Jelena Malinina
Director, Innovation and Digital Health
COCIR
9 June 2026
* JOIN US FOR THE PRE-EVENT HAPPY HOUR ON 8 JUNE 2026 FROM 18.00 – 19.00 CET
7.00 – 8.00 CET
Registration and Networking Breakfast
8:00 – 8:10 CET
CHAIR'S WELCOME AND OPENING REMARKS
PRODUCT DEVELOPMENT
Design & Innovation
Ravi Chana
Director, Diagnostics
Association of British Healthtech Industries
QUALITY & REGULATORY
Wendel Smith, M.D.
SVP, Quality and Product Safety
Edwards Lifesciences
8.10 – 8.40 CET
KEYNOTE
Peter Schulam
Chief Scientific Officer
Johnson & Johnson
Building the Next Generation of MedTech with AI, Data, and Clinical Insight
- Integrating clinical evidence generation into MedTech R&D from concept through post-market deployment
- Applying AI and advanced analytics to reduce variability, improve decision-making, and accelerate responsible innovation
- Leveraging real-world data from connected devices to monitor performance, manage risk, and drive continuous improvement
- Designing AI-enabled products that align software, workflow, and clinician trust to deliver measurable clinical value
- Establishing governance models for AI/ML-enabled devices that balance rapid iteration with MDR and global regulatory expectations
8.40 – 9.10 CET
Plenary
Jose Lima
SVP and Head, Global Quality Operations
Philips
Transforming Quality Across Supply Chain and Operations
- Aligning quality objectives with supply chain and operations strategy to ensure end-to-end excellence
- Fostering cross-functional collaboration to embed a culture of shared accountability for quality outcomes
- Leveraging data-driven systems and digital dashboards to monitor and improve real-time performance
- Embedding resilience and agility into operations to navigate regulatory shifts and global disruptions
- Driving continuous improvement to enhance efficiency, compliance, and patient safety across the value chain
9.10 – 9.40 CET
Plenary
Carsten Hurasky
SVP and Chief Marketing Officer
QNX
Breaking the Trade-off: Accelerating Medical Device Innovation Without Sacrificing Safety
- Medical device certification processes can slow down software development and the roll out of in-life updates. But research shows time-to-market pressure can cause developers to comprise safety and security
- Strategies to help maintain security, compliance, and performance whilst reducing disruptive downtime or costly recertifications
- Maximizing value and innovation with smarter software architectures and development platforms
- Learning from approaches in other sectors where performance, safety and security are non-negotiable
9.45 – 11.25 CET
Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings
11.30 – 12.00 CET
Streams
Product Development
Kathleen Van Vlierberghe
VP, Peripheral Interventions, EMEA
Boston Scientific
Strengthening Product Development Through Strategic Validation
- Defining validation objectives early to align technical requirements with user needs and compliance goals
- Integrating design validation with usability studies and risk management activities
- Ensuring process validation readiness for scalable and repeatable manufacturing outcomes
- Validating software elements and digital components in both embedded systems and connected products
- Meeting EU MDR expectations for validation documentation, traceability, and evidence
Design & Innovation
Ola Hammarlund
Chief Digital Officer and Head, Digital Platforms
Getinge
ACCELERATING DIGITAL TRANSFORMATION IN MEDTECH THROUGH AI AND PLATFORM INNOVATION
- Leveraging AI-driven solutions to support clinicians with real-time insights and decision-making tools
- Integrating digital platforms to enhance device usability, serviceability, and overall efficiency
- Addressing compliance, governance, and security challenges in deploying digital health technologies
- Building cross-functional collaboration to secure executive buy-in and drive scalable innovation
- Enabling patient safety and improved clinical outcomes through seamless human-technology interaction
Quality & Regulatory
Hortense Allison
VP and Head, Regulatory Medical Devices and Digital
Bayer
Applying Regulatory Intelligence for Proactive Compliance Strategy
- Monitoring global regulatory changes affecting product and market access
- Developing regulatory foresight to inform portfolio and submission plans
- Using intelligence tools to track competitor approvals and trends
- Engaging early with notified bodies and regulators on evolving topics
- Prioritizing markets based on changing compliance complexity
12.05 – 12.35 CET
Workshops
PRODUCT DEVELOPMENT
Somshekhar Umadi
Head, Delivery
L&T Technology Services
Leveraging 3D Printing for Rapid Iteration in Product Development
- Accelerating early-stage design cycles through rapid prototyping and iterative testing
- Reducing development costs and design errors by validating concepts before tooling
