Jackie Kunzler
SVP, Global Head of R&D
Terumo Blood and Cell Technologies
October 27, 2025
* JOIN US FOR THE PRE-EVENT HAPPY HOUR on October 26, 2025 FROM 6:00 PM – 7:00 PM
7:00 am – 7:55 am CST
Delegate Registration and Networking Breakfast
8:00 am – 8:10 am CST
Chair's Welcome and Opening Remarks
Design
Product Development
Elena Mack
Chief Quality Officer
SaniSure
Quality & Regulatory
Speaker TBA
Clarivate
Innovation
Darin Oppenheimer
VP, Regulatory Affairs
BD
8:10 am – 8:20 am CST
Mayor's Welcome Address
Tom Dailly
Mayor
Village of Schaumburg
8:20 am – 8:50 am CST
Keynote
Ganesh Mayya
SVP, Software Engineering, GE HealthCare Imaging
GE HealthCare
Fostering Innovation in Medtech: Cross-Functional Collaboration for Advanced Imaging Solutions
- Examining the importance of cross-functional teams in driving medtech innovation
- Discuss strategies for integrating software and hardware in imaging technologies
- Highlighting case studies of successful collaboration in product development.
- Exploring the impact of AI and deep learning on imaging performance and patient outcomes
- Addressing challenges in collaboration andJo ways to overcome them for success
- Envisioning future trends in medtech and their implications for healthcare delivery
8:50 am – 9:20 am CST
Plenary
Speaker TBA
ECI
Unlocking the Future: How AI is Transforming Quality and Regulatory Compliance in MedTech
- Benefits of pre-acquisition due diligence and post-acquisition gap assessments
- Tools and techniques for successful assessment of data
- Common issues uncovered during due diligence
- Considerations for integration priorities
9:20 am – 9:50 am CST
Plenary
Kim Kaplan
Senior Product Manager
The Voluntary Improvement Program
The VIP Method: Transforming Business Performance through Quality
- Learn how quality improvements can extend beyond the conventional Quality Management System (QMS), driving business growth and fostering organizational success
- Recognize the transformative potential of maturity models like CMMI to elevate your quality processes, with the added benefit of regulatory relief
- Foster improved communication and collaboration within your organization and externally with regulatory bodies like the FDA and industry partners
- Track and compare performance metrics over time against industry benchmarks, utilizing expert insights to guide adjustments and ensure excellence
9:55 am – 11:35 am CST
Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings
11:40 am – 12:10 pm CST
Sessions
Design
Alind Sahay
VP, Research & Development
Pentax Medical
Transforming Device Development: Innovation and Patient-Centric Strategies
- Understanding the foundational AI technologies transforming medical device development
- Harnessing collaboration to drive strong product submissions
- Best practices for collaboration in driving the successful submission of innovative medical products
- Strategies for ensuring patient-centricity in the development of AI-enabled devices
- Case study: Managing portfolios, M&A integration and sustaining engineering in an AI-driven R&D environment
Product Development
Kamaal Anas
CVP, Regulatory Affairs, B. Braun Medical
Braun Group
Strategies for Transforming Global Product Development with Regulatory Insights
- How to master global teams for product development
- Best practices for aligning cross-functional and international teams to ensure streamlined workflows and communication in the product development lifecycle
- Exploring how to transform regulatory insights into actionable strategies that enhance global product development, reduce risks, and meet compliance requirements
- Understanding emerging regulatory trends globally and their potential impact on medical device innovation, helping teams stay agile and proactive
Quality & Regulatory
Mizanu Kebede
