Software as a Medical Device (SaMD) refers to software intended for medical purposes that performs these functions without being part of a hardware medical device.
Under the EU MDR (Regulation 2017/745), it’s officially termed Medical Device Software (MDSW).
Key Definitions
MDSW under EU MDR aligns closely with the global SaMD concept defined by IMDRF.
A software must have a clearly defined intended medical purpose such as diagnosis, treatment, prevention, or monitoring of a condition.
Examples of SaMD/MDSW
– AI-based radiology tools
– Depression treatment apps
– Software for detecting pneumonia in chest X-rays
Regulatory Trigger: Intended Use
Your declared intended use is the most critical driver of classification. Even minor “call-to-action” features (e.g., “contact your doctor”) can elevate a wellness app into a regulated medical device.
Even with the right product, market, and team — many MedTech startups fail. And the reasons often come down to avoidable commercialization mistakes: misjudging the buyer, skipping regulatory nuance, or assuming your tech will sell itself.
This final post in the Scaling MedTech: From Product to Market series lays out the most common missteps in MedTech go-to-market and how to avoid them — with real-world examples and corrective actions.
1. Building Before Validating the Buyer
Mistake: Launching development without confirming who pays, who uses, and who benefits.
Too many founders build based on clinical need or innovation potential — without validating demand, budget holders, or economic value.
Fix: Use the JTBD (Jobs-To-Be-Done) framework + early payer interviews to design with reimbursement in mind.
2. Relying on Pilots Without a Conversion Plan
Mistake: Dozens of pilots, zero sales.
Pilots are easy to get — but unless there’s a conversion path, they drain resources and confuse investors.
Example: Many DTx startups in Germany listed under DiGA saw high downloads but failed to convert to revenue due to unclear therapeutic ownership.
Fix: Design pilots with: – Pre-negotiated success KPIs – Budget source for scale-up – Procurement-ready documentation
3. Ignoring Procurement and IT Requirements
Mistake: Gaining HCP interest, but failing at hospital onboarding.
Even if clinicians love your product, procurement, legal, and IT may reject it due to data compliance, MDR classification, or lack of integration.
Fix: – Include procurement in early demos – Prepare GDPR/Data Processing documentation – Get listed in hospital or GPO vendor systems (e.g., GHX)
4. Misunderstanding Regulatory Signals
Mistake: Confusing CE marking or FDA approval with market readiness.
Regulatory clearance allows sales, but doesn’t guarantee adoption or reimbursement.
Fix: Align your commercial roadmap with regulatory + access strategy (e.g., CE mark + DiGA listing or NICE submission).
Mistake: Hiring a large sales team before validating CAC or message fit.
Burning capital on outbound reps without understanding the sales motion leads to churn and stalled traction.
Fix: Run test campaigns with fractional reps, digital outreach, or advisor-led selling before hiring full-time field force.
Summary Table: Mistakes & Fixes
Mistake
Fix
No buyer validation
Conduct payer & JTBD interviews
Pilot fatigue
Design conversion-ready pilots
Procurement blockers
Involve early, prep documentation
CE mark ≠ market fit
Layer regulatory + access planning
Premature sales hires
Validate channels first
Final Word
Commercialization in MedTech is not just execution — it’s sequencing. Avoiding these five traps increases the odds of landing not just pilots or press — but scalable, reimbursed adoption.
For MedTech startups, success hinges not only on product quality, but also on how you reach, convince, and support stakeholders. Whether selling to hospitals, doctors, or patients, early-stage companies must design a channel strategy that reflects the healthcare buying process — slow, risk-averse, and influence-driven.
This post breaks down the most effective commercial channels in MedTech, based on what’s actually working in 2025.
1. The MedTech Sales Funnel Is Nonlinear
In traditional B2B, a sales funnel moves from awareness → interest → consideration → purchase.
In MedTech, it looks more like:
Clinical KOL → Hospital Committee → Procurement → IT → Payer → Rollout
Each stage requires a different communication style and sometimes different messengers. Sales success is more about building internal champions than pure outbound volume.
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
Model
Best for
Notes
One-time sale
Capital equipment, implantables
Require large budget cycles
Subscription
DTx, RPM, AI tools
Common for digital health; easier for payers to adopt
Outcome-based
Digital diagnostics, chronic care
Reimbursed only if outcome achieved; harder to negotiate
Bundled with services
Monitoring devices + clinical services
Enables multi-stakeholder value delivery
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.
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.
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
Country
Key Framework
Entry Point
Reimburses Digital?
