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Introduction
Europe's medical device community came together for two energetic days at the European Medical Device Summit, where leaders from across MedTech, regulatory affairs, quality, R&D, and digital health gathered to tackle the issues shaping the industry's next chapter. Guided by our outstanding chairs, Jelena Malinina (Director, Innovation and Digital Health @ COCIR), Ravi Chana (Executive Director, Diagnostics @ Association of British Healthtech Industries), and Nicolas Cors (VP, Product Development R&D @ Tecan), the summit delivered two days packed with keynotes, fireside chats, panels, and roundtables exploring AI, regulatory transformation, and the future of product development.
Across three session rooms, attendees moved fluidly between conversations on AI-powered product development, MDR and IVDR evolution, quality excellence, and the human side of leadership in MedTech, leaving with both big-picture vision and practical, ready-to-apply insights.
Table of Contents
Day 1 Highlights
Setting the Tone: Innovation, Regulation, and Trust
After a morning of registration and networking over breakfast, the Chair's welcome set the stage for a day built around innovation under pressure. Peter Schulam, Chief Scientific Officer at Johnson & Johnson, opened the keynote stage with reflections on surgical innovation, sharing hard-won experiences from the field. The conversation pivoted quickly to regulatory resilience, as Dennett Kouri, SVP of Corporate Quality, Regulatory and Clinical at Edwards Lifesciences, outlined strategies for inspection readiness in a regulatory landscape that keeps shifting beneath manufacturers' feet. Rounding out the morning's Room 1 sessions, Carsten Hurasky, SVP and Chief Marketing Officer at QNX, made the case for foundational software design as a strategic enabler - building systems meant to last while still being able to evolve.
Following a networking break and prearranged 1-2-1 meetings, the agenda split into three streams. Richard Willmann, Ph.D., VP of R&D for Image-Guided Therapy Systems at Philips, explored next-generation product development strategies in the age of AI, while Thomas Haeni of Paul Hartmann AG tackled the tension between sustainability and infection prevention in single-use device design. Meanwhile, a packed fireside chat brought together Hortense Allison and Melanie Donguy of Bayer, Inge Vandenbussche of Medtronic, and Benjamin Rochette of Coloplast to discuss how regulatory intelligence can shift compliance from reactive to proactive.
From AI Hype to Operational Reality
The late morning sessions dug into where AI is actually delivering value today. Rupam Chaudhury of L&T Technology Services shared a case study on how digital and AI gave a global MedTech OEM a 6–9 month head start and a stronger competitive moat, while Dr. Günther Heling of Vector Informatik drew parallels between software-defined systems in MedTech and automotive. Regulatory and compliance themes carried through the room with Andreas Beust, Ph.D. of GCP-Service International on clinical evidence for AI-based devices, Adam Cargill and Charlène Boumard of Veeva MedTech on building an AI foundation for ROI and scale, and Virginie Siloret of SGS breaking down the key changes coming with MDR & IVDR 2.0. Gabriel Pascualy of Ketryx, Atul Mahajan of IZiel Healthcare, and Bastian Krapinger-Rüther of Flinn.ai each brought a distinct angle on turning compliance and complaint data into genuine strategic advantage.
The energy carried into the Lunch & Learn roundtables, where attendees dug into AI-powered QARA and collaborative approaches to industry barriers.
Afternoon: Quality, Compliance, and the Long View
The afternoon sessions turned toward operational excellence. Christoph Schmotz of Baxter discussed product development across care and connectivity solutions, while Carine Cochereau, Ph.D. of Integra LifeSciences reframed MDR maturity as a competitive advantage rather than a burden. Michael Schiffner of Siemens Healthineers explored accelerating quality excellence through regulatory innovation, before Kaplan returned to unpack the FDA’s QMSR. Priya Bhutani of RegDesk examined what high-growth companies do differently in regulatory strategy, and Krapinger-Rüther closed the loop on the literature-to-intelligence evidence gap still facing the industry.
Following a final networking break, the day’s energy converged on a standout cross-company panel exploring the future of medical device innovation through product development. Thierry Glauser, Ph.D. (Teleflex), Sophie Sheedy (Cochlear), Matthieu Menut (Medline), Thomas Haeni (Paul Hartmann AG), and Karsten Klose, Ph.D. (Olympus Corporation) brought perspectives from across the industry, highlighting the different approaches organizations are taking to advance product development and innovation. Annemien Pullen of Veeva MedTech then made the case for a unified MedTech enterprise bridging quality, regulatory, commercial, and clinical functions, setting up a closing panel on the changing regulatory landscape. Dennett Kouri (Edwards Lifesciences), Simone Diorio (Baxter), Nickerson Hill (LivaNova), Susana de Azevedo Wäsch, Ph.D. (Ypsomed), Michael Schiffner (Siemens Healthineers), Kimberly Sanchez (Edwards Lifesciences), and Michael Konings (Philips Medical Systems) examined how evolving MDR and global regulations are reshaping quality expectations across the industry.
