THE Time for Checking Your Medical Device Payer Evidence Blind Spot

Are you designing a clinical trial for your medical device? Securing FDA approval is essential, but it’s only half the battle. Failing to include data that addresses payer requirements in the early stages of trial design and protocol development, your innovation could face 12–24 months of costly delays after regulatory approval, putting both your commercial goals and patient access at risk. 

It Bears Repeating: FDA Approval Isn’t a Ticket to Payment 

A critical blind spot many medical device startups continuously miss is assuming FDA approval guarantees reimbursement. They probably considered a payer assessment and reimbursement pathway in very early stages of their lifecycles when presenting to investors, but by the time clinical trials roll around, those assessments, pathways and strategies are distant memories; out of sight and out of mind.  

While your clinical trial may focus on safety and effectiveness, payers want more than this. They want evidence that your device reduces healthcare costs, improves efficiency, or provides meaningful clinical or economic value beyond the ‘table stakes’ alone. Without this plan for data collection built into your trial protocol, expect lengthy delays and costly data collection post-approval. 

Note: We acknowledge that “one and done” studies are not always feasible. If you must conduct a clinical study, capitalize on it to collect as much payer-driven evidence as is feasible for the study, without overburdening it. There may be instances in which a two-pronged approach is the better strategy; get your product to market faster with a minimally required study for FDA, then conduct a more robust post-market study for reimbursement purposes.  

Where Clinical Trial Protocols Go Wrong: The Evidence Gap 

Why do clinical trial protocols often overlook data needed for reimbursement? Small teams grapple with resource constraints and focus intensely on regulatory endpoints. Early market assessments may touch on payer needs, but without explicit integration of “medical device payer evidence” in the protocol, valuable data slips through the cracks. Even in large organizations, clinical and reimbursement teams often work in parallel, not in partnership, due to functional silos. 

As one clinical affairs leader put it: "When I designed studies, no one on the reimbursement side asked what data I was collecting. It just wasn’t on our protocol checklist.” 

This “we’ll figure out reimbursement later” mindset rarely saves time or money. More often, it sets the stage for expensive rework. 

High-Value, Low-Burden Endpoints: Real-World Examples 

The good news: integrating payer-relevant endpoints doesn’t always require an overhaul, just foresight.  

Example 1: 

• Cancer Screening: 
  A prostate cancer liquid biopsy demonstrated how a simple data point can change the payer conversation. By prospectively tracking the number of avoided prostate biopsies in a pivotal clinical trial, the sponsor generated compelling evidence of clinical utility and cost savings. This simple one item in data collection element added healthcare efficiency narrative, a key indicator in payer assessment.  

Example 2: 

• Atrial Fibrillation Ablation: 
  When sponsors prospectively capture metrics like procedure time, hospital stay length, and time to discharge, they can clearly demonstrate reductions in resource utilization compared to Sstandard of Ccare. Those insights translate directly to payer’s value, quantifying both clinical and operational impact.  

The takeaway: a few extra carefully chosen data fields, incorporated up front, unlock substantial value for coverage, coding and payment discussions post-approval. 

Integrated Evidence Planning: Your Blueprint for Market Success 

So how do you align clinical research, commercial goals, and payer requirements? Through integrated evidence planning, which means building clinical, economic, and real-world evidence needs into your clinical study protocol from day one. 

How to Operationalize It: 

• During Protocol Development, Before Locking: 
  Identify 3–5 high-value, low-burden endpoints aligned with payer needs.  

Review existing payer coverage decisions and CMS criteria for your indication. Validate these endpoints are feasible within site’s’ existing workflows before protocol finalization. 

• During Site Selection and Training: 
  Educate sites on why payer endpoints matter by connecting them to long-term patient access and efficiency gains in their operations. Confirm site workflows can support efficient, accurate capture. A few hours of expert input here can prevent 12–24 months and six figures in post-approval rework. 
  
  

Protocol Review Checklist: Are You Reimbursement-Ready? 

Use this checklist before finalizing any protocol: 

• Have CMS and top commercial payer requirements for coverage been clearly identified? 

• Are there reimbursement-relevant endpoints you can add with minimal burden? 

• Has a reimbursement expert reviewed your protocol draft? 

• Are you relying solely on “figure it out later” as your reimbursement strategy? (This is a red flag.) 

• Do you know if sites already track data crucial for payer submissions? 

If any answer is “no” or “not sure,” don’t wait. Early intervention is far less costly than late fixes. 

Medical Device Payer Evidence: From Protocol to Market Access 

At Veranex, our Commercialization, Strategy, and Market Access team collaborates with Clinical Research experts to unify your pathway to approval and payer adoption: 

• Integrated Evidence Planning: Enterprise-wide, synchronized trial design for all evidence stakeholders. 

• Clinical Data Services, Reimbursement Strategy & Market Access: Coding, economic analysis, and payer outreach support tailored for your device. 

Learn more about our integrated approach and how we can help at veranex.com/icro. 

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