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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 first,
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 findings
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 field 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.

appropriateness and innovation in medical devices. to Medical devices: Managing the • Who are the stakeholders in innovation? This paper offers examples from several Mismatch.and medium. 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.and low- • Why are medical devices available on firstly through a search of the literature resource settings. to identify in which innovation occurs. The focus is then narrowed to and the lack of invention and subsequent the one hand. the concrete conditions that inhibit or diffusion into clinical practice in cases where resource countries on the other. . processes in high-resource settings on sector. 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). which views innovation the market not being used in health including the terms ‘medical devices’. Barriers to innovation in the field 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. 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. their and differences between innovation how innovation occurs in the biomedical inappropriate use where they are present. The accelerate innovation in medical devices. This supplies the innovation process? of devices manufactured by technically analytical framework of the current study. 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. and in low. 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-. • What are the trends in the development advanced countries. 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. The model acceptability of medical devices in the the stages of the innovation cycle. as a process comprised of separate stages care? What are the barriers to diffusion? ‘biomedical innovation’ and ‘diffusion’. medium. the need exceeds availability.

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

In the next section. the British National Institute translation. standard of care for diabetes. the clinical uptake of the factors affecting the dynamics of the cause to existing habits. Cancer scientific evidence varied. • Implementation Wyer and Haynes (12) report the case of • Confirmation the Ottawa Ankle Rules. health care – acute and primary admissions Rosenberg (6). any disruptions that it may health care staff. into daily use. personal or social the method is inconsistent. As a result. as originally were appropriate mainly for acute cases communicated through certain channels meant by the designer and others “drift”1 of diabetes. and public expectations. even in circumstances where their cancer – and upon which the strength of the specialist had recommended it. Individuals that the innovation might develop in unanticipated ways. There is a drug. approving the drug not only for Its diffusion has remained at what Fitzgerald within which the new procedure is meant advanced-stage patients. progression from the laboratory to animal for Clinical Excellence (NICE) issued models and applied research. and finally to stage patients. the innovation did over time among the members of a social into alternative applications.9). 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. only partially influence implementation. to what extent. where support systems for treatment of diabetes in notably his 1995 publication Diffusion of clinical evidence. following a five-step process (18): new knowledge can be ambiguous and • Knowledge Other empirical studies identify multiple interpreted according to particular contexts. and its use in innovation process. NICE Heparin use following orthopaedic surgery. 98% sensitivity.8. as a highly sensitive bedside to guarantee that a novel medical technique follows an S-shaped curve (Figure 1).18). Based on clinical evidence of the often insufficient to achieve widespread research). dynamic pattern. factors can originate from the attributes issued its final guidance on trastuzumab this has resulted in continuous controversy. The model of diffusion in medicine. or from the interaction between in early-stage breast cancer. implied in the original prescription. the use of a leprosy drug to treat dementia). These groups. 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. . values. even complex. As a result.e. which has been adapted to other fields such as A popular way of thinking about medical Within a defined population. diagnostic method for appropriate referral will disseminate into widespread use. the specific technology and the context (9) Another instance of an innovation that failed in which the device operates (5. so scientists has a new idea (original basic ability and willingness to adopt. this is not a predominant and the postcode lottery provision of the diffusion and if so. non-linear. (14) not find wide acceptance. It illustrates that system. many patients innovations in the United Kingdom.g. i. 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. to operate. and felt that the standards as a process by which an innovation is accomplish their intended use. which adoption and use at the patient’s bedside. such as stakeholders’ interests. Rules. this According to Rogers. a directive Rogers offers a framework for considering Diffusion is affected also by its broader supported with evidence. The St. evidence was relevant to their patients in system. politicians and the public. The aim was to While some technologies may follow this charities criticized this restrictive policy.9. clinical practice remains relatively low (11). patients patient though there is much evidence concerning contingent upon a mix of factors. several Determinants include the utility of the and high acceptance by patients and perspectives are presented that reveal innovation.6. the process of diffusion of eight different manufacturing and marketing. to select guidance stating that health trusts had to Fitzgerald and colleagues (7) explored populations (targeted development). first derived in the If robust scientific evidence is not enough The ‘successful’ spread of an innovation early 1990s. (e. 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. of the technology itself. The author defines diffusion Only some technological innovations primary care. an innovation.16. Barriers to innovation in the field of medical devices—Background Paper 6 5 organ. 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. 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. but many general innovations as new ideas or practices context. 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. to provide trastuzumab only for advanced.17). social status of opinion leaders. the practitioner’s were not convinced that the adopted over time by members in a social political climate. from the context in 2006. which then moves in a linear drug’s efficacy. • Persuasion cases where validated evidence fails to which can affect the degree of translation • Decision achieve widespread implementation. 32% specificity. technical attributes of the primary care (7). which was given to 90% of early. For example. people are influenced for X-ray. often clinical professionals. see whether scientific proof would guarantee linear trajectory. Under sustained pressure from of medical innovation. innovation diffusion 1 “Drift” is a concept originating in the field of evolutionary biology (particularly in the sense of genetic drift). but also for use and colleagues (7) call the “debated” stage. Lang. there are health services research.

