In July 2025, the U.S. FDA issued a warning letter to Whoop, Inc. for marketing its Blood Pressure Insights (BPI) feature without regulatory clearance. The agency concluded that Whoop’s sleep-based blood pressure estimation feature qualifies as a medical device, not a general wellness tool. This finding has implications far beyond one wearable band.
Whoop’s case highlights a growing issue in the digital health space: where exactly is the boundary between consumer wellness products and regulated medical devices? And what happens when that boundary is crossed?
Interested in Whoop vs Hilo review?
See the Quantified Scientist test of Whoop below. Hilo band is a clinically proven device that measures your blood pressure at specific times without your intervention – somewhat similarly to Ambulatory Blood Pressure Monitoring but without cuff. It does not provide other features
What Did the FDA Say to Whoop?
According to the FDA, Whoop’s BPI function, which estimates systolic and diastolic blood pressure based on biometrics collected during sleep, is not “low risk” and is intended for medical purposes. Therefore, it cannot be marketed without appropriate FDA clearance. This runs contrary to Whoop’s claim that the feature is designed to support general wellness and self-awareness.
The agency made it clear: any feature that measures or interprets physiological parameters in a way that could be used for diagnosis, monitoring, or treatment falls squarely under the medical device category — regardless of disclaimers or marketing language.
Further analysis from industry sources confirms that the FDA is reinforcing a long-standing but often misunderstood principle: intended use is inferred not only from claims, but also from function and context. (Source: Mintz Legal Analysis)
It is worth noting, that user reviews claim that Whoop’s readings are often misleading, and it is no surprise as wrist measurement is much harder than on the upper arm cuff. However, FDA did not even discussed the reliability of the device. The case is that it did attempt to measure and monitor blood pressure at all.
Contrast with Aktiia’s Hilo Band
In stark contrast, Swiss MedTech company Aktiia pursued a fully regulated route for its cuffless blood pressure monitoring technology. The company’s flagship product marketed as the Hilo Band received 510(k) clearance from the FDA in July 2025. This made it the first-ever FDA-cleared wearable for over-the-counter cuffless blood pressure monitoring.
Unlike Whoop, Aktiia always positioned Hilo as a medical device. In Europe, it already holds a CE Mark under MDR as a Class IIa device, demonstrating compliance with EU Regulation 2017/745. It was developed in collaboration with clinicians, validated through peer-reviewed clinical trials, and built to meet regulatory requirements from day one.
Hilo’s strategy shows that it is possible to innovate in wearables while remaining on solid regulatory ground. That is if the product is clinically validated, and the claims are backed by science and cleared by regulators.
Regulatory Frameworks: EU MDR vs FDA
Under EU MDR (2017/745), any product that is intended to monitor or predict disease, or that provides data for diagnostic or therapeutic decisions qualifies as a medical device. This includes software, wearables, and connected apps. The CE-marking process requires clinical evaluation, conformity assessment, and continuous post-market surveillance.
Similarly, the FDA’s General Wellness Policy permits unregulated status only when features are demonstrably low-risk and not tied to medical decision-making. Estimating blood pressure, however, crosses that line.
Strategic Implications for MedTech and Digital Health
Intended use drives classification. If a feature informs diagnosis, monitoring, or treatment, it likely requires regulatory clearance — even if branded as wellness.
Claims matter. Disclaimers don’t override functionality. Regulators assess all available evidence: product labels, UI, marketing copy, and technical documentation.
EU and US frameworks are converging. Compliance with EU MDR (Class IIa) strengthens your case for FDA clearance — and vice versa.
Clinical validation is the foundation. Without it, wearable health features risk being blocked or recalled.
Final Thoughts: Whoop’s mistake
Whoop’s mistake wasn’t in innovating — it was in positioning a potentially diagnostic feature as a harmless wellness insight. That approach may work in fitness marketing, but not under the scrutiny of regulators.
By contrast, Aktiia’s Hilo Band shows how a regulated, evidence-based strategy enables long-term success across global markets. Its path — from CE mark in Europe to FDA clearance in the U.S. — should serve as a roadmap for future wearable startups operating in the cardiovascular or digital biomarker space.
As a European expert in medical device commercialization, I believe this moment is a wake-up call: marketing and regulatory must be aligned from day one. Otherwise, companies risk more than compliance failures — they risk losing consumer trust and market access.
Digital marketing has become a cornerstone of successful go-to-market strategies in the MedTech industry. Yet, marketing medical devices presents a distinct set of challenges, from navigating complex regulatory environments to building trust with clinical and procurement audiences.
This guide examines the unique aspects of medical device digital marketing, its evolution in 2025, and the key considerations companies operating in Europe must address to stay ahead.
What Is Medical Device Digital Marketing?
Medical device digital marketing refers to the use of online channels and technologies to promote medical devices to healthcare professionals, procurement stakeholders, and, when allowed, patients or caregivers. These efforts must strictly comply with applicable regulations and ethical standards while communicating value, efficacy, and safety clearly.
Unlike traditional advertising, digital marketing enables real-time, measurable, and often personalized engagement across the buyer journey. From search engines to webinars and content hubs, medical device marketers use a blend of tactics to educate, influence, and convert target audiences.
Key Channels in Medical Device Digital Marketing
SEO and Website Optimization
Your website is often the first point of contact. A well-optimized, medically accurate, and user-friendly website is foundational.
Use language aligned with your intended use claims.
Ensure content is accessible, fast-loading, and mobile-optimized.
Implement structured data (e.g., FAQ schema) to increase visibility in AI-driven search.
Paid Media & PPC
Paid campaigns can amplify reach, especially when launching a new device or entering a competitive market.
Google Ads must comply with medical advertising policies and applicable national regulations.
LinkedIn is commonly used for B2B outreach in medical devices.
Social Media & Video
Social media can support brand awareness and education. LinkedIn and YouTube are primary platforms for medical device marketing.
Short educational videos can support product understanding and HCP engagement.
Always disclose sponsorship and avoid off-label discussions.
Email & Marketing Automation
Email campaigns are effective for clinical updates, product launches, or training content.
Ensure GDPR compliance in Europe.
Marketing automation platforms (e.g. Marketo) enable segmentation by role or specialty.
Events & Webinars
Digital events remain vital in post-COVID medical marketing.
Webinars with KOLs (Key Opinion Leaders) can build trust.
Track attendance and engagement for sales handover.
Compliance in Medical Device Digital Marketing (EU & UK)
Medical device marketing in Europe is governed by strict laws and industry codes.
EU (European Union)
The EU Medical Device Regulation (MDR) prohibits misleading claims and mandates that promotional materials reflect the device’s intended use and CE marking status (Regulation (EU) 2017/745).
Advertising to the public is generally restricted for prescription-only devices.
UK
After Brexit, the UK follows guidance from the Medicines and Healthcare products Regulatory Agency (MHRA) and the Advertising Standards Authority (ASA).
The ASA’s CAP Code requires that promotional claims be substantiated, not misleading, and supported by appropriate evidence (ASA CAP Code – Section 12).
Always review country-specific requirements before launching any digital campaign.
Case Studies: Real-World Examples
1. iRhythm Technologies – UK Launch of Zio Service In 2020, iRhythm partnered with Medico Digital to localize its Zio® ambulatory cardiac monitoring solution for the UK market. Key digital marketing strategies included:
Keyword-optimized landing pages tailored to UK clinicians
LinkedIn and Google Ads campaigns aimed at NHS stakeholders and cardiologists
A redesigned website with local SEO and improved UX
The results were compelling:
+300% increase in organic traffic
+1,233% increase in enquiries
Over 2,000 highly qualified visits from target HCPs
2. NICE Evaluation of Zio XT – Market Credibility via Digital Validation In 2020, the UK’s NICE (National Institute for Health and Care Excellence) issued guidance supporting the use of iRhythm’s AI-enabled Zio XT patch for long-term arrhythmia detection. This regulatory milestone:
Established clinical and economic credibility
Provided a strong foundation for compliant, evidence-backed digital marketing
These verified campaigns illustrate how combining localized digital strategy with regulatory and clinical validation can powerfully support medical device adoption in competitive European markets.
Key performance indicators (KPIs) in medical device digital marketing may include:
Qualified HCP leads
Website dwell time and content downloads
Email open and click-through rates
ROI from paid campaigns
Webinar attendance and follow-up engagement
Use compliant analytics tools that respect data privacy.
Measuring Success
Key performance indicators (KPIs) in medical device digital marketing may include:
Qualified HCP leads
Website dwell time and content downloads
Email open and click-through rates
ROI from paid campaigns
Webinar attendance and follow-up engagement
Use compliant analytics tools that respect data privacy.
