Software as a medical device (SaMD) represents an opportunity to successfully build and launch patient-centric digital health products and platforms. In this article, we'll take you through the fundamentals: what is (and isn't) a SaMD, how federal and international agencies classify and regulate SaMD, and how you can get your digital health product to market faster.

At our third Software as a Medical Device meetup, Danielle Dorfman Faruq (Regulatory & Quality Director at Kintsugi) shared learnings and tips on how to get your SaMD in the hands of real users faster, while meeting regulatory requirements.

Digital therapeutics often miss the mark when it comes to connecting with patients and meeting their expectations. To build and launch a successful Software as a Medical Device (SaMD), you need to know and leverage your unique advantages. In this article, we share why we think the Jobs to be Done (JTBD) framework provides a better understanding of what drives customer behaviour than the traditional market segments and demographic information. We’ll explain what the JTBD framework is, and focus on applying the Four Forces analysis to the SaMD market to address enablers and barriers to customer demand.