FDA device chief Shuren: Recession played a role in pushing medical device industry to EU (MassDevice)
The "Device Gap" between EU and US is heating up
Jeff Shuren testified at a House Oversight & Government Reform Subcommittee on Health Care's "Pathway to FDA Medical Device Approval: Is there a Better Way?"
Shuren believes that the recession created a more "risk-averse" investment environment that helped push medical device companies to launch in Europe, rather than its relatively easier path to market clearance.
Shuren believes that only 10% of cost of bringing a new device to market is...
