FDA

Medtech companies are increasingly looking to the FDA instead of Europe’s CE mark when launching novel products, according to a new report.

“Historically, the CE mark has been the preferred route for novel medical technology registration, since its processes were faster, cheaper and more predictable. The situation is now reversed,” wrote the authors of the study, published by Boston Consulting Group and the UCLA Biodesign innovation hub.

They surveyed and interviewed leaders and executives at 102 companies that have achieved registration or approval of a combined 105 novel technologies. A little more than half of the respondents said they are deprioritizing the CE mark relative to FDA approval.

Get the full story at our sister site, Medical Design & Outsourcing.

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.

Get the full story at our sister site, Medical Design & Outsourcing.