Clearance Does Not Drive Commercialization
An interview with Arvita Tripati, advisor at NDVC
POV: Your product is in pilot. The doctor used it to catch a signal two other devices missed. The patient survived. You are a hero!
The device works. It has users. It is demonstrating real value, literally saving lives.
And then … it goes nowhere. The pilot doesn’t convert. You never reach commercialization. What happened?
Arvita Tripati saw this one first hand. As our ‘commercialization and value creation whisperer’ at NDVC, she has watched it happen enough times to name the pattern. I asked her what founders should be doing to drive better outcomes, and she walked me through 13 big ideas worth absorbing into your founder toolkit.
The gap between clearance and revenue
Q1: You work with founders on commercialization. What’s the biggest mistake you see them make between getting a working product and signing a paying customer?
Founders treat every milestone as equally valuable. A cleared device, a signed pilot, a positive quote from a clinician -- these look like progress. Sometimes they are. But a milestone only matters if it removes a risk that someone downstream cares about. A cleared device without a credible payment or budget pathway may have reduced regulatory risk, but it has not yet reduced commercial risk. A pilot that produced a happy quote may have demonstrated interest, but not workflow fit, economic value, or readiness to purchase.
Q2: Why do founders keep chasing the visible milestone even when it doesn’t move them closer to revenue?
They’re responding to the incentives in front of them. Investors ask for traction. Grant applications ask for milestones. Buyers ask for pilots before contracts. Innovation teams are easier to reach than budget owners. So founders chase what’s visible. The harder discipline is knowing which milestone closes the specific risk a future buyer or acquirer will price -- and pointing the money there.
Two evaluators, one proof problem
Q3: You talk about two evaluators running parallel checklists when a founder approaches a buyer or a funder. Walk us through those.
A healthcare buyer is quietly asking: can we trust the claim, can we defend the evidence, will this create work for teams already underwater, what happens if it’s wrong, who owns the output, can we explain the economics, and what budget does this map to. A funder is asking: does this milestone build value or just spend time, is the regulatory pathway known, will this trial prove value and not just safety. Both are asking the same underlying question: which risk does this dollar remove.
Q4: Where do those two checklists overlap, and what does that mean for how founders design their work?
More than founders expect. When you design a pilot to answer the buyer’s question, you usually make it more fundable at the same time -- because you’ve tied the spend to a value milestone instead of a roadmap item. One artifact can satisfy both evaluators. That’s the whole game.
The proof packet
Q5: You recommend founders build a one or two page proof packet before approaching a buyer or a funder. What is it, and why one page?
A short, plain-English document that answers six things both evaluators want to know: the claim you’re making today, the evidence that supports it, the evidence gap that remains and which dollar closes it, the regulatory and reimbursement position stated as a moat, the workflow change you’re asking the buyer to absorb, and the path from this milestone to the next one that matters. If it runs more than a page or two, it’s not sharp enough yet. The point is to make the opportunity easy to evaluate, easy to share internally, and hard to misread. It also forces you to face the questions a serious funder or customer will eventually ask.
Q6: Start with the claim. Why do so many founders get this wrong, and what does a strong claim look like?
Most founders describe the product in language that’s directionally true but commercially vague. “We improve patient engagement.” “We reduce clinician burden.” Reasonable aspirations -- not yet a claim anyone can fund or buy against. In health and bio the claim sets everything downstream: the evidence burden, the regulatory route, the buyer, the budget, the trial design. A narrower claim feels smaller but works harder. Weak: “We improve patient engagement.” Stronger: “We help specialty clinics reduce avoidable no-shows by flagging high-risk appointments 72 hours out and triggering outreach for scheduling teams.” Write the claim in one sentence. Then write what you are not claiming. That second sentence often builds the most trust.
Q7: What’s the right way to present early-stage evidence without overselling it?
