WASHINGTON — The Medical Device Manufacturers Association (Washington) kicked off its annual conference here last week by congratulating itself on 15 years of attempting to impress lawmakers on the importance of the medical device manufacturing sector — particularly the concerns of small-to-mid-sized companies that tend to make up the association's membership.

Mark Leahey, executive director of MDMA, told attendees, numbering about 130, that "the story here is the impact that a small, passionate" group of people can have on legislation when they speak with one voice.

Nancy Briefs, chair of MDMA and president/CEO of SmoothShapes (Merrimack, New Hampshire), said that the group's mission in 1992 was "pretty simple and straightforward:" to fight against the imposition of user fees being discussed for the device industry at the time.

The founders formed the group because it believed that, rather than user fees — which they felt would impose a financial hardship on the smaller companies, the big medical device makers — the government should focus on re-engineering the FDA process rather than throwing money at its problems.

At the time, policies affecting their companies were being driven by the behemoths of medical devices, with the Advanced Medical Technology Association (Advamed, then The Health Industry Manufacturers Association; Washington) doing the blocking and tackling for that proposal. The MDMA believes it was instrumental in fending off such a proposal — and device user fees weren't put into place until 2002 (Medical Device Daily, Oct. 29, 2002).

Briefs said that more than $1 billion was invested in medical device companies last year, and that the "most important thing is that our industry remains very robust."

A panel of past chairmen of MDMA then reflected on the association's impact in Washington since its beginnings, but the talk quickly turned to current issues at hand.

Craig Burton, deputy assistant secretary for legislation at the Department of Health and Human Services, said that HHS Secretary Michael Leavitt is all too aware that the current administration has about 600 days left in its incumbency.

Among the priorities he cited for Leavitt was the goal to provide access to healthcare for all Americans, something he said President Bush tasked him to do in his State of the Union speech.

Leavitt is searching, Burton said, for "state-specific solutions" that will then be supported by the federal government, with one of the primary targets being children in need.

Other areas in which initiatives are being studied include health information technology as a way to increase quality of healthcare while controlling costs, Burton said.

Another is "personalized" healthcare, with the secretary's focus now on genomic information and working with Congress on legislation that prohibits discrimination based on genetic testing.

Another area of concern is healthcare preparedness such that the U.S. would be as ready as possible — in the event of a national healthcare emergency, such as an influenza pandemic — to quickly and effectively deploy people and equipment to deal with such an event.

As for the still thorny issue of user fees, Burton told the audience that it was "imperative" that this legislation is passed by the House, and that he is "happy that industry came to a consensus position (Medical Device Daily, May 11, 2007).

Larry Kessler, director of the Office of Science and Engineering Laboratories at the Center for Devices and Radiological Health at the FDA, said that the agency is very interested in "global harmonization of product approval," noting later that this is one of the things that is "frightening" to many members of the MDMA.

He said that the reason for the fear is that if the regulatory approval process were universal, a turndown or indecision could mean that a company "could be off the worldwide market." (Importantly, perhaps, he provided no additional wording attempting to allay such fears.)

Kessler also said that the CDRH realized two years ago that the agency is "vulnerable" as it relates to post-market studies of devices.

Currently, he said, the adverse event reporting system for devices is inefficient. He said that it costs the agency about $4 million a year, using the current process of healthcare providers sending reports by mail to the FDA, which then must log the event into its own database.

Pushing an agenda for documenting and tracking of medical devices that would be contained in an FDA database, in addition to a separate database that would be available to the public so as not to reveal confidential information, Kessler said that the "train is moving slowly" in this area "but we're ready to engage with you at any time."

That later led to Thomas Gunerman, president/CEO of InterSurgical (Liverpool, New York) to engage with Kessler, telling him from the audience floor that the medical device makers "can trace devices now."

And he called such a proposal a "major economic barrier" that doesn't involve specifically an "issue of traceability."

As for reprocessed devices, Kessler said that the FDA doesn't want OEMS to be responsible for reprocessed devices; however, one of its concerns is how to get information on recalled processed devices back to the OEM.

Kessler also told the audience, "You guys" — meaning the smaller firms in the audience — "are actually more nimble than the big guys," which he explained as meaning that they are able to respond to government policy changes more quickly than the bigger companies in the med-tech arena.