The European Union experiences roughly the same number of medical device recalls per year as does the United States, says a report from the Boston Consulting Group at AdvaMed.
"We found the same number of recalls, even though the belief is there are more devices out in Europe," said Simon Goodall, Boston's partner and managing director. All told, both governing regulatory bodies experience about 21 recalls per year.
AdvaMed concludes that despite a far more rigorous and longer regulatory approval process, devices in the United States are no safer (or put another way—no less safe) than those in the European Union.
Recent data have shown a strong increase in the time and costs associated with obtaining 510(k)s and premarket approvals in the United States.
Likewise, the overwrought regulation process stalls innovation in several ways.First, it discourages companies from venturing into new sectors or creating devices that are unique. Second, it drives R&D outside of the United States, even for U.S.-based companies.
As President Obama recently challenged each citizen, we have to "out-educate, out-innovate and outperform" the rest of the world. In the medical devices industry, the regulatory process can either be a help or a hindrance to achieving those goals.