Short answer
To commercialize a medical device after clearance, spend the first 90 days on four things: confirm the reimbursement path for your indication, assemble the clinical and economic evidence a hospital committee will demand, select and score a short list of target accounts, and run five pilots that produce references. Hire reps after that motion works, not before.
The 90-day post-clearance checklist
- 1
Weeks 1–2 — repackage the evidence
Package the clinical evidence for a commercial audience, not a regulatory one. A value analysis committee needs an economic case and an operational case alongside the clinical data, not the FDA submission repackaged.
- 2
Weeks 3–6 — answer who pays
Build a real answer to who pays, who saves, and who decides for your specific procedure and specialty, by region. Don't wait for a hospital to ask.
- 3
Weeks 7–10 — rank 20 candidate accounts
Identify and rank your first 20 candidates, and confirm which have both procedure fit and a resolvable reimbursement picture.
- 4
Weeks 11–13 — approach the top 5
Approach them with a pilot framing, not a sales pitch. Proof, not revenue, is the goal of this phase.
What to build in-house vs. hire or outsource
Build in-house, early
The account targeting logic and the evidence packages — this is where your actual differentiation and institutional knowledge lives.
Outsource or delay
A full commercial operations team, a CRM implementation, or a large field sales force — all expensive to build before you know which accounts and which pitch work.
Most first-time teams get this backwards, hiring reps before they have a defensible target list, then wondering why activity doesn't convert to pipeline.
How to find your first 5 pilot accounts
Pull your ranked list of 20 — procedure volume, existing champion, competitive install base, resolvable reimbursement, from the commercialization guide earlier in this series — and select the 5 where a pilot framing, not a purchase decision, is realistic: an account with a champion physician willing to run and publish a case, and a value analysis process that can evaluate a pilot without a multi-year capital commitment attached. The goal of these 5 is a reference, not revenue. Revenue comes from account 6 onward, once the first 5 have generated real evidence you can point to.
When to hire your first commercial reps
Not before you have a working answer to what a rep should say, and to which 20 accounts. A talented rep with no ranked target list and no evidence package is guessing expensively. Hire once the first 2 to 3 pilot accounts are generating real utilization data and you can describe, specifically, what worked to get there — so the first rep is repeating a proven motion, not inventing one.
What commercial team structure looks like early on
Early-stage medtech commercial teams are usually smaller and flatter than founders expect: one person — often the founder or a first commercial hire — owning strategy and the first handful of accounts directly, supported by whatever data and evidence infrastructure exists, rather than a full leader-plus-reps org chart from day one. Roles specialize as the pilot accounts convert to real reference sites and the target list grows past what one person can carry personally, not before.
What "done" looks like at 6 and 12 months
At 6 months
3 to 5 pilot accounts with real utilization (not just installation), at least one published or presentable case, and a reimbursement picture confirmed for your next tier of targets.
At 12 months
A ranked list of 50+ accounts with evidence built for each, a repeatable pitch a new rep could execute, and visible tracking of where accounts stall — not just where they sign.
None of that requires a large team. It requires the infrastructure to do the targeting and evidence work at the pace the opportunity actually allows — which is what RevWorx is built to provide from day one, so a small first-time commercial team can operate like a much larger one. See the platform view on our medical device commercialization strategy page.
Sources and notes
- The LED / endoscopy market-sizing example is drawn from an internal case analysis rather than a named, publicly reported company or transaction — unlike the case studies used elsewhere in this series (Sim&Cure, Outset Medical, Akili, Butterfly Network, Asensus Surgical, PROCEPT BioRobotics, Sequana Medical, Skysona), which are tied to public, checkable sources. It is presented here as an illustrative example rather than a sourced case.
Frequently asked questions
- What should a first-time founder do in the first 90 days after FDA clearance?
- Confirm coding, coverage, and payment for your indication; write the claims your clearance actually supports; build the economic model and evidence package; score 20 target accounts and pick 5 pilots; and define what a successful pilot looks like before it starts.
- What should we build in-house versus outsource?
- Keep clinical positioning, account relationships, and the evidence narrative in-house — they compound. Outsource or buy specialist, episodic work like reimbursement dossiers, health-economic modeling, and regulatory writing.
- When should we hire our first sales reps?
- After a pilot has converted to a paid contract through a repeatable path. Hiring reps before you can tell them which accounts to call, what to say, and what evidence closes the committee produces expensive churn.
- What does an early commercial team look like?
- Usually a founder or commercial lead owning strategy and the first accounts, one clinical or field specialist supporting evaluations, part-time market access help, and one or two reps added once the motion is proven.