USA – Your device design looks great. Now how do you get reimbursement?

Until recently, the main focuses of medical device companies were designing devices and earning regulatory clearance for their new technologies. How times have changed. While innovative design and FDA approval are important for market entry, reimbursement is now a top concern for medical device CEOs, their investors and other stakeholders.

Continued increases in the cost of healthcare are driving stakeholder interest in reimbursement. Investors want to know up front whether there will be coverage, coding and payment before they risk investing in new technologies. Payers increasingly expect new technologies to demonstrate better outcomes at equal or lower costs before they pay for them. More hospitals are establishing value analysis committees to evaluate all new products prior to allowing them to enter a hospital or clinic setting. Physicians are interested in products that not only help their patients but also meet quality metrics imposed by government and private payers. Perhaps most importantly, patients are becoming more educated and prefer interventions that improve quality of life at the lowest cost possible.

Make reimbursement a priority.

With reimbursement planning, medical technology companies can boost the chances of market success for new technology. Planning a reimbursement strategy should begin early in the product development phase. Early planning can contribute to device design considerations that take advantage of reimbursement requirements. Also, early planning can save time, money, and effort by adding clinical and economic value endpoints to regulatory approval studies for a new technology…