Trends Shaping Medical Device Digital Marketing in 2025
Generative AI is accelerating content creation but must be carefully validated for medical accuracy (BCG on AI in MedTech).
Omnichannel orchestration is becoming standard—coordinating content across rep-driven, digital, and event touchpoints.
Localized digital strategies are gaining traction across Europe, where national nuances matter.
Interactive training tools like AR/VR are being explored for high-end capital equipment.
FAQs on Medical Device Digital Marketing
Q: How is medical device marketing different from pharmaceutical marketing? A: Device marketing often targets a mix of HCPs, procurement teams, and hospitals, with more focus on technical features, usability, and health economic value. Pharma marketing is more focused on prescribers and patient outcomes.
Q: Can I advertise my medical device to consumers in Europe? A: For prescription-only devices, direct-to-consumer advertising is generally prohibited under EU MDR and national laws. Some Class I devices may be promoted if compliant with local rules.
Q: What budget should I allocate? A: Budgets vary widely. However, a McKinsey report suggests top-performing medtech firms often invest 5–10% of revenue in marketing, with digital increasing in share year-on-year (McKinsey MedTech Pulse 2023).
2025 Checklist for Medical Device Digital Marketing
✅ Align all messaging with approved intended use.
✅ Ensure compliance with EU MDR / MHRA / ASA.
✅ Use GDPR-compliant platforms for data collection.
✅ Create localized content for target European markets.
✅ Implement structured data and SEO best practices.
✅ Measure outcomes using compliant analytics.
✅ Prepare content for AI assistant and voice search visibility.
Final Thoughts
Medical device digital marketing in 2025 requires more than multichannel execution—it demands compliance, credibility, and clarity. As AI reshapes content creation and European regulations continue to evolve, marketers must remain agile and informed.
By grounding campaigns in strategic insight and verified best practices, digital marketers can drive meaningful engagement, support product adoption, and build long-term brand trust.
For ongoing updates, regulatory news, and tactical guides, follow Disrupting.Healthcare.
Note: This article is for informational purposes only and does not constitute legal advice. Always consult qualified regulatory experts before launching campaigns. This content has been enhanced using GenAI tools
What is medical device digital marketing?
Medical device digital marketing refers to the strategic use of digital channels: SEO, paid media, content, social, email, to promote medical devices. It must align with regulatory approvals, data privacy requirements like GDPR, and focus on educational, trust-building content tailored to healthcare professionals and patients.
Why is medical device digital marketing different from other healthcare marketing?
Unlike pharma or general healthcare products, marketing medical devices demands higher emphasis on clinical evidence, compliance with device-specific regulations (such as EU MDR and UK ASA/MHRA guidelines), and precise messaging that reflects the product’s intended use. Medical devices are usually B2B and not B2C products.
I. Introduction: Europe’s Ascendance in MedTech Innovation
The landscape of healthcare is undergoing a profound transformation, driven by relentless innovation in medical technology. At the forefront of this evolution stands the MedTech Innovator (MTI) program, globally recognized as a premier accelerator for breakthrough medical device, digital health, and diagnostic companies. Its rigorous selection process, which identifies the top 4% of nearly 1,500 global applicants, underscores the high potential of the chosen cohort. Companies participating in this program benefit from invaluable mentorship, strategic guidance, and unparalleled access to an extensive ecosystem of industry leaders, all designed to de-risk innovation and accelerate market success.
Europe continues to solidify its position as a vibrant hub for MedTech innovation, with a significant presence in the 2025 MTI cohort. This robust ecosystem is fueled by world-class academic research, substantial grant programs such as Horizon Europe and the EIC Accelerator, and a burgeoning network of specialized investors and incubators. The groundbreaking technologies emerging from this region are not merely incremental advancements; they represent fundamental shifts in diagnostic and therapeutic paradigms, poised to address critical unmet medical needs across the globe.
This report delves into 15 European startups from the 2025 MedTech Innovator cohort. It offers a detailed examination of their pioneering technologies, introduces the visionary leaders driving their missions, and outlines their financial journeys. These companies are actively redefining patient care, from advanced diagnostics and regenerative therapies to AI-powered insights and minimally invasive solutions. Their collective efforts illuminate a future where healthcare is more precise, accessible, and effective.
II. The 2025 European MedTech Innovator Cohort: A Glimpse into Tomorrow’s Healthcare
The 2025 MedTech Innovator cohort showcases a diverse array of European startups, each poised to make a significant impact within their respective strategic interest areas. The following table provides an overview of these innovative companies:
ARTINESS is transforming medical imaging and surgical procedures, particularly in cardiovascular interventions, through innovative holographic solutions. Their flagship ARTICOR® software suite facilitates pre-procedural simulations on patient-specific 3D models using Mixed Reality (MR) reconstruction. This technology allows for shared holographic visualization among clinical teams, enabling more precise and targeted surgical planning. This represents a significant advancement from traditional 2D imaging, fostering improved communication and collaboration among surgical teams, which can lead to reduced errors and optimized patient outcomes. The ability to overlay digital information onto the real world offers a fundamentally new way for surgeons to understand complex anatomies and rehearse procedures, potentially setting a new standard for complex interventions.
The company’s leadership team includes:
Filippo Piatti (CEO & Co-founder): Holds a PhD in Biomedical Engineering from Politecnico di Milano.
Giovanni Rossini (COO & Co-founder): Also holds a PhD in Biomedical Engineering from Politecnico di Milano.
Omar Pappalardo (CTO & Co-founder): Holds a PhD in Cardiovascular Sciences from Università di Verona.
X handle is @artinessreality.
ARTINESS has secured total funding of €2.1 million. This includes a spin-out from Polytechnic University of Milan (Jan 2018), a €1.0M seed round from Vodafone (Apr 2020), support from EIT Health (Jan 2022), and a €1.1M seed round (May 2024). They have also participated in accelerators such as UniCredit Start Lab FinTech Accelerator, Berkeley SkyDeck, and the 2025 MedTech Innovator cohort. The company’s journey from a university spin-off and its engagement with multiple accelerators indicates a deliberate strategy to de-risk its technology and accelerate commercialization. This broad engagement suggests a strong network of early supporters and a commitment to structured growth. While specific 2024 revenue figures are not detailed, ARTINESS activated its membership in the Bio4Dreams Ecosystem in March 2024, signaling continued growth and engagement within the innovation community. Historical data up to 2022 shows revenues and EBITDA below €1M, but with a notable 131% growth in 2022. Main shareholders include Vodafone, UniCredit Start Lab FinTech Accelerator, Polytechnic University of Milan, Berkeley SkyDeck, EIT Health, MedTech Innovator, nVue Surgical, and B Heroes.
CathVision is advancing electrophysiology (EP) technology with its ECGenius™ System and CARDIALYTICS™ suite, designed to enhance cardiac signal recording and patient care for heart rhythm disorders. The company’s mission is to empower physicians to cure cardiac arrhythmia by providing high-fidelity EP systems and AI-based analytic tools for automated analysis during the diagnosis and treatment of complex atrial arrhythmias. The focus on improving signal clarity directly addresses a core challenge in electrophysiology, where precise signal acquisition is paramount for accurate diagnosis and effective ablation. By delivering clear signals, CathVision’s system enables more informed decisions, potentially leading to better treatment efficacy and reduced recurrence rates for conditions like atrial fibrillation.
The leadership team includes:
Mads Emil Matthiesen (Co-Founder & CEO): Co-founded CathVision in 2010. He possesses extensive experience in cardiology as both a business leader and biomedical engineer, with over a decade in medical device development and research in Europe and the U.S. He graduated from the Technical University of Denmark in biomedical engineering and received additional training at MIT and Harvard in medical device and implant design. He previously worked as a management consultant at the Boston Consulting Group. X: @MadsMatthiesen.
Rune Ørndrup (Co-Founder & CFO): Helped co-found CathVision in 2010. He brings a diverse background in corporate organizations and agile startups, with extensive experience in finance and global operations. He has successfully steered multiple funding rounds for CathVision, totaling over €20 million, and has also secured over $30 million in funding for the tech startup Labster. He is active in the Danish startup ecosystem.
CathVision has raised a total of $36.1 million over 11 funding rounds. Key investments include a $7.2 million round from existing investors in August 2022, and a $9 million round in May 2023. The largest round was a Series B for $14M in March 2020, led by Vaekstfonden. The company has also received a €2.2M grant from Horizon 2020 in 2019. In 2024, CathVision highlighted its PFAnalyzer at HRS 2024 in May, and its strategic focus for the year was to accelerate commercial adoption. The consistent investment from existing shareholders and the achievement of FDA clearance for the ECGenius™ System demonstrate strong investor confidence and a clear path towards commercialization. Main shareholders include Vaekstfonden, Borean Innovation, Innovation Fund Denmark, EIC Fund, and Lumine Capital.
