AdvaMed: July-August 2013

AdvaMed: July-August 2013


Since 1974, AdvaMed-short for Advanced Medical Technology Association-has represented the medical technology sector. Today, the organization has more than 300 members of all sizes, representing medical devices, diagnostic products and health information systems.

The idea of a medical device may conjure images of a cutting-edge machine using breakthrough technology or perhaps the latest diagnostics or genetics test; indeed, that would certainly qualify. But items such as tongue depressors and hospital gowns also fall under the umbrella of AdvaMed's membership.

"In a sort of broad-brush way, it's everything that's used in medicine that's not a drug," explains David Nexon, AdvaMed's senior executive vice president.

The medical device tax that was enacted with the Affordable Care Act is a key policy concern for AdvaMed at the moment. "It's such a drain on our U.S. competitiveness and our companies' ability to fund research and development," Nexon said.

Other policy concerns include keeping America's taxes competitive globally as part of any tax reform movement; changing the incentives in the reimbursement system to focus on sustaining medical progress while reducing costs; helping AdvaMed's members navigate the regulatory and payment structures outside the U.S.; and continually working with the Food and Drug Administration to improve the agency's efficiency at reviewing new technology. Like pharmaceutical companies, medical device companies pay user fees to FDA in order to speed up the approval process; sequestration has affected FDA's ability to use those fees for their intended purposes.

"The sequester, with the way it's set up, it keeps you paying the user fees but then doesn't let FDA use a portion of the money," Nexon said, "and that's clearly wrong."

Nexon said that Research!America's focus on advocating for all research, with the eventual end goal of better treatments for patients, is a key reason why AdvaMed is a member.

"I think Research!America is a very powerful voice for the importance of both public investment in research, but also creating a climate in the United States that's friendly to medical progress and developing innovation, whether that comes out of the private sector or the public sector," Nexon said.

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If concerted, long-term investments in research are not made, America will lose an entire generation of young scientists.
Brenda Canine, PhD; McLaughlin Research Institute, Montana