Virginia Merico
International Market Access for MedTech – A Case-Based Business Model Analysis
Across Europe, getting a medical device to patients is less about a single approval than about navigating many systems at once. With the AI Act, MDR, and divergent national HTA and reimbursement rules, market access now hinges on aligning clinical benefit with country-specific payment pathways—and proving health-economic value that resonates with payers, providers, and patients alike.
Regulatory clearance opens the door; market access is won by evidence, economics, and a country-by-country strategy that matches products to viable reimbursement paths.
Harmonization efforts help, but reimbursement remains national—and fragmented. Effective entry starts early: mapping decision-makers and routes to funding, understanding the current patient pathway to position the innovation credibly, and translating clinical benefit into a quantified value story that saves time, reduces complications, or shifts care to more efficient settings. From DiGA listings and selective contracts in Germany to hybrid financing around DRGs, phased approaches that generate real-world evidence and de-risk adoption turn promising tech into paid, routine practice.
When Market Access Becomes a Strategy:
From Approval to Adoption
What you’ll learn
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How to map national decision pathways and stakeholders to choose a viable funding route
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Where to position the device along the patient pathway to replace, augment, or shift care
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How to quantify health-economic value so providers adopt even before national add-on reimbursement
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How to phase market entry from selective contracts and innovation funds to RWE and national reimbursement
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What real cases reveal about DiGA vs selective contracts, Deprexis economics, and hybrid DRG/NUB plus value-based agreements
Virginia Merico is a strategy consultant with inspiring-health GmbH. She specializes on MedTech market access in Germany and Europe and is the founder of i-h Academy, an online on-demand platform advising MedTech start-ups and SMEs on market access competences. Additionally, she contributed as lecturer and course book author in several bachelor and master courses at International University GmbH.
About the Author
Virginia Merico, M.Sc.
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