Kelvin Health is dedicated to preventing suffering for millions globally through its Thermography AI, offering accessible and rapid non-invasive vascular diagnostics. The company leverages advanced machine learning and a unique dataset, developed with R&D partners, to deliver personalized healthcare and telemedicine solutions. The technology’s ability to provide non-invasive, potentially low-cost, and rapid screening democratizes access to early detection, shifting diagnostics from reactive hospital settings to proactive community or even home-based care. This approach has the potential to significantly alleviate pressure on healthcare systems.
The founding team includes:
Georgi Kadrev (CEO & Co-founder): Recognized as a Visual AI API pioneer, an IDC Innovator in 2016, and featured in Forbes’ “30 under 30” in 2013. He co-founded Imagga, an image recognition AI company, in 2008, and subsequently co-founded Kelvin Health in March 2020. X: @GeorgiKadrev.
Georgi Kostadinov (CTO & Co-founder): Credited with a “130K+ categories ML model” and a “30B+ images API,” highlighting his deep expertise in image processing and AI. He was recognized in Forbes’ “30 under 30” in 2020 and has a strong background in AI, machine learning, and software engineering, including leadership roles at Imagga. X: @GeorgiKostadinov.
Pavel Andreev (CPO & Co-founder): Brings over 15 years of experience in building digital products. He co-founded Imagga in 2009 and Sticky Creative in 2011, before assuming his role as Head of Product and Design at Kelvin Health.
Kelvin Health has raised a total of $5.38 million through a single Series A funding round, which closed on June 11, 2024. This round saw Racine² as the lead investor, alongside Seedcamp and three other institutional investors. In 2024, Kelvin Health was a finalist in the EIT Health InnoStars Awards and was selected as one of seven companies for Medtronic’s MedLim program, indicating strong industry validation and potential for strategic collaborations. The company also prepared for new features in 2025 by renaming its “Kelvin-Clinic” app to “Kelvin-Clinic 2024 (Legacy)” in October 2024. The company’s ambitious vision to “positively touch the lives of billions of people” underscores the vast scalability of their non-invasive diagnostic approach.
MedLumics, founded in 2011 (with roots dating back to 2009) , develops medical devices for the treatment of Atrial Fibrillation (AF). Their flagship product, the Ablaview® system, is a unique, real-time, photonically guided radiofrequency (RF) irrigated ablation catheter system. It integrates photonics and miniaturized optics to guide device placement and directly assess ablation lesions in real time. This technology directly addresses the high recurrence rate in AF ablation, a significant unmet need in a multi-billion dollar market. By enabling precise guidance and real-time confirmation of therapy success, MedLumics aims to ensure complete and continuous lesions, thereby improving patient outcomes and reducing the need for repeat procedures.
The leadership team includes:
Peter Hinchliffe (CEO): He has over 40 years of extensive engineering and operational experience in medical device design, development, and commercialization. His background includes leadership roles at companies such as Jarvik Heart, Getinge, DataScope, Rex Medical, and Medtronic. He holds over 110 issued US medical device patents and more than 100 pending.
Eduardo Margallo(Co-founder): Holds M.Sc. degrees in Telecommunication Engineering, Electrical Engineering, and Physics, and a Ph.D. in Photonics. He has over ten years of experience founding and managing photonics technology firms.
MedLumics has raised approximately €18.99 million in total funding. This includes an initial €18 million in total financing as of October 2020, with a €14 million Series E round co-led by Asabys Partners, VI Partners, and CDTI Innvierte, joined by existing investors Andera Partners, Caixa Capital Risc, and Innogest. In February 2024, the company secured an additional €0.99 million in venture funding from Center for Technological & Industrial Development and Asabys Partners. While specific revenue performance for 2024 is not detailed, the company continued to secure funding, indicating ongoing investor confidence. Main shareholders include Asabys Partners, VI Partners, CDTI Innvierte, Andera Partners, Seroba Life Sciences, Innogest, and Caixa Capital Risc.
LightHearted AI Health is developing a precision cardiology platform that utilizes laser-based technology and AI to diagnose heart disease. Their device is designed for home use, capable of gathering essential data, including unique biomarkers, through clothing and at a distance in less than a minute. The aim is to make heart disease diagnostics affordable, accessible, and timely, significantly reducing the burden on healthcare systems by enabling earlier intervention. This advanced, laser-based digital stethoscope can diagnose valve diseases in primary care settings in just 10 seconds, with the AI platform generating a diagnostic report in one minute.
The co-founders are:
Lucrezia Cester (CEO & Co-founder): An AI Engineer and Clinical Scientist, she holds a PhD in Signal Processing. Her experience includes working as an AI Clinical Scientist within the UK National Health Service (NHS) and as a Clinical Entrepreneur, where she gained deep expertise in the challenges facing healthcare systems and how to navigate them. X: @CesterLucrezia.
Dilip Rajeswari(CTO & Co-founder): A Machine Learning engineer and DeepTech Entrepreneur. He has led R&D teams in building, developing, and clinically deploying regulatory-compliant precision medicine platforms.
LightHearted AI Health has raised $3 million in funding. This includes joint investment from Entrepreneur First and SOSV HAX in Autumn 2023. The company also secured grants and closed “a million in proceeds” prior to LSI Europe ’24, with plans to raise an additional $3 million for FDA submission and market expansion. In 2024, the company was actively piloting its technology with the NHS in the UK and conducting clinical trials in Dorset. While specific 2024 revenue figures are not provided, the company projects a 100k Monthly Recurring Revenue (MRR) with its first customer in an emerging market. The company is seeking Class IIa approval by the end of 2025. Main shareholders include Entrepreneur First and SOSV HAX.
STENTiT is introducing a novel class of regenerative endovascular implants, the Resorbable Fibrillated Scaffold (RFS), for cardiovascular diseases. This temporary vascular support structure is designed to reconstruct the artery from the inside out by triggering a natural healing response from circulating blood cells. The implant is eventually replaced by new vascular tissue and fully resorbs within 12 months, leaving nothing behind. This regenerative approach represents a significant paradigm shift from traditional stents, which merely provide mechanical support or elute drugs. The RFS aims to provide a “lifelong solution” by restoring arterial health, offering a distinct competitive advantage.
The company’s founder is:
Bart Sanders (CEO & Co-founder): An engineer from TU/e, his work on heart valves inspired the idea for regenerative endovascular implants. He holds a Doctor (dr) in Biomedical Engineering (2016) and a Master of Science in Biomedical Engineering (2011) from Eindhoven University of Technology. Despite initially lacking a business background, he has built a strong, complementary team to drive the company forward.
STENTiT has raised $1.98 million in total funding. This includes a university spin-out (Jan 2015), accelerator/incubator rounds (Sep 2016, Apr 2025), and grants (June 2019, Aug 2019, March 2023). A significant seed round of €1.8 million was secured on April 15, 2022, from NextGen Ventures, Brabant Development Agency (BOM), and Ten Cate Investment Company. A later-stage VC round also occurred on July 17, 2024. In 2024, the company focused on further product development and clinical trials, having proven the technology’s regenerative nature in pre-clinical studies. While no sales have been generated yet due to the long approval process inherent in MedTech, the company aims for its first clinical trials in 2025. Main shareholders include NextGen Ventures, Brabant Development Agency (BOM), Ten Cate Investment Company, and Horizon Europe.
Indigo Diabetes (Gent, Belgium)
Indigo Diabetes is developing the world’s first continuous multi-metabolite monitoring (CMM®) system, designed for individuals with chronic diseases. Initially, the system focuses on diabetes, providing continuous glucose, ketone, and lactate monitoring. The core of Indigo’s technology is an integrated sensor based on silicon photonics, enabling the miniaturization of established spectroscopic analysis techniques into a small, implantable device. This innovative approach allows for real-time data delivery to a smartphone app, offering a significant user experience improvement over external wearables or frequent finger pricks. The ability to continuously monitor multiple metabolites offers a holistic approach to managing complex chronic conditions, which can lead to improved patient outcomes and reduced healthcare costs.
The company’s founder is:
Danaë Delbeke (CTO, Managing Director, Inventor, & Co-founder): She has a proven track record in business management and entrepreneurship, having founded or co-founded seven high-tech photonics companies over the past 12 years. She holds a Ph.D. in Applied Sciences from Ghent University (2002) and degrees in Economics and Photonics.
