Starting a medical device company in this day and age is a far cry from what it was 10 or even 5 years ago, and a world apart from the days before the 1976 Medical Device Amendments to the Federal Food, Drug, & Cosmetic Act. Medtech innovators face a raft of challenges in getting their products to market, ranging from skittish venture capital investors, to designing and running clinical trials, to the formidable burden of winning FDA or CE Mark approval – and then keeping it.

Medical device legend Dr. Tom Fogarty, who 50 years ago spent just $2,000 developing the ubiquitous catheter that bears his name, doubts he could get that device commercialized in today’s environment.

“If you were to submit that today, it was so unheard of by the FDA, they would just make you do animal after animal, bench test after bench test, and then they would make you do this in a human I don’t know how many times,” Forgarty says.

Despite the challenges, medtech startups abound. In fact, there are some 1,189 startup medical device enterprises with an average valuation of $4.6 million, according to AngelList, a portal that aims to connect nascent companies with investors, talent and incubators. Maybe that’s because, when you get right down to it, developing a successful medical device is a profoundly gratifying experience.

“It’s wonderful to be able to innovate, particularly in the medical field,” as Fogarty says. “If you develop something that’s adopted by other physicians, you’ve touched many patients. If you just operate on somebody, you’ve touched one patient.”

Young companies are at the vanguard of innovation in our industry, driving the creation of new technologies to address unmet needs across a range of diseases and conditions.

But having a revolutionary idea is a far cry from actually bringing it through to commercialization. In this issue of Medical Design & Outsourcing, we sought to answer some of the key questions facing new medical device firms.

How can I get my device approved? What do I do to make sure it stays in compliance once I do? Where should I look for a reliable outsourcing partner? What about protecting my intellectual property? And how can I raise the cash to fund it all?

You’ll find the answers to these questions and more in the following pages, along with a look at a few of the startups we found most intriguing.