It's no secret that the medical technology industry in Minnesota (and elsewhere) is concerned about an impending report from the Institute of Medicine (IOM) regarding the FDA's 510k approval process for medical devices. This is, after all, the way most medical devices are approved before being marketed in the United States.
The 510k process is controversial because it often does not require clinical studies to determine whether a device is safe and effective. The regulatory agency requested that the IOM take a look at the process to determine whether it adequately protects patients while fostering innovation in new products. FDA device chief Jeffrey Shuren has said the agency will seriously consider any major changes the impending report may suggest. (The report is scheduled to be released mid-2011.)
Med-tech insiders have privately complained that the 12-member IOM panel considering changes to the process doesn't include anyone from the device industry. The two industry representatives come from insurers Kaiser Permanente and Blue Cross/Blue Shield.
Now as the IOM's report moves into the stage where it is reviewed by an external and independent group of experts, the head of LifeScience Alley/BioBusiness Alliance, Dale Wahlstrom, says he has suggested to the IOM a number of potential reviewers from the med-tech industry to serve. The former Medtronic executive, says the IOM was "very receptive" to the names he forwarded (though he declines to name them).
Spokeswoman Christine Stencel says the "IOM strives to get many perspectives during the peer review process and in this case that includes the industry perspective." The names of the reviewers will be released in the report, she noted.
Janet Moore covers medical technology for the Star Tribune.
