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AdvaMed Creates New IVD Division, AdvaMed Dx, in Push to Expand Membership into Growing Market


By Turna Ray 

The Advanced Medical Technology Association last month announced the establishment of a new division, called AdvaMed Dx, dedicated to representing the interests and issues affecting in vitro diagnostic manufacturers.

According to Kenneth Mendez, AdvaMed's chief administrative officer, the new division was formed in an effort to “generate additional revenue, attract new members, and service existing ones.”

AdvaMed's 1,700 member companies include medical device developers, diagnostic firms, and health information systems providers. The organization is aiming to grow its membership by 10 percent through the formation of the new division, among other organizational efforts.

The newly formed AdvaMed Dx's board has not had its first meeting yet, so the issues the group will take up in 2010 haven't yet been solidified.

“We work on IVD [issues]. That's part of AdvaMed's bread and butter,” Mendez said, noting that the formation of the new group won't necessarily change the key policy issues for IVDs that the trade association already backs.

AdvaMed in 2009 supported increased funding for federal grants for medical technology research; advocated for the establishment of a more streamlined regulatory system for all diagnostic tests, including more resources for the risk-based evaluation of novel technologies; and backed the US Food and Drug Administration's efforts to “expeditiously reclassify” pre-amendment Class III device types, as recommended by the Government Accountability Office, while maintaining the flexibility inherent in the 510(k) process to review medical devices.

The device manufacturers' trade association has spoken out in support of value-based Medicare reimbursement for diagnostic tests, and backs payment initiatives such as bundling, gainsharing, and reform of physician payments that recognize innovation in medical devices. In 2009, AdvaMed also advocated for maintaining infringement damages that “fairly value medical device patents,” and backed the development of an “industry-wide code of ethics to ensure ethical collaboration among industry and healthcare professionals.”

Last year, the federal government provided $1.1 billion from the American Recovery and Reinvestment Act for research that compares the effectiveness and safety of medical products. On the issue of comparative effectiveness research, AdvaMed felt that data from such studies should inform medical decisions, but should not replace physician judgment or be used to make insurance coverage decision.

It is likely that AdvaMed Dx will take up many of the trade association's existing policy positions.

“Since [AdvaMed Dx] was just conceived and as the group pulls together — we think that will be in the next 60 days — we'll start off on a strategic planning process and ... create a path forward, both on the policy side and on the organizational side,” Mendez said. “I don't think it's going to differ much from what we've been doing policy-wise all along ...”

AdvaMed Dx will operate under the leadership of an 18-member board of directors and an eight-member executive committee, comprised of CEOs from IVD companies. The board will be chaired by Scott Garrett, Beckman Coulter’s chairman, president, and chief executive officer. Full-time staff positions will include an executive director role and a director of communications.