Germany
DiGA
BfArM application
✅ Yes
France
PECAN / LPPR
HAS + CNAM
⚠️ In pilot
UK
NICE / DTAC
NHS pilot + ICS
✅ If evidence exists
Sweden
Local procurement
Regional pilots
❌ No central track
Poland/CEE
EU-backed pilots
Academic/hospital use
❌ Not at scale
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.
Breaking into healthcare is hard. Breaking into MedTech is harder — thanks to complex regulations, long sales cycles, and conservative procurement paths. For early-stage medtech startups, choosing the right go-to-market (GTM) strategy can be the difference between scaling and stalling.
This guide breaks down the GTM playbook for MedTech in 2025, with a focus on startups launching in Europe and beyond. Based on real-world cases and regulatory insights, it’s built for those bringing medical devices, diagnostics, SaMD, or digital therapeutics (DTx) to market.
1. Choosing Your Commercial Model
Startups typically consider three primary go-to-market approaches:
With over €20 billion in public and private capital flowing into digital health ventures since 2020, the European Union has become a strategic launchpad for healthtech founders. But where exactly does this capital come from? And what’s the smartest path for early-stage startups looking to digital health funding?
This in-depth guide breaks down the EU digital health funding landscape in 2025 — covering both EU-level grants (like Horizon Europe, EU4Health, and the EIC Accelerator) and national innovation programs (from France’s Bpifrance to Germany’s HTGF). We also map out the private funding scene, spotlighting active VCs and corporate funds, and show how EU regulations like MDR and GDPR influence access to capital.
Whether you’re applying for your first public grant, looking to raise a blended round, or building a scalable platform for regulated care — this guide is for you.
The Big Picture: Why EU Digital Health Funding Matters in 2025
In 2024 alone, startups in Europe raised $4.8 billion in digital health VC — a 27% YoY increase (Galen Growth). Mega-rounds like Alan (€193M), Ōura (€200M), and Flo Health ($200M) highlighted the growing maturity of the region.
Public funding is also expanding. The European Commission committed over €14 billion to digital health via Horizon Europe, EU4Health, and the Digital Europe Programme. Countries like France, Germany, and the Nordics doubled down on national programs for startups, especially those focused on regulated innovation (e.g. DTx, AI diagnostics, RPM).
But with increased capital comes increased complexity: understanding how to access the right programs, meet regulatory expectations, and position your startup for both grants and venture capital is essential.
EU-Level Public Funding: Key Programs for Startups
The EU’s flagship R&D program with a €95.5 billion budget, Horizon Europe funds large-scale innovation consortia. While not startup-specific, early-stage digital health ventures can access funds by partnering in consortium projects (e.g. under Cluster 1: Health).
Pro tip: Join a consortium via national contact points or through platforms like CORDIS.
For high-risk, high-impact innovation, the EIC Accelerator offers up to €2.5M in grant + €15M in equity. In 2024, only 71 out of 1,211 applicants (≈5.9%) were selected (EIC Results).
Eligible: single startups incorporated in the EU. Selection: based on scalability, scientific merit, and impact.
A €4.4 billion program supporting digital infrastructure, health data, and cross-border health services. Includes funding for the upcoming European Health Data Space (EHDS).
Best fit: startups providing EHR, interoperability, cybersecurity, or public health software.
Strong privacy and data governance are mandatory. Consider external audits, ISO27001 certification, and working with GDPR Sandboxes in countries like France or Spain.
EHDS (European Health Data Space)
Coming 2025, EHDS will define interoperability and data-sharing standards across Europe. Compliance could unlock access to new tenders and cross-border pilots.
2025 Outlook: Trends and Opportunities
AI dominance: ~60% of 2025 funding so far went to AI-driven health ventures (CB Insights).
Public-private blending: More startups combining EU grants + VC in same round.
Reimbursement as ROI: Germany (DiGA), France (PECAN), and Nordics offer clear digital reimbursement paths — critical for Series A+ readiness.
CEE Rising: Low costs + EU funds = surge of new startups in Poland, Romania, Hungary.
FAQs
What are the best EU digital health funding programs for early-stage startups?
Top options: EIC Accelerator, EU4Health, national innovation agencies (Bpifrance, HTGF), and Digital Europe grants for AI/infra.
How competitive are EU public grants?
Highly. For example, the EIC Accelerator had ~5.9% success in 2024 (source). “Seal of Excellence” can still unlock national funds.
Which EU country is best for starting a digital health company?
France (strong grants), Germany (DiGA reimbursement), UK (private VC and NHS pilots), Nordics (public adoption), and Poland (cost and EU access).