious required a spare component that could that could be channelled via the invasive barrier to continuous use. Most devices put not be found or was not produced in low- devices to cause cardiac fi brillations (22). into operation generally function effectively resource countries (26). This issue was addressed in developed at fi rst, but some components will inevitably countries through intense research by need replacement after a certain period Consumables scientists who improved the design of of use. Data from an Engineering World For their appropriate use, some medical the devices. Users were also educated Health (EWH) study of medical equipment devices require accessories (i.e. accordingly. Such response to a ‘technical’ in developing world hospitals point to four consumables). An intravenous (IV) infusion barrier of this type requires knowledge, skills main reasons for this shortage of spare pump, for example, needs compatible and resources in operation, which are not parts (25). IV sets that must be replaced for each readily available in low- or even medium- • The spare parts are no longer produced. patient (22). While the pump itself might resource settings. As medical devices • Purchasing the part requires a credit be provided for free by a medical device gradually evolved, the issue of maintenance card (few people in the developing world donor, its subsequent use requires a emerged, which again, industrialized countries were able to solve by appointing technical experts in hospitals. This did not Figure 5. The hidden costs of medical devices occur in many poorer health-care systems, due to lack of financial resources, but also other factors, such as a dearth of educational opportunities and emigration of trained professionals from developing to developed countries. This example shows how priorities and opportunities diverge 0 Service contracts between high- and low-income societies 0 Spare parts 0 Downtime but also that most medical devices are 0 Test equipment 0 Space designed for the industrialized countries, 0 Depreciation 0 Licences which has implications for their appropriate 0 Upgrades use in fi nancially-disadvantaged settings. While responses to identical challenges in medical technology can differ between 0 Supplies developed and developing nations, there 0 Product 0 Installation are certain barriers to innovation that are management 0 Accessories unique to the developing world. These are 0 Labour addressed as follows. 0 Utilities 0 Training Cost The cost involved in purchasing medical devices can present a major obstacle to their use in developing countries. For Source: Adapted from (22). Barriers to innovation in the fi eld of medical devices—Background Paper 6 13

