Left to Our Own Devices

U.S. companies have led the world in the development of medical devices. According to an analysis by the consulting firm PricewaterhouseCoopers, 32 of the 46 medical technology companies with annual sales exceeding $1 billion are based in the United States … But as a prototypic example of the impacts of wrongheaded public policy, the medical device sector is being ravaged by unwise and excessive federal regulation … Even without a further tightening of regulation, a recent study from Stanford University professor Josh Makower … [finds] that European regulators approved medical technologies significantly faster than their FDA counterparts. For lower-risk products, Europe’s approval times were two years shorter than in the United States, while for higher-risk or more experimental devices, the disparity was more than 3 1/2 years. (The rates of recall are similar, so FDA’s more indolent approvals appear not to offer any premium on product safety.)

Device companies are voting with their feet. They have begun to move R&D and manufacturing offshore and even to write off the U.S. market for certain products that are so over-regulated that financing for their testing is unobtainable.

Full article on the potential consequences of medical device over-regulation.

Comments (6)

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  1. Devon Herrick says:

    Most people probably don’t realize that a toothbrush, bandage, over-the-counter birth control and feminine hygiene products are all examples of Class 1 medical devices that must be registered with the FDA.

  2. Tabitha C. says:

    The U.S. has led R&D for the medical device field for so many years…this is a sad trend. How will we manage quality control and availability when the development and supply are completely out or our hands?

  3. Paul H. says:

    Glad to see this post. This is a serious problem.

  4. Vicki says:

    This is terrible. This is precisely the sort of industry we should be promoting in the United States rather then running them our of the country.

  5. Nancy says:


  6. QuadTech says:

    It’s not just regulation that is stifling the medical device R&D field. Many companies are not willing put up the funds to develop truly revolutionary products. It’s a safer (and more profitable) route to make small changes to existing products.