1. A major push for regulatory reform

[Image courtesy of Stuart Miles on FreeDigitalPhotos.net]
“The medical device industry should never underestimate the power of the press nor the impact of product liability lawsuits. Not only do both go hand-in-hand, both are the ‘root cause’ of many of the changes in the medical device regulatory requirements being proposed by FDA and already being implemented in the E.U. Remember the adage… those who forget their history (and those who don’t acknowledge their history) are doomed to repeat it!” – Michael Drues, regulatory consultant
“With a new Democratic House that was elected in part based on their healthcare messaging, we expect the debate on improving patient access to high-quality, affordable care to remain spirited. Since medical technology has such a crucial role to play in improving care and lowering costs, we’ll be pushing our ideas for CMS reform – including automatic coverage for breakthrough devices and process efficiencies for coverage decisions – to eliminate bureaucratic obstacles to patient access to new medtech. We’re also bullish on reforms to the Anti-Kickback Statute, which could allow medtech companies to fully participate in emerging value-based care arrangements to the benefit of patients and providers.” – Greg Crist, chief advocacy officer, AdvaMed