- Enhancing cross-functional collaboration between R&D, clinical, and manufacturing teams
- Utilizing 3D printing for personalized, anatomically accurate device and implant design
- Exploring material advancements and future scalability of additive manufacturing in medtech
Design & Innovation
Speaker TBA
Vector Informatik
Software-Defined MedTech: Engineering Safe, Secure & Connected Devices at Speed
- Applying standards-driven development to accelerate delivery without compromising safety
- Building cybersecurity and secure updateability into the product lifecycle for connected and networked devices
- Using virtual validation, SIL/HIL testing, and automated regression to shorten verification cycles and improve reliability
- Ensuring traceability from requirements to test evidence to support EU MDR readiness and audit confidence
- Designing for interoperability and long-term maintainability across platforms, ecosystems, and device generations
Quality & Regulatory
Andreas Beust
Chief Executive Officer
GCP-Service International
Monitoring Real-World Performance of AI and ML-Enabled Devices Through Proactive Post-Market Surveillance
- Leveraging real-world data and digital health tools for ongoing risk assessment and signal detection
- Integrating user feedback and performance data to refine algorithms and ensure clinical relevance
- Addressing transparency and explainability challenges in post-market AI/ML performance tracking
- Establishing governance models to manage software changes and maintain compliance over time
12.40 – 13.40 CET
Lunch & Learn Roundtable Discussions and Open Seating Lunch
Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance for moderated roundtables on Day 1 is limited to attendees and speakers.
Choose from:
Somshekhar Umadi
Head, Delivery
L&T Technology Services
Integrating Artificial Intelligence Into Safe and Effective Device Design
Mike Cook
Global Medical Device Sales Executive
The Voluntary Improvement Program
Advancing Product Development With Cross-Functional Collaboration and Speed
Carsten Hurasky
SVP and Chief Marketing Officer
QNX
Accelerating Embedded Systems Development with a Secure Real-Time OS
Speaker TBA
Veeva MedTech
Cloud-Driven Transformation: Unifying Data, Quality, and Compliance in MedTech
Designing Software-Driven Medical Devices: Aligning Innovation, Safety, and Compliance
Speaker TBA
IZiel Healthcare
Digitalizing the MedTech Quality System: From Paper Processes to Audit-Ready Workflows
13.45 – 14.15 CET
Streams
Product Development
Richard Willmann, Ph.D.
VP, R&D, Image-Guided Therapy Systems
Philips
Accelerating Innovation: Strategies for Next-Generation Product Development
- Embedding emerging technologies early to shape product roadmaps and deliver new clinical capabilities
- Co designing with clinicians to integrate workflow insights and optimize usability from the start
- Leveraging rapid prototyping and virtual simulation to shorten development cycles and reduce risk
- Designing for interoperability, scalability, and manufacturability to ensure seamless integration and reliable production
- Using real world data and feedback to drive continuous improvement and next generation innovation
Design & Innovation
Thomas Haeni
VP, Research and Development, Risk Prevention
Paul Hartmann AG
Designing for Sustainability in Single Use Medical Devices: Balancing Infection Prevention and Product Innovation
- Understanding how sustainability targets from customers and legal obligations affect infection prevention requirements and product design
- Addressing the challenge of aligning regulatory obligations with practical design, performance expectations and sustainability requirements
- Case insights: successfully integrating regulatory, sustainability & product performance considerations early in R&D pipelines
- Discussing frameworks for cross-functional collaboration between engineering, marketing, sustainability and regulatory teams
- Identifying opportunities for innovation in meeting both sustainability and safety and compliance standards in medical device
Quality & Regulatory
Michael Schiffner
VP, Quality, EMEA and CWE
Siemens Healthineers
Accelerating Quality Excellence Through Regulatory Innovation
- Leveraging digital quality management systems to optimize CAPA and change control processes
- Embedding regulatory intelligence to anticipate global harmonization and emerging compliance trends
- Scaling virtual audits and remote inspections via secure data-sharing platforms
- Driving continuous improvement by analyzing post-market data and regulatory feedback loops
- Cultivating a quality-first culture across operations to support rapid product introduction
14.20 – 14.50 CET
Workshops
PRODUCT DEVELOPMENT
Mike Cook
Global Medical Device Sales Executive
The Voluntary Improvement Program
Embedding Sustainability in Medical Device Product Development for Long-Term Impact
