Miyuru Amarapala
You Have Developed an Evidence Plan. Is It the Right One?
Picture this: You're at RSNA, ASCO, or ACC. The conference is one of the most important investments in access and awareness your medical device or technology company will make. Your technology works. Your clinical advisors are exceptional. You've just secured five minutes with a business development lead from a global strategic player. They ask: "Can you walk me through your integrated evidence plan?"
What you say next may determine whether you get a follow-on meeting or a polite handshake.
Ten years ago, the question would have been "What's your reimbursement strategy?" If you couldn’t answer, you were filtered out; reimbursement strategy became table stakes. In 2026, investors are treating integrated evidence planning as a proxy for whether your business can actually win; not just whether your technology is hitting certain development or reimbursement milestones such as identifying an appropriate CPT code.
Integrated evidence planning, the strategic approach to generating the right evidence for the right stakeholders at the right time, to achieve development and commercial success, is rapidly becoming the new baseline.
Building an Evidence Plan from Regulatory Clearance to New Standard of Care
As an innovator, you may focus your evidence investment (understandably) on what is needed for regulatory clearance approval. And so, you can demonstrate your technology is safe and effective, go on to secure regulatory clearance and launch, but only then do you discover critical gaps:
You find that health care Providers won't adopt the technology as expected due to insufficient comparative data or data showing workflow impact, or Payers won't reimburse because you lack health economic data. Guidelines committees won't include you because the publication record and KOL engagement required to support clinical practice changes are not yet established.
By the time these gaps surface, you've burned capital, missed market windows, and made development decisions that are expensive to reverse. The technology might be excellent, but the path to widespread adoption, and critically, to payer coverage and reimbursement, is unclear.
An EU-based company entering the U.S. market, for instance, may have no concept of the complexity awaiting it. European pathways tend to prioritize patient benefits alongside cost-effectiveness to the health system. The U.S. system demands additional stakeholder-specific evidence tied to economic value, payer coverage, and reimbursement codes, and overall has a more “budget impact” focused approach to market access.
Evidence Strategy Requires Answers to Five Key Questions
When strategics or investors ask about your evidence plan, they're asking: How are you generating the evidence required for each critical stakeholder to make a positive decision on approval, adoption, coding, coverage and payment for your product?
Five major stakeholder groups must see clear value:
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Regulatory bodies need evidence that your device is safe and effective. This evidence is essential and foundational but not sufficient to satisfy other key stakeholder requirements.
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Payers need evidence that your technology delivers economic value (cost savings, reduced complications, or downstream efficiencies) to provide coverage and reimbursement. Without this evidence, you face prior authorization barriers or bundled payments that don't recognize your unique value, hindering optimal pricing of the technology.
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Clinical users and clinical purchasing decision-makers, including provider value analysis teams, need evidence of workflow improvements, precision gains, or capacity expansion. This includes real-world usability, training requirements, and integration burden. As our Research & Strategy team has documented in its work on medical devices transitioning to home care, assumptions about user capability and environmental constraints often fail when tested in actual use environments. That’s where adoption barriers emerge that clinical trials never expose (e.g., home monitoring, remote diagnostics).
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Guideline bodies need peer-reviewed publications and KOL advocacy to incorporate your technology into clinical pathways, which in turn drive clinical adoption and payer coverage.
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Patients and advocacy organizations need evidence of better outcomes and improved quality of life resulting from your technology. Patient advocacy increasingly influences coverage and adoption decisions.
A strong answer addresses all five groups and describes how you're building the evidence each requires. You're not just running clinical trials. You're planning health economic studies, real-world evidence collection, workflow validation, and the publication strategy that supports guidelines inclusion, clinical adoption, payer coverage, and successful reimbursement.
What a Good 90-Second Answer to an Integrated Evidence Plan Sounds Like
Here's a structure that works:
"We're developing evidence for four critical stakeholder groups: regulatory, payers, clinical users, and patients. For regulatory, we're completing our pivotal trial designed to demonstrate safety and efficacy in [indication]. For payers, we're building health economic data showing [specific cost savings]. For clinical users, we're validating workflow integration in [specific settings]. For patients, we're collecting patient-reported outcomes demonstrating [specific benefits]. Our timeline aligns these milestones with our Series B fundraising."
