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
Sponsored by:
7:00 am – 7:55 am CST
Delegate Registration and Networking Breakfast
Sponsored by:
8:00 am – 8:10 am CST
Chair's Welcome and Opening Remarks
Design
Product Development
Elena Mack
Chief Quality Officer
SaniSure
Quality & Regulatory
John Peyton
VP, Customer Success
Clarivate Analytics
Innovation
Dane Popovski
Senior Director, 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
- Addressing challenges in collaboration and the ways to overcome them for success
- 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
- Envisioning future trends in medtech and their implications for healthcare delivery
8:50 am – 9:20 am CST
Plenary
Shital Patel
Co-Founder and COO
ECI
Michelle Wu
Co-Founder and CEO
NyquistAI
Adam Foresman
Co-Founder and CEO
Ryden Solutions
Unlocking the Future: How AI is Transforming Quality and Regulatory Compliance in MedTech
- Delving into AI in Med Tech
- Exploring the impact to value, ROI, and decision framework use cases
- How to incorporate AI into organizational quality systems
- Insights into considerations related to system validation
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, R&D
PENTAX Medical, Hoya Corporation
Transforming Device Development: AI-Enabled Innovation and Patient-Centric Strategies
- AI in Healthcare Overview
- Understanding the foundational AI technologies
- Transforming the Medical Device Innovation model
- AI Enabled Patient-Centric Device Development
- Incorporating AI into normal engineering processes
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
Cynthia Hougum, Ph.D.
VP, Cardiovascular Surgery, Acute Care Therapies
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
12:15 pm – 12:45 pm CST
Workshops
Room 1
Rita King
CEO
MethodSense, Inc.
Regulating AI in Medical Devices: Lessons from the FDA and the Shifting U.S. and EU Regulatory Landscapes
- As AI continues to drive innovation in medical devices, understanding and navigating the evolving regulatory frameworks in both the United States and Europe has become essential
- Exploring how the FDA has approached AI-based device submissions over the past 12 years, including recent experiences with the FDA’s ELSA platform, and contrasts this with the emerging regulatory structure of the EU AI Act
- Drawing on real-world experience and lessons learned from over a decade of successful FDA submissions, pre-subs, and regulatory engagements
- Delving into practical insights into what works, what’s changed, and how to prepare for the future of AI regulation in medical devices
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
Atul Mahajan
Director, Engineering Services
IZiel Healthcare
Business Process Assessment with AI Tool Selection, Deployment and Training for MedTech Companies
- Evaluating business processes to uncover AI-driven efficiency opportunities
- Identifying and select the right AI tools for MedTech
- Strategically deploy AI solutions aligned with company goals
- Training teams to effectively adopt and use AI tools
- Driving long-term value through smart AI integration and support
Room 4
Marc Horner, Ph.D.
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:
Sean McCarthy
Senior Regulatory Manager
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, Inc.
Leveraging precision molding for complex medical components
Mark Flanick
Compliance Navigator Sales, North America
BSI Compliance Navigator
AI Workflow Tools for Managing Compliance Risk
Caryn Mills
Medical Device Sales Director
HID
Driving Innovation in Medical Devices with RFID: Authentication, 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
Mark Su
Digital Health Strategy Lead
Keysight Technologies
AI-Driven Test Automation in PLM: Ensuring Reliability, Delivering Business Performance
Chris Povich
VP, Sales, Automation
Ascential
Designing for Manufacturability: Building Automation Readiness Into Product Design
Ram Gudur
SVP, Healthcare & Lifesciences Sector
Qualitest
Norbert Leinfellner
EVP, Global Engineering
CAIRE, Inc.
De-Risk by Design: Proactive Strategies to Strengthen Medical Device Development
Mitch Hayes
SVP, Life Science & Healthcare
Clarivate Analytics
Real-world strategies for deploying GenAI platforms at scale
Vishaka Rajaram
Senior Director, Quality Strategy
Veeva MedTech
Amra Racic
VP, Government Strategy
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
Kim Kaplan
Senior Product Manager
The Voluntary Improvement Program
Operational Excellence in Action with Lessons from the Frontlines of MedTech
Rick Smith
Director, IoT Sales, North America
QNX
Designing medical systems with safety included from the start with commercial open source, real-time software
Gilberto Jimenez
Senior Director, Engineering
SQA Services
Ensuring Global Medical Device Quality Through Expert Supplier Management
René Zöelfl
Global MedTech Industry Advisor
PTC, Inc.
ENABLING INTELLIGENT PRODUCT LIFECYCLE FOR SMARTER, SAFER MEDICAL DEVICE INNOVATION
1:55 pm – 2:25 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
2:30 pm – 3:00 pm CST
Workshops
Room 1
Lise-Anais Swiegot
Global Healthcare Segment Director
Nefab
Silvia Del Castillo
Sustainability Manager
Nefab
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
Manu Batura
CTO and Head, Solutions & Portfolio
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
Priya Bhutani
CEO and Founder
RegDesk, Inc.
The Future of Regulatory Affairs: How Technology is Shaping Regulatory Compliance
- Understanding the shift from manual regulatory tracking to AI-powered automation
- Learning how real-time regulatory intelligence can prevent compliance bottlenecks
- Explaining the role of predictive analytics in forecasting regulatory trends
- Covering case studies on how automation accelerates submissions and approvals
- Understanding the balance between human expertise and AI-driven decision-making
Room 4
Chris Kocheran
Director, Commercial Sales and Business Development, Health
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
3:00 pm – 4:20 pm CST
Happy Hour, Networking and Pre-Arranged 1-2-1 Meetings
Sponsored by:
4:25 pm – 4:55 pm CST
Plenary
Kamaal Anas
CVP, Regulatory Affairs, B. Braun Medical
Braun Group
Amra Racic
VP, Government Strategy
Veeva MedTech
Navigating the New Frontier – Leadership, AI, and a Culture of Quality in Regulatory Excellence
- Learning how visionary leaders are using a culture of quality to navigate the complex regulatory landscape
- Seeing how regulatory teams are moving beyond traditional compliance by using AI-powered operations, e-submissions, and real-time regulatory intelligence to accelerate approvals and shape go-to-market strategies
- Understanding the importance of global harmonization and the industry shift to proactive, data-driven approaches
- Discovering how the next generation of regulatory affairs professionals are growing from document managers into strategic architects by developing expertise in data science and AI governance
4:55 pm – 5:35 pm CST
Plenary
Youzhi Li, Ph.D.
Director, 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 Services
Maryellen de Mars, Ph.D.
Head, Center for Manufacturing Innovation and Quality
Medical Device Innovation Consortium
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
John Peyton
VP, Customer Success
Clarivate Analytics
Innovation
Dane Popovski
Senior Director, Regulatory Affairs
BD
6:30 pm – 7:30 pm CST
Networking drinks reception
Sponsored by:
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