Using Real Data to De-Risk Your Pitch

From Pre-Commercial to Predictable: A 5-Part Series for MedTech Founders Part 2: Using Real Data to De-Risk Your Pitch

This is the second installment in a five-part series for MedTech founders navigating the path from early product development to a fundable, scalable, or acquirable business. Each issue focuses on a key decision point that shapes commercial outcomes:

• Part 1: Defining the End Early - Why Commercial Intent Must Come First

• Part 2: Using Real Data to De-Risk Your Pitch

• Part 3: A Focus on Credible Revenue

• Part 4: Designing a Tech Stack That Tells the Right Story

• Part 5: Commercial Strategy as a Signal of Exit Readiness

Using Real Data to De-Risk Your Pitch

Real-world data has become the critical proof point buyers and investors look for when deciding whether to move forward. In this market, traction is measured by what you can prove, not what you claim.

Strategics and investors alike are increasingly aligned on one point: if a solution cannot demonstrate real-world adoption, payer alignment, and clinical relevance, it is not ready for capital - or acquisition. You don’t necessarily need scale, but you do need evidence.

Everyone Is Trying to Minimize Risk

Strategic acquirers are reworking how they assess opportunities. Rather than taking on full acquisition risk upfront, many now structure 'build-to-buy' partnerships that hinge on hitting defined data milestones. These models allow acquirers to observe real-world adoption and validate value before committing to a deal.

Deals structured around milestone-based triggers depend entirely on hitting the right targets. Without timely, credible data - or if the data points don’t match what acquirers are looking for - momentum breaks down.

This is why early real-world data is essential. It validates that the product delivers value across the decision chain: clinical efficacy, provider usability, payer reimbursement, and system integration. Anything short of that is still theoretical.

Coverage is the New Clearance

One of the most important shifts in investor diligence is the move from regulatory-first to market access–first review. In other words, FDA clearance is now table stakes. What investors and acquirers want to understand is:

• Who pays for this?

• How does reimbursement work?

• What kind of coding or payment gaps exist?

• How long will it take to reach optimal coverage?

Founders often say, “We have a CPT code.” But having a code doesn't guarantee coverage. Payers evaluate the clinical utility, cost-effectiveness, and the burden of integration. Without data to support these points, a code itself is insufficient to drive adoption.

Real Data Starts Narrow

Early commercial data doesn’t need to cover every potential use case. In fact, it probably shouldn’t.

Strong data starts narrow and focused. Select a high-value, high-clarity use case. Define the clinical setting, the patient population, and the outcome you’re trying to shift. Build evidence that shows both efficacy and operational viability - how the product is used, billed, reimbursed, and retained.

Focused traction tells a more compelling story than broad potential of what your product could accomplish. It signals discipline, strategic clarity, and a willingness to prioritize proof over promise. It also shows that you understand your market and can design the business accordingly.

Data Changes the Conversation

With real data, your pitch evolves:

• Instead of saying “we reduce length of stay,” you show how your device led to a 1.2-day average LOS reduction in a 30-patient pilot at a regional health system.

• Instead of saying “we believe payers will cover this because...” you show ongoing discussions with two regional payers, supported by real-world outcomes and economic models.

• Instead of referencing interest from providers, you demonstrate utilization with a clinical site, complete with billing data and documented workflows.

Capital, partnerships, and validation all depend on tangible evidence. Without real-world data, you're hypothesizing. Demonstrating how your product performs clinically, operationally, and financially - in live settings - is what gains traction.

At UnifiMed, we help MedTech founders generate the kind of evidence that drives reimbursement, informs payer strategy, and validates clinical access.

Our commercialization systems are built to deliver real-world data that accelerates both funding and adoption. We align your clinical, regulatory, market access, and commercial strategies with clear, validated evidence.