Day One closed with remarks from the Chairs and a well-earned Networking Drinks Reception, sponsored by L&T Technology Services.
Day 2 Highlights
Digital Ecosystems and the Innovation Engine
Day Two opened with Karsten Klose, Ph.D. of Olympus Corporation mapping the journey from standalone devices to AI-powered digital ecosystems. Ahmet Tezel, Ph.D. (LivaNova) followed with a look at the catalysts behind LivaNova's innovation reinvention, before the agenda split into three parallel tracks covering smart regulation for medical robotics (Subramanian Murugan, CSA Group), AI-first transformation for device companies (Sarvesh Mutha, IZiel Healthcare), and how enterprise MedTech teams are using AI across the total product life cycle to accelerate delivery (Gabriel Pascualy, Ketryx).
After refreshments and more 1-2-1 meetings, Anders Rosengren of Sonova shared how data-driven prototyping is advancing R&D in hearing systems, Ola Hammarlund of Getinge explored digital platform innovation, and Benjamin Rochette of Coloplast returned to navigate the tightening landscape around advertising and product claims.
Women in Leadership
One of the summit's most resonant sessions brought together Hortense Allison (Bayer), Kimberly Sanchez (Edwards Lifesciences), Kathrin Tingelhoff (Olympus), Orit Eden (Align Technology), Susana de Azevedo Wäsch, Ph.D. (Ypsomed), and Amra Racic (Veeva MedTech) for a candid Women in Leadership panel - a powerful, personal counterpoint to the day's more technical sessions, and a reminder that culture and representation are as critical to MedTech's future as any regulation or algorithm.
The Lunch & Learn roundtables that followed covered remarkable ground: agile quality management with Petra Heerklotz, Ph.D. of Teleflex, designing trust into AI-driven clinical workflows with Miguel Ávila of Cordis, regulatory intelligence with Jan-Michael Krüger of Olympus, de-risking production with Nicolas Cors of Tecan, AI applied to learning management systems with Elena Sebastian of Edwards Lifesciences, systems engineering excellence with Ozgur Butun of Philips, and a return visit from Rosengren of Sonova on connectivity and sustainability.
Closing the Loop on AI, Security, and Scale
The afternoon sessions tackled some of the thorniest questions in the room. Thorsten Goettsche of OSYPKA dissected why 90% of active implantable medical device (AIMD) projects fail — and what separates the successful 10%. Eugen Rosenfeld of Nagarro asked what actually delivers value when scaling AI in healthcare, while David Boutellier of REMATIQ, alongside Butun and Michael Konings of Philips, examined how AI-driven compliance is accelerating MedTech innovation. John Chenoweth, Chief Product Security Officer at Elekta, then turned attention to medical device security and the regulatory expectations strengthening across the product lifecycle.
The summit's final session brought the conversation back to where innovation often starts: smaller and mid-sized companies. Thelma Marley of Aerogen, Javier Milagro of Corify, Carlos Maline of Head Diagnostics Ltd., Florus Lowag of SIS Medical AG, and Miguel Ávila of Cordis shared how leaner organizations are finding their own paths through development and regulatory complexity, proof that big transformation isn't reserved for big budgets.
With closing remarks from Malinina, Chana, and Cors, the European Medical Device Summit wrapped two days that moved seamlessly between boardroom strategy and shop-floor reality.
Conclusion
If there was one thread running through both days of the European Medical Device Summit, it was this: AI and digital transformation are no longer future-state ambitions for MedTech; instead they're already reshaping product development, quality systems, regulatory strategy, and compliance today. From AI-powered QARA and predictive quality to the evolving demands of MDR and IVDR 2.0, the conversations made clear that the organizations pulling ahead are the ones treating regulatory and quality functions as engines of competitive advantage rather than cost centers.
Equally clear was the importance of culture and people in driving that transformation whether through the candid reflections shared during the Women in Leadership panel or the resourceful approaches smaller companies are bringing to innovation under constraint.
The conversations sparked across these two days are only the beginning. We look forward to seeing the European MedTech community again at next year's summit.
Until then, keep innovating, keep regulating wisely, and keep pushing the future of medical devices forward.
Testimonials
“Excellent place to network and meet service providers. Learned about experiences and challenges of other companies. Specifically interesting were the innovative AI tools and their use in regulated environments.”- Caroline Möller, VP of Regulatory Affairs @ Sentec AG
- John Wennborg, VP QA & RA @ Stille
- Michael Bracegirdle, Risk & Programme Manager @ ExamVision A/S
- Miguel Ávila, Vice President, Global Quality, Regulatory, Medical and Clinical @ Cordis
- Nicola zaccheddu, Quality Director @ Philips
- Giorgio Gentile, Senior Director QRC EMEA @ Getinge
- Roger Halbeisen; R&D Director - IoT, Digital, Innovation @ SteelcoBelimed
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