5% of adoption) and intercepts (proportion of people adopting) as demonstrated in Figure 3. the classical S-shaped curve. If separated. and (D) B = similar pattern following a longer lag phase adoption followed by discontinuation (3). ‘Take-off’ Lag Three points are worth noting. etc. curve D (discontinuation) is the most Source: Greenhalgh et al (3). the sub-groups of adopters would each have a respective S-shaped diffusion curve with a longer or shorter Adopters Early lag phase and a greater of lesser part of adopters the population that ultimately adopts (3). is the combined majority majority 34% 34% curve of the subpopulations of adopters (i. and the challenge is to explain the different adoption curves – (A) rapid and complete Figure 3.6 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project Figure 1. phase that categories. 18) (Figure 2). 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 Adopters (cumulative) development of a diffusion process. where the number of adopters defines the unit sales of the product and its growth (19). (C) slower A = rapid and complete adoption by a population adoption and incomplete coverage. 13. (B) longer lag phase. for example. S-curves for different innovations and populations adoption. 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). Time personality features of individuals. common diffusion curve of all types. The S-curve. In the A B C product innovation context.e. the model provides forecast of first-purchase sales of innovations. those Adopters (cumulative) with one standard deviation on either side of the mean (‘early majority’ and ‘late majority’. which shows the pattern Early Late of innovation adoption. D Leadership from those whose opinions are Source: Greenhalgh et al (3). Firstly. 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% Laggards Thirdly. Distribution of new adopters of an innovation against time a population (3). respectively 34% each). Time .5% of the population). and those beyond one standard deviation from the mean (‘laggards’ making up 16%) (3.). but are mathematically defined cut-offs for the adopters of any particular innovation by Figure 2. According to Greenhalgh and colleagues Time X-2SD X-1SD X X+1SD (3). ‘early adopters’. such as “innovators” or “early adopters” are not a reflection of Source: Greenhalgh et al (3). Secondly. ‘late majority’. those between two and one standard deviation earlier (‘early adopters’ ‘Saturation point’ comprising 13.

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

clinical methods. secondary effect of the division of tasks. Blume (4) important in identifying demands for new passing on authoritative decisions (16). adoption decisions associated with physicians. other participants in the operate in informal. This has shifted understood as a long-term learning process by Hermann Boerhaave in the 1700s. often solutions. Specialists International regulators (e. Figure 4. In Biomedical engineers addition. suggests precisely that new technologies technologies. as well as which services will foster specialization (division of labour) be integrated into mainstream care. vertical networks. leaving decisions made principally by doctors technology (e. insurers more formal. translation in medicine. regulators. a key driving force behind innovation. The other is insurers) – which gradually reduces the based on the use of advanced techniques. and With these provisions in mind. acting on behalf occur via patterns of friendship. a much more complex reality. and particularly specialists. These effective in spreading peer influence. status and Patient organizations distinction. advice. agents. as the dominant mechanism for and the establishment of certain hierarchies diffusion (18). which gave clinical Users Other stakeholders professionals unlimited power to determine the demand for novel techniques. to cost-efficiency and laboratories or clinical practices). According to Greenhalgh The role of expert users is traditionally in the medical profession. particularly in public care Family members systems such as the British NHS. all of whom are increasingly placed for “cascading” information and worth considering. 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. through which they can revalidate engineering students . innovation is seen Individual patients as a symbol of higher quality of care. is now Medical professionals Manufacturers mostly outmoded. where field 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. health economists. managers.8 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project criticism that the neat stages misrepresent users (e. new technologies give a certain Medical students status to specialists in terms of availing clinicians of powerful instruments to Biomedical control. such as equity of access. are indeed diffusion process are important. of knowledge into practice can be invention of the thermometer. for example. surgeons. horizontal networks. are observed to have the reciprocal relationship – innovation government officials. While the medical profession. payers. 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. and involving non-clinicians in the decision-making process of adoption. and its the interpretation of the data obtained. In fact. A sociopolitical considerations. Patients For many physicians. opinion leaders and change options. managers Academic researchers aim to offer potential ‘customers’ a wider range of state-of-the-art technologies. research and development the physician to apply diagnostic skills to and scientists.g. nurses) process. but also in private in-patient sectors where in order Caregivers to attract a greater market share. medical practitioners retain their Health ministry Professional societies “medical mode of control” (4) and still have powers to facilitate or block innovation. Stakeholders involved in the innovative process What once could be called “an extreme information asymmetry between physician and patient” (6) . pioneered evaluated and monitored. and colleagues (16). such as the nursing profession. Doctors. include patients.g.g. distributed. paid for. with patients now active participants in decisions about health and General practitioners Vendors/distributors access to state-of-the-art services. physicians. anaesthetists) In spite of the increasing role of social and National/domestic regulators Allied health professionals economic factors in the innovation adoption (e. however. the idea of interpersonal influence through uncertainty associated with new treatment is an ascended status of doctors over non- social networks. but also as a source of prestige.g. clinicians. an example of which is the how they will be used. of their patients. It attracts research grants to hospitals. better driving forward specialization – is also and regulators. Nurses.

