A crisp week: AI diagnostics raised, sports concussion wearables funded, a Dutch conversational-AI startup got scooped up, and the UK nudged its devices policy closer to home care.
Sports Impact Technologies (Ireland): €650K Pre-Seed for behind-the-ear concussion-detection wearable; beta with athletes kicks off in September, full launch targeted for 2026.
Better Medicine (Estonia): €1M Pre-Seed to expand CE-certified AI for kidney cancer detection, fund EU rollout and FDA-aligned pilots.
Automated insulin delivery — Utrecht’s ViCentra says its next-gen closed-loop Kaleido system is slated for a Europe launch next year, signaling more AID competition on the continent.
UK devices policy — MHRA opens a stakeholder survey on the Health Institution Exemption (HIE), floating extensions to community/home use and tighter PMS/governance—practical for hospital “in-house” SaMD/device teams.
Macro: Italy watch — New data show Italy’s tech funding momentum; healthtech has already raised ~$126M in 2025, underlining ongoing digital health demand.
One thing to remember
AI-heavy workflow tools are getting their first cheques (imaging, concussion safety) while cross-border consolidation (Caro→HOPCo) accelerates go-to-market—set against a UK policy tweak that could legitimize more hospital-built software/devices beyond the hospital walls. If you’re raising: show path to deployment (pilots, CE status) and a plan for integration into care pathways.
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.
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.
For most European medtech scale-ups, the US isn’t just another market — it’s the market. A successful launch across the Atlantic can double or triple a company’s valuation. But now, that expansion plan comes with a new 15% question mark.
On 5 August 2025, MedTech Europe warned that recent trade developments could see certain EU medical technology exports hit with tariffs of up to 15% under a US Executive Order issued in July 2025. The EU–US agreement avoided an all-out trade war, but the tariffs remain on the table — and the uncertainty alone is already reshaping business plans.
This tariff uncertainty comes on top of Europe’s AI Act–MDR/IVDR regulatory collision — another headwind flagged by MedTech Europe in recent weeks. For startups, the combined effect is a squeeze on both regulatory timelines and market profitability.
Why a 15% tariff is not ‘just a cost of doing business’
Unlike software, medtech hardware comes with a real bill of materials. A 15% tariff on top-line revenue is margin poison. Companies are forced into a lose–lose choice:
Absorb the cost — eroding profitability and starving R&D, marketing, and expansion budgets.
Pass it on to hospitals — instantly making products less competitive against US-based rivals or non-EU imports.
For growth-stage companies seeking FDA clearance and a US rollout, such volatility can make financial models unreliable. That makes investors nervous — and valuations softer.
From operational headache to valuation killer
In medtech fundraising, the US market often accounts for the largest chunk of projected future revenues in a discounted cash flow (DCF) model. Introduce a politically volatile tariff into that equation, and you’ve created a risk that’s impossible to ignore.
Two otherwise identical companies could now receive very different valuations purely based on the geography of their go-to-market plan. A US-heavy strategy becomes riskier than one targeting Asia, Latin America, or the Middle East first.
This is why geopolitical risk analysis — once the domain of multinational strategy teams — is becoming a necessary founder skillset.
My position: plan for volatility, not stability
We can hope for zero-for-zero tariff agreements that exempt medical technology from transatlantic trade friction. But hope is not a strategy.
Founders should treat the 15% tariff as a real scenario and build market entry plans accordingly. That means:
Running financial models with and without the tariff.
Exploring local manufacturing partnerships or assembly in the US to reduce exposure.
Building contingency routes into Japan, South Korea, or Gulf states where demand for EU medtech is strong.
For VCs, due diligence should now include a tariff stress test — if the startup’s US plan collapses under 15%, you know the risk profile.
Founder and investor playbook
Founders:
Develop a “Plan B” market entry route that doesn’t hinge solely on US sales.
If US entry is core, investigate tariff mitigation options — including partial localisation.
Be prepared to defend your US assumptions under investor scrutiny.
Investors:
Apply a “geopolitical risk discount” to US-heavy strategies.
Reward diversification in go-to-market plans.
Work with portfolio companies on scenario planning for trade shocks.
Takeaway: In 2025, geopolitical risk is no longer a footnote in medtech strategy. It’s a line item. Founders who can model it, plan for it, and still show a path to profitability will be the ones who keep investor confidence when trade winds shift.
Join the conversation Are you already rethinking US market entry because of tariff risk? Have you successfully navigated similar trade barriers? Share your experiences and follow Disrupting Healthcare for practical, EU-focused strategies on building resilient medtech businesses.
The EU wants to be the global leader in AI and in medical technology. Unfortunately, its own flagship regulations are on a collision course. Europe’s innovators are stuck in the middle.
One year after the EU AI Act entered into force, the continent’s medtech trade body MedTech Europe is calling for a four-year delay in its application to medical technologies. Why? Because a single AI-driven device could now be regulated twice: once under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR), and again as a “high-risk” system under the AI Act.
That means two sets of conformity assessments, two quality management systems, two mountains of technical documentation and double the post-market reporting burden. For lean startups, this isn’t just red tape. It’s a growth chokehold.
The dual burden problem
At first glance, the two regimes seem complementary. Both care about safety, risk management, and continuous monitoring. In reality, their definitions, processes, and paperwork don’t line up.
An AI-powered imaging tool could be a relatively low-risk Class IIa device under MDR, yet automatically high-risk under the AI Act. That triggers an entirely separate certification pathway, with no guarantee that an MDR-designated Notified Body can handle AI Act conformity checks.
Capacity is already stretched thin. There are too few Notified Bodies for MDR/IVDR demand. Adding AI Act assessments without clear rules risks a regulatory gridlock where ready-to-market products sit idle.
Collateral damage: clinical research
The AI Act could even hit innovation before products launch. MedTech Europe warns that clinical investigations required to generate evidence for MDR/IVDR approval aren’t explicitly exempt from AI Act obligations.
In practice, that could delay or derail trials as companies wrestle with a second compliance framework mid-development. Given that several EU Member States have already missed the AI Act’s August 2025 deadlines for national authorities and sanctions, readiness is questionable at every level.
Why this matters for investment
For founders, this uncertainty means longer timelines, higher legal and compliance costs, and greater risk. All red flags for investors. For VCs, it erodes capital efficiency and predictability, making US or Asian markets look more attractive for AI-medtech plays.
My position: safety first, but smarter regulation
Patient safety is non-negotiable. The AI Act’s principles of transparency, accountability, and risk management are sound. But doubling up on processes that don’t align will drain resources from where they matter most: clinical validation and safe deployment.
Instead of overlapping statutory frameworks, Europe should consider an industry-led code of practice for AI in healthcare, modelled on the ABPI Code of Practice in UK pharma marketing. Such a code could set high, enforceable standards for AI safety and ethics, developed and policed by industry bodies, with regulators holding a backstop role.
This approach would keep standards high, compliance practical, and innovation alive without making startups navigate two regulatory mazes at once.
Founder and investor playbook
Founders:
Map your AI features against both MDR/IVDR and AI Act risk classifications now.
Build a “dual compliance” roadmap showing how you’ll meet both sets of requirements in parallel.
Use this as a de-risking narrative in investor pitches; proactivity here is a credibility boost.
Investors:
Add a “regulatory burden scorecard” to due diligence.
Prioritise teams with in-house regulatory expertise and realistic dual-compliance budgets.
Recognise that a slightly less flashy product with a watertight compliance plan may outperform in this environment.
Takeaway: The EU’s ambition to lead in AI and medtech is laudable. But until the AI Act and MDR/IVDR are harmonised, ideally through an industry-led, safety-focused code, Europe’s most innovative startups will spend more time in the compliance maze than in the clinic.
Let’s keep this conversation going If you’re a founder, investor, or policymaker navigating the AI Act–MDR/IVDR clash, I’d like to hear your perspective. Are you already planning for dual compliance, or do you see a better path forward? Follow Disrupting Healthcare for more EU medtech analysis and practical strategies for turning regulatory headwinds into competitive advantage.
FAQ #9: What Are the Regulatory Considerations for Omnichannel Marketing?
Regulatory compliance in omnichannel marketing presents complex, multi-layered challenges requiring comprehensive frameworks that address data privacy, promotional guidelines, and content approval across integrated channels. The interconnected nature of omnichannel campaigns amplifies traditional compliance requirements.1
Global Regulatory Landscape Overview
Major Regulatory Frameworks governing pharmaceutical marketing include:2
FDA Code of Federal Regulations Title 21 (United States)
EU Directive 2001/83/EC and EFPIA guidelines (Europe)
IFPMA international standards
PhRMA Codes and industry self-regulation
Local regulations varying significantly by country and region
Digital Channel Complexity: Traditional regulations often lack specific guidance for digital channels, creating interpretative variability that requires conservative approaches to ensure compliance.2
Technology serves as the foundational enabler for omnichannel marketing success, providing the infrastructure for data integration, personalization, automation, and real-time optimization. Without robust technological capabilities, true omnichannel engagement remains impossible to achieve at scale.1
Core Technology Infrastructure Requirements
Customer Relationship Management (CRM) Systems form the central hub for omnichannel operations:2
Unified customer data consolidation from all touchpoints
Real-time profile updates across channels and interactions
Predictive analytics for customer behavior forecasting
Automated workflow triggers based on customer actions and preferences
Marketing Automation Platforms enable personalized engagement at scale:3
Dynamic content personalization based on customer profiles
Multi-channel campaign orchestration with coordinated timing
Lead scoring and nurturing across different engagement stages
Performance tracking with attribution across touchpoints
Data Integration and Analytics Technologies
Data Management Platforms (DMPs) create comprehensive customer views:2
Cross-channel data aggregation from digital and offline sources
Identity resolution linking interactions across devices and channels
Audience segmentation capabilities for targeted messaging
Privacy-compliant data processing meeting regulatory requirements
Advanced Analytics and AI Technologies:
Machine learning algorithms for personalization optimization4
Predictive modeling for customer journey forecasting5
Natural language processing for content optimization and chatbot interactions4
Computer vision for visual content analysis and optimization
Channel-Specific Technology Requirements
Digital Channel Technologies:
Marketing cloud platforms for email and social media management
Content management systems for website and portal optimization6
Mobile application frameworks for app-based engagement
Video conferencing and webinar platforms for virtual interactions
Traditional Channel Integration:
Sales force automation tools connecting field representatives
Event management platforms for conference and meeting coordination
Print and direct mail integration with digital campaigns
Call center technologies for phone-based customer service
Artificial Intelligence and Automation Applications
AI-Powered Personalization represents the cutting edge of omnichannel technology:7
Dynamic content optimization based on real-time behavior analysis
Predictive customer journey mapping for proactive engagement
Automated A/B testing for continuous campaign improvement
Intelligent channel selection based on customer preferences and effectiveness
Automation Capabilities:
Campaign trigger automation based on customer actions
Content versioning for different channels and audiences
Compliance monitoring with automated regulatory checks
Performance optimization through machine learning algorithms
Technology Integration Challenges and Solutions
Legacy System Integration requires strategic planning:8
API development for system connectivity
Data migration strategies preserving historical customer information
Phased implementation approaches minimizing business disruption
Change management supporting user adoption of new technologies
Security and Compliance Technologies:
Data encryption for sensitive healthcare information9
Access control systems managing user permissions and audit trails
GDPR and HIPAA compliance tools for privacy protection
Blockchain technologies for secure data sharing and verification
Generative AI for automated content creation and personalization11
Internet of Things (IoT) integration for real-world data collection12
Augmented reality (AR) and virtual reality (VR) for immersive experiences13
Voice technologies for conversational customer interfaces
Future Technology Considerations:
5G connectivity enabling real-time data processing and analysis
Edge computing for reduced latency in customer interactions
Quantum computing potential for complex data analysis and optimization
Advanced biometrics for enhanced security and personalization
Technology ROI and Optimization
Performance Monitoring Technologies:
Real-time dashboards for campaign and channel performance14
Attribution modeling tools for cross-channel impact analysis
Customer experience mapping platforms for journey optimization
Competitive intelligence systems for market positioning insights
Cost-Benefit Analysis:
Technology total cost of ownership including implementation and maintenance
Productivity improvements from automation and integration
Revenue attribution to technology-enabled customer experiences
Risk reduction through improved compliance and security capabilities
The strategic selection and implementation of technology determines omnichannel success, requiring careful planning, phased deployment, and continuous optimization to maximize return on investment while delivering superior customer experiences.
FAQ #6: How Do You Measure the Success of Omnichannel Marketing Campaigns?
Measuring omnichannel marketing success requires comprehensive, role-based metrics frameworks that capture both quantitative performance and qualitative customer experience improvements. Traditional single-channel metrics fail to reflect the interconnected nature of omnichannel engagement.1
Customer-Centric Measurement Framework
Four key customer pillars form the foundation of omnichannel measurement:2
Customer Experience Metrics:
Cross-channel engagement rates and interaction quality
Customer journey completion rates across multiple touchpoints
Customer Engagement Scores (CES) measuring satisfaction across channels
Channel transition success rates for seamless experience delivery
Customer Engagement Metrics:
Enhanced brand share across target segments and channels
Increased engagement across customer-preferred channels
Improved adoption rates for previously underutilized channels
Content interaction rates by channel and customer segment
Cost per lead, campaign efficiency, resource utilization
Weekly/Monthly
Measurement Implementation Best Practices
Data Integration Requirements:
Unified customer data platforms for comprehensive tracking
Cross-channel tagging systems for accurate attribution
Privacy-compliant data collection methods
Real-time analytics capabilities for immediate insights
Continuous Improvement Processes:
Regular measurement review cycles with stakeholder involvement
Benchmark comparisons against industry performance standards
A/B testing frameworks for ongoing optimization
Feedback loops connecting measurement insights to campaign adjustments
Success measurement must evolve continuously as omnichannel capabilities mature and customer expectations change, requiring flexible measurement frameworks that adapt to new technologies and engagement patterns.
FAQ #5: What Are the Biggest Challenges in Implementing Omnichannel Marketing?
Implementing omnichannel marketing in pharma and medtech faces significant organizational, technical, and cultural barriers that go beyond typical technology implementations. Understanding these challenges is crucial for developing effective change management strategies.1
Leadership and Cultural Barriers
Mindset transformation represents the most understated yet critical challenge. Shifting to omnichannel requires fundamental changes in leadership thinking, moving from product-centric to customer-centric approaches.2
Key cultural challenges include:
Resistance to change from employees accustomed to traditional methods1
Risk-averse cultures in highly regulated industries3
Siloed organizational structures that impede cross-functional collaboration4
Lack of omnichannel understanding among stakeholders1
98% of pharmaceutical executives recognize omnichannel importance, yet almost 80% report little to no impact on customer engagement, highlighting the gap between intention and execution.4
Technology and Data Integration Issues
Fragmented IT infrastructure creates major implementation hurdles:5
Content approval processes that vary by channel and geography
Promotional guidelines that differ across digital and traditional media
Data privacy regulations limiting personalization capabilities
Documentation requirements for audit trails and compliance monitoring
Interpretation variability across different regulatory bodies creates additional complexity, with digital channels facing greater interpretative challenges than traditional marketing approaches.3
Content and Asset Management
Creating omnichannel-ready content requires new approaches to material development:7
Modular content architecture that works across channels
Version control for multiple content variations
Approval workflows that accommodate channel-specific requirements
Asset storage and retrieval systems for efficient content deployment
Measurement and Attribution Challenges
Tracking performance across channels proves technically and analytically difficult:8
Cross-channel attribution models for campaign effectiveness
Unified metrics that reflect omnichannel impact rather than channel-specific performance
Real-time analytics capabilities for campaign optimization
ROI measurement that accounts for channel interdependencies
Resource and Budget Constraints
Implementation costs can be substantial, creating internal resistance:5
Technology investments in new platforms and integrations
Training and change management programs for staff
Content creation costs for omnichannel-ready materials
Ongoing operational expenses for maintenance and optimization
Talent and Skill Gaps
Omnichannel expertise remains scarce in healthcare industries:9
Cross-functional collaboration skills for integrated campaign development
Data analytics capabilities for customer insight generation
Technology proficiency for platform management
Change leadership abilities for organizational transformation
Global Implementation Complexity
Multi-market deployment adds layers of complexity:10
Local regulatory variations requiring market-specific adaptations
Cultural differences in customer preferences and behaviors
Language and content localization requirements
Coordinating global and local teams for consistent execution
Successful implementation requires addressing human factors alongside technical considerations, with particular attention to stakeholder engagement and capability building throughout the transformation process.10
FAQ #4: What Are the Main Benefits of Implementing Omnichannel Marketing?
Implementing omnichannel marketing in pharma and medtech delivers measurable improvements across customer experience, operational efficiency, and business outcomes. Research demonstrates significant quantifiable benefits that justify the investment required for transformation.1
Enhanced Customer Experience and Engagement
Personalized customer journeys represent the primary benefit, with 89% of first-time buyers becoming loyal customers through effective omnichannel strategies. Healthcare professionals particularly value consistent, relevant communication that respects their time and expertise.2
Key experience improvements include:
6x to 8x better response rates from personalized pre-meeting communications3
Seamless transitions between digital and physical touchpoints4
Reduced information overload through targeted, relevant content delivery3
Improved access to educational resources when and where needed5
Enhanced partnership opportunities through better customer insights
Improved organizational agility in responding to market changes
These benefits compound over time, with organizations reporting sustained improvements in customer relationships and business performance as omnichannel maturity increases.
FAQ #1: What is Omnichannel Marketing in Pharma and Medtech?
Omnichannel marketing in pharmaceutical and medical device industries is a customer-centric approach that integrates multiple communication channels to create seamless, personalized experiences for healthcare professionals (HCPs), patients, and other stakeholders. Unlike traditional multichannel marketing where channels operate independently, omnichannel marketing connects digital and physical touchpoints into a unified ecosystem that recognizes users across their entire healthcare journey.1
The core principle involves using interconnected channels that work together to enhance customer experience and engagement. Each channel is optimized and working in harmony to provide consistent messaging while allowing for channel-specific customization. This includes everything from email marketing and social media to in-person sales visits, webinars, and mobile applications.2
Key characteristics that distinguish omnichannel from multichannel approaches include:
Unified customer data across all touchpoints
Consistent brand messaging with channel-appropriate customization
Seamless transitions between different interaction points
Personalized content based on individual customer profiles
Cross-channel insights that inform future interactions
For medical device companies, this means creating cohesive messaging across various platforms to boost engagement and conversions. The approach enables companies to reach healthcare professionals wherever they are, regardless of their preferred communication channel, while maintaining consistency in brand experience.3
Studies show that omnichannel personalization can halve acquisition costs, increase marketing budget efficiency by 10% to 30%, and increase revenue by 5% to 15%. This significant impact explains why 98% of pharmaceutical executives emphasize the importance of implementing an omnichannel strategy for their organizations.4,5,6
