
FDA clearance is the starting line, not the finish line. A b2b go-to-market strategy that starts after clearance is already a year behind, because market-product fit has to exist before a sales team has anyone ready to sell to.
Key Takeaways
Watch the full episode on YouTube
Most founders treat go-to-market as the step that starts after the product is done. That order is backwards, and it's the single most common reason a b2b go-to-market strategy in medtech underperforms.
I interviewed Fazila Seker, CEO of Insight Medbotics, on an episode about building an MRI-native robotic platform for prostate cancer. She named the pattern directly:
"Most medtech companies don't have that same level of discipline when it comes to go-to-market. Founders skip over that. They often take their one or two advisers and say that's good enough, and then as soon as they complete a clinical study, they raise money, and they decide it's time to do go-to-market."
That sequence feels efficient. It isn't. By the time a founder starts building market awareness after clearance, competitors and incumbents have had years of head start on category language the buyer already recognizes.
Seker's own path took the opposite order. Insight Medbotics went to market with customers early in product development, before the design was finished, and let that feedback shape the product itself. From founding to exit took six years, which she called fast for the category.
That's the real cost of sequencing go-to-market last. It delays revenue, and it removes the one input that would have made the product better before it shipped.
Product-market fit assumes a market already exists to fit into. In medtech, that assumption breaks the moment the category isn't clearly defined yet, which is most of the time for anything genuinely new.
Founders default to product-market fit language because it's the term everyone else uses. But it hides a sequencing problem.
Product-market fit means finding an existing market for a product. Market-product fit means the market doesn't exist yet, and has to be built before fit is even a meaningful question.
I covered this on an episode about how market engineering helps medtech startups raise capital:
"Product market fit is necessary, but it's incomplete. If a category is not clearly defined, clinicians and buyers don't really know how to evaluate you. They don't know when to use you, they don't know why you matter."
Look at how many surgical robotics companies launched to compete directly against Intuitive. Most lost because they were playing inside a category Intuitive already owned, on rules Intuitive already set.
Clinical validation proves the product works. It doesn't prove clinicians know when or why to reach for it. That gap is a market failure, not a product failure, and no amount of additional clinical data closes it.
A b2b go-to-market strategy in medtech has to sequence more than messaging. It has to sequence where trials run, where manufacturing happens, and which markets get approached first, in an order that compounds rather than competes.
Ramin Mousavi, formerly of CathWorks, laid out a nine-point playbook built from that experience, and named market sequencing as one of the two points founders most often skip. On a 2025 episode covering the full framework, he said:
"Sequence markets wisely. Run trials where rigor is rewarded. Manufacture where speed and cost align."
That's three separate sequencing decisions collapsed into one sentence. Founders who never write the sequence down make each one in a different order.
Trials run wherever a site is available. Manufacturing gets chosen for near-term cost. Markets get approached in whatever order investor pressure dictates.
Mousavi's framework treats those as one decision, not three, because a trial run in a low-rigor market produces evidence that doesn't travel to a high-rigor one. The sequence has to be designed before the first site is picked, not adjusted after.
Founders often measure go-to-market success by what happens in the room during a pitch or acquisition conversation. That's the wrong measurement window. The room is where a deal gets confirmed, not where it gets shaped.
I've spent 400+ episodes of The State of MedTech sitting across from founders and CEOs who pulled off exits from Axonics, NuVasive, Prometheus Bio, and others, worth roughly $17 billion to $20 billion combined. They all described the same pattern.
I covered this on an episode about attention and market shaping:
"The deal didn't close in the deal room. The market was shaped years before. Every single asset, every single tactic all point in the same direction, day after day, week after week, month after month, until the market shifts towards you."
A pre-revenue robotics company walks into its first conference and finds all three of its target strategic acquirers uninvited at its booth.
A founder stops cold-outbounding investors because investors start referencing the company's own category language back at them. A health system reaches out inbound after a product clearance, asking for an on-site demo.
None of that happens inside a single pitch meeting. It's the compounding result of a b2b go-to-market strategy sequenced correctly, years before any deal conversation starts.
In my experience working with medtech founders, the ones who get sequencing wrong aren't lazy or careless. They're following the order that feels intuitive: build the product, prove it clinically, then go find customers.
That order works in categories where the market already exists. It doesn't work when the category itself has to be built, which describes most genuinely new medtech.
The founders who get this right start the go-to-market sequence at the same time they start product development, not after. They treat market-product fit as a prerequisite to product-market fit, not a parallel track.
And they design the sequence of trials, manufacturing, and market entry as one decision instead of three separate ones made under pressure.
FDA clearance is the starting line, not the finish line. Great companies don't wait for markets to form. They engineer them, on a sequence they set well before the first pitch meeting.
The sequence starts with market-product fit, not product-market fit: defining the category and the language clinicians use to evaluate it, before assuming a market exists to sell into. Trials, manufacturing location, and market entry order should be planned together, not decided independently under time pressure.
Founders typically wait until after FDA clearance and a funding round to begin go-to-market work, treating one or two advisers as sufficient preparation. By the time they start building a sales team, competitors and incumbents already have years of head start on the category language buyers recognize.
Market development in medtech runs in parallel with product development and clinical work, often over multiple years rather than months. Founders who start sequencing go-to-market only after clearance are typically a year or more behind where they'd be if the sequence started alongside product design.
If you're doing this yourself. Read the medtech commercialization strategy breakdown to see the full sequence market-product fit fits inside, before you build a go-to-market plan around a category that isn't defined yet.
If you want it engineered with you. MarketCraft takes on a small number of medtech teams each quarter, starting with The Market Engineering Audit. For founders sequencing go-to-market before a raise or a launch, the audit maps where market-product fit is still missing.
Fazila Seker's full conversation with Omar Khateeb is available on The State of MedTech. Watch on YouTube. Subscribe wherever you listen to podcasts.
Fazila Seker is the CEO of Insight Medbotics, developer of an MRI-native robotic platform for prostate cancer treatment. She has led the company from early product development through commercial-stage growth, with a company exit inside six years from founding.
Omar Khateeb is the founder of MarketCraft and host of The State of MedTech, the number one podcast in the medtech industry. He works with medtech founders and commercial leaders on market engineering, commercialization strategy, and revenue growth. Visit marketcraft.ai or subscribe to The State of MedTech for weekly conversations with the people building the future of medical devices.