Stop Assuming The Market Will Say Yes | Jack O’Callaghan

Founders don’t fail for lack of ideas—they fail for ignoring payers, regulators, and real user needs. Today I sit down with Jack O’Callaghan (Director, Business Development, Northeast Biomedical) about this very challenge. Jack explains why “build it and they will come” collapses in medtech. We get practical about payer and regulatory realities, user-needs documents, TAM fantasies, voice-of-customer, KOL strategies, and why v1.0 is never the finish line.

Three Moves That Shorten the Road to Adoption

Be realistic and think about the entire product journey. Most founders pitch a giant TAM and assume clinicians will pull the product through. Replace that with a real adoption plan. Define the serviceable market you can actually reach in the first 12–24 months, by site type and procedure volume. Map the buying center for each site: the clinical champion, the economic buyer, supply chain, biomed, and IT. Tie your value to what each of them cares about. If your claim is time saved, translate it to minutes per case and the OR cost per minute. If you reduce complications, translate it to fewer readmissions and avoid penalties. Engage payers early to confirm coding, coverage, and payment so the business case survives first contact with reality.

Admit what you don’t know and hire it early. Speed comes from admitting what you do not know and buying the right help early. Before you touch CAD again, lock a one-page user needs document and a preliminary regulatory and reimbursement path. Do a quick freedom-to-operate check. In parallel, bring in fractional experts for regulatory, quality, reimbursement, clinical affairs, and product marketing. Their fees are small compared with the cost of delay or a redesign that shows up after your first animal lab. A class II pathway can reach into the tens of millions and beyond; every month you shave by parallelizing workstreams and avoiding rework is real money and earlier evidence.

Plan to learn fast rather than launch perfect. Treat version 1 as the instrument you use to collect voice-of-customer and usability data that informs version 2 and 3. Schedule bench, cadaver, or animal sessions and capture structured feedback. Build a small KOL council and put them on a cadence. Document changes, train on the procedure, and collect outcomes that quantify your promise in terms the system buys: OR minutes avoided, length of stay reduced, fewer transfers, fewer reoperations. Line those metrics up with your coding and payment story so clinical and financial value show up in the same frame.

If your deck still shows a massive TAM but you lack a sequenced GTM, bring in a fractional CMO to convert user needs and payer logic into a market-access plan that actually moves revenue: https://meshagency.com/fcmo-fractional-cmo-fractional-marketing/

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