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MEDICAL DEVICES: MANAGING the Mismatch an Outcomeoftheprioritymedicaldevicesproject

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MEDICAL DEVICES: MANAGING the Mismatch an Outcomeoftheprioritymedicaldevicesproject MEDICAL DEVICES: MANAGING THE MEDICAL DEVICES: Mismatch An outcomeofthePriorityMedicalDevicesproject MEDICAL DEVICES: MANAGING THE Mismatch An outcome of the Priority Medical Devices project Department of Essential Health Technologies World Health Organization 20 Avenue Appia CH-1211 Geneva 27 Switzerland Tel: +41 22 791 3648 E-mail: [email protected] 9 789241 564045 Medical devices: managing the Mismatch An outcome of the Priority Medical Devices project WHO Library Cataloguing-in-Publication Data Medical devices: managing the mismatch: an outcome of the priority medical devices project. 1.Equipment and supplies - standards. 2.Cost of illness. 3.Biomedical engineering. 4.Research. 5.Appropriate technology. I.World Health Organization. ISBN 978 92 4 156404 5 (NLM classification: WX 147) © World Health Organization 2010 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications – whether for sale or for noncommercial distribution – should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Design & layout: L’IV Com Sàrl, Le Mont-sur-Lausanne, Switzerland. Printed in France. Contents Acknowledgements vii Acronyms and abbreviations ix Overview xi 1. Introduction 1 1.1 Prioritizing medical devices: setting the scene 2 1.2 The Priority Medical Devices project 3 1.3 The mismatch 3 1.4 This report 4 2. Medical devices 7 2.1 Medical devices: what’s in a name? 8 2.2 Past, present, and future 9 2.2.1 Recent key trends 9 2.2.2 Future trends 10 2.3 Assistive products 11 2.4 Pharmaceuticals and medical devices: similarities and differences 12 2.4.1 Access to essential medicines 12 2.4.2 Access to appropriate medical devices 12 2.5 The medical device market 14 2.6 Medical device regulation 16 2.7 An introduction to medical device innovation 18 2.7.1 Applying non-medical innovation to health care 19 3. Public health needs 21 3.1 A health-based approach to choosing medical devices 22 3.2 Identifying current and future public health needs 22 3.2.1 Disability 25 3.2.2 Global trends 26 3.3 Public health: the missing research target 28 3.3.1 Drivers of research 28 3.4 The gap 31 An outcome of the Priority Medical Devices project iii 4. Priority Medical Devices project: methods used 33 4.1 Methodology 34 4.1.1 Identifying key medical devices in high-burden diseases 34 4.1.2 Identifying the medical device gap 34 4.2 Results 35 4.2.1 Identifying key medical devices in high-burden diseases 35 4.2.2 Identifying the medical device gaps 39 4.3 Identifying key assistive products for high-burden diseases 40 5. Medical devices: problems and possible solutions 43 5.1 Choosing medical devices 44 5.1.1 Barriers to choosing medical devices 44 5.1.2 Possible solutions to overcoming these barriers 50 5.2 Using medical devices 53 5.2.1 Barriers to using medical devices 53 5.2.2 Overcoming barriers to using medical devices 59 5.3 Medical device innovation 61 5.3.1 Barriers to innovation 61 5.3.2 Barriers to appropriate innovation uptake 63 5.3.3 Overcoming the barriers to medical innovation 63 5.4 Assistive devices 65 5.5 Emerging themes 66 5.5.1 Applying the 4 As to medical devices and medical interventions 66 6. Towards appropriate medical devices: options for future research 77 6.1 Methodology 78 6.2 Results 78 6.2.1 Scoping exercise 78 6.3 Future research areas in cross-cutting areas 78 6.3.1 Study design and clinical outcome 78 6.3.2 Laboratory diagnostic tools 79 6.3.3 Telemedicine and labour-saving technologies 81 6.3.4 Safe injections 82 6.4 Future research areas in global high-burden diseases 84 6.4.1 Perinatal conditions 84 6.4.2 Lower respiratory tract infections 85 6.4.3 Unipolar depressive