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Digital Health MedTech

Poland’s healthtech has outgrown ‘nearshore’: 10 products and 10 global hubs

Stop calling Poland a nearshore

Poland isn’t just shipping code for someone else’s roadmap. It’s producing digital health products used by tens of millions, and it’s hosting serious pharma/biotech tech operations—not just shared services. If you still think of it as a low‑cost back office, you’re reading a 2015 brochure.

Poland healthtech at a glance

MetricSnapshotSource
Healthcare marketPLN 191bn (~$52bn) (2023); projected 8.3% CAGR (2023–2028)Strategy& 2024
Medtech market (CEE)$11bn, largest in CEE; projected $13.8bnPAIH MedTech
Digital railsIKP, e‑Prescription (mandatory since 8 Jan 2020), e‑Referral (mandatory 2021)CeZ, e‑Rx analysis, policy
Enterprise hubs10+ pharma/medtech hubs (Roche, GSK, Bayer, Moderna, Astellas, BI, GEHC, Philips, Fresenius, AZ)Examples and links below

Polish products to watch (scale & potential)

CompanyWhat it doesScale / tractionMarkets & notes
DocplannerMarketplace + SaaS for clinics80m patients/month, 260k active doctors, 22m bookings/mo, 13 countriesEntered DACH via jameda acquisition
InfermedicaAI symptom‑to‑triage & intake86% user satisfaction; 76% intent to follow guidanceUsed by payers incl. Techniker Krankenkasse
DiagnostykaDiagnostics network1,100+ collection points, 156 labs; PLN 1.6bn revenue (2023); IPO priced at PLN 105; debut 7 Feb 2025Reuters
LabplusAutomated lab‑result interpretationIntegrated with leading labs incl. Diagnostyka partnershipB2B/API model across lab networks
CardiomaticsAI for Holter/long‑term ECGCE‑marked; clinician time savings reportedStudy overview
StethoMeAI‑enabled home stethoscopeCE‑marked lung‑sound analysis; remote respiratory careDeployed in telehealth programmes
AioCareConnected spirometryValidated in primary carePubMed
Saventic HealthAI for rare‑disease detectionEU roll‑out; €1.9m funding (2024)EU‑Startups
BrainScanAI for brain CT (stroke/trauma)2024 expansion across EMEAIndustry coverage
Jutro MedicalAI‑first hybrid primary care€12m Series A (2025) to expand EUEU‑Startups

Enterprise gravity: big pharma/medtech tech now runs through Poland

CompanyCityWhat happens hereScale (where stated)Source
RocheWarsaw & PoznańGlobal IT Solution Centre; Regional Clinical Trials Centre; Global Procurement Hub1,250+ employees in PolandRoche Poland
GSKWarsaw & PoznańGlobal Regulatory Centre; global trials coordination; Tech/Cyber600+ employeesGSK Poland footprint 2024
BayerWarsawDigital Hub building data platforms & productsup to 400 IT roles plannedAnnouncement, Hub page
ModernaWarsawInternational Business Services (finance, PV, HR, digital)~160 roles targetPress release
AstellasWarsawGlobal Capability Centre (2025)New hubLeadership news
Boehringer IngelheimWrocławGlobal Business Services centreLaunched 2022GBS page
GE HealthCareKrakówCommand Center software developmentPlatform in 290+ hospitalsGEHC Command Center
PhilipsŁódźGlobal Business Services hubOne of 7 global hubsPhilips GBS
Fresenius (FDT & FMC)WrocławDigital Technology & GBS hub for EMEAScaling teamsFresenius DT Poland,
AstraZenecaWarsawGlobal Clinical Trials CentrePart of AZ’s global networkAZ Poland

Why Poland now (and why it matters for commercialisation)

  • Public digital rails are in place. e‑Prescription has been mandatory since 8 January 2020; e‑Referrals became mandatory in 2021. The national P1 platform under Centrum e‑Zdrowia (CeZ) powers services like IKP/mojeIKP across the system.
  • Talent density × EU proximity. A deep engineering pool with multinationals co‑locating product and data teams in Warsaw/Poznań lowers integration costs across EMEA.
  • Export DNA. Docplanner’s acquisition of jameda shows a practical route: build in Poland, expand via M&A into regulated EU markets to accelerate trust and supply‑side liquidity.

Quick Q&A: for operators and investors

Is Poland still just a ‘nearshore’ play? No. Platform leaders (Docplanner, Infermedica) and 10+ pharma/medtech hubs now concentrate product‑adjacent work in Poland: engineering, data, regulator not only SSC/BPO.

What’s the biggest commercial bottleneck domestically? Limited, inconsistent NFZ pathways for digital health; most early revenue is private pay or export. Limited purchasing power within market. Treat Poland as an R&D and proof‑of‑value market; monetise in DACH/UK.

Best route to scale across Europe? Build MDR‑ready from day one, localise for DE/IT/ES, and consider controlled M&A to enter regulated markets (see Docplanner → jameda).

What metrics matter? Adoption proxies (e.g., Infermedica’s satisfaction and intent to follow guidance), conversion to appropriate care, reduced waiting time, and clinician time saved.

