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.