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.
Of the companies surveyed, 90 are headquartered in the U.S. and nine in the EU. One-fifth of the companies are publicly traded.
Industry executives described product registration and approval as “cumbersome and uncertain” under…