Medtronic’s Omar Ishrak: FDA should embrace the European device approach

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.”

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Comments (1)

  1. Submitted by Neal Rovick on 10/05/2011 - 08:45 am.


    ….In the EU, the GuardWire device was awarded CE marking by demonstrating safety and performance (i.e., the ability to aspirate material during the stenting procedure) in a 22-patient, single arm study.6 In the United States, this device was designated Class II. To demonstrate safety and effectiveness (defined as the ability to reduce complications associated with stenting of saphenous vein grafts) the FDA required an 800-patient, multicenter, randomized trial comparing distal protection to usual care (no protection).7

    As a result, the GuardWire was available in the EU at least two years before U.S. physicians had access to the technology. On the other hand, one may argue that this early access must be weighed against the absence of proven efficacy.


    Without careful trials evaluating efficacy, no legitimate medical judgement on the appropriate use of a medium- to highrisk medical device may be made. Unlike the United States, the EU approval process for medical devices does not incorporate such evaluations into its regulations.

    What could already be perceived by some as a shortcoming in the EU regulatory requirements is further exacerbated by the fact that: 1) “real” clinical data in the form of results from prospective clinical investigation is not mandatory for medical devices in Class IIb, even though they are relatively “high risk”; and 2) Notified Bodies are not on a level playing field in terms of their criteria for approval….

    (end quote)

    So what is the probability of a serious problem in one of 22 patients as opposed to 1 in 800?

    Is cheaper and faster better? Better for whom?

    Have medical device companies proved to be sterling guardians of people’s health or sterling guardians of their profits?

    But, hey, it all works out pretty well when you couple reduced testing with reduced ability to sue for damages. At least it works out well for the medical device industry…

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