Introduction

It all started when…

I got tapped to be the “business” side of a medical device startup company. Because the other co-founders were biomedical engineers and scientists and because I had a degree in business I was selected to be the company’s COO—Chief Operating Officer. I looked for a book that would explain things like the 510(k) process, 60601 testing, what a patent continuation is or how to find the sterility requirements for 3D printed parts used in the OR, and found nothing.

In the eight years since we launched the company out of the university, this changed somewhat, and there are some nice books and blogs available (see my other resources page), but it wasn’t all in one place and sometimes the 10,000-foot level is too general to give meaning to the concept. So with that in mind, I’m writing the on-the-ground narrative about things you might be confronted with. Maybe the anecdotes will stick with you, possibly they will be a reminder of what not to do. But in any case, it’s a data point on this LONG journey. Keep in mind it’s only one data point, and maybe the application to your business will not be useful. But if you are still reading, read on and welcome!