continuous supply of IV sets and therefore and technicians on how to use imported provided with basic conditions (e.g. a recurrent budget, the absence of which medical devices in low-resource settings power, water, road network, etc.). Material in most developing countries presents an is even greater due to the fact that health infrastructure as basic as this is not readily impediment that can lead to poor-quality professionals have less exposure during available in low-resource countries. Rural services, but also to devices being left idle, their education to advanced equipment settings in particular are exposed to or even to pressure on governments to than their colleagues in relatively wealthy recurrent shortages of water and electricity. provide for the running costs (22). nations. For instance, the poor quality of roads can make a trip to a large town to obtain water This example assumes that there is Training in the appropriate use of devices diffi cult. Basic provisions, such as oxygen access to consumables on the market is so important that the lack of trained supplies, can be scarce. For example, and that the problem lies in inability to personnel in developing countries an informal study in the United Republic provide a continuous stream of money for constitutes a considerable barrier of Tanzania in 1991 showed that three their purchase. In most cases, however, to diffusion. Complicating matters is quarters of district hospitals have cylinder the consumable is simply not available emigration of qualifi ed health practitioners oxygen supplies for less than a quarter in the country or has highly specialized to high-income countries where better of the year (30). Dobson reports (31) that features, which inhibits its replacement career opportunities await (“brain drain”). largely due to the lack of infrastructure with substitutes (25). In fact the inability “Brain leak” can also occur, that is where and failure in the ‘oxygen chain’ (fi nance, to fi nd alternative consumables is cited workers educated to perform a specifi c task vehicle and fuel, ordering and delivery, as one of the most common barriers to in a hospital then emigrate elsewhere (25), road system, storage, stock control, etc.), the purchase of medical equipment by to another district hospital for example. in many developing countries up to 75% of hospitals in the developing world, and by This phenomenon acts as a disincentive for the district hospitals are without a regular donating organizations (25). some hospitals to invest in their employees’ oxygen supply.1 education, as they might lose personnel to Expertise and training another hospital (e.g. a private one) or to Barriers to local development of medical The importance of up-to-date medical emigration abroad. devices: international and local regulation knowledge and technical skill to operate The value of regulation for medical increasingly complex equipment cannot The safety and treatment outcome of equipment is indisputable in terms of be overstated. Dankelman (21) illustrates medical devices is directly linked to the providing assurance for safety and quality the long learning curve involved in operators’ skills and to how the equipment of care. This view underpins standards mastering device-dependent procedures is managed, not only on a single-case basis developed by major international such as colonoscopy, minimally invasive but consistently. The traditional one-time organizations such as The Global surgery, robotic surgery and endovascular training by the manufacturer as a condition Harmonization Task Force, the World procedures. While there are certain benefi ts of purchase is insuffi cient, particularly in Trade Organization and the International to for patients from treatments based on view of the high turnover of personnel in Organization for Standardization (32). advanced instruments (e.g. laparoscopic developing countries and the need to train surgical tools can be inserted in the new staff frequently (22). This mandates Such standards can be helpful in providing abdominal area through small incisions, a systematic approach to education and useful directions for the governments of allowing an improved healing process), training, including the publication of many countries, especially those that lack the risks of incidents and complications instruction manuals in local languages medical device-specifi c regulation. remain high due to various factors, like and ensuring that minimum standards are working in only two dimensions and hand– maintained. Cheng (22) proposes a framework While the promotion of standards and eye coordination problems. Technical skills based on “Good Management Practices” in control of medical devices is undoubtedly on how to operate equipment form an technology management, which considers essential, excessive regulation – particularly essential element of its effective use. In this that a single health-care facility might not one that is insensitive to domestic context – respect, the lack of a training curriculum for be able to afford an in-house management can also act as a barrier to local innovation. surgeons that is adapted to rapid changes system, and recommends that a group of It can potentially hinder domestic innovation in technology (or clear guidelines and regional facilities pool resources for a shared by subjecting new technologies to lengthy standards), renders the skill of surgeons service in such a scenario. and expensive licensing processes, thus inadequate in many cases and presents a increasing the cost and the time that local barrier to technology diffusion. Infrastructure manufacturers have to invest in addition The lack of reliable electricity and water to production costs. As a consequence, Although Dankelman’s study (21) deals with supplies in many developing countries acts technologies with relatively low development the technology-driven need for training as a barrier to medical devices, particularly costs, such as immune-diagnostics, may in developed European countries, the in view of the fact that most equipment same issues concern developing countries comes from economically advanced nations 1 Oxygen for clinical use can be provided either from a cylinder of compressed gas that are at the receiving end of medical with well-developed infrastructure and is or from an electrically powered oxygen concentrator. Cylinders have been more widely used in the past, but for logistic and cost reasons they are not always devices. In fact, the need to train doctors designed to function in an environment available in suffi cient quantity – or even at all – at district hospital level in developing countries (31). 14 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project

