Losing the Innovation Race Time and cost factors not only pose challenges to medical device maker

Losing the Innovation Race

Time and cost factors not only pose challenges to medical device makers, but also to the U.S. market’s standing as the world’s key source of industry innovation. While the FDA vigorously has reprioritized its mission of ensuring public safety, the agency may have done so at the expense of efficiency, so suggests recent research by PricewaterhouseCoopers (PwC) in its January 2011 report called the Medical Technology Innovation Scorecard.

According to PwC, European regulators have struck the right balance between safety and efficiency, and only stand to improve their approval processes going forward. An overly cumbersome regulatory system represents one of several factors eroding the U.S. market’s standing as an innovation powerhouse. It typically takes twice as long for new market entrants to gain clearance or approval by the FDA as it does in Europe (or Israel), and PwC does not expect this trend to abate. As such, the European Union has become the first market of choice for an increasing number of manufacturers.

The auditor cited four medical device manufacturers’ recent experiences with U.S. and E.U. regulators to bolster its forecast of declining U.S. industry prowess. One firm, Thrombovision, failed to obtain 510(k) clearance after a two-year effort with the FDA, and has since filed for bankruptcy. The three other firms—OrthoAccel Technologies, Fairway Medical Technologies and ExploraMed (run by Josh Makower)—reported years-long efforts to commercialize their devices in the United States but speedier processes to gain CE marking in Europe. These manufacturers describe strategies of obtaining market approval in Europe before the United States as vital to maintaining healthy bottom lines, if not outright solvency.