disorders 86 6.4.4 Ischaemic heart disease 86 iv Medical Devices: Managing the Mismatch 6.4.5 Cerebrovascular disease (stroke) 87 6.4.6 HIV/AIDS 89 6.4.7 Road traffic accidents 90 6.4.8 Tuberculosis 91 6.4.9 Malaria 92 6.4.10 Chronic obstructive pulmonary disease 93 6.4.11 Cataract 94 6.4.12 Hearing loss 95 6.4.13 Alcohol use disorders 96 6.4.14 Diabetes mellitus 97 6.5 Future trends in high-burden diseases 98 6.5.1 Alzheimer disease and other dementias 98 6.5.2 Cancer (malignant neoplasms) 99 6.5.3 Osteoarthritis 100 6.6 A possible way forward 101 References 103 Glossary 115 Annex 1 List of background papers and methods used in preparing the report 119 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 focusing 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 Annex 2 Conflict of interest statement 121 Annex 3 Steering bodies of the Priority Medical Devices project 123 An outcome of the Priority Medical Devices project v Boxes, figures and tables Box 2.1 Landmarks in medical device development 8 Box 2.2 Implications of technology trends 10 Box 2.3 The differences in medical devices and pharmaceuticals 13 Figure 2.1 Medical device markets by region (% sales revenue), 2009 14 Table 2.1 Top ten countries by sales revenue, 2009 15 Figure 2.2 World medical markets by sector (% sales revenue), 2009 15 Table 2.2. Top 30 medical device companies by sales revenue, 2008 16 Table 2.3 Sales revenue from medical devices in middle-income countries, 2009 16 Box 2.4 An historical overview of medical device regulation 17 Table 2.4 Countries with a system for regulating medical devices 18 Box 3.1 The stepwise approach to meeting public health problems 22 Table 3.1 Estimated disability-adjusted life years (DALYs) and years lived with disability (YLD) for 15 leading causes of disease burden worldwide, 2004 and 2030 24 Table 3.2 DALYs for selected risk factors and high-burden diseases 24 Figure 3.1 Changing disease patterns across WHO Regions, 2004 and 2030 27 Table 3.3 Industry R&D investment by ratio of R&D to sales revenue, 2008 30 Table 4.1 Selected clinical guidelines for 15 high-burden diseases 35 Table 4.2 Availability Matrix: example of tuberculosis 36 Table 4.3 Availability Matrix: example of diabetes mellitus 37 Table 4.4 Availability Matrix: example of road traffic accidents 38 Table 4.5 Priority conditions and medical devices identified by countries 39 Table 4.6 Selected high-burden diseases and their associated core sets or functioning profiles 41 Table 5.1 Total health-care expenditure and expenditure on medical technology 46 Figure 5.1 The hidden costs of medical devices 47 Figure 5.2 A context pyramid 55 Table 5.2 Medical devices by purpose, place of use and user 56 Figure 5.3 The “valley of death” for innovations 62 Box 5.1 Local innovation leads to increased uptake 64 Box 5.2 Inexpensive innovation in action 65 Table 5.3 Summary of emerging themes relating to the barriers and possible solutions to access to appropriate medical devices 67 vi Medical Devices: Managing the Mismatch Acknowledgements The Priority Medical Devices project is the result of a collaboration, initiated in 2007, between the Dutch Ministry of Health, Welfare and Sport and the World Health Organization. This publication was produced by the Department of Essential Health Technologies of the Health Systems and Services Cluster under the direction of Josée Hansen. The project was supported by team coordinator Adriana Velazquez Berumen, Björn Fahlgren, Kaarina Klint, Kittie Rasmussen, Dima Samaha, Benjamin Schanker, Frederiek Swart, Gaby Vercauteren and Marieke Veurink. The preparation of this report would not have been possible without the support of the many colleagues at the World Health Organization headquarters and regional offices, including Steffen Groth, Director of the Department of Essential Health Technologies.
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