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

Martina, Maria Raffaella; Barsanti, Mattia; Praticò, Marco; Tallarico, Salvatore; Giambi, Francesca; Rossi, Francesca; Pellegrini, Luisa; Bianchini, Elisabetta; Asaro, Silvia; Becherini, Benedetta; Caiani, Enrico Gianluca; Calderai, Valentina; Carbone, Marina; Crocetti, Sara; De Maria, Carmelo; Lascio, Nicole Di; Francesconi, Martina; Frosini, Andrea; Gemignani, Vincenzo; Mazzini, Francesco; Menicucci, Chiara; Pugi, Alessandra; Ravizza, Alice; Romagnuolo, Ilaria; Sferrazza, Gianluca; Spaziante, Luigi; Tamarri, Silvia; Villa, Gianluca

doi:10.1016/j.hlpt.2026.101248

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. 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.

A regulation-based project lifecycle for innovative medical devices: Delphi consensus from an Italian expert panel / Martina, M.R., Barsanti, M., Praticò, M., Tallarico, S., Giambi, F., Rossi, F., Pellegrini, L., Bianchini, E., Asaro, S., Becherini, B., Caiani, E.G., Calderai, V., Carbone, M., Crocetti, S., De Maria, C., Lascio, N.D., Francesconi, M., Frosini, A., Gemignani, V., Mazzini, F., et al.. - In: HEALTH POLICY AND TECHNOLOGY. - ISSN 2211-8837. - ELETTRONICO. - (2026), pp. 0-0. [10.1016/j.hlpt.2026.101248]