It’s been 50 years since Dr. Tom Fogarty invented the catheter-based treatment for blood clots that’s now the standard of care. At 80, it would be a cinch for Fogarty to retire to his California vineyard and bask in the reflected glory of his accomplishments.
But Fogarty, a serial entrepreneur with more than 30 medical device startups under his belt, told MassDevice.com recently that he has no plans to slow down until he’s 6 feet under.
In Part 1 of our 3-part series, Fogarty tells us how a self-confessed teenage troublemaker who used to ditch school became an icon in the medical device world and a prime mover behind the rise of minimally invasive surgery
Fogarty doesn’t much care for his celebrity status in the healthcare world ("I’m asked to talk a lot. I could be talking every weekend somewhere and then I don’t have enough time to do what I really want to do"), but he’s never shy about using the bully pulpit to draw attention to the "plight of innovation in the U.S."
Fogarty, who has about 150 patents to his name, is also the founder & chairman of the Fogarty Institute for Innovation, an incubator where Fogarty mentors and supports medtech inventors. Fogarty told us that his work at the incubator, affectionately known as "The Fog Shop," stems from a desire to see thriving medtech innovation in the U.S.
"Nobody ever accused Tom Fogarty of being timid." – The Foundry founder Allan Will
When he sought to create a better way to treat blood clots, the economic and regulatory pressures facing young inventors weren’t there. But Fogarty faced another set of obstacles developing the world’s first balloon embolectomy catheter. The very concept of the device flew in the face of the the conventional medical wisdom of the day, he told us.
"At that time, the thought was that if you even touched the inside of a blood vessel, the blood vessel would clot off," Fogarty said. "That was everybody’s thought, that’s why you didn’t touch the blood vessel."
Surgeons instead performed complex and incredibly risky surgeries, attempting to remove the clot without touching the blood vessel walls. More than half of surgical embolectomy patients died on the table. Fogarty’s mentor believed the embolectomies failed because surgeons weren’t able to remove all of the clot.
Fogarty’s innovation, fashioned by hand in his attic from a urethral catheter and the tip of the pinky finger from a latex glove, was to use the catheter to push past the clot. Once the clot is cleared, the balloon is inflated and withdrawn back through the vessel, pulling the clot with it. Surgeons today routinely remove clots in under an hour, with a success rate of more than 90%.
But it wasn’t all smooth sailing from concept to acclaim. Medical journals refused to publish Fogarty’s work until, finally, a single journal accepted his paper. Manufacturers refused to produce the device until Edwards Lifesciences (NYSE:EW) picked up the technology and took over manufacturing and commercialization in the late 1960s.
"Like many other situations in his life, those around him didn’t take him seriously," said Allan Will, who established an incubator of his own called The Foundry, during the birthday gala. "For a while he was making these catheters 1 at a time and sending them."
Nearly half a century later, Edwards sells some 500,000 Fogarty catheters each year, according to chairman & CEO Michael Mussallem, who credits the catheter with changing the lives of about 20 million patients.
"He’s never been in a mental fog in his life." – California state Sen. Jerry Hill
As an adolescent, Fogarty engineered a centrifugal clutch that far outdid the existing gears on motor scooters. He also purchased cheap model airplane kits, constructing them himself and then selling them to other kids at a hefty mark-up. He was also fond of escaping out his classroom window to go fly-fishing, a hobby that helped shape his vision for the Fogarty catheter – he used techniques learned from tying flies to attach the 1st balloons to the ends of his 1st prototypes.
Early on Fogarty aspired to be a professional boxer. He’d learned to fight to defend himself against the neighborhood bullies, and he was good at it. At the age of 14 he began working at the Good Samaritan Hospital in Cincinnati, cleaning medical equipment and eventually working as a scrub technician. Inspired by his work in the hospital, he decided to study medicine. But his high school principal refused to write a letter of recommendation, saying that "any college that accepted Tom Fogarty would be wasting its time," Will said at the gala.
Fogarty is nothing if not tenacious. At the gala, which he turned into a fundraising event for the Fogarty Institute for Innovation, the recovery from a severe bout of food poisoning picked up during a birthday jaunt to New Orleans kept him mostly in his seat. Joking with friends, he said he’d caused quite a stir when he threw up in an airport trashcan after arriving back in California. Just a day before the party he’d been hospitalized for dehydration.
Perched on a chair with a glass of wine toward the back of the main hall, Fogarty brandished his characteristic combination of warmth and irreverence before a steady stream of well-wishers, dispensing hugs, kisses and inside jokes. He welcomed each person, joked about how he dragged them into medicine, urged them to try the wine and asked after their children by name.
Guests ranging from distinguished surgeons to upstart medical engineers fresh out of school recounted the many years they’d known him, many crediting him for their success.
Dr. Vincent Gaudiani, who once shared a practice with Fogarty, called him his "surgical godfather." Will, the former CEO of a Fogarty-founded company called AneuRx, told tales of Fogarty’s passion for adventure, including a time when he convinced a couple of vascular surgeons to go alligator-wrestling in the Louisiana bayou at 1 a.m. – just hours before Fogarty was scheduled to give a formal conference address as president of the Society for Vascular Surgery. At the end of the evening, Fogarty’s granddaughter sang a moving rendition of "Happy Birthday" and his colleagues presented him with a cake in the shape of a pair of boxing gloves, in honor of his role as a "champion for innovation."
Surrounded by acclaim, including a flag flown over the U.S. Capitol in his honor and a California State Resolution recognizing him for his work, Fogarty said his biggest achievement consisted of the people that he’d inspired, mentored and hired over the years.
"All these friends, I’ve been a part of almost every one of their lives for many years," Fogarty said during a brief respite between hugs and handshakes. "It feels good to help people, particularly when they’re innovating, which is what we need."