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

LifeSci Continuum with Bill Schick

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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.
00:00 Why the system won’t say “yes” by default
01:27 Jack’s path: pharma → devices → engineering services
03:08 What Northeast Biomedical actually builds
04:20 Examples: reagent processor (goat blood for lateral flow), vision-guided robots, drug-delivery catheters
05:10 Where founders underestimate the journey
08:33 Reimbursement reality: enteral feeding example
12:11 You don’t sell to a person; you sell into a system
17:00 Medicine as art: implications for product design
22:56 TAM delusions and setting reachable targets
26:09 DoD “I just need to find the right person” myth
31:00 Time, bandwidth, and the cost of learning everything yourself
36:02 Prototypes, investors, and exit clarity
41:03 “I just need a distributor” (no, you don’t)
43:07 Start with user needs (engineering + commercial)
45:14 Garage prototypes and the laws of physics
47:22 Admit what you don’t know—then staff it
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/
#MedTech #MedicalDevices #Mark