disrupting.healthcarePost-market surveillance (PMS) is required for all devices.
For Class IIa+, submit PSUR every 1–2 years.
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Each EU country has its own reimbursement process.
– Germany (DiGA): Fast track, 12-month provisional access
– France: Multiple programs (ETAPES, PECAN)
– UK: NICE approval + local commissioning (ICBs)
Evidence needs differ, it can be Randomized Controlled Trials (RCTs) or real-world evidence depending on system.
Learn more on Scaling MedTech: From Product to Market
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SaMD must show:
Use real-world evidence, literature, or clinical studies.
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Most SaMD is Class IIa or higher—requiring Notified Body involvement.
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Under EU MDR, cybersecurity is a General Safety and Performance Requirement. Failure to secure software is a patient safety risk.
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To enter the EU market, your SaMD must be developed under a Quality Management System (QMS) that complies with ISO 13485.
Use MDCG 2019-16 as a guideline for secure development. Cybersecurity is considered a safety issue under EU MDR, it is not just IT hygiene.
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EU MDR’s Annex VIII, Rule 11 determines how software is classified:
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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).
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.
– AI-based radiology tools
– Depression treatment apps
– Software for detecting pneumonia in chest X-rays
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.
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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.
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.
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
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)
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).
Resource: See MDR timeline & guidance from the European Commission.
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.
| 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 |
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.
Explore more: – Why Pear Therapeutics failed despite FDA clearance – How Bigfoot Biomedical sequenced product + payer strategy
This wraps our series on Scaling MedTech — let us know what topic you want next.
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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.
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.
Insight: On average, a hospital sale in Europe involves 5–7 decision-makers (McKinsey MedTech Commercial Benchmark).
Example: Impulse Dynamics used KOLs to validate its cardiac neuromodulation tech pre-launch.
Statistic: 75% of HCPs in Europe now prefer hybrid or remote interactions (Accenture HCP Preferences)
| Product Type | Primary Channel | Secondary |
| Surgical tools | KOLs + in-hospital demos | Procurement-led tenders |
| DTx & SaMD | Virtual platforms + payers | Primary care orgs |
| Diagnostics (AI) | MSLs + evidence portals | Radiology or lab heads |
| Monitoring devices | Peer-to-peer pilots | Distributors |
Tip: In early-stage MedTech, channel feedback is often better than user feedback — it tells you what blocks growth.
Up next in the series: 📌 Mistakes to Avoid in MedTech Commercialization (and How to Fix Them)
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