Costs related to winning 510(k) clearance for a medical device that were directly related to satisfying Food & Drug Administration rules average $24 million, according to a Stanford University report.
More than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles, according to a Stanford University report.
The report, “FDA Impact on U.S. Medical Technology Innovation,” blasts the regulatory process to bring medical devices to market in the states as “unpredictable, inefficient, and expensive.” Stanford researchers, led by Dr. Josh Makower, surveyed more than 200 medical technology companies about the regulatory process in the States. The survey was sponsored by the Medical Device Manufacturers Assn., the National Venture Capital Assn. and “multiple state medical industry organizations.”
Thereport (PDF) states that the average cost to bring a low-to-moderate 510(k) product from concept to market is $31 million. More than 77 percent of that, $24 million, was spent on FDA-dependent or related activities. High-risk PMA costs averaged $94 million, with $75 million spent on FDA-linked stages, nearly 80 percent of the total cost of bringing devices to market.
Dr. Makower pointed out today in a conference call with reporters that companies developing orthopedic, spine and cardiovascular devices are suffering most, according to his research.
The high cost of regulation in the U.S. is coupled with an unpredictable review process, according to the report. Nearly half of all respondents said they experienced some reviewer-related delays during the regulatory process, including turnover in key FDA personnel. On average, devices take two years longer to reach patients in the U.S. than in other countries, according to the report.
“[U]nder the current FDA process, millions of U.S. patients are being denied or delayed access to leading medical devices that are first (or exclusively) brought to market in other countries,” the according to Makower and his colleagues.
The report dealt out higher marks for the European Union’s CE Marking protocol for timeliness and predictability.
“The most important thing that we forget, and I really think that this is a big difference, is that in Europe… physicians are the ultimate regulator of a product. They decide what’s best for their patients. They understand what risks and benefits that particular product may have for an individual patient,” Makower said today during the conference call.
He said as long as those medical products are labelled properly, and as long as there’s reasonable assurances of safety and efficacy for those products, they will be used properly by doctors.
The Advanced Medical Technology Assn., which represents the medical device industry, applauded the report.
“We support efforts such as improving reviewer and manager training, developing specific guidance for product types, improving the de novo process and developing specific metrics to improve consistency,” said AdvaMed CEO Stephen Ubl in an email sent in response to the report.