It’s tough enough to be a startup developing and launching innovative products. For medical device startups, there’s the added burden of operating in a highly-regulated industry.
The cost of developing a medical device ranges from $25 million to $100 million, according to a 2010 research study out of Stanford University. So the cost of failure or even delay is high.
Unlike the consumer world – where an app or prototype can be developed in a garage (or dorm room), then publicized on YouTube and funded via Kickstarter – the regulated medical device development world requires a different level of commitment, process and demonstration of efficacy.