Successful Entrepreneur in Biomedical Devices Offers Advice
November 25, 2013
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.” Ruppel said he “always wanted to be a mechanical engineer,” but hadn’t even heard of the University of Rochester when he began looking for a college to attend after graduating from high school in Cincinnati. He considered Case Western in Cleveland, which was relatively close to home, and Rensselaer Polytechnic Institute in Troy, N.Y., a much longer drive. This prompted his mother to suggest he find a spot somewhere in between.
When they visited UR, Ruppel “loved it. I knew I wanted to go here.” He especially enjoyed working as a student in the Laboratory for Laser Energetics during three academic years and two summers. That experience proved invaluable when companies came to campus to recruit. A recruiter from Spectra Physics in California offered Ruppel a job. He was not particularly impressed with Ruppel’s grades, he explained. But the optics Ruppel learned at the Laser Lab would “save six months in training you.” His lab experiences also showed that Ruppel was a “hands-on person.”
“That’s what they wanted.”
Ruppel had never been west of Ohio -- didn’t know anybody west of Ohio -- but packed his bags and headed for California anyway. Which is a good starting point for Ruppel’s advice for budding entrepreneurs:
1. Don’t be afraid to take a big leap. Ruppel took it fresh out college; he’s seen others successfully switch careers in their 40s. “In California it means quitting your job and starting a winery,” he quipped.
2. Take every opportunity to learn new things. “I know a lot of people who put blinders on and do the same thing every day. They love it; I can’t stand that. I like to go out and rattle peoples’ cages. It’s amazing what you learn by wandering around talking to people, and what they’ll let you get involved in.”
3. Know your limits. “I’ve seen CEOs of technical companies who think they can do everything” – and end up squandering a lot of time and money finding out they can’t.
4. Build a network of friends and mentors – and use it. Successful entrepreneurship is “all about finding the right people to help you along the way. You can’t do it alone."
5. Love what you do. “There are some days when I don’t want to go into the office, but it would be really hard for me to do that all my life.”
6. Find an environment you are comfortable working in. “I learned that big companies aren’t my cup of tea,” Ruppel noted. “I like being involved in all aspects of a company. I just couldn’t handle doing one little sliver.”
7. Good managers and mentors can figure out your career path before you realize it yourself; if you’re lucky enough to work for that kind of manager, heed his or her advice. Especially when they suggest you take on new challenges and responsibilities.
8. “Not all exits are good ones.” The opportunity to sell a startup to another company may look good on the surface. It might even make the board of directors and stockholders happy. But it doesn't always work out well for either the employees or the technology.
9. Research the board members and managers of a company before you sign on. That’s relatively easy now with all the online sources of information, and it may help you steer clear of a company that is badly managed.
10. In developing a new device, “listen to the users” you plan to sell it to. Not just the top, established surgeons in a particular specialty, for example, but the average surgeons, and the ones just one or two years out of residency.
11. Seek funding at least a year before you actually need it.
12. Learn to adapt quickly.
13. Hire well. “You can’t know everything. So get the expertise around you to fill in the gaps. If you’re fair to people, and considerate of their needs, they’ll want to work for you. They’ll jump overboard with you to come along for the ride.”