Learning to design, manufacture and sell a medical device is hard. Having done it once, I’m writing down my thoughts on how to do it better the next time.

SBIR Season!

If you are making a medical device with novel technology, you should know about SBIRs—a key funding piece that will cost you nothing but a lot of effort! SBIRs are small and medium-sized grants from the government that help to develop the device or product you are making. The key is that there has to be real, honest-to-goodness research in the proposal, so you can only write them if you are well-versed in the details of the technology you are trying to commercialize.

The other benefit to getting SBIR funding is that the process of deciding who should get funding involves the NIH gathering the local subject experts—both technical and clinical—to consider and rank all of the proposals. Only the best ones are funded. This signals to investors that experts have vetted the technology and have thought it credible, which is key, especially if you have a completely novel idea. I doubt Elizabeth Holmes would have been able to get an SBIR with her plans, and if investors had looked more carefully, the Theranos debacle could have been avoided.

A Great Resource for Data About Healthcare Exits from Silicon Valley Bank