become unaffordable. Some products So far the paper has concentrated on They limit reimbursement to services that are of signifi cant value to low-income barriers to innovation in low- and medium- nationally agreed to be necessary for a countries may be removed from the market resource settings. It is generally thought diagnosis or therapy/treatment. This means due to perceived risks associated with their that high-resource countries experience that if there is a new device which has not use, based on high standards in advanced fewer obstacles due to better provision of yet been integrated in the DRG, it will not industrialized countries (where guidelines funding and infrastructure, and relatively be reimbursed under this system. usually originate) (33). For example, as the stable health care systems. Furthermore, EWH study found, original replacement innovation in medical devices occurs Further, many EU countries experience batteries for a defi brillator can cost between primarily in high-resource countries where administrative, regulatory and sometimes US$ 200 and 300. It might be possible for a traditionally there is more experience and bureaucratic barriers to innovation, local manufacturer in a developing country expertise in technology development. particularly in medical devices and to produce a cheaper alternative option, but Nevertheless, difficulties exist in these generally in biomedical technologies. One which is very unlikely to meet international settings as well, and can hinder innovation. such example is the lengthy assessment standards (such as operating at 0º C) (25). procedure of innovation through the One such challenge is reimbursement. This German Joint Federal Committee (G-BA) In sum, by imposing robust standards, particularly concerns European Union (EU) or the evaluation of new technologies the international community in medical countries with insurance-based health-care for provision by the British NHS through device regulation seems to deter rather than systems. Negotiating compensation for a NICE. While these institutional steps are stimulate local innovation, which “kicks new medical technology as part of statutory necessary to ensure high quality and cost- out the ladder” from under producers of mainstream health care can be a problem, effectiveness of innovation, they can slow equipment in developing countries (34), particularly with regard to innovations not down the process of delivery to patients and and compromises the ability of these local yet included in the reimbursable catalogue discourage innovation. producers to thrive, of benefits. This applies especially in cases of uncertainty about whether To summarize, there is limited, if any, Cultural and social context the new device should be included or innovation of medical devices locally in Medical devices do not exist in a vacuum, excluded from the mainstream package developing countries. Considering their but are part of a broader context. From of care. Cost-containment measures can sizeable populations, the increasing burden the very inception of a new piece of also affect reimbursement. For example, of disease, and their low fi nancial capacity equipment, treatment or procedure to Diagnosis-related groups (DRGs) have been to deal with pressing health-care needs, complete adoption in clinical practice or introduced for inpatients in many settings. low-income countries have relied heavily on decline thereafter, innovation is infl uenced by multiple interests of the involved stakeholders. Table 1. Barriers to innovation in medical devices

While some key aspects of the medical • Supplier-driven device context were already discussed, such • Linguistic barriers, i.e. literature not translated into national languages as material infrastructure and economic • Maintenance contracts are missing resources, there are other important issues • Insufﬁ cient staff which affect the creation and diffusion of • Limited access to technical information or it is unavailable equipment, such as traditional cultural • Poor maintenance and repair facilities practices for example. • Lack of a “training culture”, i.e. poor use of a daily protocol and instructions. • Manuals dense and not easily understandable Medical practitioners who apply bio- • Cost scientific principles in treating patients • No spare parts tend to view the mind and the body as two • Problems with service maintenance of defective medical devices separate entities. This often differs from • Unrecognized standards for quality control & maintenance holistic care based on traditional healing, • Inadequate guidelines which emphasizes spirituality and has less • Lack of coordination use of technology (35). Many traditional • Not enough copies of user manuals for all users communities in developing societies are • Procurement issues with mediating ministries (due to acquisition at the central level) proud of their culture, often dismissing • Direct link broken between producer/vendor & end user western values and sometimes also reject • Shortage of technical expertise medical devices, even if they are supplied • Lack of funding and trained staff for support at lower cost (1,25). • Weak management culture • Lack of quality assurance Barriers to innovation in high- • Technical information sometimes withheld by industry resource countries Source: Hansen et al. (1) Barriers to innovation in the ﬁ eld of medical devices—Background Paper 6 15

at truly addressing the needs of low-income Table 2. Stages of medical devices life-cycle countries.