For investors, this answer signals you understand how evidence, adoption, and revenue tie together, not just how to get clearance or approval. You've mapped evidence generation to business milestones. You're building a credible pathway where your device’s or technology's value gets recognized and paid for.
Contrast this with what doesn't work: "We're running our clinical trial and will figure out reimbursement after approval." That signals you'll discover critical gaps when it's too late to address them efficiently.
The Cost of Waiting
Companies often don't feel the urgency of evidence planning until they face consequences:
Your pivotal trial wasn't designed to capture the health economic endpoints payers need. You can't retrofit that data without costly additional studies.
You didn't engage KOLs early enough to build the publication record necessary for guideline inclusion. Now you're trying to generate that evidence post-launch when attention has moved elsewhere.
You optimized utility or workflow for academic centers but didn't validate your technology in the real-world setting of resource-constrained regional or community hospitals and outpatient sites. Your market adoption is limited to specialized institutions.
These mistakes fundamentally limit your commercial potential, provide advantages to competitors, delay patient access, and reduce your valuation. Even in the face of demonstrated clinical effectiveness, clinicians may be reluctant to adopt a technology that would not be adequately reimbursed by payers. A clear path to reimbursement, with evidence to secure payer coverage and adequate payment, is essential. Without considering the stakeholder ecosystem as a whole, the company that can’t drive adoption and growth because of these evidence gaps simply becomes less attractive to a strategic partner.
Increasingly, investors and strategic partners are asking for a coherent integrated evidence plan. Teams that can articulate a methodical, cross-functional plan are in a much stronger position than teams that present disconnected studies or post-hoc plans.
Early Beats Late
Companies that succeed start evidence planning before they lock in trial design. They identify stakeholder evidence needs and impact during product development, not after securing clearance.
This doesn't mean executing everything at once. It means having a roadmap. You might focus on regulatory evidence first, but also consider capturing patient-reported outcomes and developing parallel health economic analyses so that you are demonstrating clinical and economic value in tandem You engage payers early to understand their evidence requirements. You identify the KOLs necessary for guideline inclusion while your technology is still in development.
Evidence built early is far more cost-effective than evidence retrofitted later. It also de-risks your story in diligence, which directly affects price, structure, and speed of a transaction. Also importantly, it creates a credible narrative for investors-- you understand the complete pathway to adoption and sustained revenue growth, not just the pathway to regulatory approval.
Verification Through Expertise
The question investors and strategics are really asking is whether you understand how your technology actually gets adopted and reimbursed in practice. Do you know which stakeholders matter most? Have you identified their evidence requirements? Have you built a realistic timeline and budget?
If you can answer these questions clearly, you signal the strategic discipline investors look for in an acquirable asset. If you can't, you're signaling execution risk that will limit your valuation.
The goal isn't perfect evidence on day one; it’s a realistic, methodical integrated evidence plan that you can execute in sync with your business milestones. It’s to make clear that you know what evidence you need, why it matters, and how you' will generate it in sequence with your business milestones.
Miyuru Amarapala is a Product Commercialization Manager, Commercial Strategy and Market Access at Veranex.
About Veranex Commercial Strategy & Market Access (CSMA)
To meet your Integrated Evidence Planning goals, the Veranex evidence strategy team works with client cross-functional teams to map all evidence required for maximum velocity to regulatory clearance, market acceptance, and economic viability establishing the share position from which a product commercially succeeds. Those insights shape design and development pathways, quality systems, clinical research including trial design and endpoint selection, and regulatory submission strategy, so every data-generating activity moves payers toward coverage decisions.
For startups, early Veranex engagement shapes the entire development pathway. Post-approval, we compress the approval-to-revenue gap. For global strategics, we evaluate target evidence gaps, surface valuation risks, and identify challenges that impact deal economics including those related to adoption and coverage. Whether you're building for growth or acquisition, creating commercial clarity with Veranex adds velocity to your vision.
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