AbstractTo improve successful development and clinical use of medical technologies, it is suggested that manufacturers should start collecting evidence on devices effectiveness and efficiency early in their development. The aim of this study was to explore whether and how Dutch manufacturers perform an early assessment of medical devices through semi-structured interviews with key-informants from medical device companies. The primary focus was to identify why, how and to what degree these informants were engaged in early assessment activities to analyse the clinical context, the market, potential stakeholders, and the financial and health economic impact of their medical device. 37 interviews were performed with key-informants of 36 companies. The majority (N=19) of the companies are using internal resources and external consultants to perform early assessment activities. Typically, the assessment activities starts at the idea generation stage, and lasts until the post-marketing surveillance. The least developed areas of the assessment are health economic evaluation from the society perspective and formal stakeholders’ analysis. Many methods seem to be in use to assess medical devices, however, there is no clear understanding of how they should be used, what evidence manufacturers could gather with their use, and how they influence the decision-making process within the companies.
Linehan, J.H. et al (2007) Medical Device Development Models - Final report. Stanford University Press. InHealth – The Institute for Health Technology Studies.
Eng, T.R. (2004) Population health technologies: Emerging innovations for the health of the public. American journal of preventive medicine 26(3): 237-242.
Chatterji, A.K. (2009) Spawned with a silver spoon? Entrepreneurial performance and innovation in the medical device industry. Strategic Management Journal 30(2): 185-206.
Imelli, P., C. Kobe, and G. Székely (2006) Long term forecast of medical device markets through integration of scenario technique and Delphi method, Proceedings of the 5th International Conference on the Management of Healthcare and Medical Technology (HCTM). ETH-Zürich.
Davey, S.M., Brennan, M., Meenan, B.J. and McAdam, R. (2011) Innovation in the medical device sector: an open business model approach for high-tech small firms. Technology Analysis & Strategic Management 23(8): 807-824.
Kaplan, A.V., Baim, D.S., Smith, J.J., Feigal, D.A., Simons, M., Jefferys, D., Fogarty, T.J., Kuntz, R.E. and Leon, M.B. (2004) Medical Device Development from Prototype to Regulatory Approval. Circulation 109(25): 3068-3072.
Siebert, M., Clauss, L.C., Carlisle, M., Casteels, B., de Jong, P., Kreuzer, M., Sanghera, S., Stokoe, G., Trueman, P. and Lang, A.W. (2002) Health technology assessment for medical devices in Europe. International Journal of Technology Assessment in Health Care 18(03): 733-740.
Vallejo-Torres, L., Steuten, L. M., Buxton, M. J., Girling, A. J., Lilford, R. J. and Young, T. (2008) Integrating health economics modeling in the product development cycle of medical devices: a Bayesian approach. International Journal of Technology Assessment in Health Care 24(4): 459-64.
The Council of the European Communities (1993) Council Directive 93/42/EEC.
Banta, D. (2003) The development of health technology assessment. Health Policy 63(2): 121-132.
Douma, K.F.L., Karsenberg, K., Hummel, M.J.M., Bueno-de-Mesquita, J.M. and Van Harten, W.H. (2007) Methodology of constructive technology assessment in health care. International Journal of Technology Assessment in Health Care 23(2): 162-168.
Royal Netherlands Academy of Arts and Sciences, KNAW (2014) Evaluation of new technology in health care - In need of guidance for relevant evidence. KNAW. Amsterdam.
EU Law and Regulations (2016) Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. European Union.
Craven, M.P., Allsop, M.J., Morgan, S.P. and Martin, J.L. (2012) Engaging with economic evaluation methods: insights from small and medium enterprises in the UK medical devices industry after training workshops. Health Research Policy and Systems 10(1): 29-37.
Markiewicz, K., van Til, J.A. and IJzerman, M.J. (2014) Medical devices early assessment methods: systematic literature review. International Journal of Technology Assessment in Health Care 30(02): 137-146.
IJzerman, M.J. and Steuten, L.M.G. (2011) Early assessment of medical technologies to inform product development and market access: A review of methods and applications. Applied Health Economics and Health Policy 9(5): 331-347.
Pietzsch, J.B. and Paté-Cornell, M.E. (2008) Early technology assessment of new medical devices. International Journal of Technology Assessment in Health Care 24(1): 36-44.
Vallejo-Torres, L., Steuten, L., Parkinson, B., Girling, A.J. and Buxton, M.J. (2011) Integrating Health Economics into the Product Development Cycle. Medical Decision Making 31(4): 596-610.
Schensul, S.L., Schensul, J.J. and LeCompte, M. (1999) Essential ethnographic methods. Walnut Creek. CA: AltaMira Press.
Hilgerink, M.P., Hummel, J.M. Manohar, S. Vaartjes, S.R. and IJzerman, M.J. (2011) Assessment of the added value of the Twente Photoacoustic Mammoscope in breast cancer diagnosis. Medical Devices: Evidence and Research 2011(4): 107-115.
Fermont, J.M., Douw, K.H.P., Vondeling, H. and IJzerman, M.J. (2016) Ranking medical innovations according to perceived health benefit. Health Policy and Technology 5(2): 156–165.
Thokala, P., Devlin, N., Marsh, K., Baltussen, R., Boysen, M., Kalo, Z., Longrenn, T., Mussen, F., Peacock, S. and Watkins, J. (2016) Multiple Criteria Decision Analysis for Health Care Decision Making—An Introduction: Report 1 of the ISPOR MCDA Emerging Good Practices Task Force. Value in health 19(1): 1-13.
Markiewicz, K., van Til, J.A., Steuten, L.M.G. and IJzerman, M.J. (2016) Commercial viability of medical devices using Headroom and return on investment calculation. Technological forecasting and social change 112: 338-346.
Brown, A. and Soderstrom, E. (2002) Start-up and equity primer. Yale: Association of University Technology Managers Publication.
Martin, J.L., Norris, B.J., Murphy, E. and Crowe, J.A. (2008) Medical device development: The challenge for ergonomics. Applied Ergonomics 39(3): 271-283.
Chesbrough, H.W. (2003) Open innovation: The new imperative for creating and profiting from technology. Harvard Business Press.
Chesbrough, H.W. and Garman, A.R. (2009) How open innovation can help you cope in lean times. Harvard business review 87(12): 68-76.
Cosh, E., Girling, A., Lilford, R., McAteer, H. and Young, T. (2007) Investing in new medical technologies: A decision framework. Journal of Commercial Biotechnology 13(4): 263 – 271.
Hartz, S. and John, J. (2008) Contribution of economic evaluation to decision making in early phases of product development: A methodological and empirical review. International Journal of Technology Assessment in Health Care 24(4): 465-472.
Levin, L. (2015) Early evaluation of new health technologies: The case for premarket studies that harmonize regulatory and coverage perspectives. International journal of technology assessment in health care 31(04): 207-209.
The Engelberg Center for Health Care Reform at Brookings. (2014) Biomedical innovation - Identifying challenges and prioritizing needs in medical device research and development. Discussion guide.
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