Concept stage: starts with idea generation and includes technical, fi nancial and commercial viability. Solutions to this last issue can be found in Design stage: involves actual product development processes from design to prototype development. three possible avenues: (i) that technologies Testing & Trials stage: starts from prototype testing ‘in-house’ and includes trials in fi eld, going to originating in high-resource countries be market, selling and production. re-designed in a way which compensates Production stage: includes production on a large scale supported by a business & commercial rationale. for limited resources or infrastructure in low-resource countries; (ii) that barriers to Marketing & use stage: includes product launch in the market and post-launch use. the adoption of devices be addressed; and Source: Adapted from Shah and Robinson (34). (iii) that underlying barriers to development of medical devices in low-resource nations be addressed. obtaining medical devices from abroad. The response by the developed world has been Another observed trend is that low-resource Most effort so far seems to have focused on to provide various types of equipment, most countries represent a large emerging the fi rst point: fi nding ways on the part of of which remains under-used at best, not market for the medical device industry of industrialized importing/donating countries utilized, or misused at worst. Several reasons developed economies, and as such offer to re-design medical devices for low- have been identifi ed for this gap between ample opportunities for direct exports, re- resource settings. The literature on barriers procured and operating equipment, most imports, and off-shore business, with the to innovation refl ects this trend. Current notably the lack of material and human advantage of low-cost manufacturing and work seems to concentrate on barriers to resources to maintain medical devices, the cheap labour. This acts as an incentive designing medical devices for developing absence of spare parts and consumables, for industrialized nations to penetrate new countries by high-income economies, lack of technical expertise and ineffi cient markets by developing equipment which so that ideas are generated outside low- management. This prevents developing caters to local needs. This places the onus resource settings rather than within them. countries from making appropriate use of for device production on manufacturers in Table 1 lists several barriers to innovation. imported medical devices and suggests advanced donor countries and shifts the In Table 2, the stages of a medical device that one way to address the diffi culties in attention away from local innovation in low- are outlined. assimilation is for industrialized economies resource societies. This creates a problem to re-design technology so that it takes in which the market is driven by industry or into account local defi ciencies (e.g. lack of supply rather than by public health needs, infrastructure). resulting in many efforts that are ineffective 16 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project

Model for the analysis of barriers to innovation in priority medical devices

Several perspectives from the According to Roberts (38), innovation medical fields. While these innovators literature is a broad term that can be used to are seen to hold a primary function in the To dispute linearity in technology assimilation describe both the invention of dramatic innovation process, the role of the device does not mean that innovation should new capabilities and of incremental manufacturing companies tends to be be taken as a chaotic phenomenon (37). improvements to products and processes supportive and secondary with respect to Although empirical research largely rejects that have previously existed and are most innovative products. However, data diffusion models based on a neat order of modifi ed to fi t new conditions. In addition from Roberts’ 1987 study notes also that phases following each other in a predictable to medical device or product innovation, a large part of potentially valuable user sequence (16,37), it is possible to identify a innovations can apply to the manufacturing perspectives and insights are dormant in structure built around different categories process, the mode of practice and academia, due mainly to the traditionally of diffusion. This allows the identifi cation organizations. Innovation also includes restricted role of academics with respect of states of routinization and also serves as adoption, taking something that someone to commercial technology transfer and an axis for comparative studies between else had previously done and applying it exploitation. different technologies, or between diffusion in a different environment, such as the pathways of the same technology in adaptation of medical devices designed Pouvourville (39) draws a clear distinction different national contexts. in the developed world to conditions in between invention and innovation, where fi nancially-disadvantaged countries. innovation is characterized by its diffusion, This paper set itself the aim to gather namely an invention with no market is not evidence from the ‘innovation’ and With respect to the actors involved in the an innovation. A visual representation of ‘medical device’ literature on trends in innovation process, Roberts (38) disputes the this distinction is found in Figure 6. diffusion of medical technology and on model that says the manufacturer is a main models according to which innovation innovator based on successfully identifi ed takes place. The main objective is to fi nd market needs. The author asserts that the Figure 6. Innovation comprises of invention and diffusion out why medical devices available on the users (e.g. the physician, the academic market are not being used in the health medical community, or the patient) play care of selected low- and medium-resource a much more substantial role than merely Innovation countries. The purpose is to identify the being sources of helpful information reasons for suboptimal or inappropriate regarding their needs to a manufacturer use, which are termed ‘barriers to diffusion’. who then innovates. Instead, the user is Invention Diffusion A related issue also addressed by the paper seen as the principal driving force behind concerns the absence of certain medical most medical device innovations; the Source: Based on Pouvourville (39). devices from the market altogether, which user not only identifi es the need but also can be due to the lack of imports from develops the initial solution to that need, developed economies or to the absence implements it by placing the solution into Put simply, invention can be perceived of local innovation. Together these factors fi rst trial use, and often makes copies or as the creation of a new piece of medical can constitute barriers to invention and detailed specifi cations of the innovation equipment or the modifi cation of an old one, subsequent diffusion. This inevitably leads available to other practitioners. At the very following an innovative idea, while diffusion to the question of whether innovation (the least, the user acts as a linchpin to the is the process of its translation into use. whole sequence of invention plus diffusion) innovating company (38). Only later does a Diffusion involves the activities associated is able to close the gap in the availability, manufacturer enter the picture by taking on with developing the new idea into a product, appropriateness and acceptability of the users’ innovation and engaging in the bringing it to the market and succeeding medical devices in the management of high- commercial development (i.e. engineering or failing (38). Innovation encompasses burden diseases. An important distinction for manufacturing, reliable fi eld use and the entire sequence of activities from the needs to be made at this point between service, and volume scale-up). identifi cation of the need for a new medical ‘invention’, ‘innovation’ and ‘diffusion’ of device, to the generation of a solution, and medical technology. These terms are often Roberts (38) sees the medical device its onward evolution into a product used in used interchangeably, which is why it is innovation process as one dominated not practice. Therefore, innovation necessarily important to distinguish between them. by fi rms, but primarily by individuals, who incorporates diffusion. Several perspectives from the literature are usually in academic and/or clinical help to delineate the boundaries of the settings, involved in the development and Roberts (38) distinguishes the innovation innovation stages. use of new technology in their respective of medical devices from that of Barriers to innovation in the fi eld of medical devices—Background Paper 6 17