diffusion can result from relatively stable organizations and processes Finally. In countries such as although the linear model (18) has some predictable process. This costs. Barriers to innovation in the field of medical devices—Background Paper 6 9 their profession: “by inventing technologies isolation from the financial implications of and contextualized feedback mechanisms which need highly specialized medical their decisions. The next section will Germany. structure”(4). It has been shown that make it neither an entirely random. for example. and a reduction of the sufficient to ‘push’ through assimilation on through “inventing” methods whose use number of reimbursable services as part its own. and medical practitioners can be seen in linearity does not do justice to the complex . where insurance companies act merits. there is an interplay between relies on certain expertise becomes even of compulsory care. this section has considered the (‘regularities’) but can also be influenced 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. physicians are over the past 10 years. its conclusions in more detail. an important determinant of In summary. rather. patients of opinion formation within peer groups. Furthermore it securing a role for themselves” (4). Finally. with increasing development in medicine. 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 beneficiaries of the at an interface of “inter-organizational with robots (21). in its conceptualization start to unpack the implications of these as third-party payers of services. current report. shared by patients in the form was argued that scientific evidence is not ‘protectionist’ policy by clinical specialists of co-payments. nor a health care systems. This has been changing that operate to influence technological expertise to operate.

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

25 to 35% was not used due to used. often • Research attention focuses on barriers economies for profit purposes constitute with an insufficient capacity to repair the to diffusion of imported medical devices. Donations developing or developed country. usually include physical equipment and barriers to innovation do exist for both high- Europe and Japan to produce equipment spare parts. Another study reported that • Developing countries represent new of medical equipment.g. The term 2006. or lack literature to denote acquisition of equipment period 2002–2006 (28). medical equipment from developed local production of medical devices takes about 30% of the medical equipment that countries. it is under the control of multinational on between 1997 and 2001 was found acquired by developing countries remain companies for export purposes (25). account for the failure of most medical deficiencies.9 billion). generating an aggregate gross is caused mainly by persisting financial to the introduction of any innovative domestic product (GDP) comparable to problems in low-income nations. they are addition. the capacity to do so. non-linear and the sheer size of their total population care. Common economies. suboptimally or inappropriately in use. which gives large over 50% of the medical equipment in market opportunities for the medical multinational corporations considerable developing countries is not functioning. . lack of method. work in low-resource settings? The following text provides some answers. 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. 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. China is a rapidly growing market. equipment breaks). Reliance on aid for medical devices dynamic process. that of the developed nations (27). systems (29). notably the United States. or where it the World Bank spent US$ 1. Assistance can take which there are certain barriers to blame. different forms. In nominal terms. for have already established manufacturing governments (29). China and India). In sub-Saharan Africa. Barriers to innovation in the field of medical devices—Background Paper 6 11 ‘available’ in developing countries. 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. and low-resource settings. several trends entrants is the limited number and small. regardless of whether it takes place in a creates a strong incentive for high-income and a growing burden of disease. to be effective in advanced economies not within developing countries. which and safety (23). 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. overall Barriers to medical devices altogether represent an immense potential there is still a large degree of dependence As illustrated earlier. and provisions of devices once they reach developing • There is sparse literature on barriers supportive systems. 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. not device industry.5 billion • A large number of medical devices does. 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. Of the devices idle. such as China. training and lack of effective technical emerge: scale of local production and development support (29). used correctly or not maintained. technology diffusion market for medical devices in view of on donor assistance in the area of health in medicine is a complex.g. In this respect. joint partnerships. Medical technology in developing countries is often imported. one possible channel of acquisition for technology. is used as a broad term in the device market growth rate of 14. quality that are sold (often at discounted prices value in 2011 of US$ 23. In addition. income economies. with reference to medical device value. procedure or piece of equipment. almost 70% of equipment is exporting developed countries. and an estimated annual medical to recognize the management of medical movement. often the result of countries? Why does equipment known to invention of medical devices locally diplomatic initiatives funded by high. This resources in public health care systems. directly but also exploiting opportunities organizations. There are obstacles (4. facilities in new destinations. 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 fulfil its intended purpose (23). and on how industry in developed low-income countries. such as limited for export to the developing world. Exports of medical devices by developed downtime (e. many multinational companies funded by international donors or foreign not always exploited to their full capacity. and in some countries. to remain unused (22). absence of user intervention. a share of 34. market advantage.2 billion.9% in the devices as a public health priority. place in the developing world. In nearly 80% of health-care equipment is staff training on how to use the new device. This includes devices around US$ 14 billion with a projected correspond to standards of efficacy. Some companies to other governments. for but nevertheless to make a profit) by the represents an increase of 69% since example. with a Despite considerable investments.4% of the Asia-Pacific market’s majority of developing countries do not seem Import. or governments providing aid for lower production cost.

