Monday, September 29, 2014

Missing the Mark on Medical Device Marketing

The Wall Street Journal headline says "Medical Devices Lack Safety Evidence" according to a study, not from an academic medical center or high powered clinical research group, but from yet another policy think tank.  It is very disappointing, and it isn't up to their usual journalistic standard.

Safety and risk profiles are reflected in the Class ranking of medical devices: Class I (bandages and surgical gloves, for example), Class II (e.g. infusion pumps and surgical drapes) and Class III(e.g. heart valves, stents, and orthopedic shoulder replacements).

The story reports the following:
"Most devices can get FDA clearance simply by showing that they are roughly equivalent to another product, called a predicate device, that is already on the market. The theory is that if the older device has proved safe and effective, the new one should be also."
"Most devices?"  Yes, a new surgical drape or a guide catheter won't require a full fledged IDE study; that would make no sense, there would be no reason to ever change an old technology, even if materials improved or manufacturing methods allowed miniaturization.  "Roughly equivalent" is the term of a bad journalist.  The FDA guidance says,
 "If FDA agrees the new device is substantially equivalent to a legally marketed device for which premarket approval is not required, the manufacturer may market it immediately."
Were the rule otherwise, the accidental company that came first to market would argue that everybody else required a full fledged IDE study for their improvement or enhancement.  Patients and innovation would suffer for no reason.

Class III medical devices rarely fall under the 510(k) labeling, because of their risk category.  The nature of the clinical study may be different.  All of this falls under the review of FDA staffers, aided by medical consultants, and in the case of companies pushed down the IDE path, a long, expensive, arduous and risky clinical trial path.

The 510(k) substantially equivalent pathway can involve bench data, lab studies, computer simulations, animal studies, or some combination of all.  Reviewers often add more questions and require additional data after the study process has begun.  Having been through it a few times, it is a bit arcane, and having "the public" read a bench study about laminar flows for a company's device adds nothing to the quality, cost or safety of patient care.

Post-market surveillance of cleared devices is definitely one area that needs to be improved, with more burden placed both on the device developer and the medical institutions that use them.  The premarket approval process itself could be made a bit more consistent.

And, a really significant problem is turnover and under staffing at the FDA itself, which I can say from experience, is widely acknowledged but not successfully addressed.

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