A Business Model Framework for Software as a Medical Device Startups in the European Union: Mixed Methods Study.

Abstract

With the introduction of Regulation (EU) 2017/745, also known as the Medical Device Regulation (MDR), startups aiming to develop software as a medical device (SaMD) in the European Union are confronted with stringent and complex regulations, and many of them struggle with them. Complying with the MDR is a costly, time-consuming endeavor requiring expertise and substantial financial resources. However, it opens the door for new revenue models, such as reimbursement pathways. Consequently, the MDR