- Designing for sustainability by reducing material waste and carbon footprint in early stages
- Evaluating sustainable alternatives for packaging, labeling, and single-use components
- Balancing environmental goals with sterilization, biocompatibility, and regulatory requirements
- Implementing lifecycle assessments (LCA) to guide design decisions and product strategy
- Collaborating with suppliers and manufacturers to enable circular design and recyclability
Design & Innovation
Priya Bhutani
Founder and CEO
RegDesk
Harnessing AI for Smarter Regulatory Navigation in MedTech: Building a Scalable Framework for Global Success
- Accelerating regulatory decision-making through AI-powered, real-time insights across global jurisdictions
- Minimizing compliance risk by proactively monitoring regulatory shifts in key international markets
- Boosting team productivity by automating updates and reducing the burden of manual regulatory research
- Streamlining submission workflows by embedding regulatory insights directly into documentation processes
- Supporting faster market entry by aligning launch activities with evolving global regulatory requirements
Quality & Regulatory
Markus Müller
Co-Founder and CPO
Flinn.AI
Leveraging Data Analytics to Drive Quality and Innovation
- Collecting structured and unstructured data across product lifecycle stages
- Visualizing performance metrics to monitor quality trends and outcomes
- Using predictive analytics to identify potential product failures early
- Supporting decision-making with real-time dashboards and alerts
- Integrating analytics with QMS and PLM systems for holistic insight
- Training teams to interpret data and act on quality signals
14.55 - 16.15 CET
Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings
16.20 – 17.05 CET
Panel Discussion
Hanane Boutelitene
VP, General Manager
StraumannKathleen Van Vlierberghe
VP, Peripheral Interventions, EMEA
Boston ScientificThierry Glauser, Ph.D.
VP, Research and Development
BiotronikSophie Sheedy
VP, Process Engineering
CochlearMatthieu Menut
VP, Product Divisions, EMEA
MedlineJuan-Carlos Celi, Ph.D
VP and Head, Oncology Software Solutions Region Europe
Elekta
Shaping the Future of Medical Device Innovation Through Innovative Product Development
- Exploring how emerging technologies are reshaping device innovation
- Maintaining agility in product development amid evolving AI regulations
- Using real-world evidence and data analytics to enhance design decisions and iteration
- Ensuring scalability across diverse care settings and patient populations
- Identifying disruptive forces likely to redefine medtech innovation over the next decade
17.05 – 17.35 CET
Plenary
Speaker TBA
Veeva MedTech
DRIVING DIGITAL TRANSFORMATION IN MEDTECH: UNLOCKING COMPLIANCE, INNOVATION, AND SPEED-TO-MARKET
- Recognizing the new era of complexity in medical device regulation with EU MDR and IVDR reshaping global compliance expectations
- Turning regulatory challenges into opportunities to build trust, ensure patient safety, and accelerate market access
- Harnessing connected data and digital platforms to break down silos across R&D, regulatory, and quality functions
- Building audit-ready, transparent processes that strengthen compliance while reducing operational burden
- Enabling agile product development cycles to shorten time-to-market without compromising safety or quality
- Charting the digital maturity journey for medtech organizations to remain competitive and resilient over the next five years
17.35 – 18.20 CET
Panel Discussion
Dennett Kouri
SVP, Corporate Quality and Regulatory
Edwards LifesciencesMukund Paravasthu
Chief Operating Officer
NovocureScott Kaplan
Head, Quality, Regulatory Affairs
BaxterNickerson Hill
VP, Global Clinical Research and Regulatory Affairs
LivaNovaSusana de Azevedo Wäsch, Ph.D.
VP, Quality Management and Regulatory Affairs and Medical Affairs
Ypsomed
Understanding how evolving MDR and global regulations are reshaping quality expectations
- Implementing modern QMS frameworks that support agility, transparency, and innovation
- Striking the right balance between accelerating innovation and maintaining rigorous safety standards
- Anticipating and mitigating quality risks through proactive, data-driven decision-making
- Leveraging cross-functional collaboration to build a culture of quality across the product lifecycle
- Defining the next phase of regulatory and quality excellence through shared lessons and emerging best practices
18.20 - 18.25 CET
Chair's closing remarks
PRODUCT DEVELOPMENT
Jelena Malinina
Director, Innovation and Digital Health
COCIR
Design & Innovation
Ravi Chana
Director, Diagnostics
Association of British Healthtech Industries
QUALITY & REGULATORY
Wendel Smith, M.D.
SVP, Quality and Product Safety
Edwards Lifesciences
18.25 - 19.25 CET
NETWORKING DRINKS RECEPTION
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