Top Device Stories Of 2011: Living In A State Of Transition
EBI’s device team reviews of the top news stories in the medical device industry in 2011. Top stories include: 510(k) reform, user-fees, VC money dries up for medtech, hot clinical spaces of the year, where private investment dollars went in 2011, big changes at J&J, and the new physician/hospital alignments and their impact on the medical device industry.
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Reverse Innovation: Is The US Losing Its Edge In Innovation?
Is US-style innovation in the medical device industry heading towards extinction? Gone are the days when companies believed they could build robust businesses by serving largely, if not exclusively, the US market. Today, emerging markets have become growth markets. But those markets, and even a post-health care reform US, challenge an innovation model that used to reward even incremental technology enhancements with premium pricing, by a price-insensitive customer.
Regulatory News In Brief
FDA's device center issues a significant draft guidance on the 510(k) program, plus a draft on appeals processes open to sponsors. More end-of-the-year regulatory developments.
As TAVI Advances, Adjunctive Devices Multiply
As researchers work to more fully understand the risks and durability of transcatheter aortic heart valve implantation (TAVI) procedures, device innovators are already attempting to engineer solutions to some of the more obvious areas of unmet need.