Tom Fogarty was an inspiration to us all, both professionally and personally. Often described as “the Edison of medicine,”he touched countless lives. While many are familiar with his extraordinary accomplishments, we wanted to offer a deeper look at the man behind his impact on medicine, the industry and the world. To do so, we spoke with six industry luminaries who knew Tom well, gathering their insights into his character, the lessons he imparted, and—yes—stories of both foibles and fun.
- Vince Gaudiani, MD, cardiothoracic surgeon, who practiced with Fogarty at Stanford and is now at El Camino Health
- Gail Lebovic, MD, oncoplastic surgeon and serial medical device entrepreneur; co-founded multiple companies with Fogarty, all of which had successful exits
- Tom Krummel, MD, chairman of the board of Fogarty Innovation, Santé Ventures partner and former co-director of the Stanford Biodesign program
- Casey McGlynn, former partner at Wilson Sonsini Goodrich and Rosati and Fogarty Innovation board member
- Mike Mussallem, former chairman & CEO of Edwards Lifesciences and co-founder of the Linda and Mike Mussallem Foundation and the Mussallem CHD Alliance
- Allan Will, CEO of eight Bay Area venture and private equity-backed startups; founder of The Foundry; founder or co-founder of 14 companies; founding general partner at Split Rock Partners; and Fogarty Innovation board director
While we could have written a book with the input, here are some of the highlights.
There Has to Be a Better Way
If one phrase summarizes Tom Fogarty’s life, it was his belief that “there has to be a better way.” This revolutionary perspective is what defined him and is the concept that his colleagues returned to again and again.
The first impact is how he changed interventional medicine forever with the balloon embolectomy catheter. “Tom Fogarty really initiated the entire trend of less-invasive surgery with his thought process of ‘Why can’t we do this better?’” recalled Will.
“He wouldn’t accept the fact that after open surgery to remove blood clots there were going to be amputations and deaths as side effects, which meant you basically failed at what you were trying to do. For a surgeon to think about how to put himself out of business was amazingly creative, but that’s essentially how Tom led his whole life…turning a problem upside down and looking at it very differently than people traditionally had.”
Not only did his approach result in a new procedure, but it changed the thinking around the optimal way to treat patients, said Lebovic. “Maybe not all interventions should be gigantic operations. Maybe we could do things in a simpler, less invasive way,” she said. “I think about the patient and their experience and put myself in their shoes, and Tom did that all the time.”
McGlynn calls it his “inquisitive mind” and “keen sense of observation about what wasn’t right” that led Fogarty to look more closely at procedures that didn’t turn out as well as they could have and ask what could be done differently in the future.
Of course, the balloon catheter is just one high-profile example of his transformative ideas. No problem was seemingly too big or too small for him to mull over. Whether it was trying to figure out the intricacies of reel technology on Alaskan fishing trips, as he pondered why some lines flew farther, or finding a way to clear the road to his winery after a storm in record time by using a large log as a lever to move other debris, Fogarty was always looking for new and better solutions.
“When he recognized a problem, he didn’t feel compelled to think about it in the same ways in which it had been thought about before,” said Gaudiani. “His focus was on remaking the world. Tom used to tell me he didn’t like reading, especially medical literature, because he was afraid it would influence him, and subsequently make it harder to bring his trademark ingenuity.”
But inventiveness takes courage and conviction. McGlynn believed his self-confidence was integral to being able to accomplish what he did. “I just don’t think it’s easy to create great things without being able to take that last step off the ledge and feel certain that the angels are going to hold you up,” he said.
A Penchant for Pushing Boundaries
Not surprisingly, his constant pursuit of a new and better approach often made waves… and Fogarty was unafraid to dive into the deep end.
“When I asked him what was the hardest thing about innovating, he said, ‘The problem is you’re always pushing back against the establishment,’” reflected Krummel. “You’re always telling the experts that what they’re doing isn’t good enough. The challenge is changing the status quo.”
