Device go-to-market, before and after clearance
When a device company reaches clearance with no clinician list, no evidence a clinician can find and no audiences, I’ve watched the next year go to building what could already have been running. Much of that work can run during the regulatory review, inside the U.S. Food and Drug Administration (FDA) and Health Canada promotion rules.
Three stages of commercial work
Market development runs during review
For a device sold in one market while the submission for the next is under review: eight workstreams that build the clinician list, the evidence pages and the review procedure.
The eight workstreamsClearance week activation
Claims cut back to the cleared indications for use through medical, legal and regulatory (MLR) review, the list emailed, and paid reach started small, with each phase funded only when the one before meets its pass mark.
The activation checklistThe next 5 to 7 references
From the first 2 or 3 paying sites to the next 5 to 7 references in one specialty, with the clinical champion, the economic buyer and the value analysis committee mapped at each site.
The reference sitesA company cleared in one market and under review in the next works at two stages at once, and the session sets the order from what is already built. The same three stages apply to a new-product team inside a larger device company. Two answer pages sit beside them, on retargeting clinicians and on who pays for a cleared device.
Engagement model: fractional lead, two-week sprints
A fractional go-to-market lead. One to two days a week, working inside the company’s own accounts, alongside its commercial, clinical and regulatory staff.
The plan is written as states of readiness by month. At the end of each month it names what is true: the list built, the evidence pages live, the tags installed, the review procedure signed off. It is written that way because regulatory reviews, institutional review board (IRB) and research ethics board (REB) cycles, and journal review windows all run on someone else’s clock.
Sprints, with an exit at the end of each. After the $25 session we agree an opening sprint, then 2-week sprints. Either of us can stop at the end of any sprint, and each sprint closes with three options: continue, move to the next stage, or pause.
Ad spend and assets belong to the company. Ad spend sits outside my fee and is released one phase at a time, when the phase before meets its pass mark. The list, the dashboards, the procedures and the evidence pages all belong to the company, and its team runs them by the end.
MLR review sets the pace. Before the first sprint the company names its reviewers, who publishes, and who answers clinicians, and we estimate the review hours together. The workstreams move at the speed of that review.
The commercial map, before and after clearance
Four areas with the company website at the centre. Scientific exchange runs through the clinical team and stays separate from the commercial work; the other three areas grow the email list and the audiences before clearance, and activate them after.
In person
Online
Before clearance
After clearance
Scientific exchange
- Educational sessions at specialty society meetings
- Roundtables with the key opinion leaders in the specialty
- Research collaborations under IRB or REB approval and the regulatory authorizations they need
- Independent accredited education the company may support but does not control
Evidence and the list
- Publications, abstracts and reviews
- Evidence pages written for clinicians and structured for artificial intelligence (AI) search
- A clinician email list people join themselves
- Retargeting audiences built from consented visits
The company website
The evidence pages, the list and the demonstrations send clinicians and buyers to the website. With the visitor’s consent, visits to the commercial pages written for professionals feed the retargeting audiences each platform allows. Scientific exchange requests go to the clinical team, and those pages carry no ad tags.
Demonstrations and references
- Branded demonstrations and conference booths in cleared markets
- Visits to reference sites
- Value analysis committee packs
- The full sales effort, inside the cleared indications for use
Activation
- Claims updated through MLR review to the cleared indications for use
- Email to the clinicians who joined the list before clearance
- Retargeting the audiences still inside each platform’s retention window
- Case studies and the return-on-investment calculator, once reviewers approve each figure
My record in medical devices
- At Medlantis, a medical-education company, I was chief operating officer while we grew from 12 hospitals to 143 in 3 years. The about page has the rest of my record.
- As vice president of operations at Insight Medbotics, I took a magnetic resonance imaging (MRI)-guided breast-biopsy robot to U.S. Food and Drug Administration (FDA) 510(k) clearance, 3 months early and under budget, and owned regulatory, quality, verification and validation, and the corporate financials.
- For a medical device company before clearance, we identified and qualified 200+ physicians across 31 private clinics, and built the qualification funnel, the sales-cycle stages, the clinical evidence hub and the 36 to 60 month pro-forma models.
- For that company I built a scientific exchange protocol with external counsel, inside its quality management system (QMS), which is audited to International Organization for Standardization (ISO) 13485.
- In 2016 at Medlantis, a working demonstration at a medical society meeting needed 5 leads to pass. It produced 7, and one buyer paid more than 10,000 United States dollars on the spot. The method page has the full experiment board.
The work fits a device company with revenue in another market, or a paid pilot where that market’s rules allow one, where the founder or the team lead still takes part in each sale. The company’s regulatory team confirms what any paid pilot allows.
The work starts from the sites already paying: why each one bought is the first evidence for who buys next.
A company with no revenue in any market yet faces clearance itself as the constraint, and the free kit covers that stage: it runs the same method in the company’s own artificial intelligence (AI) assistant, at no cost.
The clinician list, the evidence pages and the review procedure can all be built inside the promotion rules while the regulatory file is under review.
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.