Medical device entrepreneurs must fully understand the current health economic and reimbursement landscape. No longer will new technology be reimbursed simply because it has FDA approval. Regulatory clearance only gives medical device companies the opportunity to market a device – it does not ensure payment.
Payers and providers are now requiring technology innovators to demonstrate both clinical AND economic value before they will consider reimbursing or using any new product. And, if financing is a critical consideration in your business plan, be prepared for investors to ask hard questions about whether there is a path to reimbursement for your technology in addition to asking if you have met minimum regulatory requirements. Failing to have a plan to address these issues risks being stalled in the market place.
Early and savvy planning can result in product design revisions that take advantage of medical device reimbursement requirements. You may be able to save time, money, and effort by adding economic value endpoints to your regulatory approval studies.
Effectively proving and communicating a product’s clinical and economic value to payers, patients, physicians, and hospitals can determine the product’s commercial success. RCRI understands how to address this from a comprehensive viewpoint.
“We have found your reimbursement assessment for our technology to be very helpful and oftentimes refer to it to help us develop our reimbursement strategy.“
– Director Program Development, genetic testing company
RCRI’s strategic reimbursement services support the entire commercialization journey from early concept through post-market launch. This Integrated Approach ensures a smooth and market-focused progression. Working with the knowledgeable and objective RCRI reimbursement strategy consultants improves your chances of market acceptance, and faster returns on investment.
Avoiding market access delay due to incorrect product classification
A start up company (with the help of two innovative physicians) developed a tool that provides a safer, more effective way to alleviate a common orthopedic condition. Although early funding came at a cadence that kept progress moving steadily ahead, rounds for managing the entire life cycle to reach commercial distribution were relatively small. But by correctly classifying the device, time to market was minimized.