Split it three ways. What we know. What we believe. What we still need to prove. A single-site pilot is not a multi-site study. A retrospective analysis is not prospective validation. User enthusiasm is not operational improvement. You don’t need to apologize for early evidence -- you need to be precise about it. That reads as more credible than “our pilot showed strong engagement,” not less.
Q8: How should a founder frame the evidence gap and connect it to a specific dollar?
Name the risk that still stands between you and a buyer, and name the spend that retires it. Before you apply for any capital, write this sentence: “This trial closes the evidence gap a regional payer named as the reason they could not contract.” If you can’t write it, the money may still help, but it’s unlikely to move you closer to revenue. A study that shows the economic or operational result a buyer pays for is a study a strategic funder will help underwrite and a buyer will reward. One artifact, two evaluators satisfied.
Q9: You argue that regulatory and reimbursement position should be stated as a moat, not a worry. What does that mean in practice?
A known pathway with clearance behind you and a reimbursement route a buyer can model is the commercial asset and can be moat. It isn’t infallible (others can do the work and overcome it), but it is substantial. State the intended use, the user, the pathway you’re on, and what’s already established. If you have a clearance, say what it covers and what it does not -- so no one discovers the boundary later. If a CPT code or coverage decision exists, say so, because that’s the line that connects your product to a budget. If it doesn’t, say where you are in creating one. The goal is to show the regulatory and payment position is known, bounded, and working in your favor.
Q10: Workflow change seems obvious to address, but you say it’s the gap you see most often. Why does it keep getting skipped?
Founders are selling a product. The buyer has to adopt a behavior change. A product can be clinically interesting, technically impressive, and strategically sound -- and still too hard to put into practice. Healthcare teams are overloaded. IT roadmaps are full. Nobody wants another dashboard. Name it directly: who uses the product, when, what existing workflow it replaces or creates, what data it needs, what work it removes, and what work it adds. The people whose day you’re changing are the ones who quietly kill deals.
Q11: What’s the discipline around next steps that most founders are missing?
Ask earlier and more often than feels comfortable: if this pilot works, who decides whether to continue, who owns the budget, what metric justifies moving forward, what would block expansion even if users love the product. A milestone with no next step attached is not a milestone. It’s activity. Sometimes activity is worth funding. Just name which kind it is.
A cautionary story
Q12: You watched a mobile ECG product with strong clinical signal still fail to commercialize. What happened?
The clinical signal was as strong as it gets. One cardiologist used it on a patient who had collapsed, and it was the only tool that caught the correct reading when two others came back blank. The patient had a pacemaker the next day. Cardiologists were using it in clinic every week. And it still went nowhere -- not because the product failed, but because when the team asked how these doctors would pay for it, the answers were “I’m not sure how to bill for this” and “I’ve never heard of that code.” The product had clearance. It had clinical believers. What it did not have was a reimbursement line that connected the clinical win to a budget. That’s the gap a well-aimed dollar could have closed first: the coding and economic evidence, not the next feature.
The founder test
Q13: Before a founder accepts the next grant or agrees to the next pilot, what should they ask themselves?
Five questions. Which specific risk does this dollar remove, and who downstream cares about it? If this works, do we know what the buyer or the next funder would do next? Are we measuring what the budget owner cares about, not what’s easy to measure? Is the regulatory and reimbursement position one we can state as an advantage? Can our champion explain the value internally without us in the room? If the answers are no, the work might still be worth doing. But know which kind it is. Clearance is permission to sell. It’s not a sale. The grant is fuel. It’s not a result. The pilot is a test. It’s not a contract.
Arvita Tripati is a commercialization & value creation advisor at NDVC and a product, regulatory, and go-to-market operator in healthtech, medtech, diagnostics, SaMD, and AI-enabled healthcare. She works with founders on buyer readiness, evidence strategy, and commercial trust signals through her firm Vahana Labs. She also runs the Healthcare-Market Fit Lab on Maven and writes for founders and operators at Operating in Healthtech and for investors at Signal & Noise in Healthtech.