As the new year dawns, it remains to be seen whether the promised belt-tightening and budget-slashing rhetoric that marked 2010’s Congressional campaigns will translate into real reform. The new Republicans and Tea Partiers will find Washington to be a target-rich environment. Not that they’ll need any help but research from the University of Stanford may be raising the profile of the FDA at the worst possible time.1 

The study sought to identify where the greatest deterrents to innovation exist within U.S. premarket regulatory processes and the costs (in time and dollars) these issues place on U.S. medtech companies. The researchers collected surveys from 204 unique companies, representing approximately 20 percent of all public and venture-backed medical device manufacturers in the United States. Survey participants were asked about their experiences working with the FDA and with European regulatory authorities so that comparisons could be made between aspects of the two dominant systems. 

Some of the more damning conclusions:
  • The suboptimal execution of FDA premarket regulatory processes has a significant, measureable cost to U.S. patients in the form of a device lag, the researchers say. Respondents reported that their devices were available to U.S. citizens an average of two full years later than patients in other countries, due to delays with the FDA and/or company decisions to pursue markets outside the U.S. before initiating time-consuming, expensive regulatory processes in their own country. In some cases, this device lag reached up to nearly six years.
  • Unpredictable, inefficient and expensive regulatory processes put the U.S. at risk of losing its global leadership position in medtech innovation. Data from the survey clearly indicate that European regulatory processes allow innovators to make new medical technologies available to patients more quickly and at a lower cost. To the question of whether European efficiency comes at the expense of patient safety: “No information is currently available to suggest that patient safety in Europe has been compromised,” the group says.
  • Fewer medical device start-ups are being launched in the United States as investment capital in the industry continues to move to other sectors. And, innovators and medical device companies are relocating to other countries in greater numbers, taking valuable jobs and tax revenue with them. 


1. FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies. Josh Makower, MD, Aabed Meer MD, Lyn Denend