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

I recently finished a bunch of NIH SBIR grants and vowed that I would not let the next five months go to waste (pro-tip: the SBIR deadlines are not distributed evenly every 4 months).  So, my self-imposed deadline is to write one useful blog post every 2 weeks until one month before the next deadline, Sept 5.  Short version: SBIRs ARE GREAT IF YOU CAN GET THEM to get your company off the ground.

So, having met SBIR deadlines last week, I wanted to explain why it’s worth spending the time to write SBIR grants.

 

·        It gets you funding without finding the individual investors who believe in your technology. 

·        The funding also doesn’t take any equity away from your investors

·        The funding verifies your technology by both clinical and business experts in the review committee [there’s a reason why Theranos never got a government grant!]

·        The process of writing an SBIR grant forces the company principals to focus on a concrete milestones/company structure

·        Agreeing on the organizational structures of a nascent company can force difficult conversations that future investors might have an interest in.

What are the downsides of NIH SBIR awards?

·        TIME:  the typical lag between the time you finish writing your grant and the time you get feedback is 4 months.  IF you get a good score and 2 months later, get funded, the start of the project is 6-8 months after the Notice of Award.  So, not a strategy to keep the medical device company afloat.

·        Asking for a real time by doctors, biomed PhDs, academic Offices of Research Administration, friends who write letters of recommendations uses up political capital.

·        Significant time with university centers that conduct animal trials,  university centers that conduct human trials subject—a lot of paperwork!!!

·        Lots of “organizational” parts of the company must be compliant before an award can be made (this is a good thing in the long run but for many Phase I companies, it can be difficult).

A Quick Reality Check for SBIRs

Waitressing