Tag: Digital Health

Pricing in MedTech isn’t just a number — it’s your business model. In the EU, where public payers dominate and health systems are increasingly value-driven, getting paid requires clinical validation, health economic proof, and a clear story about long-term cost savings.

This post breaks down how to approach reimbursement and pricing for MedTech startups, with examples from DTx, devices, and AI diagnostics. We focus on the frameworks that matter and what early-stage founders must do to prepare.

1. Understand What Payers Actually Buy

Public and private payers (like insurers and national health services) don’t buy tech — they buy outcomes. Successful pricing strategies show how your product: – Improves health outcomes (efficacy) – Saves money (cost avoidance) – Improves workflow or capacity

Tip: Frame pricing in terms of cost per QALY (quality-adjusted life year) or ROI within 12–24 months.

2. Pricing Models That Work in MedTech

Example: Kaia Health offers MSK therapy via reimbursed app + coaching in Germany, priced as monthly license.

3. EU Reimbursement Pathways to Know

Germany: DiGA Pricing

• Startups can set their own price in the first year post-listing.
• After 12 months, price must be negotiated with the GKV-Spitzenverband (National Association of Statutory Health Insurance Funds).
• Must show comparative evidence vs standard of care.

Caution: DiGA price averages dropped 30% post-negotiation in 2024 (IQVIA DiGA Report).

France: PECAN / LPPR

• PECAN pilot covers early-stage pricing with proof-of-concept.
• Long-term reimbursement requires HTA via HAS and inclusion on LPPR list.
• Prices often benchmarked to existing therapies.

UK: NICE HTA and Value-Based Pricing

• NICE uses cost-effectiveness models (e.g., ICER thresholds: ~£20k–£30k per QALY).
• Pilots with NHS can inform real-world pricing.
• Commercial frameworks like NHS England’s MIA allow negotiated price-volume deals.

4. Building Your Reimbursement Strategy Early

a. Collect Health Economics Evidence

• Use budget impact models (BIMs)
• Simulate payer scenarios: what happens if 1,000 patients adopt your solution?

b. Start Conversations With Payers

• Germany: GKV associations
• France: CNAM and HAS
• UK: NICE and NHS regional leads

c. Use External Tools

• Partner with health economics consultancies like Coreva Scientific
• Validate models with HTA reviewers and KOLs

5. Common Pricing Mistakes to Avoid

• Pricing too high without evidence → rejection by payers
• Free pilots without contract conversion → unsustainable
• Lack of cost comparator → HTA rejection
• Misunderstanding budget holder (hospital vs insurer)

Insight: In France, even successful pilots stalled due to unclear budget responsibility between national and regional health bodies.

Quick Reference Table: National Pricing Characteristics

Final Takeaways for MedTech Startups

• Start pricing strategy early — not after CE mark
• Understand payer incentives and outcome expectations
• Prepare BIMs and value dossiers during pilot phase

Up next in the series: 📌 Commercial Channels That Actually Work in MedTech

This content has been enhanced with GenAI tools.

Getting into the hospital is no longer the endgame. For MedTech startups in Europe, getting reimbursed — and doing so consistently across fragmented markets — is what separates hobby projects from scalable businesses.

In this second post of our series, we dive into the European market access landscape for medical devices and digital health, with a founder-focused lens on systems in Germany, France, the UK, and Nordic/CEE markets.

1. Germany: DiGA and the Fast Track for Digital Health

Germany remains Europe’s most structured digital reimbursement market thanks to the DiGA Fast Track, launched in 2020 by the Federal Institute for Drugs and Medical Devices (BfArM).

What qualifies: Apps or software-based interventions classified as low-risk medical devices (Class I or IIa under MDR).
Who pays: Statutory health insurance (covers 73M+ Germans).

Key Steps: 1. CE Marking as a medical device 2. Apply for DiGA listing (provisional or permanent) 3. Submit evidence (clinical, economic, usability)

Success story: Selfapy — a digital mental health therapy platform — was listed in 2022 and now reimbursed nationally.

Caution: Only 55 apps were listed as of mid-2025, with >40% later withdrawn due to insufficient evidence or pricing issues.

2. France: PECAN Pathway and Public Evaluation

France doesn’t have a DiGA equivalent yet, but the new PECAN pilot launched in 2023 offers early funding for digital therapeutics.

Agencies involved: – HAS (clinical evaluation) – CNAM (payer negotiations)

Key routes for market access: – PECAN for DTx and AI diagnostics (pilot program) – LPPR for physical devices (Listing for reimbursement)

Tip: Leverage French Tech Health20 status to speed up access via Bpifrance support.

3. United Kingdom: NICE, NHS Pathways, and DTAC

In the UK, access is driven by public health pilots and evidence-based appraisals.

Key frameworks: – NICE DHT Evidence Standards – NHS DTAC (Digital Technology Assessment Criteria)

Best path for startups: 1. Pilot with NHS via accelerators like NHS Innovation Accelerator 2. Gather local data and enter NICE appraisal 3. Align with Integrated Care Systems for regional deployment

Example: Huma has scaled UK pilots into global expansion after evidence-driven adoption in NHS settings.

4. Nordics: Digital-First, But Decentralized

Sweden, Denmark, and Finland lead in digital infrastructure but lack a unified reimbursement track.

Approach: – Run local hospital pilots (funded by Vinnova, Business Finland) – Engage with regional procurement bodies

Tip: Nordic health systems value co-creation and evidence transparency over hype.

5. Central & Eastern Europe: EU-Backed Access with Cost Advantage

In Poland, Romania, and Czechia, adoption is slower but aided by EU structural funds.

Tactics that work: – Partner with local CROs or academic hospitals – Position for structural fund-backed pilots – Focus on affordability + clinical value

Note: EIT Health plays an active role in startup acceleration and validation across CEE.

Summary Table: Market Access Pathways by Country

Takeaways for Founders

• Don’t treat Europe as one market — the access frameworks are radically different.
• Start with pilots and evidence in 1–2 strategic countries.
• Use programs like DiGA and PECAN if applicable, but expect pricing pressure and compliance overhead.

Up next in the series: 📌 Cracking Reimbursement — Value-Based Pricing for MedTech Startups

This content has been enhanced with GenAI tools.