By Fink Densford
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.
