Medical Device Daily Washington Editor

ROCKVILLE, Maryland - "The thing that is so exciting about the device sector is just how vibrant it is," said David Feigal, MD, director of the FDA's Center for Devices and Radiological Health (CDRH). "The sector continuously adopts innovation and brings out whole new product areas."

Feigal's five years as head of CDRH and 12 years at the agency overall draw to a close tomorrow as he prepares to move to Arizona, where his wife is pursuing a career opportunity. He told Medical Device Daily that his departure comes at an "exciting time" for the center and for the device industry, but that he is looking forward to re-entering academic life as part of a medical school faculty, as well as staying active with special projects in the area of therapeutics.

Of the many things Feigal looks back on as accomplishments as the center's director, he said communications and relationship building were among the most important. "I've done a lot of outreach," he said. "I have a record that will never be challenged, I don't think, which is that in five years I visited 21 FDA district offices and a lot of regional device associations." He said that part of the directive when he was appointed as head of CDRH was to get out into the field to learn what was really going on.

"I realized that if you just stay back here at headquarters you get a very myopic view," he said. "You sort of think everything revolves around the applications and products that come here. In five years I delivered 400 speeches at universities, trade associations, scientific meetings and professional meetings. I think it was even more important to do that for devices than for drugs, because everybody knows about drugs and FDA, but you sort of have to remind people about all of the exciting things going on with devices and all the interesting ways that they're different."

Feigal said visiting device developers and manufacturers helped provide a more real-world view of the industry, and how the FDA must interact with the sector. "It has been very interesting for me to work with the device companies," he said. "I've walked through about 40 different manufacturers while I've been here and certainly have met a lot of the leadership in the device industry. There are a lot of people who are really trying to make progress and move things forward. I think working with people is the thing I have enjoyed the most."

He said the people aspect also extends to the CDRH staff. Feigal said the center has a very distinct character compared to other branches of the FDA. "We have a tremendously motivated and talented staff here. The thing that gives the center its unique personality is that it's not organized by academic disciplines. If you go to one of our review teams, you'll have engineers mixed in with clinical people, mixed in with physicists, mixed in with people with biological and life sciences training."

Noting that the other units of the FDA are much more segmented by scientific discipline, Feigal said, "Part of what makes interacting with people here interesting is the very high quality and being able to learn across multiple disciplines."

It's the educational culture that Feigal said he is most proud of. He said the center has more educational programs going on now than at any other time in its history. "I've really sought out opportunities to make a difference on the strength of the education and science programs at the center," he said. "One of the things we've done is to create both bachelor's and master's level course work within the center, taught by local educational institutions."

For example, CDRH offers a joint program called the Medical Science Leadership Program where faculty from Georgetown (Washington) and Virginia Tech (Blacksburg, Virginia) are teaching graduate-level courses. Feigal said the two schools complement each other nicely because Georgetown has a medical school and ethics and humanities program, and Virginia Tech has an outstanding bioinformatics center, engineering department and school of veterinary medicine.

"The courses we have offered so far have been in bioethics, risk assessment and statistics," he said, adding that the rationale was to provide different groups with skill sets or information they may lack in order to round out their experience and make them more valuable to the center. "Certainly not the physicians, and probably not even the electrical engineers, took a course in biomaterials," Feigal said.

The center also offers courses to staff without science backgrounds. Its Consumer Safety Officer series, which requires a certain amount of credit hours of undergraduate science, prepares personnel to become program planners or project managers. "Right now, if you were to look at the center, we have about one person in 25 enrolled in a course for college credit or graduate student credit being taught onsite," he noted.

Feigal said he also is proud of the work he has done to develop a program for external experts and consultants to offer their expertise to the center. Right now, he said that the advisors and consultants program provides 350 experts for the center's 27 panel meetings a year. "This comes partly as a response to a real request from industry," Feigal said. "Prior to the user fee days, [companies] even offered to pay for it when they requested it. While we didn't use the mechanism of them paying for the outside experts, we took that to heart as a good idea to get us much more involved and interactive with the universities around the country and to work with faculty."

He says these are the kinds of things that have his stamp on them. "In the big picture of our budget, they're not terribly expensive," Feigal said. "They're sometimes labor-intensive to get started, but once you get them rolling there's a lot of enthusiasm for them."

The Medical Device User Fee and Modernization Act of 2002 will, he said, support the center's effort to increase education, staffing, and make it more responsive to the pace of development.

"I think that it financially got off to a slower track than any of us wanted," Feigal noted. "But in the third year of the program, in the 2005 budget, the president, the OMB [Office of Management and Budget] and the department are all on board to bring the center's appropriated funding up and maintain that adjusted for inflation. So that's back on track."

He said the struggle has been whether or not the fees are assigned correctly. "It was largely industry's strong feeling that the program should be funded from the application process, rather than also from the manufacturing registration and listing, as they do for drugs and biologics," he explained. "It's probably too soon to say whether that is going to work out or if that is putting too much of a financial burden on the applications." Feigal said that by the 2005 fiscal year, the center would be very close to the financial level originally envisioned.

"I think we'll make the goals, or we'll be very, very close," he said. "What industry will get back from that is they'll participate in the rebuilding of the center as we hire all of these new people, and that participation will help us actually set the priorities for the center and a partnership with industry."

Feigal says the program also will enable a faster time to market, especially for breakthrough products in ways not available before.

"I think the program is in very good shape," he said. "Though there is a lot of discussion about specific features or making changes, I don't think that should detract from the fact that hiring is on track, progress toward the goals is on track, and I actually think we're in good shape with it."

Medical Device Daily, April 29, 2004