Early Assessment of Medical Devices in Development for Company Decision Making: An Exploration of Best Practices

摘要

To 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.