Medtronic (NYSE:MDT) CEO Omar Ishrak has had an it-is-what-it-is approach to healthcare reform in the United States. But this weekend he told London’s Financial Times he believes the United States should embrace the European approach to medical device approvals — a process that has been getting devices to market much faster than the U.S. Food and Drug Administration’s 510(k) process.
“The response time is quicker, the clinical trial cycle is quicker, and maybe some of the barriers are less stringent,” Ishrak told the Financial Times in a wide-ranging interview, adding: “It will certainly put products on the market more quickly, so from a very selfish device manufacturer perspective, absolutely.”
And the Financial Times’ headline went further, to say that Ishrak “rues” the current approval process in the United States.
Ishrak’s role in the future of FDA approvals could be significant. His predecessor, Bill Hawkins, lead some of the industry lobbying during negotiations on changing 510(k) regulations. Plus, second to the medical device tax, industry officials have focused their ire on the approval process and there remains a constant debate about the process.
This is Ishrak’s second major media interview in recent months. Last month, he told MedCity News of his plans to intensify his focus on opportunities in India as well as further globalize his workforce. With the Financial Times, he also discussed in depth his reaction to the recent Infuse controversy, and also offered a spirited defense of the company’s pipeline.
Mr. Ishrak said that Medtronic’s pipeline should not be underestimated and that the company was now focusing more on ’customer economics’ when developing new products.
Ishrak will have a chance to further elaborate on his perspective this week. He’s a featured speaker on Tuesday at the Cleveland Clinic Innovation Summit in a keynote titled: “Revitalizing a market-leading cardiac franchise in a time of economic challenge.”