What's the Real Reason for FDA Device Delays? (MDDI)
You've heard of the first mover advantage, but what about a first mover disadvantage? It appears that new medical devices that are the first of their kind have a slower process through FDA. Since the technology is new, it make some sense that the process at FDA would take longer, right?
But new research from Harvard Business School finds that unfamiliarity with the technology isn't the cause of this delay. Lack of familiarity with protocol is actually what makes the FDA process take longer, assistant professor of business administration Ariel Dora Stern, PhD, finds in her working paper "Innovation under Regulatory Uncertainty: Evidence from Medical Technology."
Stern finds that medical device first entrants between 1977 and 2007 waited, on average, 7.2 months longer for regulatory approval than similar devices that came later, as opposed to the reverse phenomenon reported in drug regulation. Her analysis included 847 different PMA device approvals covered by 249 product codes. This delay represents an opportunity cost of approximately 7% of total R&D expenses, she writes.
Cardiovascular devices were the most popular specialty...
