This week’s highlights: a landmark UK medtech exit, a €403 million EU funding boost for AI-powered devices, and strategic momentum building across Europe for medtech commercialization. Otherwise it seems we are on annual leave.
People on the move
No newly reported high-level hires, board moves, or fund leadership changes in the European medtech/digital health sector this week.
Money flows
OrganOx (UK) — Acquired for $1.5 billion, marking one of the largest UK medtech exits ever and demonstrating that acquisition remains a powerful route to scale.
Founders: now is the time to align innovation pipelines with EU priorities—combine clinical validation and AI integration with a clear path to strategic M&A to attract both Brussels funding and corporate buyers.
€200 million. Not a sum we see every day in European HealthTech, especially outside AI hype-cycles. Munich-based Ortivity broke the mould—raising a mega‑round led by Apheon, with new capital from Unigestion, allowing existing shareholders a partial exit.
What is Ortivity?
If you are not living in Germany, you probably never heard about it. Founded in 2022 Ortivity has over the past four years bacame one of Germany’s most prominent outpatient healthcare platforms. It operates over 100 sites across three regional clusters in Germany, offering a full spectrum of orthopaedic services, including diagnostics, anaesthesia, surgery, prevention, and aftercare.
Ortivity’s physician partnership model and emphasis on clinical excellence is unique. It is owned equally by physicians and capital providers.
Leadership & Founders: Meet the Faces Behind the Platform
Founding Doctors
Ortivity was launched in 2022 through a collaboration between Dr med Reinhard Wichels and Apheon, along with a network of leading physicians. Wichels framed the vision from day one as “physician networks closing gaps in access and quality,” a quote that still anchors the company’s ethos.
New Co-CEO: Dr Michael Thorwarth
Joining Ortivity as co‑CEO on 1 June 2025, Dr Michael Thorwarth brings dual expertise in medicine (MKG surgery), healthcare management (MBA), and consulting. Prior to Ortivity, he was a Partner at BCG, CEO at DEIN DENTAL, and Group CEO at Ergéa Group, a pan-European player in oncology, radiology and diagnostics.
Why This Round Matters
Mega‑scale in a cautious market: A €200 million deal in EU HealthTech is rare. It signals renewed investor confidence in service-oriented MedTech, beyond devices or AI.
Leadership reflects intent: Bringing on a seasoned strategist with transformation credentials like Thorwarth indicates clear intent to scale fast and structure for international growth.
Physician-led, but platform-focused: Ortivity’s buy‑and‑build model expanding into regional orthopaedic clusters in NRW, Bavaria, Baden-Württemberg shows a credible path to consolidation in a fragmented EU market
The Bigger Picture for EU MedTech
From cottage to platform: Europe’s MedTech strength has been in manufacturing devices, but scaling integrated care platforms remains elusive. Ortivity’s rise suggests that’s beginning to change.
Orthopaedics as export vertical: With ageing demographics, musculoskeletal care is a high‑demand field. A platform that delivers standards, scale, and efficiency across borders has global potential.
Private equity getting serious: Apheon remains the lead investor, indicating commitment and patience. With Unigestion joining, it’s clear the capital strategy is long‑term, not flip‑and‑sell
Takeaway
This isn’t just another €200 million HealthTech round. It’s a watershed moment for European MedTech. A proof that physician‑led outpatient platforms can attract serious capital, build organisational muscle and potentially export a scalable model. And, ironically, the biggest disruption in health might come not from injecting AI into everything, but from getting people back on their feet: efficiently, compassionately, and at scale.
Quantum Computing in Healthcare - IBM Quantum One in Cleveland Clinic. Source: Cleveland Clinic
Quantum computing is the latest shiny object in healthcare IT. Headlines trumpet its ability to solve the unsolvable, to accelerate drug discovery, and to personalise medicine at a level classical AI can only dream of. The reality, however, is a little noisier, literally. In 2025, we are firmly in what researchers call the NISQ era. NISQ stands for Noisy Intermediate-Scale Quantum, where machines are powerful but error-prone, and purely quantum solutions remain more PowerPoint than product.
Why the Hype?
The hype is not entirely misplaced. Biology and chemistry are inherently quantum systems. Simulating how a drug molecule interacts with a protein is not just hard for classical supercomputers; it’s unnatural. Classical methods rely on approximations. Quantum computers, in theory, model these interactions directly. That’s why pharma giants are experimenting: Cleveland Clinic has an IBM Quantum System One installed on-site, the first dedicated to healthcare. Early results show hybrid quantum-classical workflows can outperform DeepMind’s AlphaFold on narrow protein-folding tasks.