Chief Quality and Regulatory Officer
Smith & Nephew
Key Impacts of EU MDR on Product Development and Quality
- Key impacts of EU Medical Device Regulation (MDR) on product development and quality
- Recertification timelines and strategies for seamless compliance
- Navigating new post-market surveillance requirements
- Short- and long-term implications of MDR on market access
- Gaining a competitive edge by proactively aligning with MDR standards
Innovation
Robert Kraal
VP and General Manager, Connected Health
Zimmer Biomet
Innovating Products That Empower, Inform and Elevate
- Driving impact in musculoskeletal health through strategic P&L management
- Crafting digital health ecosystems for enhanced patient and caregiver experiences
- Navigating data strategy complexities in the expansive healthcare ecosystem
- Overcoming challenges and ensuring compliance in the rapidly evolving industry landscape
12:15 pm – 12:45 pm CST
Workshops
Room 1
Rita King
CEO
MethodSense
Regulating AI in Medical Devices: Lessons from the FDA and the Shifting U.S. and EU Regulatory Landscapes
- Delving into the benefits of LuminLogic Smart Enterprise Suite in managing critical content in regulated environments
- Exploring the AI/ML landscape and clinical validation expectations and strategies
- Guiding you through commercialization process from FDA submissions to establishing GxP controls
- Leveraging AI/ML for post-market surveillance and risk management
Room 2
Hema Deepak
Senior Manager, Product Marketing & Management, Edge ID and Authentication Solutions
Infineon Technologies
Dustin Barrett
Regional Marketing Manager
Infineon Technologies
Protecting Patient Safety and Supply Chain Integrity with Advanced Security ICs
- The latest threats and risks in healthcare devices and disposables
- Common challenges including counterfeiting and unauthorized reuse or refurbishment
- The role of security chips in MedTech designs: Threat models and regulatory requirements
- Security ICs and their applications in healthcare devices and supply chains
Room 3
Speaker TBA
IZiel Healthcare
Delving Into Effective Change Management: The Evolving PFAS Story
- Assessing PFAS implications for medical devices
- Developing strategies to manage ongoing and emerging changes
- Exploring material change qualification and supplier management
- Understanding the regulatory landscape for PFAS changes
Room 4
Marc Horner
Distinguished Engineer
Ansys
Accelerating Innovation in the Age of Digital Engineering
- Computational models can predict real-world behavior, optimize complex designs, and reduce the need for physical prototypes
- Benefits include enhanced quality, patient safety, brand reputation and faster time-to-market In silico clinical trials can reduce/refine/replace clinical trials in humans
- Regulatory acceptance and global harmonization are supporting adoption by medical device/drug companies
12:50 pm – 1:50 pm CST
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:
Speaker TBA
ECI
QMSR Readiness: Common Challenges and Practical Strategies
Brett Freeman
President
Providence Enterprise
Medical Device Contract Manufacturing in the East & West + Managing Tariffs
Manish Nayyar
SVP
Agiliad
Experiences in Improving Productivity through Gen AI
Christian Ballard
Director, Business Development and Client Services
Mission Plastics
Leveraging precision molding for complex medical components
Speaker TBA
BSI Compliance Navigator
Ensuring Compliance and Innovation in Medical Device Safety Standards
Caryn Mills
Medical Device Sales Director
HID
Driving Innovation in Medical Devices with RFID: Visibility, Safety, Compliance
Bob Rajewski
Founder and President
CriTech
FDA Compliance: Avoid common pitfalls in software development to ensure compliance and steer clear of FDA Requests for Additional Information
Youzhi Li, Ph.D.