its subsequent use requires a emerged. . While responses to identical challenges in medical technology can differ between 0 Supplies developed and developing nations. Only 12. pacing or blood pressure monitoring consumables (e. a single MRI scanner can cost have a credit card). 0 Depreciation 0 Licences which has implications for their appropriate 0 Upgrades use in financially-disadvantaged settings. 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. but also other factors. there 0 Product 0 Installation are certain barriers to innovation that are management 0 Accessories unique to the developing world. The hidden costs of medical devices occur in many poorer health-care systems. depreciation. Such response to a ‘technical’ in developing world hospitals point to four consumables). Most devices put not be found or was not produced in low- devices to cause cardiac fibrillations (22). to frustration. with many a spare part). The cost of capital. the issue of maintenance card (few people in the developing world donor. patient (22). This did not Figure 5. An intravenous (IV) infusion barrier of this type requires knowledge. Data from an Engineering World For their appropriate use. which again. etc. Used at first in presented in Figure 5. which are not parts (25). such as a dearth of educational opportunities and emigration of trained professionals from developing to developed countries. into operation generally function effectively resource countries (26). An example of this can be seen in the case recurrent costs hidden underneath. Users were also educated Health (EWH) study of medical equipment devices require accessories (i. however. skills main reasons for this shortage of spare pump. and catheters entering needles). 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). 0 Utilities 0 Training Cost The cost involved in purchasing medical devices can present a major obstacle to their use in developing countries. requesting a new However.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.g. for example.12 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project hostility on the part of established medical example. While the pump itself might resource settings.e. accessories such as and/or corruption. spare parts. needs compatible and resources in operation. is only the better option than meeting the cost of tip of the proverbial iceberg. accordingly. device altogether from a sponsor in a ways that countries are able to respond to developed country can be seen as a these challenges.g. These are 0 Labour addressed as follows. 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.or even medium. As medical devices • Purchasing the part requires a credit be provided for free by a medical device gradually evolved. This issue was addressed in developed at first. This example shows how priorities and opportunities diverge 0 Service contracts between high. such as • Technical staff members do not act due of invasive interventions such as cardiac service contracts. • The spare parts are no longer produced. a significant proportion of a developing of resources (e. differences are observed in the country’s health-care budget. training.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. For Source: Adapted from (22). However. practice and reluctance to admit the need more than a million US$ to purchase. Such costs are the heart or great vessels. through electrodes. some medical the devices. industrialized countries were able to solve by appointing technical experts in hospitals. lack of tools and manuals. the EWH study also found that the 1950s. IV sets that must be replaced for each readily available in low. due to lack of financial resources.

Infrastructure manufacturers have to invest in addition The lack of reliable electricity and water to production costs. including the publication of many countries. 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 difficult. which inhibits its replacement career opportunities await (“brain drain”). thus inadequate in many cases and presents a increasing the cost and the time that local barrier to technology diffusion. Barriers to innovation in the field 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. that is where and failure in the ‘oxygen chain’ (finance. 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. the World procedures. 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 or from an electrically powered oxygen concentrator. robotic surgery and endovascular training by the manufacturer as a condition Harmonization Task Force. to diffusion. In fact the inability “Brain leak” can also occur. such as immune-diagnostics.1 education.g. 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. 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. 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). 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. For example. As a consequence. Cylinders have been more that are at the receiving end of medical with well-developed infrastructure and is widely used in the past.g. such as oxygen access to consumables on the market is so important that the lack of trained supplies. laparoscopic developing countries and the need to train surgical tools can be inserted in the new staff frequently (22).). advanced instruments (e. 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. Complicating matters is quarters of district hospitals have cylinder the consumable is simply not available emigration of qualified 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). to find alternative consumables is cited workers educated to perform a specific task vehicle and fuel. The traditional one-time organizations such as The Global surgery. 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. and by This phenomenon acts as a disincentive for the district hospitals are without a regular donating organizations (25). surgeons that is adapted to rapid changes system. Dobson reports (31) that features. can be scarce. provide for the running costs (22). road network. stock control. particularly costs. may in developed European countries. This mandates Such standards can be helpful in providing abdominal area through small incisions. 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). etc. the purchase of medical equipment by to another district hospital for example.). a private one) or to Barriers to local development of medical The importance of up-to-date medical emigration abroad. ordering and delivery. in many developing countries up to 75% of hospitals in the developing world. training. as they might lose personnel to Expertise and training another hospital (e.g. In this that a single health-care facility might not one that is insensitive to domestic context – respect. the absence of which medical devices in low-resource settings power. storage. but also to devices being left idle. Basic provisions. While there are certain benefits of purchase is insufficient. water. which considers essential. and expensive licensing processes. 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). 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. a systematic approach to education and useful directions for the governments of allowing an improved healing process). not only on a single-case basis developed by major international such as colonoscopy. some hospitals to invest in their employees’ oxygen supply. the lack of a training curriculum for be able to afford an in-house management can also act as a barrier to local innovation. This view underpins standards mastering device-dependent procedures is managed. as one of the most common barriers to in a hospital then emigrate elsewhere (25). excessive regulation – particularly essential element of its effective use. . however. In fact. remain high due to various factors. a recurrent budget. largely due to the lack of infrastructure with substitutes (25). etc. but for logistic and cost reasons they are not always devices. In most cases. renders the skill of surgeons service in such a scenario. Rural services. like and ensuring that minimum standards are working in only two dimensions and hand– maintained. especially those that lack the risks of incidents and complications instruction manuals in local languages medical device-specific regulation. road system. minimally invasive but consistently.

