Simon-Kucher & Partners


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Regulatory & Reimbursement

Crossing the Valley of Death: MCIT, Pricing, and Implications for the Medtech Ecosystem

For medtechs, overcoming the “valley of death” between FDA approval and coding, coverage, and payment for their innovations is a struggle. The proposed MCIT pathway could enable many start-ups to cross the valley more easily. Pricing remains a key unknown, but if the program is implemented, it could have far-reaching implications for innovators and their FDA Breakthrough devices. By David Lee and Stacey Zhang, Simon-Kucher & Partners.

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