Strategy, marketing, and commercial execution for healthcare technology companies.
The study that satisfied the FDA rarely carries the comparator a hospital wants or the endpoint a payer counts.
A 510(k) proves substantial equivalence to a predicate. A hospital wants outcomes against the product on its shelf, and a payer wants health outcomes in its own population. Here is how to sequence evidence work by lead time so it lands before the buying decision.
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When a launch underperforms, the message gets rewritten first. The cause is usually the layer underneath it: no single source of truth for claims, no lead routing, no defined handoffs. Learn what to build before the next campaign runs.
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FDA clearance is often the fastest step in a device launch, not the longest. Coding, coverage, and evidence run on clocks you do not control. Learn how to build a launch schedule backward from your expected clearance date.
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In most health systems a committee, not your physician champion, decides whether your device gets bought. Learn the four questions it asks and the six-part dossier that gets a decision instead of a deferral.
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FDA clearance lets you sell. Reimbursement decides whether anyone pays. Learn the three questions every payer answer must resolve, and what the new RAPID pathway changes.
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Physicians trust peers, not ads. Learn how to map real clinical influence, sustain KOL relationships, and turn credibility into adoption and revenue.
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FDA clearance is a milestone, not a finish line. Learn why 75% of MedTech companies fail to scale after clearance and what a proven commercialization strategy actually looks like.
Read Post →We work with commercially-viable health technology companies that are ready to scale. If that sounds like you, let's talk.
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