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Tailoring post-market studies for orthopedic startups - BoneChat #30 short

7 Jun 2024 · 0 min

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0:15

Orthopedic startups often design post-market studies to serve three goals: FDA compliance, scientific credibility, and reimbursement support. One study rarely satisfies all three. Talk to regulators early about what your study actually needs to prove.

Is this study to get an inch past the FDA? Is this study to prove, make a point to the scientific community? Is this study designed for reimbursement or whatever the cause? Like, you know, there's not just one paper you can wave in front of everybody, all those different constituents, and they're not all going to be satisfied.
And if you are going for regulatory, it's always beneficial, you know, always talk to the regulatory before design, finalizing the design of this study.

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