Indigo Diabetes has raised over €45 million in total funding since 2016. This includes a €38 million Series B round concluded in July 2020, led by Fund+, with participation from Ackermans & van Haaren, imec.xpand, Capricorn Digital Growth Fund, QBIC II, Titan Baratto, and Series A investors. The company was founded in 2016 as a spin-off of Ghent University and imec. In 2024, Indigo Diabetes was recognized as a Key Innovator by the European Commission’s Innovation Radar (April 2025) and completed the SHINE Study, validating its breakthrough in continuous multi-metabolite monitoring (March 2025). The company was also selected for the 2025 MedTech Innovator Accelerator Cohort in June 2025. Main shareholders include Fund+, Ackermans & van Haaren, Thuja Capital, PMV, Capricorn Partners, imec.xpand, Qbic, and private investors.
Microplate Dx is developing RapidPlate Technology, a rapid antibiotic susceptibility testing (AST) platform designed to combat drug-resistant infections. This technology combines groundbreaking hardware with novel data processing algorithms to perform rapid AST on patient samples. A pre-clinical study focusing on urinary tract infections (UTIs) demonstrated 96% accuracy in detecting bacterial growth with results available in just 30 minutes. This rapid turnaround time is crucial for combating antimicrobial resistance (AMR), a growing global health threat that delays effective treatment and contributes to the spread of resistance.
The founding team includes:
Damion Corrigan (Co-founder & Chief Technology Officer): Brings over 10 years of academic and industrial experience in biosensors and assay development. He is a Professor of Chemistry at the University of Strathclyde, a founder of two spinout companies (AureumDx, Aureum), holds four patents, and is a Longitude Prize Discovery Award Recipient (2017).
Paul Hoskisson (Co-founder & Chief Scientific Advisor): Possesses over 15 years of experience in molecular microbiology. He is a Professor of Molecular Microbiology and Royal Academy of Engineering Research Chair at the University of Strathclyde, and previously licensed intellectual property to GSK.
Poonam Malik (Co-founder & Chair of the Board): An entrepreneurial business and commercial strategy leader with extensive experience as a board member, non-executive director, and advisor in life sciences, biotech, health, digital, and MedTech.
Stuart Hannah (Co-founder & CEO): Has over 10 years of academic and industrial experience in biotechnology, medical devices, and diagnostics development. He holds a PhD in Electronic & Electrical Engineering from the University of Strathclyde and is a former Royal Society of Edinburgh Enterprise Fellow.
Microplate Dx has raised a total of $3.73 million over two funding rounds. The first round, a $610K Seed round, closed on December 9, 2022. The latest, a $3.12 million Seed round, closed on September 11, 2023, with SIS Ventures as the lead investor. The company’s annual revenue was £35K as of April 30, 2022. However, for the legal entity Microplate DX Limited, turnover significantly increased by 92% to £901.29K for the period ending April 30, 2024, indicating strong early commercial traction and market validation. Main shareholders include Deepbridge Capital, SIS Ventures, Scottish Enterprise, Kin Capital, and the University of Strathclyde.
MiWEndo Solutions, a spin-off founded in 2019 from multiple Spanish universities and a hospital, is developing microwave medical diagnostic systems primarily for early colorectal cancer (CRC) detection. Their innovative endoscopy accessory uses low-cost, safe microwave imaging technology. It attaches to a standard endoscope, providing a 360° field of view, emitting an alarm upon polyp detection, and differentiating between malignant and benign polyps. This technology directly addresses the limitations of current colonoscopy methods, which can miss a significant percentage of polyps, and has the potential to dramatically increase early diagnosis and prevention of CRC.
The management team includes:
Tomàs Escuin (CEO): An Industrial Engineer with a Master’s degree and a postgraduate degree in Financial Management. He possesses extensive experience in technology transfer, finance, and business development.
Glòria Fernàndez Esparrach (Co-Founder & CMO): A Medical Doctor (MD, PhD), gastroenterologist, and endoscopy specialist at Hospital Clínic de Barcelona, and a professor at Universitat de Barcelona. She co-founded MiWEndo in 2019, focusing on developing smart systems to improve endoscope diagnostic capabilities.
Marta Guardiola (Co-Founder & CTO): Holds M.Sc. and PhD degrees in telecommunications. She is an associate professor at the International University of Catalonia and Universitat Pompeu Fabra. Co-founded MiWEndo in 2019, she holds two patents and has received over 10 awards.
MiWEndo Solutions has received substantial funding through numerous grants from various Spanish and European bodies, including the EIC Accelerator (Grant Agreement No. 960251 in 2020). Its investors include GENESIS Ventures, AVANÇSA, FI Group, and CDTI Innovación. In 2024, David Ruiz joined as RAQA Manager, responsible for managing the quality management system and ensuring MDR 2017/745 compliance for CE marking, indicating a mature approach to commercialization. Marta Guardiola also received the Premio Salvà i Campillo al Emprendimiento in October 2024. Main shareholders include Glòria Fernández-Esparrach, Marta Guardiola, Miriam Cuatrecases, and Ignasi Belda.
Icometrix develops AI-driven software solutions for brain imaging, transforming MRI and CT scans into actionable data for a wide range of neurological conditions, including Alzheimer’s, multiple sclerosis (MS), Parkinson’s disease, stroke, traumatic brain injury, and epilepsy. Their core technology, icobrain, has specialized modules like icobrain aria for monitoring Amyloid-Related Imaging Abnormalities (ARIA) in Alzheimer’s care. The company also launched icolung for AI lung analyses during the COVID-19 pandemic and icompanion, a patient-oriented care platform for MS patients. The broad application of icobrain across multiple neurological conditions addresses significant global health burdens, providing objective data for early diagnosis, differential diagnosis, and monitoring treatment efficacy.
The leadership team includes:
Wim Van Hecke (CEO & Co-founder): An academic engineer with two Master’s degrees in applied biomedical engineering and neuroimaging, and a PhD in diffusion MRI analysis. He is the author or co-author of over 150 scientific publications and the editor of a clinical neuroimaging handbook. He founded icometrix in 2011 as a spin-off from Belgian universities and hospitals.
Dirk Smeets (CTO & Co-founder): Heads the R&D team and serves as product manager for icobrain and icolung, as well as information security manager. He holds a Ph.D.
Icometrix has raised a total of $20.2 million over 10 funding rounds. The largest round was a Series A for $18M in May 2019, co-led by Optum Ventures, Forestay Capital, and Capricorn Venture Partners. The company was founded in 2011 as a spin-off from two Belgian universities and hospitals. In 2024, icobrain aria became the only FDA-cleared CADe/CADx solution in neuroradiology for ARIA monitoring in Alzheimer’s care. Icometrix was also named a finalist for the Scale-Up of the Year 2024 Award in October 2024. The company collaborated with the American College of Radiology (ACR) and the International Registry for Alzheimer’s Disease (InRAD) to improve standardization of care and real-world evidence generation in Alzheimer’s disease. Main shareholders include Optum Ventures, Forestay Capital, Capricorn Venture Partners, Heran Partners, EIT Digital, European Union, KU Leuven, University of Antwerp, Antwerp University Hospital, and Biover II.
Precisis GmbH specializes in innovative medical devices for device-controlled brain therapies. Their flagship product, EASEE®, is an implantable bioelectric brain stimulation system for treating epilepsy. This minimally invasive device is positioned beneath the scalp, directly over the epileptic origin, without requiring the cranial bone to be opened or the brain to be touched. EASEE® offers individualized brain stimulation with two modes of action: a high-frequency pulse for interrupting upcoming seizures and a DC-like mode for seizure prevention. This represents a significant advancement over highly invasive surgical alternatives for drug-refractory epilepsy, offering a low-risk and highly effective treatment option.
The leadership team includes:
Angela Liedler (CEO & Main Shareholder): A medical doctor and serial entrepreneur. She founded and led a healthcare agency before transitioning to the MedTech sector and taking over a majority stake in Precisis in 2011. She is also one of the inventors of EASEE®.
Karl Stoklosa (Managing Director, CEO): Has extensive experience in global marketing and sales leadership from his time at Abbott (Cardiac Rhythm Management, Neuromodulation) and St. Jude Medical. He holds a BA from the University of Minnesota and an MBA from the University of Chicago Booth School of Business.
Michael Tittelbach (Managing Director, CTO): His experience includes R&D for interventional cardiology at Biotronik AG. He studied Physics.
