Innovation and competition. These go hand in hand and they are the topic of nearly every press conference and land on the agenda of almost every industry meeting. But the focus is not how to innovate. Rather, it’s on why the US leadership position is in jeopardy—and what we need to do to stop further erosion. And while fixing the problem is more important than fixing blame, all eyes are on FDA. Studies, reports, and experts all say that FDA, while not the whole problem, plays a crucial role in reversing this trend. We don’t mean to pressure you FDA, but our future is sitting squarely on your shoulders.

“We’re facing critical issues. Our watchword for the year is competitiveness,” said James Mazzo, president of Abbott Medical Optics and chairman of AdvaMed. “The press is talking about it; members of Congress are talking about it. It’s going to be the driving force for AdvaMed’s advocacy agenda for the foreseeable future.” Mazzo and AdvaMed president Steve Ubl spoke in detail on this topic at a press conference in February.

And there are reasons for concern. Mazzo said that he is concerned that our innovation could be slipping because of the regulatory issues. “The recent PwC report echoed those concerns. America’s positive trade balance for medical technology continues to shrink. Venture capital investment is growing faster in Europe than it is in America.” And how does VC funding fit into this regulatory picture? VCs, Mazzo said, are reluctant to fund our earlystage companies, meaning that “some potentially game-changing technologies will never see the light of day here in the United States.”

At the heart of the problem, they said, is a regulatory system that while “fundamentally sound” simply must be fixed to ensure that the US medtech industry retains its unchallenged leadership position.

A key ingredient of our continued competitiveness, said Ubl, is a predictable regulatory process. Ubl quoted President Obama’s recent op-ed in the Wall Street Journal in which the president talked about improving US competitiveness with predictable regulation. In his op-ed, he included a specific reference to improving the 510(k) process.

“We believe a strong, properly restored, and well-managed FDA benefits everyone,” said Ubl. “There have been a series of reports in the last few weeks that show a disturbing trend.” Ubl was referring to a report by PricewaterhouseCoopers (PwC), one by the Boston Consulting Group, and one by Stanford professor and medical device entrepreneur Josh Makower, MD. All were released in recent weeks. All had similar findings that pointed to an inconsistent and lengthy regulatory review process as the primary factor in our slipping grip on innovation.

“Because of FDA’s declining performance, American companies and American patients are increasingly left out and left behind. The report from PwC shows that regulatory systems in competing countries were less burdensome and more consistent,” said Ubl.

“The data show that the US is at risk of losing its global leadership position in medical technology innovation,” said Makower, in reference to the findings from his study. Makower’s study was supported by the Medical Device Manufacturers Association. “By overwhelming majorities, the companies surveyed reported that European regulatory authorities were more predictable and more transparent than FDA.”

The California Health Institute also recently held a press conference in which it announced similar findings from its 2011 California Biomedical Industry report (conducted in conjunction with BayBio and PwC).

“The danger is that other parts of the world are quickly catching up with the pace of innovation,” said Gail Maderis, president and CEO of BayBio. “They are taking steps to build biomedical ecosystems of their own, and they are aggressively competing with this infrastructure.” By contrast, she said that US federal policies are putting US companies at a disadvantage. “FDA is at the top of the list,” she said. Like others in industry, she echoed that such inconsistency in the review process has created an environment of unpredictability.

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