Re: "Biotech's hidden stepsister,"1 about the current hurdles facing the device industry, I was the founder and CTO of Avocet Medical, a medical device start-up producing a hand held meter to prevent strokes by monitoring proper level of oral anticoagulants. We raised $38 million in venture capital financing between 1991 and 2001.
Although we obtained FDA approval, the FDA changed the rules on us by insisting at the last minute, after all clinical trials were done, that users do additional (and redundant) safety checks each time they used our product. These redundant checks pushed the cost per use from $6 to $21, and made the product uneconomic.
We had to exit the field. Although this hurt our investors and employees, the much bigger damage was probably to the thousands of patients per year that we might have been able to save. Failure of a medical device is conspicuous, while preventable ...
