How to Start a Med Device Startup From Your Garage

Are you struggling to get a med device startup off the ground?

Many of us have had the experience of launching a business and, if you haven’t, I can tell you that it’s not all roses.

Medicine is well-known as a field which is difficult for small players to enter.

Hardware startups are known for being more difficult than software startups.

Put the two together and you’ve got a recipe for extreme challenge.

Luckily for any would-be med-device bootsrappers, I gave a talk at HxD Vancouver on the topic on Thursday.

This was a revised version of a talk that I had given a year prior at Hacking Health New York City.

My goal was for everyone to learn the fundamentals of 510k / FDA regulatory, reimbursement, coding and R&D: essentially all of the different facets of getting a medical device startup off the ground with no outside funding.

The idea may sounds far-fetched, but it’s more realistic than you might think, as R&D costs continue to fall and fall due to advances in technology. Software, hardware, 3d printing, etc are all more cheap, powerful, and flexible than ever before. What this means is that, increasingly, we are only limited by our creativity and domain knowledge to bring these technologies to bear.

One would think that the entire medical industry would be taking advantage of these technological advances, but no, the large players continue to become increasingly risk-averse and R&D-averse over time.

This means that there is an opportunity for small startups to innovate on R&D and then exit to the large players.

This talk, “How to Build a Med Device Startup From Your Garage,” is an attempt to teach these fundamental principles to the would-be med device startup entrepreneur.

Here are the slides, but I admittedly don’t think they do justice to the topic.

Let me know if you find the topic interesting. If you’re eager to learn more, I can take the time to record a screencast.

Written on April 4, 2016

David Kay has dedicated his life to the advancement of the technological singularity. He is a serial entrepreneur, working to impact the future of software development and medicine. If you found this article helpful, join his weekly newsletter.