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Medical device manufacturers routinely design products that, even a few short years ago, were the stuff of science fiction. And let’s not even mention the amazing research underway today that will animate tomorrow’s medical products, from Tricorder-like devices performing on-the-spot diagnostics to 3-D printers producing replacement body parts. But there’s a problem: money. To succeed in today’s marketplace, medical device original equipment manufacturers (OEMs) must take into account funding and reimbursement pathways, the critical role that health technology assessment (HTA) can play, and other factors that may have little to nothing to do with how well or how safely a device performs its intended task.