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.

Danielle led Apple’s Digital Mental Health Study and the development, testing, and deliverables for de novo submissions of Apple’s first FDA-regulated features on the Apple Watch. Now, she’s on a mission with Kintsugi to make mental healthcare access available for everyone, with a novel AI-based digital health product to detect signs of depression and anxiety from speech.

Key Takeaways:

Hope to see you at our next SaMD meetup!


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roadmap through a stethoscope around a mobile phone
Yena Lee, Strategist

A core component of a premarket submission is clinical evidence. Clinical evidence is gathered through a process of clinical validation, which involves gathering data on the safety and effectiveness of the product. The overarching goal of clinical validation is to demonstrate to regulators that the device will work, as intended, for target users.

Venn diagram overlapping a mobile device
Kitty Makra, Director, Digital Strategy
Yena Lee, Strategist

Last week at our second SaMD meetup, we discussed how to apply agile product management strategies to building and validating digital therapeutics.

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Yena Lee, Strategist
Kitty Makra, Director, Digital Strategy

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.