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

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

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

Speaker TBA


MethodSense

Developing AI/ML Validation Strategies for Medical Device Clearance

  • 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 and Quality of Care through Computer Modeling and AI

  • Exploring top-line and bottom-line benefits to your business
  • Leveraging simulation to predict and perfect designs, reducing costs, and accelerating time-to-market
  • Computational methods playing a critical role in quality, patient safety, and brand reputation
  • Driving ESG initiatives and advancing sustainability in engineering
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

Speaker TBA


Agiliad

Integrating AI and advanced engineering in device design

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

SOFTWARE DEVELOPMENT DOESN'T HAVE TO BE RISKY BUSINESS. MEDICAL DEVICE SAFETY, CYBERSECURITY, AND REGULATORY COMPLIANCE

Speaker TBA


Keysight Technologies

Enhancing Medical Device UX with AI-Driven Test Automation Solutions

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

Speaker TBA


Veeva Systems

Accelerating Medical Innovation with AI-Powered Cloud Solutions Across R&D, Quality, and Commercial Functions Speaker

Speaker TBA


Ascend Performance Materials

Innovating Medical Devices with Sustainable, High-Performance Engineered Polymer Solutions

Speaker TBA


PTC

Enabling Digital Thread for Smarter, Safer Medical Device 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

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

Speaker TBA


Agiliad

Unlocking the Power of Automation and Equipment in Medical Device Manufacturing

  • Innovative automation technologies reshaping medical device manufacturing
  • Proven strategies for seamless automation integration to boost quality and reduce operational costs
  • Case studies highlighting successful implementation of robotics and smart equipment
  • Addressing and overcoming challenges in automating complex manufacturing processes

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: Transformative 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: Description of image
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

Speaker TBA


Keysight Technologies

Cloud & AI: Transforming Medical Device Innovation, Compliance, and Care

  •  Accelerating innovation cycles with scalable, secure cloud-native development environments
  • Using AI to automate compliance, risk management, and regulatory reporting workflows
  • Improving clinical outcomes through AI-driven data analysis and predictive modeling
  • Enabling real-time device monitoring and updates via connected cloud infrastructure
  • Enhancing interoperability and patient experience through AI-personalized digital health ecosystems
5:35 pm – 6:20 pm CST

Panel Discussion

  • Rebecca Wilkins

    DVP, R&D, Neuromodulation
    Abbott

  • Michael Owens

    VP, R&D
    Philips

  • Danielle Humphrey

    VP, Compliance Officer, Chief Regulatory Counsel
    BD

  • Juan Daccach

    VP, Global Product Safety
    Merz Aesthetics

  • Umesh Satyanarayana

    VP, MedTech, Life Sciences
    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
4:25 pm – 4:55 pm CST

Plenary

  • Chris Brown

    VP, Sales
    CADDi Co

  • Brian Loushine

    Strategic Development
    Chamfr

Optimizing R&D Procurement in MedTech with Similar Parts

  • Cutting costs with smart similarity searches
  • Leveraging operational efficiency by searching similar drawings
  • Streamlining procurement and minimizing manual tasks
  • Enhancing innovation by leveraging past drawings for future projects
3:55 pm – 4:25 pm CST

Sessions

Design

Neeta Mhatre

VP, China Strategy, Operations
Intuitive

Advancing Patient Care Through Digital Integration in the OR

  • Collaborating on the future of patient care
  • Leveraging AI to further preventative care
  • Enhancing treatment options through innovative tool development and design
  • Case study: exploring new tools to streamline minimally invasive surgery

Product Development

Jean Chaoui, Ph.D.

VP, Digital, Robotics and Enabling Technology
Stryker

PUSHING THE BOUNDARIES OF MEDICAL TECHNOLOGY TO DRIVE PATIENT OUTCOMES

  • Understanding customer needs to enhance product development
  • Driving digital transformation in healthcare
  • Defining cutting edge technology pipeline solutions
  • Diving into Stryker's commitment to technology adoption through computer assisted surgery, AI, robotics and IoMT

Quality & Regulatory

Kamaal Anas

CVP, Regulatory Affairs, B. Braun Medical
B. Braun Group

Leveraging Data From Regulatory Bodies for Successful Future Submissions

  • Strategically integrating FDA insights into proactive product development processes
  • Maximizing efficiency in product testing and workflow optimization through data utilization and feedback integration
  • Harnessing leadership and teamwork to streamline device design and testing

Innovation

Raghu Jainapur

VP, Quality
Baxter International

Amarjot Singh

Director, Quality, Digital Health and Innovation
Baxter International

NAVIGATING THE EXCITING WORLD OF AI/ML IN MEDTECH

  • Understanding the fundamental concepts and MedTech applications of Artificial Intelligence, Machine Learning and Deep Learning.
  • Examining the advances in global regulatory policies and standards to ensure reliability, accuracy, and safety of AI/ML applications.
  • Assessing the quality processes needed to maintain high-quality standards throughout the development and post- deployment of AI and machine learning technologies.
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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