Medical technologies (medtech) encompass a wide range of products from medical devices to digital health solutions. Traditionally, health technology assessment (HTA) has not been required as routinely in medtech as in pharmaceuticals, but this is changing for some medtech classes. Recent trends in regulatory review and HTA have emphasised the importance of involving patients and their perspectives throughout the development and assessment processes. This chapter explores the unique challenges and opportunities of involving patients at different stages of medtech development and evaluation. Factors such as the iterative nature of product development, regulatory requirements, and the need for bespoke involvement processes must be considered. The approaches taken by different HTA bodies to involving patients are compared ranging from participation to primary and secondary research. Drawing from frameworks such as the Medical Device Innovation Consortium (MDIC) and the Innovative Medicines Initiative’s PREFER project (IMI PREFER), we discuss methods for eliciting and integrating patient preferences at various stages of medtech development and HTA and the potential for generation of real world evidence. Case studies highlight the impact of patient involvement on decision-making processes, from regulatory approval to post-market assessment. Despite progress, barriers to patient involvement persist, and overcoming these barriers requires collaboration among stakeholders across the healthcare ecosystem.

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Patient Involvement in the Life Cycle of Medical Technology Development

  • Barry Liden,
  • Stella O’Brien,
  • Deborah A. Marshall,
  • Harry Kotlarz,
  • Karen M. Facey

摘要

Medical technologies (medtech) encompass a wide range of products from medical devices to digital health solutions. Traditionally, health technology assessment (HTA) has not been required as routinely in medtech as in pharmaceuticals, but this is changing for some medtech classes. Recent trends in regulatory review and HTA have emphasised the importance of involving patients and their perspectives throughout the development and assessment processes. This chapter explores the unique challenges and opportunities of involving patients at different stages of medtech development and evaluation. Factors such as the iterative nature of product development, regulatory requirements, and the need for bespoke involvement processes must be considered. The approaches taken by different HTA bodies to involving patients are compared ranging from participation to primary and secondary research. Drawing from frameworks such as the Medical Device Innovation Consortium (MDIC) and the Innovative Medicines Initiative’s PREFER project (IMI PREFER), we discuss methods for eliciting and integrating patient preferences at various stages of medtech development and HTA and the potential for generation of real world evidence. Case studies highlight the impact of patient involvement on decision-making processes, from regulatory approval to post-market assessment. Despite progress, barriers to patient involvement persist, and overcoming these barriers requires collaboration among stakeholders across the healthcare ecosystem.