You sell in one market and you’re clearing the next. Start the engine there now, so it’s running the day you can sell.

The map: before and after clearance, in person and online

Four quarters with your website at the centre, powering the retargeting. Before clearance, the job is to grow the email list and the retargeting pools. After clearance, the job is to activate them.

Your website powers the retargeting

The conference session, the published paper, the roundtable and the evidence page all send clinicians to the same place. If they are on your site, they want to learn, gain trust and eliminate uncertainty. Before clearance it offers two next steps and only two: a scientific exchange, routed to your clinical team, or a place on the list for clearance day.

Either way, the visit is tagged and the visitor joins your retargeting audiences, so your evidence follows them for months and brings them back. That is how a year of conferences and content turns into warm audiences on clearance day, ready to activate.

What we will and won’t do before clearance

• We will build clinician-grade content and authority, run research collaborations under ethics protocols, collect letters of intent for deployment after clearance, grow the email list and retargeting pools, and route patient enquiries to your clinical team.
• We won’t imply clearance or “clinical-grade” status, make claims beyond what the rules allow at your stage, or take orders before you may sell.

Two rules sit behind that list. In the United States, the Food and Drug Administration (FDA) rule is Title 21 of the Code of Federal Regulations (CFR), section 812.7, which says a sponsor, an investigator, or anyone acting for them, shall not “(a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution”, or “(d) Represent that an investigational device is safe or effective for the purposes for which it is being investigated.”

In Canada, section 27 of the Medical Devices Regulations says nobody may advertise a device above Class I (Health Canada’s lowest risk class) for the purpose of sale until the manufacturer holds a licence for it, or an authorization under section 68.12, with one narrow exception for a catalogue that carries a clear warning.

Sources, checked 29 October 2026: 21 CFR 812.7, eCFR; Medical Devices Regulations, section 27, Justice Laws Website.

Every approval goes in your quality management system

The marketing engine and every content approval are documented in your quality management system (QMS): each public claim, the evidence behind it, who approved it and when. Your regulatory counsel reviews every public asset, and the record lets an auditor trace any statement back to its evidence. That discipline is what makes the strategy defensible to investors and to the regulator.

I’ve built this before. For a medical device company, I built a scientific exchange protocol for pre-clearance market development directly with external counsel. The process is fully auditable, was audited to International Organization for Standardization (ISO) 13485, and is traceable through the company’s QMS.

Paid reach is funded by signal, one phase at a time

Paid reach runs in gated phases. Tracking comes first, then a small test with a tightly defined clinician audience, then retargeting, then wider audiences. Each phase is funded by the signal from the one before, and no phase commits the next. Spend at scale waits for evidence from after clearance, so the budget follows signal and never faith.

If no market is commercial yet, start with the kit

When your device isn’t cleared or licensed anywhere yet, the binding constraint is clearance itself, and no pipeline moves it. The free kit runs the same method in your own artificial intelligence (AI) assistant, so you can rank your go-to-market assumptions now and be ready when the first market opens. Already cleared somewhere with paying sites? The medical device page is for you.

Tell me your origin story

We book 1 to 2 hours. It’s recorded, with a mutual non-disclosure agreement in place at booking, so you can talk openly about why you’re building this, your first sites, your pricing and the pipeline decisions keeping you up at night. For a device company I add the four questions after clearance to the agenda.

Within 24 hours you get a written playbook, broken into steps your team can take. For a device company it carries one more page: for each of the four questions, what’s known, what’s still unknown, and who on your side answers it.

It costs $25, basically enough to cover the tokens to analyze our call and build out your report. If the session isn’t worth your hour, I’ll refund double: $50. And if anything stalls, you hear from me within one business day.