Study: FDA Hampering Technology in Healthcare


FDA Claimed times in red, actual in blue, EU times in green

Mobile healthcare is poised for major progress through incorporating technology, but a new study shows the Food and Drug Administration (FDA) is negatively impacting this process in general. Companies trying to leverage technology in healthcare are finding that once the FDA gets involved, it becomes a time-consuming, expensive process. Many companies are heading to Europe to develop medical technology, due to a regulatory climate more conducive for such efforts.

The study deals with technology in healthcare in general, but the findings impact mobile in particular, as it’s totally technology based. The FDA creates such a barrier to bringing technology into healthcare that the financial implications are disturbing. The cost of bringing simple technology (such as mobile devices) to use in healthcare is $31 million, a staggering $24 million of which is incurred dealing with the FDA. When looking at more complex technology, the FDA costs companies a whopping $75 million out of the total $94 million to bring it to market. It is no wonder companies are fleeing the reach of the FDA.

The advancement of technology used in mobile healthcare is already impacted by the rapid evolution of mobile technology compared with the slow pace of the medical field. When you add the FDA effect into the mix, it becomes almost impossible to get new tech into practice in a timely fashion. The study found that getting new “simple” gadgets to market takes only seven months in Europe, but an average of 31 months in the U.S. due to the involvement of the FDA. Such technology is available for patients in Europe years before it hits the U.S., and strictly due to the FDA effect.

The FDA reaches into all areas of mobile healthcare advancement, even the development of smartphone apps as we discovered. It’s one thing to protect consumers from technology that doesn’t work, but quite another to consistently get in the way of progress. At what point do American companies working on this technology just pack it up and head to Europe?

Image credits: Flickr user HazPhotos and

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Quentin Dewolf

being the head of regulatory at a software company the quoted numbers are absurd. we integrate iso processes so the only pure FDA process is the 90 days you wait for the 510k approval and the every 2 year audit cycle.
A PMA might take 20 or 30 million and years but not a 510k.

Glenn Laffel, MD, PhD

There’s a similar problem with electronic health records, where the FDA has indicated it wants to become the arbitor the safety of these “devices.” This decision would not only cost vendors hundreds of millions of dollars, but it would threaten to block the initiatives of another federal agency, the Office of the National Coordinator for HIT, also known as the ONC (both agencies are part of HHS). This latter agency is determined to stimulate the adoption of EHRs on a national scale through the HITECH incentive program.

The issue of EHR safety is real. It should be the subject of regulatory scrutiny. But the locus of this scrutiny should be the ONC itself, not the FDA. Otherwise, we have a counterproductive situation in which one federal agency is interfering with the strategic objectives of another.


Don’t we want our medical devices to work flawlessly 100% of the time? To rigorously adhere to claimed functions and tight specifications of the device? I certainly would not trust my buggy Android phone to be monitoring vital functions, or regulating the frequency of delivery of medication. We want everything to be cheap and easy but people freak out when Toyota recalls millions of cars for a (potentially fatal) flaw that occurs in a TINY fraction of their cars. Should we expect less from medical devices? It’s a case of diminishing retunes when pursuing perfection but that’s what we expect when it comes to our well-being. Get used to it, we want the FDA to apply a high level of scrutiny.


Do not be concerned. With Obamacare there will be such massive savings that the FDA will pass these on as incentives to the mobile technology researchers.

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