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Medical device industry calls for White House innovation office

by Brendon Nafziger, DOTmed News Associate Editor | June 06, 2011
A medical device industry lobby launched Monday a six-point plan for protecting device manufacturers, calling for everything from increased funding for basic research to creating an innovation office at the White House and scrapping the medical device tax.

The "Competitiveness Agenda" was unveiled by AdvaMed, a medical device lobby, which said it spent the last year working on the document to support the estimated 7,000 medical device companies in the United States.

The plan comes as the industry says it faces growing competition from developing countries, such as China, India and Brazil, slowing Food and Drug Administration approval times for new devices, and pressures from health reform.

"We're not making random stuff here, we're improving peoples' lives," Stephen MacMillan, chairman, president and CEO of the medical device company Stryker, said in a call with reporters.

The ambitious plan mostly focuses on encouraging innovation in a sector that AdvaMed says employs around 420,000 people. The group calls for establishing an office of medical device innovation policy at the White House, which would have oversight on policies that affect medical innovation. As part of this proposal, the group also wants federal agencies to draft an "innovation impact" statement -- similar to an environmental impact statement -- for any policy in the health care field.

In its second point, AdvaMed wants to speed up what it considers to be sluggish FDA review times. The medical device industry wants approval regulations to be more in line with Europe's, where products generally come to market a couple of years earlier, the trade group said.

For its third program, the lobby wants to ensure new Medicare programs, such as accountable care organization plans, don't penalize early adopters of new medical technology.

In addition, for its fourth program, the group wants the Obama Administration to continue fighting against barriers to trade. The industry had $36 billion in exports last year and a favorable balance of trade, AdvaMed said, but the trade surplus had shrunk by more than two-thirds over the past 12 years.

On the tax front, AdvaMed called for making the research and development tax credit more generous and simpler to apply for, and it again called for axing the 2.3 percent excise tax on medical device companies included in last year's health reform legislation.

Lastly, for its sixth proposal, the group wants to protect the budget for basic science research at the National Institutes of Health and the National Science Foundation, under threat in current congressional budget squabbles, and grants to start-ups.

A recent report by PricewaterhouseCoopers (PwC) cited by the lobby found that America still beat the other nine major world economies on the five dimensions of medical device innovation analyzed, but that its lead was slipping.

“The innovation ecosystem for medical device technology, long centered in the United States, is moving offshore," the study said.

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