Study: FDA Hampering Technology in Healthcare

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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 nvca.org

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