Reimbursement basics and tips on coding, coverage and payment
Global Market Access Strategy 2026: Navigating the intersection of clinical evidence and economic value is now a universal requirement. Whether you are addressing **US Payer coverage** requirements or **European G-DRG and GHS shortcuts**, success depends on early synchronization of your clinical and reimbursement roadmaps. The resources below provide strategic guidance for medical device, biomed and diagnostic companies navigating coding, coverage, and payment across major healthcare markets.
These resources address reimbursement planning from early development through commercialization, with a focus on aligning regulatory strategy, health economics, and payer expectations in the United States and international markets.
How to Avoid the Pharma / Medical Device Reimbursement Casino — Strategy for mitigating the high-risk financial uncertainty in pharmaceutical and biotech market access.
The Crucial Role of Clarifying Your Decision Maker – A guide to identifying the stakeholders who actually control the budget in the US healthcare system.
Developing a Winning Global Reimbursement Strategy – Core frameworks for aligning clinical data with the economic requirements of payers.
Synchronizing Reimbursement and Regulatory – Why regulatory clearance (510k/CE) is only half the battle for market access.
5 Tips for International Medical Device Reimbursement — Essential considerations for harmonizing global clinical data to meet diverse regional payer requirements.
Breaking Common Reimbursement Myths – Debunking the most frequent misconceptions that stall MedTech commercialization.
Medical Device Reimbursement Myopia — Avoiding the common trap of focusing on regulatory approval while neglecting long-term payment sustainability.
Implementing Lean Startup Principles in Medical Device Reimbursement — Using agile methodologies to streamline evidence generation and market validation.
Reimbursement DOs and DON’Ts – Essential strategic tips for medical device startups and established firms alike.
Reimbursement by Distributors (PDF) — Evaluating the pros and cons of delegating reimbursement responsibilities to local distribution partners.
Reimbursement pathways vary significantly by country, requiring market-specific expertise and local payer insight.
Germany Market Access
France market Access
Success requires identifying the specific stakeholder who controls the budget. In the US, this often shifts between the clinical department, the hospital Value Analysis Committee (VAC), and the private payer’s medical director, depending on the site of service.
Strategic synchronization means generating clinical evidence that satisfies both the FDA/CE safety requirements and the payer's demand for economic value. Waiting until after regulatory clearance to plan for reimbursement often leads to a "coverage gap."
The NUB (Neue Untersuchungs- und Behandlungsmethoden) process allows hospitals to apply for additional funding for innovative devices not yet covered by the standard G-DRG system, providing a faster route to market for new technologies.
The Liste en Sus is an "add-on" list in France that allows specific, high-cost innovative medical devices to be reimbursed separately from the standard hospital GHS (Groupes Homogènes de Séjours) rates.