No matter how hard it is to manufacture a safe and efficacious medical device, it is not going to generate the anticipated revenues unless it can be properly reimbursed by insurers. While considerable time, effort and expense are required to successfully carry out a reimbursement strategy, such a plan is essential to assuring a favorable reception of a medical device upon its commercial release. This being the case, it is important for manufacturers to seek relationships with medical policy decision makers in whose hands success or failure of a medical device will rest. These entities include governmental agencies, public and private payers, specialty medical societies and physicians. Of all factors contributing to product success, payer access could be the most critical. Without the best reimbursement status for a medical device, investments a company made during medical device development may end up as a lost cause.
Bringing a medical device to the marketplace can be long, tortuous and complicated. Understanding this as expected, a reimbursement strategy, a month-by-month plan for action whose purpose is to demonstrate that a new medical device and/or its related procedure should obtain broad coverage by payers, is crucial for success. A reimbursement strategy also defines realistic benchmarks and timelines to achieve these goals. While significant time, effort and expense are required to ensure the successful implementation of a reimbursement strategy, such a plan is essential to facilitating adoption of a medical device. So as not to fail, it is crucial that manufacturers, both large and small, have a well-conceived reimbursement plan to raise equity from potential investors or borrow money from financial lenders to fund their business enterprise. Remember, it only takes a “YES” from a handful of payers to get your device covered and begin achieving your revenue goals.
Randomized controlled trial (RCT)
Conducting a randomized controlled trial (RCT) is the key to gaining reimbursement. It is the ‘gold standard’ of evidence-based medicine for the very reason that it is a true experimental study using primary data generated in the clinical environment to compare your medical device with the current standard of care using objective clinical outcomes
or endpoints after enough time of follow-up. Properly executed, the RCT yields the strongest proof of clinical efficacy for therapeutic and diagnostic medical devices in the eyes of insurers. Most companies will benefit from the services of a reimbursement consultant. In the early stages of development of a medical device, it is wise to collaborate with a proven expert in the field to maximize reimbursement potential, guide your course of action, and facilitate development and implementation of a reimbursement and economic strategy.