Playbook for founders and operators

  • Build for export from day one. Multilingual, MDR‑ready, and priced for DACH/UK.
  • Piggyback on the hubs. Partner with Roche/GSK/Bayer/Moderna teams locally for pilots, data pipelines, or co‑dev—your buyer is often already in Warsaw.
  • Measure what matters. Track adherence, conversion to appropriate care, and time‑to‑diagnosis—Infermedica’s adoption proxies are a good template (2024 data).

Bottom line

Poland isn’t Europe’s healthtech subcontractor anymore. It’s a product‑making, enterprise‑integrated node.
The smart money will treat Warsaw and Poznań as launchpads, not low‑cost destinations.

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Digital Health MedTech

Why SaMD Launches Fail in Europe

Common Pitfalls

  1. Vague intended use leading to misclassification
  2. No QMS or weak cybersecurity
  3. Poor clinical evidence strategy
  4. Failure to engage clinicians or users

Fixes:

  • Start regulatory early
  • Build real clinical value
  • Design with adoption in mind

Learn more at Scaling MedTech: From Product to Market

This post is part of SaMD Europe Launch Guide.

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Digital Health MedTech

Investment Trends in European Digital Health

Where Capital Flows

Investors favor:

  • AI-powered platforms
  • Value-based care tools
  • Female health (menopause, hormones)

Valuation Benchmarks:

  • 4–6x revenue for most healthtech
  • 6–8x for AI/diagnostics
  • 10–14x EV/EBITDA for EBITDA-positive firms

Learn more at Scaling MedTech: From Product to Market

This post is part of SaMD Europe Launch Guide.

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Digital Health MedTech

Post-Market Surveillance for SaMD

Staying Compliant Post-Launch

Post-market surveillance (PMS) is required for all devices.

Requirements:

  • Plan for data collection
  • Trend analysis and signal detection
  • Regular updates to clinical files
  • Vigilance reporting (e.g. EUDAMED)

For Class IIa+, submit PSUR every 1–2 years.

This post is part of SaMD Europe Launch Guide.

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Digital Health MedTech

SaMD Market Access & Reimbursement in Europe

CE Mark ≠ Reimbursement

Each EU country has its own reimbursement process.

Highlights:

– 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

This post is part of SaMD Europe Launch Guide.

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Digital Health MedTech

Clinical Evidence for SaMD in the EU

MDR Requirements

SaMD must show:

  • Clinical association (medical logic)
  • Analytical validity (correct processing)
  • Clinical validation (real-world benefit)

Documentation:

  1. Clinical Evaluation Plan (CEP) = how you’ll gather evidence
  2. Clinical Evaluation Report (CER) = full evaluation
  3. Post-Market Clinical Follow-up (PMCF) = follow-up after launch

Use real-world evidence, literature, or clinical studies.

This post is part of SaMD Europe Launch Guide.

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Digital Health MedTech

The CE Marking Process for SaMD

Get CE Mark

Most SaMD is Class IIa or higher—requiring Notified Body involvement.

Key Steps:

  1. Prepare tech documentation (Annex II, III)
  2. Implement QMS (ISO 13485)
  3. Create clinical evaluation plan (CEP) and report (CER)
  4. Work with a Notified Body

Class-specific routes:

  • Class I: self-certify
  • Class IIa-III: Notified Body review + ongoing surveillance

This post is part of SaMD Europe Launch Guide.

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Digital Health MedTech

SaMD Cybersecurity and GDPR

Security = Safety

Under EU MDR, cybersecurity is a General Safety and Performance Requirement. Failure to secure software is a patient safety risk.

Technical Steps:

  • Secure architecture and testing (MDCG 2019-16)
  • Access control, encryption, logging
  • Vulnerability management and patches

GDPR Considerations:

  • Health data = special category
  • Explicit consent and purpose limitation
  • DPIA (Data Protection Impact Assessment) required if high-risk AI involved

This post is part of SaMD Europe Launch Guide.

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Digital Health MedTech

Building a Compliant QMS for SaMD

To enter the EU market, your SaMD must be developed under a Quality Management System (QMS) that complies with ISO 13485.

What You Need

  • ISO 13485: General quality framework
  • ISO 14971: Risk management integration
  • IEC 62304: Software development lifecycle

Best Practices

  • Build your QMS, don’t buy a generic one
  • Ensure continuous documentation and audits
  • Tie QMS to real clinical risk management

Cybersecurity Integration

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.

Learn More:

This post is part of SaMD Europe Launch Guide.

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Digital Health MedTech

Rule 11 Explained: Classifying SaMD in the EU

EU MDR’s Annex VIII, Rule 11 determines how software is classified:

  • Class IIa: Most diagnostic and therapeutic decision-support tools
  • Class IIb: Tools whose incorrect use may lead to serious harm
  • Class III: Life-critical functions (e.g., software controlling pacemakers)

What Determines the Class?

  • The intended use and severity of the condition it addresses
  • Whether the software makes decisions or just informs them
  • If a human-in-the-loop can reliably override the software

Example:

  • Software interpreting chest X-rays → Class IIa or IIb
  • Sepsis detection app triggering alerts → Class IIb or III

References:

This post is part of SaMD Europe Launch Guide.

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