Business Modeling for Highly Regulated, Multi-Stakeholder Environments: Design Support for Software as a Medical Device Startups in the European Union

Digitalization holds the potential to address challenges in healthcare systems. In the European Union Software as a Medical Device sector, startups play a pivotal role in driving and shaping the digital transformation of healthcare sectors. However, the complexity of the sector, especially the European Union medical device regulations and the multi-stakeholder environment, poses challenges for startups. A sustainable business model can be essential to tackle these challenges. This study adopts a design science research approach. We design the Software as a Medical Device Business Model Canvas based on the derived meta-requirements and design principles. The canvas consists of thirteen components and aims to support startups in developing a business model for their Software as a Medical Device in the European Union. The canvas aims to reduce complexity by covering key aspects on a strategic level. This study derives a solution tailored to the unique needs of digital health startups in the European Union Software as a Medical Device sector. Still, it addresses global challenges in healthcare systems, such as the lack of human resources and the quality of health service delivery. The derived design principles and the artifact can be generalized and applied to industries similar to the European Union's Software as a Medical Device sector, characterized by strict regulations and multi-stakeholder settings.