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FDA Helps Industry Push Medical Device Innovation

Medical Device Innovation Consortium logo

December 4, 2012 ~ The FDA will collaborate with the medical device industry it regulates in a public-private collaboration, all to speed up the approval of new devices.

The newly formed nonprofit group,  Medical Device Innovation Consortium (MDIC), has a goal of speeding up and simplifying the design and testing of medical devices, reports CBS (here).  Since many medical device companies are small businesses and cannot adequately test their products, they will be able to have support from government and academia and others in the industry.

The industry says the slow approval process is hurting industry and causing many companies to take their new innovations to launch in Europe first which does not have a centralized approval process such as the FDA.

The new consortium has raised about one half-million dollars from industry to launch but plans to double that amount shortly. The Medical Device Innovation Consortium is a creation of LifeScience Alley, which is a Minnesota-based lobby and trade association.

Included in the consortium are Mayo Clinic, the University of Minnesota, Boston Scientific, Becton Dickinson, Abiomed, Cyberonics and Medtronic Inc.

Where is Patient Safety?

Consumers Union says most Americans don’t want faster approvals, they want better reviews. The consumer safety group finds 17 percent of Americans have an implanted medical device whether a heart valve, stent, hip, knee, lap band internal defibrillator or surgical mesh.

The bulk of medical devices are marketed based on the 510(k) process which does not require any clinical trials.   Dr. Steven Nissen of the Cleveland Clinic has authored a report that finds 2,800 people died in 2006 because of defective medical devices.

“I think people make the assumption that when their doctor implants a device, whether it be an artificial joint or a pacemaker, that it’s undergone very rigorous testing,” Nissen said to CBS. “That assumption isn’t always true.”

Patient safety does not appear in the focus of the partnership. After creating a “vibrant medical device industry” MDIC  says that will serve “the public health needs of the U.S.”

In a poll, Consumers Union asked consumers if safe medical device approvals were at the top of their list. The poll, part of the Safe Patient Project (here)  revealed patients overwhelmingly supported strong medical device safety oversight.

The poll revealed:

  •  82% of Americans believe that preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation.
  • 91% of poll respondents said each implant should be safety tested before being sold even when similar implants were in use.
  • 71% said that a new device should not be allowed to be sold based on its similarity to an existing implant that has a safety problem or has been recalled.
  • 95% said that effective consumer protections for medical implants should include a nationwide system for tracking medical implants so patients can be notified about safety problems or recalls. No such system currently exists in the U.S. even though it was required by Congress’ previous reauthorization of the law.
  • 66% indicated a high level of concern about safety decisions or recommendations made by expert committees that included doctors who had current financial relationships with medical device makers.

 

One Comment

  1. Hope's Sister :) says:

    Thank you for this article Jane!………one point and sentence I wanted to expand on,…..

    “Included in the consortium…Medtronic Inc.”

    Now to your readers, consider Googling……”The Supreme Court’s Riegel v. Medtronic ruling” ,

    which protects makers of certain FDA approved medical devices from being sued after a patient has been harmed. The patient harmed has no rights for justice against the medical manufacturer because of this ruling. I know this from experience. Medtronic was supported by the Supreme Court, granting medical device manufacturers the legal right to harm people ( the way I see it)……and NOW, Medtronic is granted the honor of being part of the “consortium partnership” with the FDA to push the approval of medical devices even faster. (and 1000 red flags raise up.) Maybe I’m reading into this wrong, but if I understand this all correctly, the FDA, the Supreme Court are not protecting the safety of the public, but big profit for the medical device industry.

    Someone made a very valid point in a response I read in another article on this subject.

    ” The FDA is supposed to watch over these folks. How can they do that if they are in bed with them!”

    Is it me, or how is this all legal? I’m at a loss. I’ve written my congressman, no response.

    May those speeding the process, advocating,and profiting……be treated with the same devices they are pushing.

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