[Responsible innovation in medical devices: a practical pathway for nursing teams]

A practical, guiding and non-linear pathway is proposed to help nursing teams within Spain's National Health System transform clinical needs into transferable medical devices, integrating responsible research and innovation principles (anticipation, reflexivity, inclusion and responsiveness) and the requirements of Regulation (EU) 2017/745 and related standards (risk management and usability). The pathway brings together definition of real-world use, review of evidence and the technology landscape, prototyping and co-creation, regulatory alignment, an intellectual property protection and transfer strategy, and proportionate evaluation (formative/summative usability and clinical evidence). As a demonstrator, ERGOMIC -a non-invasive voiding device for women in the supine position- is presented, addressing a design gap with a gender equity dimension, a usability plan and a life cycle assessment. This approach supports solutions that are safe, acceptable and adoptable.