The biomedical devices domain is one of the toughest for an entrepreneur to break into.
It is highly regulated, not only by the FDA in the United States, but by FDA-comparable regulatory agencies in just about every other developed country, which means a company may have to repeat, at great expense, the same clinical trials that were conducted to gain approval elsewhere.
Venture capital is scarce, and many of the remaining VCs are more interested in funding projects that are at or near commercialization rather than start-ups.
So why even venture into medical devices?
Ted Ruppel ’88, Executive Vice President of Vascular Dynamics, offered a compelling reason during his presentation, “My Medical Device Journey: Failures, Startup Challenges and Lessons Learned,” as part of the Center for Entrepreneurship’s observance of Global Entrepreneurship Week.
A 13-year-old Canadian girl suffers headaches and dizziness. Doctors find a golf-ball sized aneurysm in a blood vessel in her brain. There is nothing they can do. Prognosis: The girl will probably die within two years.
One of her doctors, however, approaches a physician who is known for doing very complicated cases, who comes up with a novel solution. Why not rebuild the girl’s artery by combining 7 or 8 of a new variety of stent, into one, which can be inserted into the vessel, much like sliding one pipe inside another to stop a leak?
A “compassionate use waiver” is obtained from the FDA so that normal regulatory trials can be bypassed. The novel stent is implanted.
The girl is now 18, and a freshman in college. The only medication she takes is one baby aspirin a day. She recently won a cross-country championship, is active in community outreach in Canada, and spends summers volunteering at hospitals in Mexico and Canada—and wants to be a neurosurgeon.
“That’s why we do this,” Ruppel says. “There are so many things stacked against you, you have to believe that what you’re doing is making a difference, by getting products into physicians’ hands that they really can use.”
Since graduating from the UR with a degree in mechanical engineering, Ruppel has worked for, or co-founded, a half dozen San Francisco area companies, many of them startups. Spectra-Physics. Applied Biosystems. Biometric Imaging. CYBON Inc. Micrus Endovascular. And now Vascular Dynamics.
He’s experienced it all.
The excitement of developing game-changing medical devices; the anger when a promising device is shelved after a takeover.
Lawsuits filed by partners who didn’t want a company to go public; lawsuits filed by shareholders after it did.
Working for good managers who became valued mentors; working for bad managers who didn’t know their own limits.
“Having a great idea is the easy part,” Ruppel said. “But finding the resources required to take that idea through research, development and commercialization—that is where a lot of people misunderstand what is involved.”
– Bob Marcotte