A regulation-based project lifecycle for innovative medical devices: Delphi consensus from an Italian expert panel

Background: The consideration and management of regulatory aspects within the lifecycle of medical device research projects in Public Research Institutions could facilitate translation to final users, but remains complex. Although the Medical Device Regulation (MDR) EU 2017/745 and related guidance define specific requirements, available tools and support structures are often oriented toward commercial manufacturers. Public Research Institutions may lack dedicated regulatory expertise and management processes. A practical gap therefore remains in translating regulatory requirements into phase-specific actions that can be integrated into academic research projects. Objective: This work aimed to identify effective items to be considered throughout the lifecycle of research projects developing medical devices, in accordance with MDR EU 2017/745, to support adoption in practice of the resulting innovation. Methods: A modified Delphi method was designed by a team of facilitators to collect/analyze suggestions from a selected panel of Italian experts with experience in medical device regulation and development. The team developed a questionnaire consisting of 46 questions organized according to key phases of a research project lifecycle: concept phase, research project design and plan, project execution and device development, project monitoring and control, and project closure. Results: Twenty expert contributions were collected and harmonized. Thirty-three expert-derived statements were compiled, providing an overview of essential regulatory aspects to consider throughout the lifecycle of a medical device research project within Public Research Institutions. Conclusions: This work may inspire effective practices and procedures to support a regulation-based approach for developing innovative medical devices in Public Research Institutions.