Director of MedTech Instrumentations
Keysight Technologies
Optimizing product lifecycle management performance for accuracy, consistency, and performance with AI-driven end-to-end software test automation
Speaker TBA
Ascential Medical & Life Sciences
Driving MedTech Breakthroughs with Seamless Design, Automation, and Scalable Manufacturing
Speaker TBA
Qualitest
Accelerating Medical Device Development with GenAI Testing, Cloud Assurance, and Continuous Automation
Speaker TBA
Clarivate
Fast-Tracking Medical Device Innovation: Clarivate’s Data-Driven GenAI, Cloud, and Automation Solutions
Vishaka Rajaram
MedTech Quality Strategy
Veeva MedTech
Amra Racic
VP, Global Government Strategy MedTech
Veeva MedTech
Enabling an Agile and Efficient Culture of Quality
Vikram Gopal
SVP and Chief Technology Officer
Ascend Performance Materials
Designing the Future: Engineered Polyamides for Medical Innovation
Speaker TBA
Tata Elxsi Limited
Design-Led Digital Innovation for Smarter, Sustainable Medical Device Solutions
Kim Kaplan
Senior Product Manager
The Voluntary Improvement Program
Operational Excellence in Action with Lessons from the Frontlines of MedTech
Carsten Hurasky
SVP, Chief Marketing Officer
QNX
Designing medical systems with safety included from the start with commercial open source, real-time software
Speaker TBA
SQA Services
Ensuring Global Medical Device Quality Through Expert Supplier Management
René Zöelfl
Global MedTech Industry Advisor
PTC
ENABLING INTELLIGENT PRODUCT LIFECYCLE FOR SMARTER, SAFER MEDICAL DEVICE INNOVATION
1:55 pm – 2:35 pm CST
Sessions
Design
Madhu Ayyagari, Ph.D.
Chief Technology Officer
HOYA Surgical Optics
Optimizing Medical Device Design and Lifecycle Management: From Innovation to Surveillance
- Driving innovation with patient feedback to refine device safety and efficacy Integrating real-world data into post-market surveillance for proactive risk management
- Leveraging advanced analytics to enhance medical device design and functionality
- Ensuring compliance through lifecycle management and continuous performance monitoring
- Fostering cross-functional collaboration to accelerate innovation and streamline device lifecycle
Product Development
Vish Charan
DVP, Product Development
Abbott
Innovating Medical Devices: Excellence in Product Design and Development
- Aligning design with patient needs for enhanced user experience
- Incorporating feedback loops to accelerate development cycles
- Balancing innovation and regulatory compliance effectively
- Integrating cutting-edge technology into device development processes
- Streamlining cross-functional collaboration for faster go-to-market timelines
Quality & Regulatory
Vishvas Garg, Ph.D.
Head, Health Economics and Outcomes Research, Dermatology
AbbVie
Leveraging FDA Guidance on CFL to Demonstrate Value of FDA Cleared Devices
- Harnessing real-world data to demonstrate long-term effectiveness, safety, product differentiation and actionable strategies for stakeholders
- Highlighting patient outcomes, economic impact, and innovation to support market access
- Enhancing stakeholder engagement through value-driven messaging for prescribers, patients, payers, and policymakers to drive adoption
- Regulatory compliance and market access through aligning regulatory requirements with commercial strategy to optimize positioning and ensure compliance
Innovation
Cynthia Hougum, Ph.D.
President, Maquet Cardiovascular
Getinge
Transforming Cardiovascular Surgery: Innovation, Growth and Global Impact
- Driving business growth through innovation and global expansion
- Advancing coronary bypass and grafting for better patient outcomes
- Leveraging digital transformation to enhance surgical efficiency
- Maximizing ROI with strategic partnerships and market expansion
- Best practices for shaping the future of cardiovascular surgery
2:40 pm – 3:10 pm CST
Workshops
Room 1
Lise-Anais Swiegot
Global Healthcare Segment Director
Nefab Group
Sustainable Packaging Innovation for Medical Devices: Strategy, Compliance and Impact
- Supply chain optimization and sustainable packaging solutions through innovative, eco-friendly designs to reduce environmental impact
- Advanced testing capabilities to ensure durability, safety, and compliance with testing standards
- Tracking high-value assets with digital tracking tools
- Sustainability and Life Cycle Assessment (LCA): Exploring data-driven insights for carbon footprint reduction
- Compliance and regulations: Meeting global standards with sustainable packaging solutions
Room 2
Amol Patil
Principal Technologist, (AVP)
Agiliad
Medical Imaging and AI: From Hospital Scans to Doctor’s Screens
- From data ingestion to diagnostic insights, delivered seamlessly
- Rich, high-performance imaging tools accessible via modern web platforms
- Expertise in building HIPAA/GDPR-compliant, enterprise-grade systems
- Optimizing experiences for desktops, tablets, and mobile devices to serve diverse clinical environments
- Cloud-native or on-premise solutions tailored to security, performance, and regulatory needs
Room 3
Speaker TBA
RegDesk
The Path, Pitfalls, and the Use of RIM for Managing Regulatory Submissions
- Exploring the common regulatory submission management practices
- Discussing the pitfalls of the current methods
- Discovering through use cases how companies are leveraging technology to streamline submissions and document management
- Uncovering parts of the regulatory submission process that can utilize AI most effectively
Room 4
Speaker TBA
Battelle
Innovating for a Healthier Tomorrow: Sustainable Medical Device Solutions
- Advancing health through innovative materials science and medical device breakthroughs
- Harnessing data science to revolutionize patient care and diagnostics
- Driving engineering excellence for safer, more effective healthcare solutions
- Building partnerships to tackle health challenges with cutting-edge technology
3:10 pm – 4:30 pm CST
Happy Hour, Networking and Pre-Arranged 1-2-1 Meetings
Sponsored by:
4:30 pm – 5:00 pm CST
Sessions
Design
Ian Purdy, Ph.D.
