FDA Helps Industry Push Medical Device Innovation
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.