If you’re developing a new medical device and want to know how much time and cash it could take to get FDA 510(k) clearance or De Novo classification, a recent report offers some guidance.
Boston Consulting Group and the UCLA Biodesign innovation hub questioned leaders at 102 different companies that have achieved registration or approval of a combined 105 novel technologies. Ninety of the companies are headquartered in the U.S. and nine in the EU. One-fifth of the companies are publicly traded.
Survey questions and interviews yielded detailed cost information for 50 products that successfully navigated the 510(k) pathway at a median cost of $3.1 million and 13 products that won De Novo classification at a median cost of $5 million.