Obama Orders FDA To Streamline Medical Tech Regulations
Executive order signed the same day PricewaterhouseCoopers reports that the U.S. is losing ground on medical device innovations, partially due to the agency's cumbersome and costly approval process.
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Chris Wasden, PwC's managing director of strategy and innovation, told InformationWeek it takes twice as long for the U.S. to approve the same medical devices when compared with European countries like the United Kingdom, Germany, and France.
"We need to have a regulatory system that operates more like the European system where it's transparent, reliable, and predictable," Wasden said. "Venture capital is holding back and not as focused on medical device technology innovation because they don't know how much money it's going to take or how long it's going to take to get through the FDA 510 (k) process."
A supportive regulatory system is one of five key areas that PwC analysts looked at when determining specific factors that contribute to medical technology innovation in nine countries -- Brazil, China, France, Germany, India, Israel, Japan, the United Kingdom, and the United States.
Other areas that affect the capacity to develop medical technology innovation in these nations are: powerful financial incentives, leading resources for innovation, demanding and price-insensitive patients, and a supportive investment community.
In addition to providing a current view of innovative capacity and capability in these countries, PwC's Innovation Scorecard looked at the past five years to gain a historical perspective and projected into the future to present the outlook for technology innovation leadership over the next decade to 2020.
A top-line view of current results of the Innovation Scorecard reveals:
-- On a scale of 1 to 9, with 9 as the highest score, the U.S. currently has a total score of 7.1. Because of decades of innovation dominance, the U.S. continues to show the greatest capacity for medical technology innovation.
-- The scores of the other developed nations (the U.K., Germany, Japan, and France) fall within a tight band of 4.8 to 5.4. Among the developed countries included in this study, Germany and the U.K. demonstrate the strongest support for innovation, and Japan the weakest.
-- Israel, despite its small size, ranks near the level of the European nations, which indicates its strong capacity to foster innovation.
-- Emerging markets lag behind developed ones. China, with its powerful economic growth engine, scores 3.4, ranking it higher than India and Brazil, each of which scored 2.7.