Innovation in Health at the Service of Emergency Department and Clinician-Researchers: the Journey and Clinical Evaluation of a Medical Device

The alliance of the world of health with that of new technologies can generate a new field for research and medical practice. The new European Community (CE) marking regulations (2017/745) now require any medical device (MD), including computer software, to undergo a rigorous clinical evaluation. Emergency services are particularly at the forefront in terms of their appetite for new technologies. They are increasingly solicited by existing or new companies working in the field of engineering for the health sector, but also by researchers in fundamental engineering. In view of these elements, it seemed relevant to us to define the stages and milestones of an innovative health project involving a MD for doctors and clinician-researchers in emergency medicine. After passing the first stages of development, materialized by the Technology Readiness Level (TRL) scale, clinical investigations are necessary in order to obtain a CE mark from a notified body. Depending on the characteristics of the medical device, different ways of being covered by the community are possible, and may require additional clinical, medico-economic or organizational evidence. The expectations of stakeholders and the steps associated with the market access process can be a barrier to the development of future MDs. The association between researchers, clinician-researchers and industrialists should allow the emergence of innovative and practical tools for tomorrow's emergency medicine, provided that these steps are well understood.