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AdvaMed unveils plan for protecting U.S. device industry.

The Advanced Medical Technology Association (AdvaMed) recently unveiled a six-point plan for protecting the domestic medical device industry, 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" comes as representatives from the device trade group say the industry is facing growing competition from developing countries, such as China, India and Brazil; slowing U.S. Food and Drug Administration (FDA) approval times for new devices; and pressures from healthcare reform.

The association advocated the following six steps:

* Innovation in life sciences must be a government priority, including requiring an innovation impact statement for significant new regulations that affect the health sector.

* The FDA review process must be reformed to reduce total review times.

* Payment policies of Medicare, Medicaid and private insurers must support medical innovation and not penalize early adopters of new treatments and cures. According to Steve Ubl, president and CEO of AdvaMed, medical device manufacturers are not the cause of rising healthcare costs. The average growth rate of prices for medical devices is half the rate of inflation, he said.

* A vigorous trade policy must support export growth and provide a level playing field for U.S.-based manufacturing. Foreign governments often block access to their burgeoning markets, Ubl said during a conference call with reporters. The industry had $36 billion in exports last year and a favorable balance of trade, according to AdvaMed, but the trade surplus has shrunk by more than two-thirds over the past 12 years.

* Strategic tax policies to level the playing field must be implemented, including improvements to the research and development tax credit to keep it competitive with other countries.

* The American research and development infrastructure must be sustained and improved. Special emphasis should be placed on creating research structures that support commercialization of R&D.

"We're not making random stuff here, we're improving peoples' lives," Stephen MacMillan, chairman, president and CEO of orthopedic giant Stryker Corp., said during the conference call. "Our industry plays such a great role in improving patients' lives around the world, and we are a great source of producing good manufacturing jobs. As the markets for our products grow around the world, we want U.S. policies to be encouraging job creation here."

AdvaMed also called for the establishment of 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, which would be similar to an environmental impact statement--for any policy in the healthcare field.

A recent report by PricewaterhouseCoopers 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.

Part of the problem is that FDA manages to the wrong metrics, AdvaMed officials claim. "What matters to industry and to patients is not time on the FDA clock, it is the total time from the time the product is submitted to FDA for review to the time it is cleared for market. Accordingly, FDA must set a goal of reducing total review times."

Adoption and execution of these policies will not be easy, Ubl said, "But the payoff will be great. Medical technology companies can be a driver of long-term economic growth and prosperity, as well as improved public health, but government must do its part by sustaining the innovation ecosystem that is essential for long-term success."
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Title Annotation:Washington Roundup
Publication:Medical Product Outsourcing
Date:Jun 1, 2011
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