October 27, 2025

* JOIN US FOR THE PRE-EVENT HAPPY HOUR on October 26, 2025 FROM 6:00 PM – 7:00 PM

Sponsored by: agiliad logo
7:00 am – 7:55 am CST

Delegate Registration and Networking Breakfast

Sponsored by: agiliad logo
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

John Peyton

VP, Customer Success
Clarivate Analytics

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
  • 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

Athar Mirza

VP, Global Infusion Systems
Baxter International

Chris Gutmann

VP, Enterprise Technology & Value Generation
Baxter International

FIRESIDE CHAT: FROM CONNECTION TO IMPACT: HOW CONNECTED CARE DRIVES RESULTS

  • Creating smarter hospital networks where technologies and devices connect seamlessly to deliver a better care experience for both patients and clinicians
  • Using connected solutions to simplify care delivery, enabling smoother workflows, stronger coordination, and more personalized outcomes
  • Turning data and customer insights into action by applying real-time insights that enhance safety, support clinical decisions, and fuel ongoing improvements in healthcare
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

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, 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

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: 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

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 Medical & Life Science

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

Carsten Hurasky

SVP, Chief Marketing Officer
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

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
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

Amol Patil

Principal Technologist, (AVP)
Agiliad

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 – 4:30 pm CST

Happy Hour, Networking and Pre-Arranged 1-2-1 Meetings

Sponsored by: Description of image
4:40 pm – 5:10 pm CST

Sessions

Christina Arnt

VP, Global Corporate Quality
Zimmer Biomet

Navigating FDA Regulations and Ensuring Compliance in a Complex Medical Device Landscape

  • Understanding the latest FDA regulations and how they impact medical device development
  • Effective strategies for ensuring regulatory compliance and avoiding common pitfalls
  • Adapting quality systems to align with new regulatory requirements
  • Case studies on navigating complex regulatory environments in global markets
5:15 pm – 5:45 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
5:45 pm – 6:15 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
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.
6:15 pm – 6:25 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

Darin Oppenheimer

VP, Regulatory Affairs
BD

6:25 pm – 7:25 pm CST

Networking drinks reception

Sponsored by: L&T Technology Services

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