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State’s Medical Device Sector Raises Issues with FDA

Impact of Policies Key Topic at Boston Forum With Agency Head

BOSTON – July 11, 2011 – The head of the state’s medical device association today raised key issues of concern with the Commissioner of the Food and Drug Administration (FDA) during a forum in Boston with over 50 device executives.

In the forum arranged by Sen. John Kerry, Tom Sommer, the president of the Massachusetts Medical Device Industry Council (MassMEDIC), said he was concerned about “inconsistent guidance” from the FDA.

“Unfortunately, over the past several years, from the perspective of most in this industry, we have seen troubling signs that we believe will jeopardize our position as the world’s foremost medical device cluster,” Sommer told Dr. Margaret A. Hamburg, the FDA Commissioner and Dr. Jeffrey Shuren, Director of the agency’s Center for Devices and Radiological Health.

The Massachusetts medical device industry represents 12 percent of the state’s exports, and the exports are growing at double the rate as all other Massachusetts exports combined. Massachusetts has the second largest number of jobs in the medical device industry with over 82,500 direct and related positions behind only California.

Sommer discussed the frustration with the current regulatory environment, including the lack of consistent guidance, the inability of the agency to assess new technologies in a timely manner, and concern that the industry’s voice is not being fully considered in policy development and execution.

Sommer said the delays in product reviews due to changing requirements often brought up by FDA reviewers just before the “90 day 510(k)clock” is about to expire, and have reached a critical point where delays have:

  • Forced device companies to place a primary focus on introducing products to market in Europe, where a predictable but no less rigorous product review process is in place. This growing trend provides European doctors and patients access to products developed in the US up to a year before our providers and patients.
  • Stalled hiring of additional workers for new product lines – such as one MassMEDIC member start-up that has been waiting for over six months to hire up to 60 workers to manufacture and market its new product.
  • Postponed investment for early-stage medtech companies – limiting access to the new technologies they develop and delaying additional hires.

“If you were to spend a few hours researching the corporate mission statements of US medical device companies, you would in the vast majority of cases find that improving patient outcomes is priority one. In order for us to continue to make these devices available in a timelier manner, we urge the agency to listen to testimonials and policy reactions and to work with us more effectively in the future,” Sommer said at the forum.

Sommer also cited the concern surrounding the proposed revisions to the 510(k) process last August that, if fully implemented, will likely lengthen review times and impose additional costs and process to a product review protocol that has become unreliable and inconsistent.

“The state’s medical device companies very much appreciate the efforts by Sen. John Kerry and his staff in arranging today’s forum and we hope it will lead to improvements in the relationship between the FDA and our device companies,” Sommer said.