Software as a medical device (SaMD) has been used in the healthcare sector for many years, particularly in the space of imaging and treatment planning. At the same time, the medical device industry and regulations were still viewing this space as mostly hardware-centric; therefore, the evolution and understanding of the design, development and commercialization needs of standalone software devices were not very appropriately covered in the regulatory regime.
Significant technological advancements (e.g. the AI boom), the COVID-19 pandemic and increasing time and resource pressures in healthcare systems have accelerated the development of digital applications to aid data management, reduce human bias, and improve disease diagnosis, treatment, and prevention. This has pushed regulators to accelerate the development of supporting mechanisms (via regulation, guidance or special programs) for such innovative and much-needed software.
Most eyes are on how key markets, such as the EU and the US, are looking to ensure the public benefits from innovative SaMD products that are both appropriately assessed and can reach their intended users fast enough. At the same time, they are also allowed to evolve at a good pace.
In this Ask the Experts session, we answered questions concerning topics such as:
- Which questions should one be able to answer in order to decide whether to enter the EU or the US first with their SaMD?
- How can a CE-marked SaMD capitalize on its data to accelerate US market entry and vice versa?
- Which programs (i.e. Regulatory Bodies consultations, “Fast Track” for innovative devices, etc.) and regulatory paths can SaMD developers/manufacturers benefit from in the US and the EU?