Recommendations for Effective Patient Involvement in the Assessment of Medical Devices

OBJECTIVES: Health Technology Assessment (HTA) regulatory landscape is evolving in both Europe and Spain. This study aims to analyze the current level of patient engagement in HTA processes for medical devices and to suggest ways to improve patients’ participation in the near future.

METHODS: A literature review was conducted, followed by a think-tank session with a multidisciplinary Advisory Committee (n=8) comprising experts from HTA, academic, and patient advocacy backgrounds. The experts conducted a diagnostic questionnaire to assess the current landscape of patient participation in HTA and identify existing challenges. Subsequently, a primary meeting and a follow-up meeting with another expert were held to formulate a roadmap aimed at guiding patient involvement in HTA processes.

RESULTS: General and specific recommendations were formulated, covering participation spaces, patient profiles, degree and mode of involvement, training, and other relevant topics such as recruitment, transparency, feedback, incentives, and resources. The Advisory Committee highlighted the importance of patient engagement throughout all stages of the HTA process, as well as during the previous identification, prioritization and development stages. They also emphasized the need for tailored patient profiles, strategic planning, enhanced recruitment methods, improved communication channels, specialized training programs, expectation management, and increased feedback on participation. In the European context, recommended strategies included aligning methods of participation across stakeholders and Member States representatives, considering patient participation as an indicator of HTA quality, establishing systematic feedback mechanisms, and encouraging a greater role for patients in the identification of emerging technologies, with a responsive “horizon scanning” program in medical devices.

CONCLUSIONS: The proposed action recommendations across various domains could be key to incentivize, harmonize, plan, and regulate patient involvement in the HTA process of medical devices. It could also address and overcome the barriers for an effective participation at national and at the European level.