August 02, 2011 19:24 ET

The Impact of Washington Policy on Medical Device Innovation

Washington Insight From MDMA VP at August 9, 2011 SEMDA Meeting

ATLANTA, GA--(Marketwire - Aug 2, 2011) - Thomas Novelli, Vice President of Government Affairs for the Medical Device Manufactures Association (MDMA), will speak at the August 9, 2011 meeting of the Southeastern Medical Device Association (SEMDA). Novelli will provide an inside view of the government policies and agencies impacting medical technology companies. The meeting will begin at 5:30 PM and will be held at the Ravinia Club ( to register).

"The greatest challenges today for medical device companies center on a lack of certainty and predictability from the FDA and the lingering impact of health care reform," says Novelli. "We see several trends within the industry from these two issues.

"However, the primary trend is that many new medical technology companies are choosing to commercialize first in Europe and then in the U.S. (if at all)," Novelli continued. "Larger companies are also trending towards performing clinical studies outside the U.S., as well."

The meeting is being sponsored by the Global Center for Medical Innovation (GCMI), a state-of-the-art product development center affiliated with leading medical and academic institutions. Learn more at

"Tom spoke briefly at a SEMDA Conference, and he brings unbelievable insight and honesty to the challenges facing medical device companies," said David Hartnett, SEMDA's 2011-2012 president and Vice President, Bioscience Industry Development at the Metro Atlanta Chamber. "I am delighted that we can bring someone with Tom's national standing to our August meeting."

One topic Novelli will address is the challenge of balancing patient safety against innovation. "I believe that the FDA must do a better job in providing innovators a more predictable and rational pathway for products to be cleared or approve through the regulatory system," he said. "Several academic and FDA-sponsored studies have found that, especially for 510k products, the FDA has done a good job of ensuring safety, with more than 99% of those products NOT being subject to a recall. The agency, unfortunately, has been less predictable and transparent with companies; moving the goalposts midway through the process."

Novelli manages a portfolio of policy issues for MDMA. He joined MDMA after working on the U.S. Senate Committee on Finance for former Chairman and Ranking Member Senator Charles Grassley for four years. At the Committee, Novelli worked on several areas directly affecting the medical device and pharmaceutical industries including federal reimbursement, drug and device safety and approval, and fraud and abuse in the Medicare and Medicaid programs. Novelli conducted several high-profile investigations into the pharmaceutical and medical device industries including the investigations of the use of educational grants and off-label marketing, clinical research organizations, and conflicts of interest in the healthcare industry.

Novelli holds a Master of Arts in Policy, with Honors, from the Catholic University of America and a Bachelor of Arts in Political Science, with Honors, from the University of Dayton. He is currently pursuing a Master of Business Administration degree from the Johns Hopkins University.

The Southeastern Medical Device Association (SEMDA) is a non-profit trade association that supports and promotes medical device companies in the Southeast. Created in 2004, the association provides a unique resource and networking opportunity for medical device companies, inventors, physicians, and investors interested in accelerating the growth of the medical device industry in the Southeast. Through quarterly and members-only meetings, as well as its highly regarded annual Conference, SEMDA meets the needs of members of the medical device community. Learn more at

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