complete adoption in clinical practice or introduced for inpatients in many settings. they can slow equipment in developing countries (34). 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. there are other important issues •Insufficient staff which affect the creation and diffusion of •Limited access to technical information or it is unavailable equipment. usually originate) (33). original replacement innovation in medical devices occurs Further. the increasing burden the very inception of a new piece of also affect reimbursement. regulatory and sometimes US$ 200 and 300. •Lack of a “training culture”. and can hinder innovation. based on high standards in advanced fewer obstacles due to better provision of yet been integrated in the DRG. i. treatment or procedure to Diagnosis-related groups (DRGs) have been to deal with pressing health-care needs. It might be possible for a traditionally there is more experience and bureaucratic barriers to innovation. nationally agreed to be necessary for a countries may be removed from the market resource settings. Table 1. •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 applies especially in cases of uncertainty about whether To summarize. •Inadequate guidelines which emphasizes spirituality and has less •Lack of coordination use of technology (35). but Nevertheless. i. often dismissing •Direct link broken between producer/vendor & end user western values and sometimes also reject •Shortage of technical expertise medical devices. poor use of a daily protocol and instructions. if any. and their low financial capacity equipment. From of care. there is limited. 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. 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.and medium. many EU countries experience batteries for a defibrillator can cost between primarily in high-resource countries where administrative.e. of benefits. This German Joint Federal Committee (G-BA) In sum. by imposing robust standards. it will not industrialized countries (where guidelines funding and infrastructure. 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. It is generally thought diagnosis or therapy/treatment. Cost-containment measures can sizeable populations. procedure of innovation through the One such challenge is reimbursement.25). For example. and relatively be reimbursed under this system. local manufacturer in a developing country expertise in technology development. •Technical information sometimes withheld by industry resource countries Source: Hansen et al. producers to thrive. Some products So far the paper has concentrated on They limit reimbursement to services that are of significant value to low-income barriers to innovation in low. •Manuals dense and not easily understandable Medical practitioners who apply bio. excluded from the mainstream package developing countries. difficulties exist in these generally in biomedical technologies. even if they are supplied •Lack of funding and trained staff for support at lower cost (1. EWH study found. as the stable health care systems. This often differs from •Unrecognized standards for quality control & maintenance holistic care based on traditional healing. literature not translated into national languages as material infrastructure and economic •Maintenance contracts are missing resources.14 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project become unaffordable. 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. Barriers to innovation in medical devices While some key aspects of the medical •Supplier-driven device context were already discussed. While these institutional steps are stimulate local innovation. Considering their but are part of a broader context. 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. •Weak management culture •Lack of quality assurance Barriers to innovation in high. such •Linguistic barriers. Negotiating compensation for a NICE. For example.e. such as traditional cultural •Poor maintenance and repair facilities practices for example. One which is very unlikely to meet international settings as well. of disease. such example is the lengthy assessment standards (such as operating at 0º C) (25). low-income countries have relied heavily on decline thereafter. innovation is influenced by multiple interests of the involved stakeholders. (1) . effectiveness of innovation. particularly in medical devices and to produce a cheaper alternative option. Furthermore.

not market for the medical device industry of industrialized importing/donating countries utilized. The literature on barriers procured and operating equipment. This creates a problem to re-design technology so that it takes in which the market is driven by industry or into account local deficiencies (e. Several reasons developed economies. lack of supply rather than by public health needs. Solutions to this last issue can be found in Design stage: involves actual product development processes from design to prototype development. 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. Barriers to innovation in the field of medical devices—Background Paper 6 15 at truly addressing the needs of low-income Table 2. the stages of a medical device that one way to address the difficulties in attention away from local innovation in low.g. This acts as an incentive designing medical devices for developing absence of spare parts and consumables. resulting in many efforts that are ineffective . and off-shore business. Concept stage: starts with idea generation and includes technical. are outlined. lack of technical expertise and inefficient markets by developing equipment which so that ideas are generated outside low- management. and Source: Adapted from Shah and Robinson (34). and as such offer to re-design medical devices for low- have been identified for this gap between ample opportunities for direct exports. most countries represent a large emerging the first point: finding ways on the part of of which remains under-used at best. This prevents developing caters to local needs. countries from making appropriate use of for device production on manufacturers in Table 1 lists several barriers to innovation. or misused at worst. for industrialized nations to penetrate new countries by high-income economies. the adoption of devices be addressed. resource settings. (ii) that barriers to Marketing & use stage: includes product launch in the market and post-launch use. selling and production. assimilation is for industrialized economies resource societies. infrastructure). with the to innovation reflects this trend. Stages of medical devices life-cycle countries. three possible avenues: (i) that technologies Testing & Trials stage: starts from prototype testing ‘in-house’ and includes trials in field. imported medical devices and suggests advanced donor countries and shifts the In Table 2. re. This places the onus resource settings rather than within them. for limited resources or infrastructure in low-resource countries. (iii) that underlying barriers to development of medical devices in low-resource nations be addressed. going to originating in high-resource countries be market. financial and commercial viability. re-designed in a way which compensates Production stage: includes production on a large scale supported by a business & commercial rationale. most imports. 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.

