While Software as a Medical Device (SaMD) represents a niche market, it constitutes a valuable addition to the hardware and services provided by the MedTech industry. Moreover, because software design and improvement are much less resource intensive than hardware development, the area is rapidly growing and maturing. Big players from the software industry and the healthcare industry have developed products and there are many examples of the benefits of SaMD.
This report aims to provide an overview of relevant stakeholders to see how advanced technology-based products can help EU industry to stay ahead of global competition. The objective is to map the key players in the SaMD value chain, as well as to identify their strengths and weaknesses. Analyses were based on desk research and interviews.