An increasing number of European med-tech companies are first seeking regulatory approval from the U.S. FDA because of the growing backlog and frustrations with requirements under the new regulatory framework of the EU Medical Device Regulation (MDR), which has been described as “not working.”

Companies such as Medtronic plc have become risk averse and are unlikely to takeover early stage medtech firms, Ori Hadomi, vice president strategic initiatives & partnerships, at Medtronic, told delegates at the LSX World Congress in London. Hadomi, who joined Dublin-based Medtronic after his firm Mazor Robotics Inc. was taken over by the company in a $1.64 billion deal in 2018, told early-stage startups “don’t waste their time” in approaching the company.

Regulatory harmonization is perhaps highest on the regulatory wish list of medical device manufacturers, but the FDA’s device center has tamped down expectations of a medical device single review program. Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH) said the agency will release a strategic plan later this year for regulatory harmonization, but declined to offer any details other than to state that differences in risk classification schema are not as significant a source of drag on harmonization as may commonly be believed.

As companies increasingly use artificial intelligence (AI) in medical devices and applications to help treat and diagnose patients, innovators must be careful of excluding large sections of the population in their algorithms and in their data gathering process, delegates heard at the Medtech Futures conference in Cambridge, U.K.