Roberts (38) disputes the this distinction is found in Figure 6. but primarily by individuals. 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. a large part of potentially valuable user sequence (16. innovation medical fields. Innovation also includes restricted role of academics with respect of states of routinization and also serves as adoption. innovation is characterized by its diffusion. Innovation encompasses burden diseases. the Source: Based on Pouvourville (39). the physician. Therefore. and medical technology.and medium-resource a much more substantial role than merely Innovation countries. or the patient) play care of selected low. An important distinction for manufacturing. 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.e. This allows the identification organizations. engineering or failing (38). in the developed world to conditions in between invention and innovation. while diffusion to the question of whether innovation (the least. Innovation comprises of takes place. diffusion of medical technology and on model that says the manufacturer is a main models according to which innovation innovator based on successfully identified Figure 6. which user not only identifies the need but also can be due to the lack of imports from develops the initial solution to that need. Instead. However. The purpose is to identify the being sources of helpful information reasons for suboptimal or inappropriate regarding their needs to a manufacturer use. the user acts as a linchpin to the is the process of its translation into use. involved in the development and Roberts (38) distinguishes the innovation innovation stages. subsequent diffusion. reliable field use and the entire sequence of activities from the needs to be made at this point between service. invention can be perceived of local innovation. The author asserts that the invention and diffusion out why medical devices available on the users (e. Together these factors first trial use. These terms are often Roberts (38) sees the medical device its onward evolution into a product used in used interchangeably. who incorporates diffusion. developed economies or to the absence implements it by placing the solution into Put simply. 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). devices from the market altogether. to the generation of a solution. innovation necessarily important to distinguish between them. data diffusion models based on a neat order of modified to fit new conditions. which is why it is innovation process as one dominated not practice. by firms. This inevitably leads available to other practitioners. where financially-disadvantaged countries. the mode of practice and academia.37). 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. A visual representation of ‘medical device’ literature on trends in innovation process. ‘innovation’ and ‘diffusion’ of device. use of new technology in their respective of medical devices from that of . it is possible to identify a innovations can apply to the manufacturing perspectives and insights are dormant in structure built around different categories process. manufacturer enter the picture by taking on with developing the new idea into a product. In addition from Roberts’ 1987 study notes also that phases following each other in a predictable to medical device or product innovation. different technologies. At the very following an innovative idea. and volume scale-up). Only later does a Diffusion involves the activities associated is able to close the gap in the availability. 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. and often makes copies or as the creation of a new piece of medical can constitute barriers to invention and detailed specifications of the innovation equipment or the modification of an old one. The main objective is to find market needs. who then innovates. due mainly to the traditionally of diffusion. the academic market are not being used in the health medical community. or between diffusion in a different environment. identification of the need for a new medical ‘invention’. commercial development (i.g. Several perspectives from the literature are usually in academic and/or clinical help to delineate the boundaries of the settings.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) . taking something that someone to commercial technology transfer and an axis for comparative studies between else had previously done and applying it exploitation. such as the pathways of the same technology in adaptation of medical devices designed Pouvourville (39) draws a clear distinction different national contexts. which are termed ‘barriers to diffusion’. whole sequence of invention plus diffusion) innovating company (38). 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.

✓ problem reporting. Barriers to innovation in the field of medical devices—Background Paper 6 17 pharmaceuticals by arguing that the former problems of obtaining and maintaining Figure 8. • Training of user before use. devices. provides an interesting insight into the often mediated by peers). Therefore the lack of financial 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”. a cyclical. 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 specific local innovation (Figure 8). Instead. including: systems to facilitate alert notification. the use of a wooden form of invention and consequent diffusion. The phases in the lifespan of a medical device Conception and Manufacture Packaging Advertising Sale Use Disposal development 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. A cyclical model of diffusion process is usually incremental rather than affordable wheelchairs by disabled relying on fundamentally novel knowledge Nicaraguans (41). function in “barrier-free” industrialized points. MANUFACTURER apply existing knowledge or techniques giving the users little flexibility or mobility. more so cord injuries. from conception and development in the infrastructure of Nicaragua. • User networks and medical device vigilance • Clinical trials/testing. Frequently it is appropriate prototype. The second observation in this technology. is essential for effective control of medical safety and effectiveness. 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. simpler and stronger folding mechanism for use in a context different from the doctors.or third- of drug innovation. denoting an unplanned. . • Adequate management and disposal of system on imported medical devices. • Collaboration on international quality • Vendor registration. • After sales obligations. users. however.g. discarded devices. • Regular maintenance of devices in systems and product-specific standards. Although cushions were instance concerns the essential role of than the manufacturers themselves and provided during the first year of use of the users as innovators. particularly those designed to This example highlights two important This model of neat linear steps. high pavements and product by the vendor. accordance with operation and service • Agreement on systems for conformity • Prohibition of fraudulent/misleading manuals. Figure 7 addition to frequent reported breakdowns presents the different phases in the lifespan and inappropriate functionality for of a medical device. advertising. VENDOR gradual engineering problem-solving by These chairs often have hard tyres and Pre-market control individuals (users) or small firms. ✓ complaint handling. to use and disposal lack of access to buildings for wheelchair by the end-user. who often non-removable armrests and footrests. • Product registration. as a linear sequence of outdoor conditions (41). Important activities include: Important activities include: Important activities include: • Collaboration on acceptance criteria. as previously noted. environments. decentralized and largely horizontal process. dissemination Figure 7. such surveillance THE USER by the manufacturer. Certain features Post-marketing actions. Users often invent. ✓ recall procedures. medical hand hospital-type chairs imported from Sales Monitoring device innovation is based primarily on the US and other developed countries. Source: WHO (40). to advertising the as narrow doorways. in to newly defined problems (38). However. it allowed for a conditions. most Nicaraguans could not in the scheme to its beginning. biomedical engineers or patients) than the average imported US wheelchair original infrastructure constitutes a valid who are best positioned to innovate and (41) . Firstly. wore out. innovation in medical devices is largely outmoded. informal. impede the use of many medical devices. 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 vast majority of or long periods of basic research typical people in the country use second. designer of wheelchairs for Nicaragua for change in the design for local users (41). assessments. This is afford a replacement once the cushions Greenhalgh and colleagues (16) discuss the captured in Figure 9. Furthermore. therefore can move from the end stage wheelchairs. Adaptation of a medical device the final user of medical equipment (e. • Appropriate and effective customs control ✓ distribution records.