Precisis has secured substantial funding, including a €20 million Series A round in 2015 from private investors and grants from the German Federal Ministry for Research and Education. In October 2021, the company concluded another €20 million funding round with Cochlear Ltd, a global leader in implantable hearing solutions and a strategic partner. Additionally, Precisis received €2.4 million from the EIC Accelerator in December 2022. In 2024, Precisis began generating revenue and projected €6 million in revenues for 2025, with market launch anticipated for early 2022. EASEE® has seen successful implantations in Germany, Austria, and Switzerland, and was expected to be available in the UK from Q2 2024. The company also commenced a pediatric study in May 2023. Main shareholders include Angela Liedler and Cochlear Ltd.
Connected Consumables is revolutionizing medical fluid consumables by integrating data and power capabilities, transforming what were once simple plastic conduits into intelligent system-solutions. Their patented technology embeds a data line directly into medical consumables, enabling digital end-to-end control and automated fluid management. The primary focus is on enhancing the precision and safety of oncological infusion therapy. This innovation directly addresses critical issues such as medication errors and the significant burden on medical staff due to repetitive manual tasks, ultimately leading to substantial cost savings and improved patient safety through continuous ID checks and direct translation of therapy plans into fluid control.
Founders of Connected Consumables are: Jochen Hampe – CEO, Speaker at Else Kröner Fresenius Center for Digital Health, Professor for Internal Medicine and Gastroenterology at TU Dresden.
Nora Herzog – CEO, Clinician Scientists at Universitätsklinikum Carl Gustav Carus. Founder of Clinicum Digitale, a program bridging medicine and technology. Winner of the Female Transformers in Healthcare Award for her work in interdisciplinary medical education
Connected Consumables has participated in several funding rounds, including Accelerator/Incubator rounds in January 2021 and June 2025, and a Seed Round in August 2023. While specific revenue or performance figures for 2024 are not detailed, the company’s continued participation in accelerator programs indicates ongoing development and investor interest. Main shareholders include MedTech Innovator, Cellex Cell Professionals, Murrplastik Medizintechnik, TUDAG, and Thuringian Regional Innovation Program. The company’s technology, which introduces the “first wire” into medical consumables, represents a foundational innovation with broad potential across various medical fields beyond oncology where precise fluid management is critical.
MOMM Diagnostics is a privately held Swiss startup poised to revolutionize diagnostics with its rapid diagnostic test technology. The company’s primary focus is the development of the préXclude rapid preeclampsia test, a high-sensitivity diagnostic tool capable of identifying or ruling out preeclampsia in minutes from a single drop of the mother’s blood via a finger prick. Preeclampsia is a life-threatening pregnancy condition affecting 3-8% of all pregnancies, making a rapid and accurate diagnostic tool critically important for preventing severe complications for both mother and baby.
The company’s founder is:
Mathias Wipf (Founder & CEO): His background is in nanoscience and physics, with a focus on biosensor technologies. His work at Yale University on simplifying biosensor manufacturing laid the groundwork for MOMM Diagnostics. He is recognized as an innovation-driven scientist and entrepreneur.
MOMM Diagnostics has raised CHF 1.2 million in funding. This includes an $80.6K Grant (prize money) round in May 2019 from the European Union and Venture Kick. The company’s first interaction with Venturelab was in 2018 through Venture Kick. While specific performance figures for 2024 are not detailed, the company’s technology aligns perfectly with the increased demand for sensitive and accurate rapid diagnostic tests, a need highlighted by the COVID-19 pandemic. Main shareholders include the European Union and Venture Kick.
Multi4 Medical has developed a unique and patented technology for automated endoscopic cancer diagnosis and treatment, specifically targeting urinary bladder cancer. Their handheld, multipurpose instrument integrates four key functions: applying local anesthesia, taking tissue samples in a novel way, automatically transporting samples through the instrument, and destroying cancer tissue or stopping bleeding. Designed for outpatient care, this technology eliminates the need for general anesthesia or operating rooms, allowing patients to go home immediately after treatment. This innovation significantly reduces the high costs and lengthy treatment times associated with traditional bladder cancer procedures, while improving patient quality of life.
The company’s founder is:
Miden Melle-Hannah (CEO & Founder): A urologist, surgeon, and entrepreneur. She founded Multi4 Medical in 2017, driven by her frustration with the inefficiencies in existing bladder cancer treatments. Her deep clinical insight has led to the development of a solution highly practical and relevant to clinical practice. She has received numerous awards for her innovative work.
Multi4 Medical has raised $2.7 million in total funding. This includes Accelerator/Incubator rounds in March 2024 and June 2025. A significant milestone in 2024 was securing a €2.5 million grant from the European Innovation Council in July. The company was also selected for the 2025 MedTech Innovator Cohort. In 2024, Multi4 Medical relocated to Gothenburg, leveraging the city’s thriving life science ecosystem for talent acquisition and partnerships. The first surgeries using their instrument are underway as part of a clinical study involving 25 bladder cancer patients in Gothenburg. The company submitted its Technical File for MDR/CE-mark and an Application to the FDA in 2025. Main shareholders include MedTech Innovator, European Innovation Council, and Science Park Jönköping.
The Flume Catheter Company is dedicated to developing an improved alternative to the traditional Foley indwelling urinary catheter, a device used by 100 million patients worldwide. Their FLUME catheter features a unique balloon configuration designed to envelop the tip of the catheter upon inflation, allowing the bladder to contact the compliant balloon rather than a rigid catheter tip. This innovative design directly addresses the significant patient discomfort, infections (CAUTI), and blockages commonly associated with existing catheters, aiming to enhance quality of life and reduce catheter-associated healthcare costs.
The founding team is composed of:
Dr. John Havard (Chairman & Founder): A Suffolk GP with a career-long interest in medical innovations. His inspiration for FLUME stemmed from community nurses’ feedback on the pervasive issues with the Foley catheter. He has been recognized as one of the UK’s Top 50 Innovators by the Health Service Journal.
Roger Holmes (Co-Founder & Chief Executive): A former CEO of M&S, an engineer, an accountant, and a private equity partner. He is a Partner at Change Capital Partners LLP and was drawn to FLUME’s potential for significant patient impact and healthcare financial benefits.
The Flume Catheter Company has raised a total of $6.19 million in funding. This includes seed funding of £450k (2016-2019), followed by three Angel rounds: £825k (March 2020), £2.1M (March 2022), and £1.4M (July 2024). The company also received grant support from an MRC-funded Elizabeth Blackwell ‘Proof of Concept’ award and an NIHR ‘Research for Patient Benefit’ award. In 2024, the company successfully completed its third Angel funding round and saw Kristian Olsen join as VP Engineering in January. The latest FLUME catheter was ready to ship in March 2025, with product arriving in the U.S. warehouse, marking a significant step in market expansion. The company is licensed to sell in 49 U.S. states and D.C., and the FLUME® catheter is covered under Medicare Part B. The company was also selected for the 2025 MedTech Innovator accelerator cohort in July 2025. Main shareholders include the founders, Angel investors, and MedTech Innovator.
III. Our Top Three Most Promising Startups
Identifying the “most promising” startups involves considering several factors: the disruptive potential of their technology, the size and urgency of the unmet medical need they address, their progress in clinical validation and regulatory approval, the strength and experience of their team, and their financial traction. Based on these criteria, the following three European startups from the 2025 MedTech Innovator cohort stand out for their potential to significantly transform healthcare:
1. Precisis (Heidelberg, Germany)
Precisis is a standout innovator due to its EASEE® system, which offers a minimally invasive bioelectric brain stimulation solution for drug-refractory epilepsy. This technology addresses a critical unmet need for millions of epilepsy patients who do not respond to medication, for whom current surgical options are highly invasive and carry significant risks. EASEE®’s unique design, placed beneath the scalp without opening the cranial bone or touching the brain, drastically reduces surgical complications and patient burden. The compelling clinical results, with 84% of severely ill study participants benefiting and 53% achieving a ≥50% seizure reduction (17% becoming completely seizure-free) , demonstrate a profound improvement in patient quality of life. This level of efficacy in a minimally invasive package positions EASEE® as a truly disruptive therapy.
Furthermore, Precisis’ strategic partnership with Cochlear Ltd, a global leader in implantable solutions, is a significant accelerator for its market penetration. This collaboration provides not only substantial funding but also invaluable access to Cochlear’s vast expertise in implantable devices and its established global market presence. The fact that Cochlear’s investment is tied to clinical and development milestones, including CE Mark certification , aligns incentives for rapid progress and de-risks the venture. The company’s achievement of CE Mark approval under the new MDR regulation as a small company in just seven years is a testament to its robust development and regulatory capabilities. The platform nature of EASEE®, with potential applications in other functional brain diseases like depression and cognitive dysfunctions , indicates a broader long-term vision and scalable market potential beyond epilepsy, making it a highly attractive investment.