Why the Reality Check?
The breakthroughs so far are niche, fragile, and deeply dependent on clever hybridisation with classical HPC. A systematic review of nearly 5,000 research papers (2015–2024) found no consistent evidence that quantum machine learning currently beats classical methods for healthcare. Many proofs of concept run in “noiseless simulations” that collapse when ported to real hardware. And the qubit counts remain too low for practical drug-scale simulations.
Even in genomics, often billed as the killer app for quantum computing, the maths doesn’t add up. Encoding billions of data points into qubits introduces overhead that wipes out theoretical speedups. For now, Europe’s quantum advantage is likely to remain incremental: narrow use cases, tightly scoped, with the real value in hybrid algorithms.
Why Europe Must Care Now: Security
The most immediate and non-negotiable issue is not discovery but security. A sufficiently powerful quantum machine will break today’s public-key cryptography (RSA, ECC). Healthcare is especially exposed, with decades-long data sensitivity. The threat isn’t theoretical, it’s already here. Adversaries are harvesting encrypted medical data today, betting on decrypting it later (“Harvest Now, Decrypt Later”). The US NIST has finalised post-quantum cryptography standard (CRYSTALS-Kyber, CRYSTALS-Dilithium) in 2024. GDPR’s mandate for “appropriate technical measures” means EU hospitals, medtech, and pharma firms will have to migrate.
Strategic Takeaway
Quantum computing in healthcare is not snake oil, but nor is it a silver bullet. In the short term, Europe’s smartest bets are twofold:
Defensive: Migrate to post-quantum cryptography before Y2Q arrives.
Pragmatic: Invest in hybrid models where quantum adds value to a specific pain point, not the whole pipeline.
Quantum may indeed change healthcare. But for now, the winning strategy is less “revolution at the bedside” and more “upgrade in the back office.” The future belongs to those who can separate signal from quantum noise.
Forget IPO hype. Europe’s MedTech scene is quietly reinventing exit strategies. The recent blockbuster OrganOx deal shows that patient-growth capital and global acquirers, not public markets, may set the real pace for scaling life-saving innovation.
OrganOx’s $1.5B Exit: A MedTech Precedent in a Quiet Market
Oxford-based OrganOx, a university spin‑out, has secured one of the UK’s largest MedTech exits, a $1.5 billion acquisition by Terumo. The deal delivered a 10× return for BGF, one of the UK’s most active investors. OrganOx’s technology, automated liver perfusion, has already supported over 6,000 transplants worldwide. In layman terms, it allows fors fully automated, easy-to-use preservation of the donor organ in a functional state for up to 24 hours.
In a market where IPOs have gone quiet, this deal sets a new precedent: high-value, clinically proven MedTech start-ups don’t need to chase the volatility of public markets to deliver impact and returns.
Europe’s MedTech Funding Engine: A Public‑Private Lever
The European Commission has approved a €403 million funding IPCEI programme for MedTech SMEs, with a focus on digital health and AI-enabled devices. The package is expected to attract €826 million in private capital and create 800 jobs across Europe.
For startups, this funding represents more than a financial lifeline: it’s a validation that EU policy is actively supporting MedTech innovation and aiming to rebalance Europe’s lagging venture ecosystem.
What This Means for Start-ups? Beyond IPOs to Real Outcomes
Exit without IPO: OrganOx proves that acquisition can be just as transformative as a listing.
Policy-driven growth: Founders should align their pipelines with EU funding priorities to maximise non-dilutive leverage.
Execution over hype: Europe rewards clinical validation and scalable access models—not moonshot projections.
Startups should design strategies that are M&A ready while embedding pathways to tap into EU-backed scaling opportunities.
Implications for Strategy and Investors
For founders: Patient growth capital and regulatory navigation matter more than vanity valuations. Position your business for strategic buyers who can unlock global reach.
For investors: The OrganOx exit underscores the value of holding through scale. In a funding environment tilted towards policy-supported growth, long‑term bets on MedTech SMEs can deliver double‑digit returns.
Conclusion
OrganOx isn’t just a headline; it’s a guidepost. In Europe’s MedTech world, execution and ecosystem alignment outperform aspiration for the trading floor. The lesson? IPO dreams may dominate headlines, but the real exits are happening elsewhere.
AI meets approvals, mental health consolidates, and early-stage device builders get fuel — a tidy week for cardiology/ophthalmology AI, workflow rollouts, and surgical tools.