in terms of variable spread. Problematization. clinical • Integration – diffusion. The structure. namely: managers. degree of manual skill or development.g. and service providers in insurance-based specialized medical training needed evaluation and assessment). complex network of organizations. or on negotiated clinical utility. financial streams between sickness funds sensitivity. an organization) and sustainability (making successful use. innovation became routine practice. This phase ends with technology literature (42–44). which might of new regulatory requirements in regard concern that they may be unable to build have a similar (limited) effect or conversely. In the case view held by Blume (4) that technologies of imaging innovation. also on budgets allocated by hospital innovation diffusion. It shows the to the utility of the innovation. Wyer and vivo images using the first prototype of maintained in the social construction of Haynes (12) use this term to describe the technology. on an analysis of new diagnostic imaging and sensitivity). 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. For ‘status hierarchy’ depends on his/her an innovation. Innovations . it began with evolve through acceptance by “relevant This process can also be considered as the publication of the first human in social groups” of actors via negotiation as ‘knowledge translation’. the establishment flexible approach to innovation. which is determined by a comprehensiveness and rate of diffusion. weak institutional of concentrating on a single factor – which. integration (diffusion. (e. change. assessment. and diagnostic It comprises several phases – exploration. However. planned. This will be discussed below. This is a suitable method to compare • Feedback – development of improved high levels of regulation. include technical features such as sociological analysis of technology diffusion. maintained and updated an innovation routine until it reaches • Development – the industrial involvement by the industrial sector. the United Kingdom). The it began with the first specification of authors distinguish between “close knit” Fitzgerald and colleagues (7) identify its clinical use and ended when the and “loose knit” configurational types in six levels of dissemination: widespread. Meyer and Goes (9) see innovation diffusion as a dynamic. in the emerging technology. which is provided. any activity or process that facilitates commercial manufacture and the new the transfer of high-quality evidence into device being brought to market. This model all hospitals using the instrument). different European nations. career and problematization based improvements in devices (e. underdeveloped regulation and as was concluded in the last section does about the technology. Brown.18 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project (active.e. accommodate the innovation. for example. Blume (4) argues that the techniques. that is what is problematic integration.g. better speed stages and steps are presented in Figure 9. validity. This does not imply 100% diffusion (i. For instance. stable. multilevel process of choice Blume (4) established a structure for In this model. by government institutions in 1. Rappert and Webster (45) propose a effective changes in health policy. but capacities to respond to technological considers dissemination in relation to the a widespread consensus that it is good change. Attributes of the innovation: These The concept of career is central to Blume’ s state-funded health-care systems. or regulations governing the innovative momentum. evaluation- on three concepts: inter-organizational solvers and actors who bring incremental choice and adoption-implementation. might bear more significant consequences circumstances under which it can be used for the assimilation process. Problematization can take of this type are expected to provide a more power – the model restricts the intensity of many forms. a radiologist’s vertical hierarchies). a “close knit” influence of scientific evidence on the practice and that professionals need to arrangement.g. to a device. For example. 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. implementation (active leading up to the first working prototype status in the hierarchy depends on how efforts to mainstream an innovation within and the first publications reporting its well he/she masters the X-ray equipment. this approach considers innovation to be successful. 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. debated. of country-specific “configurations”. formal. for whom and low resource-dependency. to use the new technique. or its use reimbursed. At the opposite end of the spectrum in terms of the relative determining power of lie “loose knit” configurations comprised of only one factor – clinical evidence. The research design aspects of a new technology. the nations’ integrative and coordinating pilot and no spread at all. While structures not necessarily have much explanatory with what result. By way Blume’s (4) third concept refers to ‘de-centred’ relations. 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. there is a the search for other factors. This exemplifies the obsolescence). Germany). and feedback: systems (e. Lang. scientists have a key role in with nine identified steps under three broad comparative analysis of technologies based the innovation process as technical problem stages: knowledge-awareness. applications if the innovation is judged due to overspecialization and reluctance to However. evaluation and model for considering innovation in terms practice or products. more likely to occur via an imaging technology this is the period performance. limited pockets. when. For imaging technology.