SVP, Regulatory and Quality Assurance
Intuitive
Harnessing Innovation within Regulation to Accelerate Medical Device Development
- Adopting a risk-based and flexible regulatory framework to accelerate innovation
- Using machine learning and automation to streamline regulatory submissions and approval processes
- Integrating AI tools to improve real-time risk assessment and predictive quality management
- Exploring real-time compliance monitoring across multiple markets
- Leveraging real-time data to adapt to global regulatory changes
Quality & Regulatory
Asim Nigam
VP, Global Quality, Cardiac Ablation Solutions
Medtronic
Reimagining Quality in MedTech: Driving Innovation and Patient Impact
- Integrating safety and risk management frameworks to ensure robust, scalable product launches
- Embedding quality and regulatory considerations early in R&D to streamline approval and market access
- Aligning global regulatory strategies with digital health innovation and AI-driven technologies
- Cultivating a culture of excellence that fuels faster, more reliable innovation and enhances long-term commercial value
5:05 pm – 5:35 pm CST
Plenary
Youzhi Li, Ph.D.
Director of MedTech Instrumentations
Keysight Technologies
TRANSFORMING MEDICAL DEVICE INNOVATION AND COMPLIANCE
- Optimizing medical device design with advanced simulation and emulation
- Gaining insights to ensure device compliance to new regulations and standards
- Ensuring readiness for C63.27 wireless coexistence compliance
- Assessing and analyze your medical device vulnerabilities early to ensure cybersecurity compliance
5:35 pm – 6:20 pm CST
Panel Discussion
Rebecca Wilkins
DVP, R&D, Neuromodulation
Abbott
Danielle Humphrey
VP, Compliance Officer, Chief Regulatory Counsel
BD
Juan Daccach
VP, Global Product Safety
Merz Aesthetics
Umesh Satyanarayana
VP, Business Development
L&T Technology
Leveraging Product Development for Innovation, Patient-Centricity, and Quality
- Aligning digital transformation initiatives with product development goals to drive innovation
- Leveraging data-driven insights to enhance product design, testing, and quality assurance
- Structuring technology teams for agile product delivery through cross-functional collaboration and iterative development processes
- Exploring EU MDR and IVDR updates and global regulatory alignment
- Risk management strategies and quality control best practices
- Streamlining processes to manage risk and ensure compliance during rapid development cycles
- Integrating customer feedback and user-centered design into the product development lifecycle
- Exploring emerging technologies to enhance quality and accelerate time-to-market
6:20 pm – 6:30 pm CST
Chair's closing remarks
Design
Jackie Kunzler
SVP, Global Head of R&D
Terumo Blood and Cell Technologies
Product Development
Elena Mack
Chief Quality Officer
SaniSure
Quality & Regulatory
Speaker TBA
Clarivate
Innovation
Darin Oppenheimer
VP, Regulatory Affairs
BD
6:35 pm – 7:35 pm CST
Networking drinks reception
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