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

The findings highlight the crucial role of regulations in business modeling. Notably, the MDR is a central regulation for startups aiming to develop SaMD. The study uncovers the impact of the MDR on business modeling for SaMD startups. Our research provides a framework that integrates this regulation, thereby reducing its complexity and facilitating startups in deriving a sustainable business model. Concurrently, this research integrates the domains of business modeling and the MDR. Therefore, it contributes to the academic discourse in both fields and addresses a notable gap in the existing literature.