The medtech space is facing increasing challenges, particularly in the reimbursement space. Although the process is difficult, device makers may find that regional reimbursement strategies better suit their immediate needs to get products to market, according to Seth J. Goldenberg, PhD, director of product development strategy at NAMSA.
Device makers are under increasing pressure to ensure that their devices are not simply achieving regulatory approval, but have a plan for payments. And these days, Goldenberg said, CMS is not always the best route. “Going for a national coverage can seem like the best option,” Goldenberg said. “The problem with CMS is that if you don’t get what you want, it’s a national decision.”
Such blanket decisions are oppositional to the nature of medical technology today. “Medical devices are too complex, too dynamic, and too customized.”
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