That comes with pushback, even when the change radically improves outcomes and transforms an industry the way the Fogarty catheter did. Fogarty recalled that the idea was vilified at the time because it went against accepted standards. When Krummel accompanied Fogarty to Washington, D.C., to receive the Presidential National Medal of Technology and Innovation, Fogarty told him that the medical community had initially called the catheter “a dangerous device and a procedure that borders on malpractice,” adding that it was “so uninformed that it’s something only a medical student would dare to think.”
Unbeknownst to those critics, those words helped crystallize the value of looking beyond convention for the most innovative answers. “We always said, ‘Well, that’s why we leverage students broadly at Biodesign and Fogarty Innovation, because they don’t know what can’t be done,’” said Krummel.
And yet, that can be hard in the business of surgery, which is often taught by the book, said Gaudiani. “Most doctors believe that if they’ve always used a specific technique that they were taught, there’s no reason to do it any other way.” Accordingly, Gaudiani believes Fogarty’s independent mindset was the most critical to his success. “He never wanted to lose his capacity to be a creative thinker and to recognize new solutions by simply following convention. He just always danced to his own tune, and he was good at it.”
Mussallem believes Fogarty might even have considered it a badge of honor to be known as someone who would push through. “I’m sure he upset as many people as he impressed along the way. But that was Tom. One of the things I respected most is not being afraid to be bold, to have your own ideas, and to ask the question ‘Why not?’”
Pushing the Boundaries – Part 2 – The FDA
Fogarty was unafraid to challenge the status quo in any situation, from the hospital to the halls of power. Taking on the FDA around 2010 is a perfect example; at the time, the agency did not yet have a deep understanding of the medtech startup world. “Most of us in the industry would be terrified to criticize the guys regulating us because they have an awful lot of influence on your potential success,” Mussallem said. But he went about it in true Tom Fogarty fashion. “He was openly critical of their conservative view, suggesting they were more interested in protecting themselves than helping patients. And he was vocal about it, and not afraid to use a little profanity along the way to make his point. We’d be silently cheering Tom on.”
McGlynn recalls the period when, because of this pervasive attitude, the approval pipeline was essentially closed to medtech devices. “It was catastrophic because we couldn’t get important new therapies into the marketplace and because of that, patients suffered.”
Fogarty knew his crusade was honorable and intended to open the FDA’s eyes to the lifesaving possibilities of medtech devices. “He always believed that, if they only knew what was going on in medical technology innovation, they wouldn’t be afraid of it; they would welcome it,” Mussallem said. “Innovators aren’t just focused on making a buck; these are good people trying to create something better for patients.”
And that’s how the educational partnership between Fogarty Innovation and the FDA was born, marked by the launch of the FDA Fellowship program to help the agency gain a more accurate understanding of the challenges inherent in device development, and Fogarty entrepreneurs better appreciate the reasons behind the steps required in the regulatory process. “The FDA today is far more receptive to innovation, and Tom was an important catalyst of that change. If you would’ve asked any of us 15 years ago whether that was possible, we would have been skeptical. And now it’s evolved to that,” Mussallem said.
Expanding Silicon Valley’s Mission
This advocacy with the FDA had grown out of Fogarty’s larger vision of ensuring that the wave of technology innovation in Silicon Valley included the medtech ecosystem. In many ways, the two are aligned: tech visionaries know their solutions are force multipliers, as is medtech.
As Krummel explained, “A doctor can do 500 operations a year, but if you develop a new technology, it can help 500,000 patients a year. It’s the Silicon Valley concept of ‘leverage’ in spades.”
Fogarty also shifted how doctors saw their own role in the ecosystem. At a time when physicians thought promoting medical technology was inappropriate, he showed that advocating for innovations was about saving lives, not making money. “When we look back, it’s very obvious how he changed the world in this particular way because we now have many inventive doctors,” McGlynn said. “In today’s world, innovation is highly valued in any profession.”
A Rare Gift for Reading People
Fogarty had an uncanny ability to size up people and situations; as McGlynn put it, he was “very astute with regard to evaluating people.” The result was strong relationships throughout the industry, as Fogarty identified people he trusted—and whom he believed had good ideas—and collaborated with them over and over.
“We all get tested by fire in these companies, and sooner or later, you find out what people are made of,” said McGlynn. “And that would result in either Tom wanting to work with someone again, or saying, ‘We’re going to stay away from that guy.’”
As Will noted, “People meant a lot to Tom. He knew that the way to be successful is to gather the best and brightest and work together to attack a problem.” On that note, he made sure to take care of team members to continue to get the best out of them. “Some investors try to get talent as cheaply as possible or try to be as economical as possible when it came to raises, bonuses, or equity, but Tom never did,” Will said.
“A lot of people brought Tom their ideas. He was always open-minded and would really think about them, often ultimately taking a position that was different than what others thought,” said Mussallem. “He had a good instinct about people, and whether they were the real deal.”
“He respected everybody,” said Lebovic. “Until he didn’t.” She recalls seeing him fire the CEO of a company during a board meeting. “He knew the guy was full of it, and we all did too,” remembered Lebovic. “And then Tom just said, ‘Get the [heck] out of here!’”
For those who did make the cut, Tom was there as a mentor, but not in the classical sense. Typically, a mentor is someone you call when you have an issue, or with whom you meet to discuss your strengths and career trajectory.
Fogarty wasn’t that guy. “He wouldn’t sit down and say, ‘Here are a few words of advice.’ They just came out while you were working,” Will said. “You knew he had your back and he supported you by showing up for you.”
Will experienced that firsthand one time when he was CEO of a company and a board member questioned the company strategy. “Frankly, I think that person wanted to fire me,” said Will. “That board member called a meeting with a subset of the board that didn’t include Fogarty, but Tom attended anyway as support. He believed in me and supported me as the leader and CEO, even when things got tough.”
As Lebovic said, “He wasn’t preachy. He led by example.” Over the years of their close collaboration, she came to know him as a man of few words who only spoke when it was important. “I wanted to learn as much as I could from Tom. I could feel I was in the presence of greatness, even though he was so humble, which is what I loved most about him. What he said was so powerful that he didn’t have to say much.”
A Legacy of Lives Changed
The true measure of Fogarty’s work isn’t found in any single achievement, but in the countless lives he has improved in many different ways.
No one metric tells the story.
McGlynn believes his biggest contribution to society is the acceptance of doctors being inventors and being able to make money with those inventions, whether through a venture-funded startup or licensing arrangements.
Fogarty’s own inventions prove that out. “His products alone have extended and improved millions of lives,” said Mussallem. And, in an echo of McGlynn’s take, he underscores how this happens. “When a physician does his magic, it touches one patient. When medical technology is brought to market, it can help patients around the world and then the numbers get big. For Tom, that’s hundreds of millions… maybe even billions of people. It’s humbling. Then multiply that impact by all the other companies he built that brought forward important new technologies.”
“He gave credibility to a lot of devices that might have otherwise died on the vine. There are so many great ideas—especially in cardiovascular medicine—it’s having the commitment and the willingness to stay with them,” Mussallem said. “A lot of companies wouldn’t have made it if they didn’t have his endorsement, the ‘Fogarty seal of approval.’”
While he might be best known for his cardiac interventions, he also left a lasting impact on breast cancer, breast healthcare, and women’s health. “I think he always had a soft spot for advancing women’s healthcare,” said Lebovic. “It was important to him, and that kind of focus in the 1980s and 90s was uncommon among medtech entrepreneurs and physicians at the time.”
Will added, “Thinking about how many people Tom impacted…if we look at the ‘family tree’ of companies and people Tom influenced, there are too many branches to count.”
The personal impact ran deep as well. Krummel reflected, “Working and collaborating with him was truly an adventure—the chance conversations, the lessons learned, the shared meals, the laughter, the many board meetings and fundraising efforts. It was more than work; it was deeply rewarding, incredibly fun, and, quite honestly, life-changing.”