are urban. and high levels of education. the models according to which new or physicians have been recently trained. 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%). Innate characteristics use. Factors arising from the interaction attributes – are the independent variables. Contextual attributes include: include able to apply the new technique. expose patients and doctors to experiences of potential users. the presence of medical practitioners adoptability (this factor accounted for 40% 2. Knowledge-awareness 2. such as of the technology significantly affect fewer risks and are more observable. and where determinants – innovation attributes. Figure 10. into use. The three determinants of innovation review complex and eager to penetrate new adoption are presented Figure 10. namely: Figure 9. Innovation diffusion as a multilevel process of choice 1. the identified barriers executives have long tenures and is the dependent variable. and of variance in technology diffusion between characteristics of market environments. Innovations are for 12% of the variance in adoption. 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). A model of innovation assimilation CONTEXTUAL ATTRIBUTES Characteristics of environments. several key points are worth noting markets. Adoption-implementation Apprehension Acquisition-proposal Trial Consideration Medical-fiscal Acceptance evaluation Discussion Political-strategic Expansion evaluation Source: Based on Meyer and Goes (9). are influential proponents. Lastly. and its three to innovation in the developing world. Barriers to innovation in the field 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. In sum. compared to other context: These include an innovation’s factors strongly influence the diffusion of innovations. 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. terms of resource allocation. Evaluation-choice 3. and leaders’ ‘power’ in or opposes adoption. . The combined organizational size and structural chief executive officer (CEO) supports effect of innovation and context accounted complexity. affluent and in which few medical specialization and where CEOs patients rely on state health insurance. context and “innovation-decision” adapted equipment is seen to translate 3. or the 25 studied hospitals). Technologies are more likely to be Outcomes of the literature adopted in organizations that are large. they require less skill to compatibility with the tasks and medical innovation. the extent to which a manager.

institutional adaptation to fit local conditions. innovation in low. diffusion (translation into use). which applying already existing devices in a gradual process.20 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project • Innovation comprises invention and socioeconomic. instead is affected by a combination of industrialized economies and their . but obtained through procurement from medical device. often based on frequently occurs in an upstream different environment. and medium-resource countries attributes of the medical device. historical.e. • Innovation takes place under the takes place in a complex. i. • Innovation in medical devices is a of medical device innovation. • In essence. and political influences. • Users play a key role in the process • Innovation can include adaptation. influence of three main factors: dynamic pattern. • Innovation in biomedical technology products. incremental improvements to existing direction. 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. non-linear.

lack of consumables needs (locally) and design of devices manufacturers. be applied to high. sales. Stronger industry stakeholders in high. medium-resource countries. devices are imported in low-resource • Absence of systems to record where. absence still exist in wealthier countries. The lack of . survey (1) confirmed. can prevent innovators • Insufficient (if any) post-marketing between the components of the model. for example. insufficient This model presents the key elements is the lack of clear-cut mechanisms to management. brain drain. academic necessary for diffusion of new technologies Clinical setting researchers are missing in low-resource countries. and what is necessary for a new device to reach market.as well as to medium. established technical capability. Barriers to innovation in the field of medical devices—Background Paper 6 21 Towards a new model of medical device innovation Figure 11 captures the main stages of Figure 11. For from moving forward. settings from elsewhere. As the literature review illustrated. Despite this. Significant steps includes the invention of a new device and of mainstream health care. many of the elements clinicians. The model can are many more missing blocks in low. and the Teaching hospital. There are by high maintenance cost. Dynamics of medical device innovation innovation diffusion. In high-resource innovation infrastructures to take up new • Cultural and social incompatibilities settings there is relatively good connectivity ideas. poor road networks (abroad). training. inconsistent • Lack of a direct link between clinical also established links between academia. 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 finances to facilitate inventions. One issue of procurement culture. marketing and and spare parts. Industry Following the phases in the figure below Patients (clockwise from research) shortcomings and barriers include: • Development of ideas into a • Lack of sufficient 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 • Modification of Unmet existing MD’s • Low domestic investment (capital and clinical New workforce) in innovation needs technological • The majority of medical devices being capability Discovery imported. inadequate user manuals necessary for innovation to occur (this reimburse innovative technologies as part and additional barriers. Small enterprises observation and feedback mechanisms instance. However there need to be made to address the barriers its diffusion for wider use). which leads to: of new • Little incentive to build experience indications for use • Marketing and in pre-market clinical evaluation 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 innovation contexts (low-resource countries) • Cost • Need for spare parts and consumables • Lack of expertise and training • Limited infrastructure and low-resource settings.and to innovation. Where medical during use able to pick up where clinical needs lie. post-marketing. problems and physical infrastructure. rarely have the financial means to develop • Lack of systematic reporting of faults expertise and innovation systems are a product on their own.

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