pharmaceuticals by arguing that the former problems of obtaining and maintaining Figure 8. A cyclical model of diffusion process is usually incremental rather than affordable wheelchairs by disabled relying on fundamentally novel knowledge Nicaraguans (41). The vast majority of or long periods of basic research typical people in the country use second- or third- of drug innovation. Furthermore, medical hand hospital-type chairs imported from Sales Monitoring device innovation is based primarily on the US and other developed countries. VENDOR gradual engineering problem-solving by These chairs often have hard tyres and Pre-market control individuals (users) or small fi rms, who often non-removable armrests and footrests, MANUFACTURER apply existing knowledge or techniques giving the users little fl exibility or mobility, in to newly defi ned problems (38). Figure 7 addition to frequent reported breakdowns presents the different phases in the lifespan and inappropriate functionality for of a medical device, as a linear sequence of outdoor conditions (41). Certain features Post-marketing actions, from conception and development in the infrastructure of Nicaragua, such surveillance THE USER by the manufacturer, to advertising the as narrow doorways, high pavements and product by the vendor, to use and disposal lack of access to buildings for wheelchair by the end-user. users, impede the use of many medical devices, particularly those designed to This example highlights two important This model of neat linear steps, however, function in “barrier-free” industrialized points. Firstly, innovation in medical devices is largely outmoded. Instead, a cyclical, environments. In an attempt to adjust this is not limited to the creation of an entirely dynamic model of constant exchange of type of medical device to local conditions, new piece of equipment but can instead information between multiple stakeholders Hotchkiss came up initially with a wooden involve the alteration of existing devices is a more accurate way to describe folding seat that was thought to be an in order to adjust them to specifi c local innovation (Figure 8). Frequently it is appropriate prototype; it allowed for a conditions. Adaptation of a medical device the fi nal user of medical equipment (e.g. simpler and stronger folding mechanism for use in a context different from the doctors, biomedical engineers or patients) than the average imported US wheelchair original infrastructure constitutes a valid who are best positioned to innovate and (41). However, the use of a wooden form of invention and consequent diffusion, who identify the need for a novel device chair requires a cushion to prevent the which altogether make up the innovation or for the improvement of an existing formation of ulcers on people with spinal process. The second observation in this technology. Users often invent, more so cord injuries. Although cushions were instance concerns the essential role of than the manufacturers themselves and provided during the fi rst year of use of the users as innovators, as previously noted. therefore can move from the end stage wheelchairs, most Nicaraguans could not in the scheme to its beginning. This is afford a replacement once the cushions Greenhalgh and colleagues (16) discuss the captured in Figure 9. wore out. Therefore the lack of fi nancial differences between diffusion (which the means to replace a consumable as simple authors also call “pure diffusion” or “passive Hotchkiss’ personal experience as a as a cushion was one of the major reasons spread”, denoting an unplanned, informal, designer of wheelchairs for Nicaragua for change in the design for local users (41). decentralized and largely horizontal process, provides an interesting insight into the often mediated by peers), dissemination

Figure 7. The phases in the lifespan of a medical device

Conception and development Manufacture Packaging Advertising Sale Use Disposal

MANUFACTURER VENDOR USER

PRE-MARKET CONTROL SALES MONITORING POST-MARKET SURVEILLANCE Close cooperation is needed with the A national database on vendors and products Correct use is the ultimate determinant of manufacturer/importer of the product. is essential for effective control of medical safety and effectiveness. devices. Important activities include: Important activities include: Important activities include: • Collaboration on acceptance criteria; • Training of user before use; • Collaboration on international quality • Vendor registration; • Regular maintenance of devices in systems and product-speciﬁ c standards; • Product registration; accordance with operation and service • Agreement on systems for conformity • Prohibition of fraudulent/misleading manuals; assessments; advertising; • User networks and medical device vigilance • Clinical trials/testing; • After sales obligations, including: systems to facilitate alert notiﬁ cation; ✓ • Appropriate and effective customs control distribution records; • Adequate management and disposal of ✓ system on imported medical devices. complaint handling; discarded devices. ✓ problem reporting; ✓ recall procedures.

Source: WHO (40). 18 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project

(active, planned, formal, often centralized • Exploration – describes the history of A health professional’s position in the efforts to persuade target groups to adopt attempts to realize a certain vision. For ‘status hierarchy’ depends on his/her an innovation, more likely to occur via an imaging technology this is the period performance. For example, a radiologist’s vertical hierarchies), implementation (active leading up to the fi rst working prototype status in the hierarchy depends on how efforts to mainstream an innovation within and the fi rst publications reporting its well he/she masters the X-ray equipment, an organization) and sustainability (making successful use. which is provided, maintained and updated an innovation routine until it reaches • Development – the industrial involvement by the industrial sector. This exemplifi es the obsolescence). in the emerging technology. In the case view held by Blume (4) that technologies of imaging innovation, it began with evolve through acceptance by “relevant This process can also be considered as the publication of the fi rst human in social groups” of actors via negotiation as ‘knowledge translation’. Lang, Wyer and vivo images using the fi rst prototype of maintained in the social construction of Haynes (12) use this term to describe the technology. This phase ends with technology literature (42–44). any activity or process that facilitates commercial manufacture and the new the transfer of high-quality evidence into device being brought to market. Brown, Rappert and Webster (45) propose a effective changes in health policy, clinical • Integration – diffusion, evaluation and model for considering innovation in terms practice or products. assessment. For imaging technology, of country-specifi c “confi gurations”. The it began with the fi rst specifi cation of authors distinguish between “close knit” Fitzgerald and colleagues (7) identify its clinical use and ended when the and “loose knit” confi gurational types in six levels of dissemination: widespread, innovation became routine practice. different European nations, in terms of variable spread, debated, limited pockets, This does not imply 100% diffusion (i.e. the nations’ integrative and coordinating pilot and no spread at all. This model all hospitals using the instrument), but capacities to respond to technological considers dissemination in relation to the a widespread consensus that it is good change. For instance, a “close knit” influence of scientific evidence on the practice and that professionals need to arrangement, which is determined by a comprehensiveness and rate of diffusion. accommodate the innovation. stable, complex network of organizations, This is a suitable method to compare • Feedback – development of improved high levels of regulation, and high resource- “states” of achieved adoption rather models and the search for new dependency is expected to resist innovation than “processes” or patterns of diffusion. applications if the innovation is judged due to overspecialization and reluctance to However, this approach considers innovation to be successful. change. At the opposite end of the spectrum in terms of the relative determining power of lie “loose knit” confi gurations comprised of only one factor – clinical evidence. By way Blume’s (4) third concept refers to ‘de-centred’ relations, weak institutional of concentrating on a single factor – which, Problematization, that is what is problematic integration, underdeveloped regulation and as was concluded in the last section does about the technology, when, for whom and low resource-dependency. While structures not necessarily have much explanatory with what result. Problematization can take of this type are expected to provide a more power – the model restricts the intensity of many forms, for example, the establishment fl exible approach to innovation, there is a the search for other factors, which might of new regulatory requirements in regard concern that they may be unable to build have a similar (limited) effect or conversely, to a device, or regulations governing the innovative momentum. might bear more signifi cant consequences circumstances under which it can be used for the assimilation process. or its use reimbursed. Meyer and Goes (9) see innovation diffusion as a dynamic, multilevel process of choice Blume (4) established a structure for In this model, scientists have a key role in with nine identifi ed steps under three broad comparative analysis of technologies based the innovation process as technical problem stages: knowledge-awareness, evaluation- on three concepts: inter-organizational solvers and actors who bring incremental choice and adoption-implementation. The structure, career and problematization based improvements in devices (e.g. better speed stages and steps are presented in Figure 9. on an analysis of new diagnostic imaging and sensitivity). Blume (4) argues that the techniques. This will be discussed below. successful introduction of a new medical The authors conducted a study tracking device cannot be accomplished without 300 decision-making processes concerning Inter-organizational structure designates the cooperation of the medical profession the adoption of 12 medical innovations the interaction between clinical and market as the source of clinical reports attesting across 25 hospitals. The research design aspects of a new technology. It shows the to the utility of the innovation. However, used built on a proposed model that information flow between the hospital routine use of a new device depends captures three classes of determinants of department and industry. also on budgets allocated by hospital innovation diffusion, namely: managers, by government institutions in 1. Attributes of the innovation: These The concept of career is central to Blume’ s state-funded health-care systems, (e.g. include technical features such as sociological analysis of technology diffusion. the United Kingdom), or on negotiated clinical utility, validity, and diagnostic It comprises several phases – exploration, fi nancial streams between sickness funds sensitivity; degree of manual skill or development, integration (diffusion, and service providers in insurance-based specialized medical training needed evaluation and assessment), and feedback: systems (e.g. Germany). to use the new technique. Innovations Barriers to innovation in the fi eld of medical devices—Background Paper 6 19

