ARTICLE SUMMARY:
Typical software development practices don’t naturally line up with medtech regulatory requirements, but companies working in digital health ignore the rules at their own peril. Even for firms that don’t envision crossing into regulated medical device territory, early planning and periodic expert check-ins on the regulatory landscape can help avoid problems down the line, Pascal Werner advises in this edition of Consultants Corner.
Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access
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Pascal Werner (pascal@regulatory.me) is an independent consultant for start-ups and small/medium enterprises on quality/integrated management systems, technical documentation, and regulatory strategy with a focus on digital therapeutics, digital health, AI, and SaMD. He previously co-founded Mimi Hearing Technologies, and he trained in biomedical engineering. |
Question: Is This a Software or Medical Device Project?
As the lines between app developer and medtech start-up increasingly blur, digital health companies need to be vigilant in understanding how their evolving software development plans line up against the formalities of global medical device regulation.
But that’s not the typical mindset for software upstarts looking to make an impact in the healthcare arena, notes Pascal Werner, an independent digital health regulatory consultant. Companies in this context are often targeting the consumer app space rather than setting their sights, initially at least, on making a clinical-grade tool. As a result, they don’t have much motivation to spend a lot of time thinking about or engaging with device regulations.
“Since you're not really working on a medical device and you are trying to stay out of that, why should you talk about medical device regulation?” Werner poses, reflecting the sentiment of many software firms moving into digital health. But that mindset can be risky, he suggests.
