Eight workstreams during regulatory review

The eight workstreams, month by month

They run in parallel, and each one has a starting month.

1. Pre-clearance claims procedure, month 1. A written procedure drafted with the company’s regulatory counsel: what may be said in each market, who reviews it, the review times for a normal and an urgent piece, and where the record lives in the quality management system (QMS). It carries one claim set per market, each claim traced to its evidence, a market-status line on every device page, and a demonstration-only sign at trade shows in markets where the device is not yet authorized. Uncertainty about what may be said before clearance often keeps a company silent for the whole review, and the procedure removes that uncertainty.
2. Evidence pages for clinicians and for artificial intelligence (AI) search, month 1. One clinical question per page, with the author, the medical reviewer and the review date, the sources linked, structured data, and an entry in the llms.txt file that AI assistants read. I measure how often AI assistants cite the company at a baseline, then again each quarter.
3. Scientific exchange at specialty meetings, month 2. Educational sessions at specialty society meetings, roundtables with the key opinion leaders in the specialty, and research collaborations once institutional review board (IRB) or research ethics board (REB) approval and the regulatory authorizations are confirmed, each recorded where the meeting’s rules and counsel allow.
4. The clinician list, month 2. Built from public signals: publications, conference faculty lists, society roles and the sites doing the procedure. The clinicians closest to the clinical problem go to the company’s clinical team for a scientific conversation, and the rest are invited to join the email list. Only people with their own relationship to the company, and the consent the law asks for, go into an uploaded audience.
5. One-to-one outreach from the clinical team, month 2. Each message comes from a clinical or medical affairs lead, sent by a person, and asks how the clinician handles the clinical problem today, with an invitation to a scientific conversation with the clinical team. No message asks for a meeting about the device, and these conversations stay out of the commercial measures.
6. Ad tags and audiences with no ad spend, month 1. The tags go onto the pages written for professionals and fire only after the visitor consents, through a setting on each page. Patient pages and health forms carry none. Audiences fill from organic visits, built on job, employer and site visit: on LinkedIn first, on Google for campaigns written for clinicians once its review allows them, and on Meta for awareness. A LinkedIn campaign needs at least 300 matched members, and platform audiences expire when unused, so the email list is the asset that lasts until clearance.
7. Device software functions sorted by regulatory status, month 3. For a software device, each feature is sorted into three groups: software functions that are not devices, functions under FDA enforcement discretion, and device software functions that need authorization. The company’s regulatory advisers confirm every sort, and the map makes no regulatory determination of its own. Revenue starts wherever the rules already allow it.
8. An operating dashboard that doubles as the investor data-room page, month 3. The same measures run the team’s weekly operating review and the page in the company’s investor data room.

Website retargeting from consented visits

The published paper and the evidence page send clinicians to the same website. Before clearance it offers two next steps: a scientific exchange request, routed to the clinical team on a page that carries no ad tags, or a place on the list for clearance.

Consented visits to the other pages written for professionals build retargeting audiences that are still inside each platform’s retention window on the day of clearance. Patient pages and health forms carry no tags at all. The retargeting page sets out which pages carry ad tags and what the ads may say at each stage.

Promotion rules before clearance

Specialty conferences before clearance

An educational session at a specialty society meeting reaches the clinicians in the specialty before and after clearance. Before clearance, the company’s regulatory counsel decides what the talk may say and show and where the recording may go. Our own policy keeps the talk on the clinical problem and the published evidence.

What we will and won’t do

• We will build clinician-grade content and authority, run research collaborations under the ethics approvals and regulatory authorizations they need, record interest from sites for after clearance, with no terms of sale, in wording the company’s regulatory counsel reviews first, grow the email list and the retargeting audiences, and route patient enquiries to the clinical team.
• We won’t imply clearance or “clinical-grade” status, make claims beyond what the rules allow at the company’s stage, or take orders, or get ready to take them, before the device may be sold.

Calling something scientific exchange settles nothing by itself. Health Canada weighs the sponsor, the content, the context, the audience and the frequency, so every piece goes through the procedure.

The three rules, quoted

In the United States, Title 21 of the Code of Federal Regulations (CFR), section 812.7, 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.”

For a device awaiting 510(k) clearance, FDA’s compliance policy says that “a firm may advertise or display a device that is the subject of a pending 510(k)”, while “a firm may not take orders, or be prepared to take orders, that might result in contracts of sale for the device unless limited to research or investigational use”.

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; FDA, Compliance Policy Guide Sec. 300.600; Medical Devices Regulations, section 27, Justice Laws Website; Health Canada, Distinction Between Advertising and Other Activities.

Claim approval in the quality system

Each public claim, its evidence, its reviewers and its approval date are recorded in the QMS, so an auditor can trace any public statement to its source. The procedure names who drafts, who reviews for medical accuracy, who reviews for compliance and who approves, and how long a normal review and an urgent one take. The company’s regulatory counsel reviews every public asset.

For a medical device company, I built a scientific exchange protocol for pre-clearance market development directly with external counsel, inside a QMS audited to International Organization for Standardization (ISO) 13485.

A company with no revenue in any market faces clearance itself as the constraint. The free kit runs the same method in the company’s own AI assistant, so the go-to-market assumptions can be ranked now. A company close to authorization starts with the clearance week checklist, and a company with paying sites starts with the next 5 to 7 references.

Before clearance, a device company can build its evidence, its clinician list and its review procedure; it cannot take orders or claim the device is safe or effective.

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 under review, the agenda adds the regulatory timeline and the claims each market allows today.

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.