Healthcare and medtech companies need a growth leader who understands regulatory complexity, clinical evidence, and reimbursement, not a generalist marketer learning the space on your dime. You can't wait until FDA clearance to start building demand.
FDA timelines make hiring impossible to time
You don't control when clearance lands, but you're expected to have a fully staffed marketing function ready the moment it does. Hire too early and you're paying salary against a product you can't sell yet. Hire too late and competitors with faster review pathways own the launch window.
Clinical evidence rarely gets translated into a sales asset
Your clinical and regulatory teams produce study data that proves efficacy, but almost none of it reaches the field as something a hospital committee or payer can actually evaluate. Most early-stage medtech teams have nobody whose job is that translation, so strong trial results sit in a PDF nobody reads.
Reimbursement decides your addressable market before pricing does
A device with a clean CPT pathway and prior-authorization support sells differently than one facing coverage ambiguity, and most marketing plans are built as if reimbursement is a finance problem instead of a demand problem. Get this wrong and your CAC model breaks the first time a health system's utilization review stalls a deal.
We build go-to-market plans that work inside regulatory constraints instead of pretending they don't exist. That starts with regulatory-aligned sequencing: pre-clearance, we build the growth strategy, KOL relationships, and content pipeline; post-clearance, we execute the launch in weeks instead of the quarter it usually takes a company to staff up from scratch.
We work directly with your clinical and regulatory leads to turn study results into evidence-based messaging that a hospital value-analysis committee or payer reviewer can actually use. This is not a copywriting exercise, it's translation work done alongside the people who ran the study.
On reimbursement, we build pricing and channel strategy around real coverage dynamics: CPT status, prior-authorization friction, and payer mix by region. That shapes which segments we target first and how the sales motion is structured, not just how the product is priced.
Every healthcare engagement runs inside a compliance framework so marketing activity stays inside FDA and FTC advertising rules while still moving fast commercially. We'd rather build a compliant campaign that ships on time than a bold one legal kills in week three.
What makes this different from an agency or a full-time hire: we're embedded, not advising from the outside, and we own outcomes, not slide decks. Our [growth strategy](/services/strategy/) work is built around a 90-day sprint with clear phase gates, so you're not waiting six months to find out if the plan works.
We set baseline [measurement](/services/measurement/) before we change anything, so every recommendation is judged against real numbers, not intuition. Monthly reporting shows what moved, what didn't, and what we're changing next, with no vanity metrics tied to clinical or commercial risk.
Most medtech companies wait for FDA clearance to start building their go-to-market function. By the time they hire, competitors with the same clearance date already have distribution moving.
The first 30 days are a full audit: current commercial infrastructure, clinical data available for translation, payer landscape by target region, and the competitive field already active in your indication. We interview clinical, regulatory, and sales stakeholders together, because in healthcare those three functions make or break a launch and they rarely talk to each other on a shared timeline.
Days 30-60 turn that audit into a sequenced plan tied to your actual regulatory milestone, not a generic marketing calendar. We build the evidence-to-messaging pipeline, set up baseline measurement, and start the pre-launch work that doesn't require clearance: KOL development, content, and payer conversations.
Days 60-90 shift to execution against whatever your actual timeline delivers, whether that's clearance landing on schedule or a delay that shifts the plan. By day 90 you have a functioning growth engine built around your regulatory reality, with clear ownership of every workstream, that keeps running whether we stay on or not.
In the first 30 days, we audit your current commercial and clinical assets, interview stakeholders across clinical, regulatory, and sales, and map where your FDA timeline intersects with your go-to-market plan. We leave that phase with baseline metrics and the three to five highest-impact moves.
Days 30-60 are strategy and early execution: building the evidence-to-messaging pipeline, restructuring team roles where needed, and starting the pre-clearance groundwork that doesn't depend on regulatory approval. Weekly check-ins keep clinical, regulatory, and commercial stakeholders aligned on one plan instead of three.
Days 60-90 are full execution, adjusted to whatever your actual regulatory timeline delivers. We report monthly to leadership on what's working, what's not, and what changes next.
Most healthcare and medtech engagements run 3-6 months initially, sometimes longer given regulatory timing outside anyone's control. We work 15-25 hours a week embedded with your team: sitting in leadership meetings, managing vendor and agency relationships, and making the resource calls that keep the plan moving between milestones.
If your healthcare & medtech company needs fractional cxo leadership, we should talk.
Let us take a custom approach to your growth goals by assembling and leading the best-in-class marketing team to support your next stage.
We build and run go-to-market strategy sequenced around your FDA timeline, translate clinical evidence into messaging providers and payers can act on, and build reimbursement into pricing and channel decisions. Our background spans medical devices, digital health, and healthcare services companies, so we're not learning regulatory basics on your engagement.
A general consultant treats FDA timing, clinical evidence, and reimbursement as someone else's problem. We build the plan around them from day one, working directly with your clinical and regulatory teams instead of around them. That's the difference between a launch plan that survives a clearance delay and one that doesn't.
Fractional CXO engagements typically run $15K-$25K per month depending on scope, company stage, and weekly time commitment. Compare that to a full-time CMO or CGO hire at $250K-$400K in base salary alone, plus equity, benefits, and the risk of hiring before you have a repeatable go-to-market motion. You get senior operator expertise scaled to where you actually are in the regulatory process.
Diagnostic findings and quick wins, like fixing evidence messaging gaps or reimbursement blind spots, typically surface in the first 30 days. Structural changes such as the evidence-to-messaging pipeline and measurement framework show impact by day 60-90. If your engagement starts pre-clearance, the biggest compounding effect is having the go-to-market plan ready the day approval lands instead of three months later.
We work 15-25 hours a week embedded with your team, including direct working sessions with clinical and regulatory leads to translate study data into commercial messaging. Weekly check-ins keep everyone on one sequenced timeline instead of three separate ones. We attend leadership meetings and make resourcing calls alongside you, not from outside the room.
We set baseline metrics in the first 30 days, before any changes, so results are measured against real numbers specific to your business, not generic marketing benchmarks. For medtech, that often includes provider engagement with evidence-based content, payer conversation velocity, and pipeline built ahead of clearance. Monthly reporting ties every metric back to commercial outcomes, not vanity numbers.
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