Howard Root

This is the story of Vascular Solutions (VSI), a med device company in Minnesota that makes (among others) a product that treats varicose veins. It is also the story of Howard Root, the CEO and founder of VSI and the five years he spent at the hands of the US Government (FDA) and lawyers after being accused of mis-branding the product. Essentially, the government accused Howard and his company of ten counts of fraud and off-label use of the product. Off-label use is what it sounds like - show more promoting a med device for use(s) for which it is not indicated to be used for.

It is well-written and on point - telling his story with humor interjected with the legalese. In areas, he uses verbatim transcripts from his trial, along with photos he took along the way. I received this book from the author directly after he came to speak to my company, another medical device company. show less