Clearance week: the activation checklist
The cleared indications for use can come back narrower than the ones submitted, and every claim drafted during the review then has to be cut back to fit them in the week the letter lands. The list, the evidence pages and the audiences built during the review are activated that week, through the medical, legal and regulatory (MLR) review the company already runs.
Five activation steps, in order
All five are prepared during the review, so clearance week runs from a checklist.
- Claims updated to the cleared indications for use, through MLR review, one claim set per market.
- Email to the list: the clinicians who joined before clearance and asked to hear when the device could be discussed.
- Retargeting the audiences built before clearance that each platform still allows, inside their retention window and above the minimum size, with the claims the reviewers approve.
- Calculators and case studies made public once the medical and regulatory reviewers approve each figure, its evidence and its limits.
- Reference visits booked with the sites already using the device in another market.
Paid reach in five gated phases
Each phase is funded only when the one before meets its pass mark, and no phase commits the next. Spend at scale waits for evidence from after clearance. Each gate names its measure before the phase starts: matched audience size, cost per qualified conversation, or demonstration requests from target job functions. Ad spend sits outside my fee.
| Phase | What runs | The gate before the next phase |
|---|---|---|
| 1. Tracking | Tags live on the pages written for professionals, after consent, since the first month of the review. Every web address, form field and event they send is checked against each platform’s rules, and nothing names a condition. | Every tag checked page by page; matched audiences above each platform’s minimum |
| 2. A validation test | A small budget aimed at a defined clinician audience, with one claim set and one next step, inside the cleared indications for use | Cost per qualified conversation at or below the pass mark set before the test |
| 3. Retargeting across platforms | The audiences built before clearance, on LinkedIn, Google and Meta where each allows them and where they remain above the minimum size, such as LinkedIn’s 300 matched members | Demonstration requests from target job functions at or above the phase’s mark |
| 4. Wider audiences | Job and employer targeting widened across the cleared market, then new specialties one at a time | Cost per qualified conversation holding as the audience grows |
| 5. Scale | Budget moved to the channels that met their gates | Reviewed at the end of every sprint, and pulled back when a channel falls below its mark |
Ads in cleared markets only
Ads that mention the device run only in the market where the U.S. Food and Drug Administration (FDA), Health Canada or another regulator has cleared it, and only for the cleared indications for use. Every device page carries one market-status line near the top saying where the device is cleared or licensed, with the number, and that it is not for sale elsewhere. Location targeting is approximate, so geography limits the exposure in an uncleared market without removing it. The status line tells a visitor where the device may be sold, and it gives no legal cover in a market that restricts the page, so the regulatory reviewers confirm each campaign’s markets before it runs.
In some markets the ad itself needs local approval, or the device cannot be advertised at all before approval there. No campaign runs into Japan, China, Saudi Arabia, the United Arab Emirates or South Korea until the local distributor or regulatory agent confirms the route. The retargeting page lists the rules by platform and by country.
Winning the first 2 or 3 paying sites is covered under the next 5 to 7 references, and payment under who pays for a cleared device.
In clearance week, claims are cut to the cleared indications, the list is emailed, and paid reach starts small, with each phase funded only if the one before meets its pass mark.
Tell me your origin story
We book 1 to 2 hours. It is recorded, with a mutual non-disclosure agreement in place at booking, so you can talk openly about why you’re building this, the customers, pricing and pipeline decisions that are keeping you up at night. For a device company the agenda adds the four questions after clearance, and the playbook carries one page on what is known, what is unknown and who answers each.
From that session, you’ll get a written playbook, broken into steps your team can actually take.
It costs $25. Basically enough to cover the tokens to analyze our call and build out your report. I’m definitely not making money off this. But I am committed to showing up and using our time well. If the session isn’t worth your hour, I’ll double your refund: $50, as an apology for wasting your time.