Could "sunshine" rules squash medical innovation? | MassDevice.com On Call

April 17, 2013 by Arezu Sarvestani

Researchers warn that burdensome rules governing relationships between physician entrepreneurs and medical device manufacturers could harm one of the industry's most important sources of innovation.

MassDevice On Call

MASSDEVICE ON CALL — Medical device companies rely on physician-owned startups for many of the patents that drive innovation at large companies, but rules that govern the relationships between physicians and device makers may cool those relationships, researchers warned.

A study conducted by Wolters Kluwer Health concluded that patents emerging from physician-owned startup companies more frequently supported premarket approval applications filed with the FDA than patents generated by non-physician-owned startups.

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"Various types of financial relationships between physicians and medical device manufacturers are common, but are increasingly subject to policies regarding disclosure of potential conflicts of interest," according to a press release. "The new findings raise concerns that, if conflict of interest rules are too tight, they could have the unintended effect of slowing the pace of new advances in the medical device industry."

Such transparency rules may engender more trust among patients and consumers, but could harm innovation if companies drift away from investment in physician-owned startups, the researchers said.

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