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.

Theranos thoughts

I just finished a couple of SBIRs and was struck, again, by how much thought and effort needs to go into getting a grant for developing a medical device, never mind how much work, time, expense etc. it takes to market said device. There are so many people who take this process seriously and lots of inventors can find legitimate engineering partners to work with them and move the project forward. It takes time, however, and patient people will ultimately get their devices into patients for the betterment of medicine, and patients.

But in the vein of charlatans out there, I think the Theranos trial, taking place right now, is evidence of not only how non-medical investors misinterpreted the science entrepreneurs present, as well as the potential ROI but also how different it is to develop a medical device compared to the other startups traditionally funded by Silicon Valley. I think Bad Blood by John Carreyrou should be required reading by all entrepreneurs in medical devices, and if nothing else it should convince you to play the successes and the failures straight with your investors. I have my own thoughts about why Elizabeth Holmes got away with fraud (and my personal view is that she should be convicted) but the fact that most of her investors were not in the medical field should have been a red flag for every last investor.

In my small, parochial experience, I also have anecdotes about getting the right investors that I will blog about later. But (spoiler alert) if you are reading this and have the luxury of non-medical investors vs medical investors, take the medical every time (despite the terms).

Suffice it to say, I will be watching the Theranos trial intensely—if you are in this medical device space, I encourage you to watch the details as they emerge. They may not ever be relevant to your company but they will surely be red flags to avoid in your journey.

What if you can't afford { }?

How to Allocate Shares to Founders and Employees