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Inventor Thomas Fogarty's Newfound Optimism About FDA

In an interview with "The Gray Sheet," renowned inventor and entrepreneur Thomas Fogarty says he is encouraged, based on his recent experience with FDA, that regulatory trends slowing U.S. device innovation can be reversed.

Mountain View, CA – March 21, 2012 – The idea that risk-aversion and opaqueness at FDA are weakening the U.S. medical device innovation model is a truism among large segments of industry. But renowned inventor, entrepreneur and frequent FDA critic Thomas Fogarty says his recent dealings with top CDRH leaders give him reason to hope that the agency is moving in the right direction.

"What you see with FDA now is a change in attitude," Fogarty said in a recent interview with "The Gray Sheet." "They do not now want to be a deterrent to innovation in the medical field, and are really trying to change that."

That is a significant adjustment in perspective from an industry leader who has labeled FDA an obstruction to medical progress. The adjustment is informed by Fogarty's experiences over the past six months working directly with CDRH officials to develop new pathways for innovative products.

In October, Fogarty was one of 20 entrepreneurs, scientists and business leaders who joined CDRH's "entrepreneurs-in-residence" program to assist the center in developing its new "innovation pathway" pre-market program for breakthrough products. (See "Start-Up FDA? CDRH Seeks Entrepreneurial Spirit With New "In-Residence" Program" –"The Gray Sheet," Oct. 10, 2011.)

Policies developed as part of the entrepreneurs-in-residence program "should work, will work," Fogarty said, but with one major caveat: "The question is, can they be implemented?"

The initial effort, sponsored by the White House Office of Science and Technology Policy, was slated to wrap up sometime this month, allowing the kick-off of the so-called "Innovation Pathway 2.0" program. (See "Risk And Benefit, Quantified: CDRH Expands Use Of New Statistical Framework" – "The Gray Sheet," Jan. 2, 2012.)

Fogarty says he will leave it to FDA to announce the details developed by the team, but he is clearly enthusiastic about the experience. "I learned a lot," he said. "They have certainly come up with directives that are very, very positive."

Going Backwards
Fogarty, who last month was selected as the first Fellow of the National Academy of Inventors, has a long history dealing with the device side of FDA. He counts the ubiquitous balloon catheter, developed in 1960s, among his 100-plus inventions, and he has founded or co-founded more than 30 medical device companies. He also co-founded the device-focused venture capital firm Three Arch Partners and, most recently, the Fogarty Institute of Innovation. (See "The Fogarty Institute For Innovation: A Device Incubator For Difficult Times" – IN VIVO, July 2011.)

The regulatory environment has gone downhill in recent years, he asserts. "In the field of innovation, and particularly medical device innovation, we have actually gone backwards to a significant degree," Fogarty said.

It used to be that when someone developed a new medical technology, "everybody recognize[d] that what you were trying to do was to basically help patients," he explained. Now, he laments, many regulators "look at the attempts to help people as being motivated by selfish motives."

The view of "physicians and industry as evil people" persists within FDA's culture, he argues. But, he suggests with some optimism, there is a growing dynamic, particularly among top brass at the agency, in favor of shifting course and collaborating with industry.

A Change Of Heart
"The senior people recognize that they have not been as efficient as they should be in getting products to the marketplace," Fogarty said. "They openly acknowledge that we have a problem."

As recently as a year or year-and-a-half ago, "they were taking the stance of, 'Well, the problem is not as bad as you think.'" Now, he said, "I think they have acknowledged that the problem is bad and that it is getting worse. They are very sincere about that."

In particular, he noted, device center officials have sought advice and collaboration from outside critics.

"The fact that they asked me to help them means that they are really trying to change, because I have not been too friendly with the FDA," Fogarty said. "And I think the fact that they said, 'Maybe there is something to our shortcomings. We ought to talk to those who have been berating us.' That in itself is very positive."

The yet-to-be-released policies developed as part of the entrepreneurs-in-residence program "should work, will work," he said, but with one major caveat: "The question is, can they be implemented?"

The segments of the agency that remain "so suspicious of industry that they have a difficult time collaborating" could stand in the way, he said.

"If there is not truly significant change, the deterioration of the medical-industrial complex in the U.S. will continue," he said. "What has to occur is increased throughput at a lower cost for devices in the U.S. What we are doing now is not a sustainable thing."

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