Your first FDA clearance is just a fishing license.

Orthopedic startups chase FDA clearance like it’s the ultimate prize. Years of grinding through R&D, clinical trials, and regulatory hoops lead to that moment of victory when the FDA grants approval. It’s a milestone worth celebrating—a signal to investors and the market that your product has legs. But let’s be clear: FDA clearance isn’t the endgame. It’s a fishing license. Without sales, your startup isn’t a company—it’s just a dream.
FDA Clearance: A Gate, Not a Goal
FDA clearance is a critical step. Whether you’ve developed a next-generation implant, a precision surgical tool, or a dig...


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