“Healthcare reform will continue to force providers to take action in 2011, so that they don't incur unnecessary risk” to patients, Fincher says. “We expect to see a dramatic increase of up to 40 percent of new construction projects compared to 2009, along with increased capital purchases, which may have been put off or delayed due to the economy.”
Food and Drug Administration officials and medical devicemakers will take a deeper dive into unsettled regulatory waters in 2011. Last year, the two sides began work to hash out a revamped product-review process that addresses new safety concerns brought on by rapidly changing technology while simultaneously encouraging innovation.
The process has prompted vocal and often opposing comments from patient-safety groups and legislators whose state economies hinge on the financial success of medical devicemakers. This year will likely prompt a last-ditch effort by devicemakers, their supporters and critics to influence the FDA's final guidance, expected in early 2011.
In the coming year, providers, suppliers and distributors will accelerate efforts to adopt universal medical-product tracking standards, says Curtis Rooney, president of the Healthcare Industry Group Purchasing Association. The industry will be motivated not only by a group of voluntary sunset dates set by group purchasing organizations for getting various stakeholders to adopt tracking standards, but also by an approaching legislative mandate that requires the FDA to fully implement a universal tracking system by September 2013.