2. Microplate Dx (Glasgow, United Kingdom)
Microplate Dx presents a compelling case for its disruptive potential by directly confronting the urgent global health crisis of antimicrobial resistance (AMR). Their RapidPlate Technology offers a rapid antibiotic susceptibility testing (AST) platform that can deliver results in just 30 minutes with 96% accuracy for urinary tract infections. This is a game-changer compared to current methods that can take days, often leading to “best guess” antibiotic prescriptions that contribute to resistance and delay effective treatment, especially in time-sensitive conditions like sepsis. The ability to provide immediate, targeted antibiotic guidance can significantly improve patient outcomes, reduce hospitalizations, and slow the progression of AMR.
The company’s strong academic foundation as a spin-out from the University of Strathclyde, with multiple founders holding professorships and extensive experience in biosensors and microbiology , provides a solid scientific and technical bedrock. This academic rigor, combined with the university’s commercialization support, enhances the credibility of their innovation. Financially, the significant increase in turnover for Microplate DX Limited, which saw a 92% growth to £901.29K in the fiscal year ending April 2024 , demonstrates strong early commercial traction and market validation. This rapid revenue growth, coupled with their direct impact on a major global health challenge and a clear path to market through their platform, positions Microplate Dx as a highly promising venture.
3. Multi4 Medical (Gothenburg, Sweden)
Multi4 Medical stands out for its innovative approach to cancer diagnosis and treatment, particularly for urinary bladder cancer, by shifting complex procedures to an outpatient setting. Their patented, handheld, multi-purpose instrument automates critical steps like local anesthesia, tissue sampling, sample transport, and tissue destruction, eliminating the need for general anesthesia, operating rooms, and catheters. This transformation addresses a significant pain point in bladder cancer care, which is often costly and time-consuming, with high recurrence rates. By enabling patients to go home immediately after a 20-minute procedure, Multi4 Medical promises substantial cost savings for healthcare systems (e.g., $140,000 per case in the US) and a dramatically improved patient experience.
The company’s innovation is driven by the direct clinical expertise of its founder and CEO, Miden Melle-Hannah, a urologist and surgeon. Her firsthand frustration with existing inefficiencies in bladder cancer treatment provided the impetus for developing a highly practical and clinically relevant solution. This “doctor-turned-entrepreneur” narrative lends significant credibility to the company’s mission. Furthermore, the technology’s generic nature, with potential applicability to other cancers of the esophagus, stomach, lungs, and intestines , indicates a broad market potential and scalability beyond its initial focus. The recent €2.5 million grant from the European Innovation Council and the strategic relocation to Gothenburg’s thriving life science ecosystem further underscore the company’s strong validation and ambitious growth plans.
IV. Conclusion
The 2025 MedTech Innovator cohort highlights Europe’s pivotal role in shaping the future of healthcare. The featured startups demonstrate a collective commitment to addressing critical unmet medical needs through groundbreaking technologies, ranging from AI-powered diagnostics and regenerative therapies to minimally invasive surgical solutions.
A recurring theme among these innovators is the strategic application of advanced technologies, such as AI, photonics, and mixed reality, to create solutions that are not only clinically effective but also enhance accessibility, reduce costs, and improve patient quality of life. Many of these companies originate from strong academic foundations, leveraging deep scientific expertise to develop robust, evidence-based products. Their ability to secure substantial funding from diverse sources, including venture capital, grants from European bodies, and strategic partnerships with industry giants, underscores the market’s confidence in their disruptive potential.
The progress demonstrated by these companies, including successful clinical studies, regulatory clearances (FDA, CE Mark), and early commercial traction, indicates a maturation of the European MedTech ecosystem. These ventures are not merely developing novel devices; they are actively working to integrate their solutions into existing healthcare workflows, streamline patient pathways, and ultimately redefine the standards of care. Their collective efforts forecast a future where healthcare is more proactive, personalized, and efficient, promising significant advancements for patients worldwide.
This content has been enhanced with GenAI tools.
References:
1. News – The Flume Catheter Company, https://www.flumecatheter.com/news 2. The new way to look inside – Artiness, https://www.artinessreality.com/en/home-eng/ 3. Filippo PIATTI | PhD Candidate | Ms, Biomedical Engineering | Politecnico di Milano, Milan | Polimi | Department of Electronics, Information, and Bioengineering | Research profile – ResearchGate, https://www.researchgate.net/profile/Filippo-Piatti-2 4. Giovanni Rossini – COO And Co-founder at Artiness – The Org, https://theorg.com/org/artiness/org-chart/giovanni-rossini 5. Artiness company information, funding & investors | Dealroom.co, https://app.dealroom.co/companies/artiness 6. Artiness company information, funding & investors | South Moravia Innovation Ecosystem, https://ecosystem.brnoregion.com/companies/artiness 7. Artiness 2025 Company Profile: Valuation, Funding & Investors | PitchBook, https://pitchbook.com/profiles/company/434224-18 8. Artiness activates membership in the Bio4Dreams Ecosystem, https://bio4dreams.com/en/membership-artiness-mixed-reality-cardiac-surgery/ 9. CathVision – EP Recording. Enhanced., https://cathvision.com/ 10. CathVision Aps Asset Profile | Preqin, https://www.preqin.com/data/profile/asset/cathvision-aps/238680 11. Mads Matthiesen – HRX 2024, https://experiencehrx.com/speaker/mads-matthieson/ 12. Mads Emil Matthiesen – CEO & co-Founder at CathVision | The Org, https://theorg.com/org/cathvision/org-chart/mads-emil-matthiesen 13. CathVision Receives Competitive EU Grant – PR Newswire, https://www.prnewswire.com/news-releases/cathvision-receives-competitive-eu-grant-300949032.html 14. Rune Ørndrup – CoFounder, CFO at CathVision – The Org, https://theorg.com/org/cathvision/org-chart/rune-orndrup 15. Rune Justesen Ørndrup – Ownership Screening – Graphlytic, https://graphlytic.com/screening/rune-justesen 16. 2025 Funding Rounds & List of Investors – CathVision – Tracxn, https://tracxn.com/d/companies/cathvision/__U6Wzgu2f9X5mDReWGQps2XQMpEyEEfbGkjjEPTUrjhM/funding-and-investors 17. CathVision Announces Close Of $7.2 Million Financing Round, https://cathvision.com/news/cathvision-announces-close-of-7-2-million-financing-round/ 18. About us – Kelvin Health, https://www.kelvin.health/about-us 19. Kelvin Health: Advancing the standard of vascular care, https://www.kelvin.health/ 20. Georgi Kadrev | Biotech Atelier, https://biotech-atelier.com/speakers/georgi-kadrev/ 21. AI Diabetes Care: Keynote by Georgi Kadrev, CEO & Co-founder of Kelvin Health – YouTube, https://www.youtube.com/watch?v=beheQqVS7kI 22. Georgi Kadrev – Center for Health Technology & Innovation, https://ahahealthtech.org/panelists/georgi-kadrev/ 23. Georgi Kostadinov – Co-founder & CTO at Kelvin Health | The Org, https://theorg.com/org/kelvin-health/org-chart/georgi-kostadinov 24. Georgi Kostadinov – LinkedIn – Clay.earth, https://clay.earth/profile/georgi-kostadinov 25. Georgi Kostadinov – Player profile 24/25 – Transfermarkt, https://www.transfermarkt.co.uk/georgi-kostadinov/profil/spieler/198816 26. Georgi Kostadinov Co-founder & CTO, Kelvin Health – Astea Conference: A Path to Knowledge, https://conference.astea.solutions/en/speaker/96 27. Pavel Andreev – Co-founder and Head of Product and Design at Kelvin Health | The Org, https://theorg.com/org/kelvin-health/org-chart/pavel-andreev 28. Andreev, Pavel – Directory – Telfer School of Management – University of Ottawa, https://telfer.uottawa.ca/en/directory/pavel-andreev/ 29. Kelvin – 2025 Funding Rounds & List of Investors – Tracxn, https://tracxn.com/d/companies/kelvin/__VT97M0V7EPkJDHWM3zwrxHB509I-_nqsNMh7hc6PDsk/funding-and-investors 30. Kelvin-Clinic 2024 (Legacy) – Apps on Google Play, https://play.google.com/store/apps/details?id=com.kelvinpd 31. News – MedLumics, https://www.medlumics.com/news-3/ 32. Medlumics, S.L. Asset Profile | Preqin, https://www.preqin.com/data/profile/asset/medlumics-s-l-/78418 33. Management Team – MedLumics, https://www.medlumics.com/management-team/ 34. Peter Hinchliffe | Medical Device Leader and Technologist, https://www.peterhinchliffe.com/ 35. WISTA Draws Record Participation | Blank Rome LLP, https://www.blankrome.com/news/wista-draws-record-participation 36. Eduardo Margallo-balbas Inventions, Patents and Patent Applications, https://patents.justia.com/inventor/eduardo-margallo-balbas 37. Eduardo Margallo (2025 Oral) – Measuring By Light, https://measuringbylight.com/speakers/eduardo-margallo-2025-oral/ 38. Patents Assigned to MEDLUMICS, S.L. – Justia Patents Search, https://patents.justia.com/assignee/medlumics-s-l?page=3 39. The costs to global health – JHU Hub, https://hub.jhu.edu/2025/07/07/the-costs-to-global-health/ 40. Bio – José Rubio-Zepeda, https://www.josedrubiozepeda.com/new-page 41. US9310563B2 – Integrated system for active equalization of, https://patents.google.com/patent/US9310563B2/fr 42. Medlumics raises €14M in a Series E financing co-led by Asabys Partners, VI Partners and CDTI Innvierte, together with existing investors Andera Partners, Caixa Capital Risc and Innogest, https://www.criteriabioventures.com/news/medlumics-raises-eu14m-in-a-series-e-financing-co-led-by-asabys-partners-vi-partners-and-cdti-innvierte-together-with-existing-investors-andera-partners-caixa-capital-risc-and-innogest 43. LightHearted AI | Portfolio | Entrepreneurs First, https://www.joinef.com/companies/lighthearted-ai/ 44. LightHearted AI Health – Forbes, https://www.forbes.com/profile/lighthearted-ai-health/ 45. LightHearted AI – HAX – Hands-on Venture Capital for Hard Tech, https://hax.co/company/lighthearted-ai/ 46. Medical device uses AI to detect heart diseases. – NHS Clinical Entrepreneur Programme, https://nhscep.com/2024/02/07/medical-device-uses-ai-to-detect-heart-diseases/ 47. Lucrezia Cester — Topol Digital Fellowships, https://topol.hee.nhs.uk/digital-fellowships/fellows/lucrezia-cester/ 48. Lucrezia Cester, LightHearted AI – Quick, Cheaper, & Contactless Heart Diagnostics | LSI Europe ’24 – Life Science Intelligence, https://www.lifesciencemarketresearch.com/videos/lucrezia-cester-lighthearted-ai-quick-cheaper-contactless-heart-diagnostics-lsi-europe-24 49. Light Hearted AI Archives – NHS Clinical Entrepreneur Programme, https://nhscep.com/tag/light-hearted-ai/ 50. Dilip Rajeswari – HAX – Hands-on Venture Capital for Hard Tech, https://hax.co/founder/dilip-rajeswari/ 51. Dilip Rajeswari diliprajeswari – GitHub, https://github.com/diliprajeswari 52. STENTIT – The next generation in stent technology., https://www.stentit.com/ 53. About Us – STENTIT, https://www.stentit.com/about-us/ 54. STENTiT: Regenerating artery health right on High Tech Campus, https://blog.hightechcampus.com/htce/stentit-regenerating-artery-health-right-on-high-tech-campus 55. MedTech Company STENTiT Raises €1.8 million in Seed Round, https://www.stentit.com/2024/04/15/medtech-company-stentit-raises-e1-8-million-in-seed-round/ 56. ‘In five years, we want to help hundreds of thousands of patients with vascular diseases – if at all possible from Brabant’ – IO, https://innovationorigins.com/en/in-five-years-we-want-to-help-hundreds-of-thousands-of-patients-with-vascular-diseases-if-at-all-possible-from-brabant/ 57. Bart Sanders – CEO & Co-Founder at STENTiT | The Org, https://theorg.com/org/stentit/org-chart/bart-sanders 58. STENTiT 2025 Company Profile: Valuation, Funding & Investors …, https://pitchbook.com/profiles/company/481207-24 59. STENTiT raised €1.8 million in a seed funding round backed by NextGen Ventures, Brabant Development Agency (BOM) and the Ten Cate Investment Company. | Nordic 9, https://nordic9.com/news/stentit-raised-18-million-in-a-seed-funding-round-backed-by-nextgen-ventures-brabant-development-agency-bom-and-the-ten-cate-investment-company/ 60. Indigo Diabetes, https://indigomed.com/ 61. Indigo Diabetes Company Information – Funding, Investors, and More – Seedtable, https://www.seedtable.com/startups/Indigo_Diabetes-R9WD8W4 62. Indigo Diabetes incorporates fully owned subsidiary in the US and appoints Peter J. Devlin as President, Indigo Medical US Inc. | flanders.bio, https://www.flanders.bio/news/indigo-diabetes-incorporates-fully-owned-subsidiary-us-and-appoints-peter-j-devlin-president 63. Indigo Diabetes Incorporates Fully Owned Subsidiary in the US and Appoints Peter J. Devlin as President, Indigo Medical US Inc., https://indigomed.com/indigo-diabetes-incorporates-fully-owned-subsidiary-in-the-us-and-appoints-peter-j-devlin-as-president-indigo-medical-us-inc/ 64. Management Team – Indigo Diabetes, https://indigomed.com/about/management/ 65. Danaë Delbeke Presents Indigo at LSI Europe ’23 – YouTube, https://www.youtube.com/watch?v=7tDskwd66U8 66. Indigo Diabetes – EuroQuity, https://www.euroquity.com/en/company/indigo-diabetes 67. Indigo Diabetes concludes a €38 million round of financing, https://indigomed.com/indigo-diabetes-concludes-a-e38-million-round-of-financing/ 68. Indigo Diabetes stabilises $44.5m – – Global Corporate Venturing, https://globalventuring.com/university/indigo-diabetes-stabilises-44-5m/ 69. About | Indigo, https://indigomed.com/about#investors 70. OUR SOLUTION – Microplate Dx, https://microplatedx.com/our-solution 71. Microplate Dx – 2025 Company Profile, Team, Funding, Competitors …, https://tracxn.com/d/companies/microplate-dx/__dA4MwS5UQ0uETpzvgKx5_bUPw45S6IuACMNfAXrimJ4 72. The silent pandemic: how Microplate Dx is fighting antimicrobial resistance -, https://globalventuring.com/university/profile-microplate-dx/ 73. Damion Kevin CORRIGAN personal appointments – Find and update company information, https://find-and-update.company-information.service.gov.uk/officers/v2KUPU9SSx8aQd5kEcVBAS-DJ5M/appointments 74. MEET THE TEAM – Microplate Dx, https://microplatedx.com/meet-the-team-1 75. Damion Corrigan (0000-0002-4647-7483) – ORCID, https://orcid.org/0000-0002-4647-7483 76. Damion Corrigan – University of Strathclyde, https://pureportal.strath.ac.uk/en/persons/damion-corrigan 77. A structural and dynamic investigation of the inhibition of catalase by, https://ueaeprints.uea.ac.uk/id/eprint/48406/ 78. Dr Poonam Malik – Royal Society of Edinburgh, https://rse.org.uk/fellowship/fellow/dr-poonam-malik-23806/ 79. Poonam Malik | Microplate Dx – HealthTech Alpha, https://www.healthtechalpha.com/person/poonam-malik 80. Kangana Ranaut, Mandira Bedi criticise Poonam Pandey’s ‘pathetic and cheap publicity stunt’: She should be boycotted – Hindustan Times, https://www.hindustantimes.com/entertainment/tv/kangana-ranaut-mandira-bedi-criticise-poonam-pandeys-pathetic-and-cheap-publicity-stunt-she-should-be-boycotted-101706962407046.html 81. Stuart Hannah – AMR Conference, https://amr-conference.com/speakers/stuart-hannah/ 82. Stuart Hannah – Microplate Dx – University of Strathclyde, https://www.strath.ac.uk/workwithus/strathclydeinspire/casestudies/stuarthannah-microplatedx/ 83. Stuart Hannah – Player profile | Transfermarkt, https://www.transfermarkt.co.uk/stuart-hannah/profil/spieler/297417 84. Microplate DX Limited – Company Profile – Endole, https://open.endole.co.uk/insight/company/SC706330-microplate-dx-limited 