People on the move
CMR Surgical: Chris O’Hara joins as Commercial President & GM (U.S.) to drive Versius robot expansion following FDA authorization; signals Cambridge-based CMR’s acceleration of global go-to-market. Mr. O’Hara brings experience at Intuitive Surgical (a company that builds DaVinci that Versius robot is challenging) and Globus Medical (specialists in spine sugery devices), his appointment is a strategic bet from CMR Surgical.
Money flows
Nami Surgical (Glasgow, UK): $10M, Series A (opened); developing a mini ultrasonic scalpel for robotic surgery. Proceeds support product development and commercialization prep. Tech from Nami addresses a critical unmet need in the field. Ultrasonic scalpels, which use high-frequency vibrations to simultaneously cut tissue and cauterise blood vessels, are indispensable tools in modern minimally invasive surgery. What they have is 90% smaller than available competitors.
Mindler (Sweden) acquires ieso Digital Health UK on undisclosed terms; creates a cross-border digital mental health platform spanning Nordics & UK buyers (employers, insurers, public payers). As there is an urgent need to address crisis of mental health and lack of (human) specialists, platforms such us Mindler and ieso are indispensable. Mindler is acquiring only ieso’s UK-based telecare services business, which is responsible for direct patient care delivery to the NHS. The parent company, ieso, will remain an independent entity pivoting to focus on the development and commercialisation of its evidence-based clinical AI platform, Velora, with an initial focus on the US market.
On the press
• ZEISS lands CE mark for CIRRUS PathFinder: integrated AI decision-support for OCT that flags abnormal macular B-scans and improves OCTA visualization; EU-ready software update/licence.
• Affidea x Skin Analytics: pan-European partnership to deploy Class III CE-marked AI dermatology (DERM – Deep Ensemble for the Recognition of Malignancy) across sites, starting in Romania and Lithuania with Greece next.
One thing to remember The EU’s AI-in-diagnostics momentum is real: new CE/MHRA greenlights (ZEISS, FemBloc) are pairing with deployment deals (Affidea × Skin Analytics), while funding still finds focused hardware/robotics and safety wearables (Nami Surgical, SIT). Founders: bring regulatory-grade proof and a crisp rollout plan.
Eight years of lawsuits. Zero damages paid. And now, a partnership.
After nearly a decade of courtroom brawls, Veeva and IQVIA have finally ended their long-running legal dispute. On 18 August 2025, the rivals dismissed all claims with prejudice (read: permanently), and instead signed multi-year agreements to integrate their data and software platforms
From Courtroom Drama to Cooperation
2017: IQVIA sued Veeva for alleged trade secret theft and data misuse [IQVIA vs Veeva case filing].
Veeva countered, accusing IQVIA of antitrust abuses and blocking customer data access ([Veeva statement].
Years of litigation followed, with motions, sanctions, and counterclaims clogging US federal courts.
Fast forward to 2025: instead of exchanging damages, both firms agreed to exchange data. All lawsuits are dropped, no money changes hands (beyond Veeva’s $31m legal bill under outcome-based fees, and the rivalry shifts from courtroom to boardroom.
The Resolution: What’s in the Deal?
The truce is more than symbolic, it’s operational:
Third-Party Access (TPA): IQVIA’s data can now flow into Veeva platforms (Network, Nitro, AI), while Veeva’s data is unlocked for IQVIA.
Clinical Collaboration: IQVIA joins the Veeva Clinical Data Partner program, plugging into Veeva’s Clinical Suite (EDC, SiteVault, etc.) for faster trial builds and smoother data delivery.
AI & Tech Integration: IQVIA signs onto Veeva’s Technology, AI, and Services Partner Programs.
Translation: instead of duplicating systems and blocking interoperability, both firms now enable cross-platform data use exactly as biopharma customers (and regulators) have been demanding.
Why It Matters for Europe
European life sciences has long struggled with fragmented data flows across GDPR-guarded patient datasets, MDR/IVDR compliance, and DiGA-like digital health pathways.
This resolution is strategically significant because:
Interoperability accelerates adoption: Pharma won’t need to choose between data suppliers—systems finally talk to each other.
Clinical trials speed up: CROs and sponsors can cut timelines by integrating EDC and analytics directly.
Commercialisation gains efficiency: Omnichannel marketing becomes more data-driven when IQVIA real-world data meets Veeva’s CRM and AI.
Eight years of legal warfare ended not with a knockout, but a handshake. The life sciences sector gets what it wanted all along: a functioning data ecosystem where Veeva and IQVIA finally play on the same team.
And if you’re tracking commercialisation playbooks, revisit our piece on omnichannel pharma and medtech strategy; this deal just made the data plumbing a lot easier!
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.
