Medical device companies producing pioneering medical technology have a much longer, more expensive road to travel to achieve FDA approval than those developing new drugs, according to a new study out of the Harvard Business School.
Lead investigator Ariel Stern examined 30 years of FDA data, between 1977 and 2007, comparing processing time for all new drugs and high-risk medical devices cleared by the federal watchdog.
Stern found that while new drugs are generally the fastest to win FDA approval, with 1st entrants reaching approval 1-2% faster than follow-on drugs, new medical devices on average take a whopping 34% longer to get approved.
The longer approval process results in an average delay of 7.2 months, Stern said. The cost associated with the extra delay can be prohibitive as well, with a conservative estimate at $6.7 million. This comes on top of the estimated average of $94 million to bring a new high-risk device to market.
The delay costs an approximate 7% of the total R&D costs, something Stern says prohibits pioneering development by smaller firms in the medical device field. Small device firms make up a meager 7-17% of the longer, more expensive new device applicants, Stern reports.
Instead, small firms tend to stick to follow-on applications, where they make up 14.3-21.7% of all FDA new device applications. By comparison, small drug firms make up 36.4-54.5% of new drug applicants and only 11.5-46.9% of follow-on applicants.
Part of the reason for this delay is the difference in testing, Stern said. While drug testing with the FDA has been streamlined, the same has not been true for devices.
This is partially due to the myriad different uses and implementations inherent with medical devices and how to test such varying pieces of technology in a streamlined manner, Stern said.
The FDA categorizes devices by their function, not the underlying technology, Stern said. That kind of labeling can lead to excessive testing on devices that have already been approved by the agency for other uses.
Stern concluded by suggesting that the FDA could accelerate the regulatory approval process by “mitigating content and format related uncertainties for medical device manufacturers,” but offered the caveat that implementing such changes to the FDA would be complicated task.
“The results do not address the onerous process of regulatory reform. While it seems likely that some amount of earlier engagement and articulation of regulatory requirements by the FDA could decrease regulatory approval times and minimize delays, the process for implementing any large changes to formal regulatory policy is complex, time-consuming and institutionally entrenched,” Stern wrote.