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Cake day: November 22nd, 2023

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  • This is normally good advice but these people are often dangerous in this scenario because of the regulations involved.

    I’ve worked with many of these people - doctors and researchers and fundraisers with big dreams of technology solving a problem but zero clue of what is actually required to build and release such a product. These people all dramatically underestimate the amount of work it takes to build a regulated medical device.

    Traditional start-up types are the worst here. They all want to follow the traditional start-up advice and build a minimum viable product, launch early, and make big claims about what the product will do. That’s all great in a non-regulated industry. As a regulated medical device, those things might land you in prison for making false claims or releasing an unapproved device. That is not an exaggeration.

    Find someone who’s built and launched a successful, FDA-cleared medical device, or maybe someone from a pharmaceutical company who’s launched new drugs. They’re the ones who know what it takes.


  • I really hate to rain on your parade, but you should really, really know this before you embark on this path:

    Any software designed for to help doctors diagnose and/or treat patients is classified as a medical device and is going to require a massive amount of certification before you can bring it to market.

    Things like IEC 62304. ISO 27001. ISO 9000 QMS. HIPAA and GDPR. Don’t forget about the clinical trials you’ll need to run to gather evidence to present to the FDA that your software works as stated. After all that, you need to go the the FDA and get approval… and they may simply say “no” and you’ve wasted everything.

    These things take years of time and millions of dollars to create all the documentation and get the necessary approvals and audits. That’s on top of building the actual product.

    I love the entrepreneurial spirit, but take it from someone who’s been down that path and failed, unless you’ve got a massive amount of funding lined up and industry backing and experience, medical device software is one of the worst industries to make a startup.