7 Reimbursement Challenges Every MedTech Innovator Should Know

If you’re launching a medical device, having a strong reimbursement strategy isn’t optional—it’s foundational to your company’s success. 

In Velentium Medical’s latest webinar, industry experts Chris Hanna (Walnut Hill Medical) and Mike Tutera (Nalu Medical) share key insights into navigating the often complex and high-stakes world of healthcare reimbursement. Here are seven critical challenges they say every medical device company should be aware of—and how to tackle them. 

1. Align Business Fundamentals with Reimbursement Realities
Great technology won’t go far if providers can’t get paid to use it. Early in development, innovators must reverse-engineer their business models based on reimbursement expectations. Understanding physician and hospital incentives, procedure costs, and payer dynamics is essential to building a financially viable company. 

2. Understand the Process—and Its Complexity
Reimbursement isn’t a one-size-fits-all process. Medicare and private payers differ significantly in their requirements, and coverage can vary regionally. Success depends on aligning three elements: coverage (is it medically necessary?), coding (how is it billed?), and payment (how much is reimbursed?). Missing one can doom your launch. 

3. Build a Data Strategy Beyond FDA Approval
FDA approval focuses on safety and efficacy, but payers need more. You’ll need randomized controlled trials, real-world evidence, and health economics data to justify reimbursement. This type of data takes time, so start early and plan to publish in peer-reviewed journals—not just conference posters. 

4. Prepare for the Unique Challenges of New Therapies
Bringing a new therapy to market often means facing outdated coding frameworks or limited coverage policies. Even minor changes in delivery methods can knock your device out of reimbursable pathways. Understanding CPT coding (especially the difference between Category I and III) is vital. 

5. Monitor Policies—and Defend Your Turf
Reimbursement isn’t static. Payers can and do change policies, reclassify therapies, and consolidate coverage categories. Your company must actively monitor for threats and be ready to engage legal, policy, or coalition-based responses when needed. 

6. Maintain Ethical, Compliant Practices
Shortcuts in reimbursement strategy can backfire fast. Upcoding, misleading claims, or gaming silent policies may yield short-term revenue but damage your company’s long-term prospects—and the reputation of the entire sector. Integrity matters. 

7. Mature Your Strategy Over Time
Reimbursement isn’t a box to check; it’s a strategic pillar. Integrate it into product design, budgeting, and commercialization. Assemble a team of internal and external experts, and plan for how your strategy must evolve as your business grows. 

Final Thought
Reimbursement can make or break your innovation. Success demands strategic foresight, ethical discipline, and cross-functional collaboration. By addressing these seven challenges early and proactively, MedTech leaders can unlock sustainable growth and deliver meaningful patient impact.