Diagnostics & Imaging Week Washington Editor

WASHINGTON – The annual meeting of the Association for the Advancement of Medical Instrumentation (AAMI; Arlington, Virginia), which ended here Monday, gave attendees a close look at a variety of new technologies and ways of doing business, but the lunchtime address on the second day of the three-day event reminded device and diagnostics makers that as innovators continue to surge forward with their innovations, the FDA is in scramble mode to keep up with industry.

Donna-Bea Tillman, PhD, director of the Office of Device Evaluation at the Center for Devices and Radiological Health (CDRH), recommended that industry begin to take a less-jaundiced view of postmarket studies of their products, insisting that such studies can pay handsome dividends as technologies change.

Tillman titled her presentation "Medical Device Life-cycles: The Myth of 'Premarket'" to emphasize the changed nature of the typical product lifecycle and how that change affects the agency's regulatory workload.

"The notion that there is a premarket and a postmarket phase is a little outdated," she said – a clear understatement. Due in part to the fact that medical device and diagnostic development now more often involves products already on the market, postmarket monitoring, "is one of the most challenging roles" that she and her colleagues at the agency face.

"The model we're not looking at is more of a circular model" due to the fact that devices and diagnostics are "constantly evolving," Tillman said. But this is not the only reason that CDRH is feeling the pinch. "The complexity of technology is enormous," she noted, but devices are also getting smaller, and homeland security issues are putting an additional burden on FDA.

"Congress is coming to the agency and saying 'You have a role to play,'" Tillman said, pointing out that Congress wants the nation's drug and device watchdog to come up with devices that will detect anthrax and other pathogens that may be of interest to terrorists.

The fact that doctors are sending patients home with more equipment than in times gone by and the addition of microprocessors to make devices "smart" also have boosted the technical and tracking demands on the agency.

On another front, the need for more population-specific technology also increases the load.

While pediatric devices are a great point of interest at FDA, Tillman noted that such technology "raises a lot of questions," and she said that CDRH expects this to be an area "where we will spend more of our attention in the years to come."

Combination products made their way into the ODE chief's presentation, and she reminded the audience that a combination product can include the ordinary use of a drug and a device – such as contrast agents and imaging technology – or the co-packaging of a drug and device.

Tillman acknowledged "a real culture difference" between CDRH and the Center for Drug Evaluation and Research, despite the considerable effort that the agency has put into building a regulatory regime to address combination products. "Making them mesh is quite a challenge," she said.

Despite the secretive and exotic machinery under development at well-financed agencies such as the Defense Advanced Research Projects Agency, she said that the FDA does not have the kind of state-of-the-art technology possessed by some of the firms it regulates. "This mismatch is the bottleneck" that is part of what the Critical Path Initiative seeks to address, Tillman said.

She added that while the tremendous boost in funding for the National Institutes of Health (Bethesda, Mary-land) during the 1990s has advanced medical technology greatly, one effect of this has been practically to swamp its sister regulatory agency.

And she said that media exposure hasn't made the agency's task any easier at times. The constant stream of reports of product failures and recalls creates "a lot of concern for us and a lot of people on Capitol Hill," with the latter not being at all bashful about loudly voicing its concerns to FDA headquarters.

Medical device reports totaled more than 180,000 in FY05, Tillman said, thus constituting "a really big challenge" in terms of figuring out which are suggestive about the safety and efficacy of the product and which are essentially incidental in nature.

Bringing up the controversial subject of the Medical Device User Fee Modernization Act (MDUMFA), she told attendees that the legislation "has been a critical part" of CDRH's efforts to staff up and get products out of the pipeline and into the market. She pointed out that MDUFMA will expire in 2007 and asked industry to make its voice heard on how it wants to reshape and improve MDUFMA II.

Reverting to the subject of revamped medical devices and diagnostics, Tillman urged industry to see post-approval studies and studies imposed as conditions of approval as "not just a burden," but as an opportunity. And she charged that some elements of industry have not approached these in a serious manner.

"Historically, [such studies] have not been particularly well designed," she said, "and have not always been completed."

But she argued that these types of studies often are crucial to further device development because the data can be employed to support proposed design changes and additional applications.

Of the seven guidances the agency published in 2005, Tillman expressed special interest in two, those addressing cyber security and software employed in premarket submissions. "We have some outdated technology," she said, but offered the hope that one day, "maybe we'll rely on electronic submissions" as a way to streamline the paperwork burden.

Several members of the audience expressed amazement at her comment that "it's not really efficient" to scan submission documents into the CDRH database. She also noted that the Office of In-Vitro Diagnostics (OIVD) has rolled out the successor to the Turbo 510(k) program, dubbed CeSub (CDRH electronic Submissions).

According to the OIVD page at the FDA web site, this downloadable program "contains a number of data capturing tools and helpful dialog boxes to reduce redundant responses for you, and to allow us to capture data in a more useful, structured format."

Tillman told Diagnostics & Imaging Week that other centers at the agency are looking into the software and that while the program is currently treated as shareware, "we're not sure we're going to follow that model" in future versions.