BLA Regulatory

BLA Regulatory

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Although regulatory approval of medical devices is often seen as the “brass ring” for new medical device companies, the fact remains that this is just the first step on the path to financial success. Companies work hard to obtain regulatory approval, yet often overlook the creation of a comprehensive reimbursement strategy during the early stages of product development. If the two are not pursued simultaneously, reimbursement can be delayed for another five or six years after the date of approval. 

Reimbursement is a critical part of getting a medical device or in vitro diagnostic (IVD) to market. Our medical device reimbursement team guides companies to apply for coding and multiple healthcare economic pathways for entering health insurance reimbursement systems such as Government Healthcare Systems, Private Payers, and Self-pay.