Father of invention
What's the master medical device maker's secret?
By TRACIE WHITE
Tom Fogarty, MD, is the Mickey Mantle of medical device inventors. In 2001, he was inducted into the National Inventors Hall of Fame, joining the ranks of the Edisons and the Wright brothers of the world. Over the past 40 years he has acquired more than 100 surgical patents, including his first, and most well-known, the Fogarty balloon catheter.
“He’s one of the most prolific medical device inventors ever,” says Paul Yock, MD, professor of medicine and director of the Stanford Biodesign Program, which promotes the invention and development of new health technologies.
“He’s also a brilliant and caring man.”
Fogarty is also a renowned cardiovascular surgeon, a successful entrepreneur and, in his spare time, an award-winning vintner.
The key to his success? Persistence to the point of obnoxiousness, he says, and an unwillingness to give up.
“Medical innovators and inventors are very impatient,” Fogarty says. “They truly believe what they are creating is better than what currently exists. They want to get it to the patient as quickly as possible.” Fogarty, who is a former faculty member at the Stanford School of Medicine, says he follows a simple set of rules as an inventor of medical technology: “How can I make this better? How can I reduce pain? How can I get the patient out of the hospital more quickly?”
And throughout his career, he says, he has always, always put the patient first.
Fogarty has been the founder/co-founder and chairman of the board of more than 33 business and research companies based on devices designed and developed by Fogarty Engineering Inc., located near Stanford in Portola Valley. He calls himself the “poster child” for conflict of interest because he believes patients benefit most if inventors play a major role in testing their own medical innovations. (His philosophy goes against the trend at academic medical centers to keep those with a financial interest at arm’s length from testing.) But he adds, “You’d have a hard time finding anyone saying that I was more interested in money than in the patient.”
Asked if his original career goal was to be an inventor, he shakes his head no.
“I wanted to be a boxer,” he says.
Question: The Fogarty balloon catheter seems so simple — a slender tube with an inflatable balloon at its far end to drag out a clot from a blood vessel. What’s this idea’s origin?
Fogarty: In the 1940s I was working as a scrub technician at Good Samaritan Hospital, in Cincinnati, handing instruments to the surgeons during the summer off from high school. I saw a lot of surgery. When people had a blood clot in their arm or leg, they usually ended up having three operations. Fifty percent of the patients died. I thought there must be a better way.
Q. You then developed the balloon catheter at home between study sessions for medical school, tinkering in your attic. How did you develop it and get it into the hands of physicians?
Fogarty: Essentially, I cut the baby finger off of a surgical glove and tied that onto the end of a catheter with fly-tying techniques I learned as a boy.
I tried to get somebody to manufacture it — that was from around 1959 to ’61— but I couldn’t. My mentor, Dr. Jack Cranley, was so convinced this would work that he kept encouraging me. I started making the catheter system myself and gave it to Dr. Cranley. He used it and gave it to his friends who said, “Oh man, this is great, get me more.”
Eventually, I assigned and licensed the patent to Edwards Life Sciences, the only company willing to take the chance that this balloon catheter would be a viable product.
What did your early struggles as a budding inventor teach you? And how have those experiences prodded you to become a mentor for today’s young inventors?
Fogarty: If there’s one lesson I’ve learned, it’s to never give up. You learn from what doesn’t work. I look back and appreciate how much my mentors have done and how they encouraged me to look further, to see what you can make better.
Q. What’s wrong with medical device development today?
Fogarty: It takes much too long right now. For example, medical devices are being replaced every seven to eight years. If it takes five to seven years to get through the regulatory and reimbursement approval process for a new device, they’re already outdated. Also, in our training as doctors, we’re not taught to accommodate emerging technologies. Put those two drawbacks together and it becomes very difficult to move forward.
Q. Would you describe what it takes to market an invention and how it has changed over the past 40 years?
Fogarty: We don’t have enough time! Add the encumbrances of a hospital system, the government regulations, plus the issues of getting somebody to pay for it — it’s a very torturous trail. When I first started, all you needed was the approval of the senior physician at your hospital.
Q. Critics contend that the explosion in medical technology has driven up the costs of medical care. Can you comment on the future costs to the patient of medical technology?
Fogarty: It can drive up costs. But also, you can develop technology with the guideline: I want to get this therapy to the patient at a reduced cost. In the past, physicians and industry haven’t talked that way. They often added more bells and whistles that increased the costs and, looking back, they often added nothing in benefits.
It’s very important for innovators today to keep in mind that, if you want to extend medical benefits, you’re going to have to decrease costs.
Q. With all its drawbacks, why should today’s young inventors navigate the field of medical innovation? Any advice to them?
Fogarty: It’s a wonderful endeavor in terms of bringing benefits to society, knowing you’ve reached out to many, many patients through many, many doctors. Remember, the patient comes first. If you make money, that’s fine but that should not be the primary objective.
Comments? Contact Stanford Medicine at