Medical Device Daily Washington Editor

WASHINGTON – A pair of the FDA's top brass addressed the 12th annual meeting of the Medical Device Manufacturer's Association (MDMA; Washington), discussing the agency's interest in keeping the pace of innovation up in the years to come, but it seems unlikely that PMA filings will move through the regulatory mill any more quickly in the next few years than they do now.

Acting FDA Director Andrew von Eschenbach addressed the 2006 edition of the MDMA meeting on Wednesday morning and commended attendees for their “incredible evolutions in technology.” Von Eschenbach said that he will challenge the agency to be not just a science-based entity, but to “proactively facilitate the fruits of research” in pursuit of public health. He cited the “increasing complexity of medical device development” as one of the hurdles the FDA and industry must find a way to rise above in their efforts to save lives, but that the complexity was the result of innovation that will inspire “a much greater degree of hope” and more effectively address both mortality and morbidity.

Von Eschenbach also remarked that “the pace of innovation is accelerating” largely due to progress in research, but that patients “could care less about our drugs, our biologics, [and] our devices” if those products fail to address their ills. He argued that combination products will continue to play a greater role in healthcare, a situation he said “requires an integration” of effort.

“Too often, we have worked in silos, but more and more,” the agency and industry must find ways to merge multiple products to maximize the benefit to public health. The former director of the National Cancer Institute (Bethesda, Maryland) observed that the exponential pace of change in medicine is due largely to the “molecular perspective” that particle physics has opened on the cell and even the cell nucleus and its contents.

Von Eschenbach spoke of a more aggressive role for the FDA in advancing both innovation and ensuring that those innovations make their way into hospitals, doctor's offices and pharmacies. He stated that the agency is committed to strategically placing itself “between discovery and delivery,” and vowed that the agency is “committed to providing the infrastructure” needed to bring technology to the patient, including those innovations spurred by nanotechnology. He added that “the integration of FDA at the White Oak [Maryland] campus” will help the agency to “not just regulate, but to facilitate” innovation.

The agency's inventory of data processing hardware and software is in need of improvement, von Eschenbach noted, but between such upgrades and a more timely and relevant guidance framework, the agency hopes to “relieve the regulatory burden for both of us.”

CDRH chief Dan Schultz followed his boss at the microphone and discussed a few of the things the center is working on. He noted that the mission of his arm of the FDA is still to establish a “reasonable assurance of the safety and effectiveness of medical devices and the safety of radiological products,” emphasizing that “reasonable” is a crucial concept. However, Schultz did not elaborate on this.

He reminded attendees that patient awareness has moved into the foreground of medical care. “The idea of a patient going into a doctor's office” and getting a referral or a prescription without wanting to know more about what is involved “is a thing of the past.” Schultz also pointed out that “we see an increased emphasis” on computer-related recalls, much based on problems with software, and noted that many new technologies, including nanotechnology, are making their way into widespread use.

Schultz commented that while the Critical Path Initiative is primarily aimed at drug development, “we think that there's a real role for a critical path for devices” that takes into account the different characteristics of devices. As part of the device Critical Path, CDRH is working on a computer model to simulate the action of stents in a virtual in vivo world for both adult and pediatric populations, and will develop surrogates for outcomes to aid this process. The so-called virtual family will consist of rigorous, dynamic software models that will help firms weed out problems before the loss of sizeable investments that contribute so much to the cost of healthcare.

Schultz admitted that the Medical Device Innovation Initiative (MDII) (Medical Device Daily, May 30, 2006) does not represent a paradigm shift at CDRH, but that it is “a look at some of the things we have been doing as well as some of the things we want to do” in a way that “puts it all in a package.” He commented that part of MDII will be an emphasis on regulatory clarity via guidance documents in a more streamlined system.

“We're trying to put together a focused process on guidance development for areas of greatest need,” including an emphasis on “getting guidances out the door.” For better or for worse, some of the CDRH staff will serve double duty on both guidance development and product review, but Schultz reassured the audience that the staffing problem is easing.

“We're hiring again,” he remarked, noting that the CDRH has added “an incredible group of energetic young people.” Schultz's chart indicated that staff numbers for most functions are up in FY 2005 over 2002, but not for administrative staff. In terms of raw numbers, the staff in the engineering is up from just over 170 to more than 230. Biological science staffing is also up, but consumer safety officers, a.k.a. field investigators, are down in numbers.

However, “[o]ur statistical group has been reborn,” Schultz reported.

Site visits represent a function that Schultz said “gives us a greater understanding of what your challenges are,” but he warned that “we will not be able to hire our way into [a state of] expertise on each project.” However, the medical device fellowships should fill most of those holes adequately. Schultz pointed out that four out of every five dollars CDRH spends goes toward salaries.

“The amount of information we're getting is increasing exponentially,” Schultz lamented, but the agency is working on an e-consult system to speed up the exchange of ideas between FDAers to more quickly expedite things. He also mentioned the Turbo 510(k) program as one of the other systems that the agency rolled out in 2005, but urged industry to jump on the electronic bandwagon.

“This is my plea to you today: if we could get one e-copy [for PMAs, 510(k)s and other filings in addition to har copy], it would allow us to reduce or eliminate our document scanning contract and save us $1 million a year.”

The stretch goal for PMAs has not materialized as was acknowledged last month by Linda Kahan, the deputy director at CDRH (MDD, May 24, 2006), and Schultz remarked that “the system has been much more distorted” by the effort to meet the objective of returning a decision within 180 days for half of PMAs. He reiterated the assertion by Donna Tillman, the director of the Office of Device Evaluation, that the more aggressive schedule prompted more deficiency letters. However, he noted that “we are open to ideas” on how to use meetings to hash some of these issues out.