are more likely to be adopted by between the innovation and its The study demonstrates that the three organizations if, compared to other context: These include an innovation’s factors strongly infl uence the diffusion of innovations, they require less skill to compatibility with the tasks and medical innovation. Innate characteristics use, expose patients and doctors to experiences of potential users, such as of the technology significantly affect fewer risks and are more observable. the presence of medical practitioners adoptability (this factor accounted for 40% 2. Contextual attributes include: include able to apply the new technique, and of variance in technology diffusion between characteristics of market environments, the extent to which a manager, or the 25 studied hospitals). The combined organizational size and structural chief executive offi cer (CEO) supports effect of innovation and context accounted complexity, and leaders’ ‘power’ in or opposes adoption. Innovations are for 12% of the variance in adoption. Lastly, terms of resource allocation. Innovations more likely to translate into practice contextual factors had the least predictive are more likely to be assimilated into in organizations where the new power in regards to technology diffusion organizations in environments that technologies are compatible with (11%). are urban, affl uent and in which few medical specialization and where CEOs patients rely on state health insurance. are infl uential proponents. Technologies are more likely to be Outcomes of the literature adopted in organizations that are large, The three determinants of innovation review complex and eager to penetrate new adoption are presented Figure 10. In sum, several key points are worth noting markets. There are better prospects based on the literature review of trends in to diffuse in organizations where chief In this model the uptake of an innovation medical technology, the identifi ed barriers executives have long tenures and is the dependent variable, and its three to innovation in the developing world, and high levels of education, and where determinants – innovation attributes, the models according to which new or physicians have been recently trained. context and “innovation-decision” adapted equipment is seen to translate 3. Factors arising from the interaction attributes – are the independent variables. into use, namely:

Figure 9. Innovation diffusion as a multilevel process of choice

1. Knowledge-awareness 2. Evaluation-choice 3. Adoption-implementation

Apprehension Acquisition-proposal Trial

Consideration Medical-ﬁ scal Acceptance evaluation

Discussion Political-strategic Expansion evaluation

Source: Based on Meyer and Goes (9).