85. Meet Our Expert Team in Cancer Detection – MiWEndo Solutions, https://miwendo.com/our-team/ 86. Innovating in Colorectal Cancer Detection – MiWEndo Solutions, https://miwendo.com/the-company/ 87. MiWEndo: Revolutionising the detection of colorectal cancer – European Commission, https://ec.europa.eu/regional_policy/en/projects/Spain/miwendo-revolutionising-the-detection-of-colorectal-cancer 88. Gloria FERNÁNDEZ-ESPARRACH | Consultant | Hospital Clínic de Barcelona, Barcelona | Endoscopy Unit | Research profile – ResearchGate, https://www.researchgate.net/profile/Gloria-Fernandez-Esparrach 89. Gloria Fernández-Esparrach – Hospital Clínic Barcelona, https://www.clinicbarcelona.org/en/professionals/gloria-fernandez-esparrach 90. Bright spot regions segmentation and classification for specular, https://www.scilit.net/publications/5ea30819ac9b6c0db4525ccc3f213fb7 91. Dra. Gloria Fernández-Esparrach: “Estem avançant amb un dispositiu que detectarà precoçment el càncer colorectal” – Catalonia Talent, https://www.cataloniatalent.cat/cat/noticia/dra-gloria-fernandez-esparrach-estem-avancant-amb-un-dispositiu-que-detectara-precocment-el-cancer-colorectal 92. MiWEndo Solutions, S.L. | EuroQuity, https://www.euroquity.com/en/company/miwendo-solutions-sl 93. GUARDIOLA GARCÍA, Marta – Teacher detail | Universitat Internacional de Catalunya, https://www.uic.es/en/teacher/mguardiola 94. Marta Guardiola, CTO de MiWEndo Solutions, recibe el Premio Salvà i Campillo al Emprendimiento, https://miwendo.com/es/marta-guardiola-cto-de-miwendo-solutions-recibe-el-premio-salva-i-campillo-al-emprendimiento/ 95. Marta Guardiola PhD Research Director at MiWEndo – ResearchGate, https://www.researchgate.net/profile/Marta-Guardiola 96. Preclinical Evaluation of a Microwave-Based Accessory Device for, https://www.mdpi.com/2072-6694/15/12/3122?type=check_update&version=2 97. About us | icometrix, https://www.icometrix.com/about 98. Wim VAN HECKE | co-founder | icoMetrix, Leuven | Research profile – ResearchGate, https://www.researchgate.net/profile/Wim-Van-Hecke 99. A Novel Digital Care Management Platform to Monitor Clinical and Subclinical Disease Activity in Multiple Sclerosis – PubMed Central, https://pmc.ncbi.nlm.nih.gov/articles/PMC8469941/ 100. Wim Van Hecke, PhD – Lyfebulb, https://lyfebulb.com/people/wim-van-hecke-phd/ 101. InRAD and icometrix partner to improve the standardization of care and real-world evidence generation in Alzheimer’s disease, https://www.icometrix.com/post/the-international-registry-for-alzheimer-s-disease-inrad-and-icometrix-partner-to-improve-the-stan 102. RFC Wetteren – KFC Sparta Petegem, Apr 21, 2024 – 2de Nationale, https://www.transfermarkt.co.uk/rfc-wetteren_kfc-sparta-petegem/index/spielbericht/4129127 103. Public profile – Dirk Smeets, PhD – HealthManagement.org, https://healthmanagement.org/viewProfile/116432/Dirk_Smeets 104. Dirk SMEETS | CTO | PhD | icoMetrix, Leuven | Research profile – ResearchGate, https://www.researchgate.net/profile/Dirk-Smeets 105. Over 30 US insurers are already reimbursing CPT-III® codes 0865T & 0866T for icobrain., https://www.icometrix.com/reimbursement 106. Dirk Smeets – VAIA – Flanders AI Academy, https://www.vaia.be/en/experts/dirk-smeets 107. DIRK SMEETS | Paper Digest, https://www.patentdigest.org/isearch/?name=dirk_smeets 108. Epilepsy | icometrix, https://www.icometrix.com/disease/epilepsy 109. icometrix – 2025 Funding Rounds & List of Investors – Tracxn, https://tracxn.com/d/companies/icometrix/__iBK8_XMHC30-yEyx-F-y0jdT4f7ac3mZBeiuolJ8mKU/funding-and-investors 110. Icometrix processes $18m in funding – – Global Corporate Venturing, https://globalventuring.com/icometrix-processes-18m-in-funding/ 111. icobrain-aria – icometrix, https://icometrix.com/services/icobrain-aria 112. Awards – icometrix, https://www.icometrix.com/blog/categories/awards-1 113. Company | Precisis, https://precisis.de/en/company/ 114. Precisis concludes funding round of €20 million for its bioelectric …, https://precisis.de/en/press/precisis-concludes-funding-round-of-e20-million-for-its-bioelectric-brain-stimulation-system/ 115. Innovator Spotlight with Angela Liedler: leading a ground-breaking treatment for epilepsy, https://dealflow.eu/innovator-spotlight-with-angela-liedler-leading-a-ground-breaking-treatment-for-epilepsy/ 116. Angela Liedler Presents Precisis at LSI Europe ’23 – Life Science Intelligence, https://www.lifesciencemarketresearch.com/videos/angela-liedler-presents-precisis-at-lsi-europe-23 117. Precisis AG announces successful conclusion of a funding round of EUR20 million with Cochlear Limited – Private Equity Wire, https://www.privateequitywire.co.uk/precisis-ag-announces-successful-conclusion-funding-round-eur20-million-cochlear/ 118. Dr. Angela Liedler | Healthcare Frauen e.V., https://www.healthcare-frauen.de/ueber-uns/mitglieder/aktuelle-mitglieder/dr-angela-liedler/ 119. Neurotech, the Next Frontier: Building, Investing, & Commercial Success in Brain Health, & the Ethical Implications of Neuroinnovation | LSI Europe ’23 – Life Science Intelligence, https://www.lifesciencemarketresearch.com/videos/neurotech-the-next-frontier 120. Angela Liedler GmbH, Freiburg | Sortlist, https://www.sortlist.co.uk/agency/angela-liedler-gmbh 121. Connected Consumables, https://conncons.com/ 122. Connected Consumables 2025 Company Profile: Valuation, Funding & Investors | PitchBook, https://pitchbook.com/profiles/company/537471-19 123. Investors | MOMM Diagnostics, https://www.mommdiagnostics.com/investors 124. MOMM Diagnostics: The Venture Leader Medtech developing high …, https://www.venturelab.swiss/MOMM-Diagnostics-The-Venture-Leader-Medtech-developing-highsensitivity-rapid-diagnostic-tests 125. MOMM Diagnostics – 2025 Company Profile, Funding & Competitors – Tracxn, https://tracxn.com/d/companies/momm-diagnostics/__e-zizh59vtIMov0CR_RIgt3pLr5Omnc6DwbttX7l1as 126. Dr Mathias Wipf – BRCCH, https://brc.ch/team/dr-mathias-wipf/ 127. The Page of Jens Gobrecht from Paul Scherrer Institut Laboratory for, https://www.scilit.com/scholars/760344 128. MOMM Diagnostics – 2025 Funding Rounds & List of Investors – Tracxn, https://tracxn.com/d/companies/momm-diagnostics/__e-zizh59vtIMov0CR_RIgt3pLr5Omnc6DwbttX7l1as/funding-and-investors 129. Multi4 – Hey cancer. You picked the wrong fight., https://www.multi4.se/ 130. Multi4 2025 Company Profile: Valuation, Funding & Investors …, https://pitchbook.com/profiles/company/222348-61 131. Multi4 is aiming to revolutionise cancer care | Invest In Gothenburg, https://www.investingothenburg.com/news/all-news/meet-doctor-turned-entrepreneur-aiming-revolutionise-cancer-care 132. Miden Melle-Hannah | Multi4 Medical AB – Mynewsdesk, https://www.mynewsdesk.com/se/multi4-ab/images/miden-melle-hannah-2203805 133. Multi4 company information, funding & investors | The Andorra startup ecosystem, https://ecosystem.andorra-startup.com/companies/multi4 134. Who we are – The Flume Catheter Company, https://www.flumecatheter.com/contact 135. Research Study on Comfort of the New FLUME Catheter to Begin Recruitment, https://dcri.org/news/research-study-comfort-new-flume-catheter-begin-recruitment 136. Development and first-in-human testing of FLUME urinary catheter with protected tip and relocated drainage holes, https://pmc.ncbi.nlm.nih.gov/articles/PMC10719115/ 137. John Havard – Faculty Web Pages – Kennesaw State University, https://facultyweb.kennesaw.edu/jhavard/index.php 138. Faculty and Staff – Radow – Kennesaw State University, https://www.kennesaw.edu/radow/academics/english/about/faculty-staff.php 139. The Flume Catheter Company – Lightning Pitch – YouTube, https://www.youtube.com/watch?v=xMwNiy5_7xo 140. Flume 2025 Company Profile: Valuation, Funding & Investors | PitchBook, https://pitchbook.com/profiles/company/525474-64 141. FLUME funding — The Flume Catheter Company, https://www.flumecatheter.com/fundraising-to-date
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:
