Superstar medical device inventor and industry legend Dr. Thomas Fogarty may have ended up in a very different place had he come up under today’s FDA.
Dr. Fogarty’s namesake balloon catheter opened the door for minimally invasive surgery and has saved countless patients’ lives since it was patented in 1969, but the inventor is pretty certain that the technology wouldn’t have made it to the market if it had been subjected to today’s regulatory environment.
The FDA monitored only food and drugs in the early 1960s when the idea for Fogarty’s balloon embolectomy catheter was taking shape. Fogarty, under the watchful eye of his mentor, tested his prototypes and began experimenting in patients without regulatory intervention, ultimately spending about $2,000 to get the device to 1st-in-man use, he told MassDevice.com.
The technology is rather simple, comprised of a hollow tube with a balloon at one end that doctors can thread through blood vessels via a small incision, rather than resorting to open surgery. However, the concept was so far from clinical practice at the time that Fogarty believes a present-day FDA would have forced it through years upon years (translating to millions upon millions of dollars) of testing.
"If you were to submit that today, it was so unheard of by the FDA, they would just make you do animal after animal, bench test after bench test, and then they would make you do this in a human I don’t know how many times," he said. As far as the cost, he guessed somewhere around $20 million. "But I’m not sure about that. Part of the reason I’m not sure is the FDA is unpredictable. You’re not going to know what the hell they’re going to ask for."
It wouldn’t be impossible to get the catheter through today’s FDA, he noted, but it would be very costly and take a very long time, and Fogarty’s seen those hurdles break other companies. The pressure sometimes drives innovators out of the industry or simply bankrupts young firms.
When asked if he would have put up with it for his balloon catheter, he flatly responded, "No way."
Fogarty has been a vocal critic of the FDA, while also providing consulting services to the agency. He holds more than 70 patents, was in 2001 inducted in to the National Inventors Hall of Fame and in 2007 founded the Thomas Fogarty Institute for Innovation in Mountain View, Calif. The institute is an incubator for young innovators, providing facilities, mentorship and other resources and opportunities to help companies navigate the path to the market.
Although he’s got some tough love to pass down to emerging innovators ("Don’t think you know anything, because you know nothing."), Fogarty also emphasized the gratifying nature of developing medical devices.
"It’s wonderful to be able to innovate, particularly in the medical field," he said. "If you developed something that is adopted by other physicians, then you’ve touched many patients. If you just operate on somebody, you’ve touched one patient. It’s much more satisfying to have been involved to such an extent you benefit many patients, that’s very satisfying."