WH0/HSS/EHT/DIM/10.6 MedicAl devices: MAnAging the Mismatch An outcome of the Priority Medical Devices project Barriers to innovation in the field of medical devices Background Paper 6 August 2010 Contents Preface 2 Introduction 3 Literature review of innovation diffusion: nature, stages, trends 4 Diffusion of innovation in health care 4 Unpacking the concept of innovation diffusion 5 Critique of the linear model of innovation diffusion 7 The changing composition of the users of new medical devices 8 Trends in medical device development and barriers to innovation 10 Imported versus locally produced medical devices 11 Barriers to medical devices 11 Barriers to innovation in high-resource countries 14 Model for the analysis of barriers to innovation in priority medical devices 16 Several perspectives from the literature 16 Outcomes of the literature review 19 Towards a new model of medical device innovation 21 References 22 2 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project Preface In 2007, at the request of the Government • projections of future burdens of These problems, challenges, and failures of the Netherlands, the World Health disease and disability in the context of amount to a mismatch, rather than a Organization launched the Priority Medical demographic trends; gap, that prevents medical devices from Devices (PMD) project to determine • cross-cutting issues, such as the training achieving their full public health potential. whether medical devices currently on of medical device users, medical device the global market are meeting the needs design, contextual appropriateness The PMD project also produced a report of health-care providers and patients of medical devices, and regulatory Medical Devices: Managing the Mismatch throughout the world and, if not, to propose oversight; aimed at achieving two objectives: the fi rst, remedial action based on sound research. • catalysts of, and barriers to medical to inform national health policy-makers, device innovation and research. international organizations, manufacturers The project gathered the information and other stakeholders of the factors required by conducting literature reviews The original objective of the PMD project preventing the current medical device and surveys, and by convening meetings was to identify gaps in the availability community from achieving its full public of specialist consultants. of medical devices. The findings of health potential; the second, to provide a the project showed that gaps in the basis on which all players in the medical The project addressed various availability of medical devices is not the device scene can together use the fi ndings complementary issues: primary issue, but rather a number of and recommendations of the PMD project • the global burdens of disease and shortcomings spanning several facets of to make public health the central focus of disability; the medical device sphere. This result their activities. • guidelines on clinical procedures for prompted a change of direction in which the management of diseases and the project shifted its focus onto the many disabilities; shortcomings related to medical devices. This paper is part of a series of documents produced as background material for the PMD project report. The following papers are available as part of this series: 1 A stepwise approach to identifying gaps in medical devices (Availability Matrix and survey methodology) 2 Building bridges between diseases, disabilities and assistive devices: linking the GBD, ICF and ISO 9999 3 Clinical evidence for medical devices: regulatory processes focussing on Europe and the United States of America 4 Increasing complexity of medical devices and consequences for training and outcome of care 5 Context dependency of medical devices 6 Barriers to innovation in the fi eld of medical devices 7 Trends in medical technology and expected impact on public health 8 Future public health needs: commonalities and differences between high- and low-resource settings This document was developed under the primary authorship of Hristina Petkova. Her work is gratefully acknowledged. Thanks are also due to Benjamin Schanker and Dima Samaha for providing valuable contributions in editing, writing, and research. This publication was produced under the direction of Josée Hansen. The named authors alone are responsible for the views expressed in this publication. Barriers to innovation in the fi eld of medical devices—Background Paper 6 3 Introduction This paper forms a background contribution • What are the barriers to innovation? likely to impact on the innovation process. to Medical devices: Managing the • Who are the stakeholders in innovation? This paper offers examples from several Mismatch. Its objective is to locate the empirical studies in order to substantiate factors that explain the absence of priority Consideration is given also to the similarities theoretical claims from the literature about medical devices from certain markets, their and differences between innovation how innovation occurs in the biomedical inappropriate use where they are present, processes in high-resource settings on sector. The focus is then narrowed to and the lack of invention and subsequent the one hand, and in low- and medium- the concrete conditions that inhibit or diffusion into clinical practice in cases where resource countries on the other. The accelerate innovation in medical devices. the need exceeds availability. Questions the purpose is to understand what prevents Following this is a more detailed account paper aims to address include the following: innovation from occurring domestically of the barriers to use in medical devices • What defines innovation in medical within low-resource countries, and what and a review is offered of models by which devices? What are the stages of the hinders the optimal use in poorer countries innovation takes place. This supplies the innovation process? of devices manufactured by technically analytical framework of the current study. • What are the trends in the development advanced countries. The paper concludes with a comparative of medical devices? What are the model of innovation in priority medical barriers reported in the literature? These goals are pursued in several ways: devices for high-, medium- and low- • Why are medical devices available on fi rstly through a search of the literature resource settings, which views innovation the market not being used in health including the terms ‘medical devices’, as a process comprised of separate stages care? What are the barriers to diffusion? ‘biomedical innovation’ and ‘diffusion’. The and which captures the disparities between • Would innovation close the gap in purpose of this is to explain the nature of different economies in terms of the way the availability, appropriateness and innovation in medical devices, to identify in which innovation occurs. The model acceptability of medical devices in the the stages of the innovation cycle, and to reflects the empirical findings from the management of high burden diseases? report trends in their development that are Priority Medical Devices Project survey (1). 4 Medical devices: managing the mismatch—An outcome of the Priority Medical Devices project Literature review of innovation diffusion: nature, stages, trends Knowing is not enough; within which to explore the development of the fi nancing and delivery of health care, we must apply. Willing is technology for several reasons. They can including the level of reimbursement that be grouped under three broad assertions. new interventions will be able to obtain (6). not enough; we must do. For example, percutaneous transluminal 1. Medical innovation frequently occurs coronary angioplasty (PTCA),1 first GOETHE in ways different from other fi elds due assigned to a surgical Diagnosis Related to the emotional factors attached to the Group (DRG),2 provided a much higher The WHO Commission on Intellectual concept of health and illness and the compensation than the procedure itself Property Rights, Innovation and Public political commitment to offer citizens the cost. This stimulated rapid adoption of the Health views innovation as a “process cycle latest advances in medicine (11). method, and a high level of incremental of three major phases that feed into each innovation in PTCA catheters. On the other other: discovery, development and delivery” 2. Novel biomedical technologies have hand, cochlear implants3 were placed (2). Within the innovation cycle, a public two aspects – on the one hand, they in a DRG that covered only a fraction of health need creates a demand for products stand for promises for better health the cost of the device. This led to under- of a particular kind, suited for the particular and improved quality of life, and on diffusion but also to reduced subsequent medical, practical or social context of a the other, they are associated with research and development. Therefore, group, and feeds into efforts to develop new higher cost of services. In the context by limiting payment for sophisticated or improved products (2). of scarce resources and attempts to technologies, some of which are based reduce expenditure, health policy- and on the latest advances in science, cost- decision-makers have to prioritize. As reducing mechanisms such as DRGs can Diffusion of innovation in health a result, some technologies diffuse disincentivize innovation. care whereas others do not. The ‘innovation diffusion’ literature spans Cost