Figure 10. A model of innovation assimilation

CONTEXTUAL ATTRIBUTES Characteristics of environments, organizations and leaders

INNOVATION-DECISION ATTRIBUTES Organizational ASSIMILATION of Characteristics of innovation-context technological innovations interactions

INNOVATION ATTRIBUTES Features inherent in new technology

Source: Adapted from Meyer and Goes (9). 20 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project

• Innovation comprises invention and socioeconomic, historical, institutional adaptation to fi t local conditions. diffusion (translation into use). and political infl uences. • Users play a key role in the process • Innovation can include adaptation, i.e. • Innovation in medical devices is a of medical device innovation, which applying already existing devices in a gradual process, often based on frequently occurs in an upstream different environment. incremental improvements to existing direction. • Innovation in biomedical technology products. • Innovation takes place under the takes place in a complex, non-linear, • In essence, innovation in low- influence of three main factors: dynamic pattern. and medium-resource countries attributes of the medical device, the • Innovation does not happen solely as predominantly consists in the context where it operates and the a direct and logical consequence of modification of medical devices interaction between the context and established scientific evidence, but obtained through procurement from medical device. instead is affected by a combination of industrialized economies and their Barriers to innovation in the fi eld of medical devices—Background Paper 6 21

Towards a new model of medical device innovation

Figure 11 captures the main stages of Figure 11. Dynamics of medical device innovation innovation diffusion, and what is necessary for a new device to reach market. As the literature review illustrated, and the Teaching hospital, survey (1) confi rmed, many of the elements clinicians, academic necessary for diffusion of new technologies Clinical setting researchers are missing in low-resource countries. Industry Following the phases in the fi gure below Patients (clockwise from research) shortcomings and barriers include: • Development of ideas into a • Lack of suffi cient local research and product research tradition • Device Pre-market • Inability to develop new ideas into prototype clinical prototypes using only local resources evaluation due to lack of established know-how Research mechanisms to capture domestic • Production projects and ideas • Modifi cation of Unmet existing MD’s • Low domestic investment (capital and clinical New workforce) in innovation needs technological • The majority of medical devices being capability imported, which leads to: Discovery of new • Little incentive to build experience indications for use in pre-market clinical evaluation and • Marketing and adoption of other stages before procurement • Post-marketing new MD • Multiple barriers to adopting imported • Observation • Use devices designed in different contexts • Feedback (high-resource countries) to local • Continued contexts (low-resource countries) innovation • Cost • Need for spare parts and consumables • Lack of expertise and training • Limited infrastructure and low-resource settings. In high-resource innovation infrastructures to take up new • Cultural and social incompatibilities settings there is relatively good connectivity ideas, for example, can prevent innovators • Insufficient (if any) post-marketing between the components of the model. For from moving forward. Small enterprises observation and feedback mechanisms instance, established technical capability, rarely have the fi nancial means to develop • Lack of systematic reporting of faults expertise and innovation systems are a product on their own. Where medical during use able to pick up where clinical needs lie. devices are imported in low-resource • Absence of systems to record where, Stronger industry stakeholders in high- settings from elsewhere, their adequate when and how ideas are generated income countries are well-placed in terms local use is made all the more difficult and followed through of fi nances to facilitate inventions. There are by high maintenance cost, inconsistent • Lack of a direct link between clinical also established links between academia, training, brain drain, lack of consumables needs (locally) and design of devices manufacturers, sales, marketing and and spare parts, poor road networks (abroad). post-marketing. Despite this, problems and physical infrastructure, absence still exist in wealthier countries. One issue of procurement culture, insufficient This model presents the key elements is the lack of clear-cut mechanisms to management, inadequate user manuals necessary for innovation to occur (this reimburse innovative technologies as part and additional barriers. Signifi cant steps includes the invention of a new device and of mainstream health care. However there need to be made to address the barriers its diffusion for wider use). The model can are many more missing blocks in low- and to innovation. be applied to high- as well as to medium- medium-resource countries. The lack of 22 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project References

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