2026 Agenda

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February 23rd

2:20 pm

Registration

3:15 pm - 4:15 pm WELCOME DAY SPECIAL CONTENT

Panel: The Next Frontier of Quality: Smarter Systems, Stronger Partnerships, Safer Patients

Chuck Medovich

VP & Chief Quality Officer

Johnson & Johnson

Rosaleen Burke

SVP, Global Quality & Regulatory

Boston Scientific

Mizanu Kebede

Chief Quality & Regulatory Officer

Smith & Nephew

Paul Arrendell

Chief Quality Officer

Jabil

Robbie Roark

SVP Quality & Regulatory Affairs

TEAM Technologies, Inc.

Session Details

Defining the future of quality through innovation, digital transformation, and industry best practices
Positioning quality as a strategic advantage for senior leaders in the future of MedTech
Applying advanced technologies, AI tools, and automation to revolutionize quality management
Capturing and analyzing data to drive risk management and proactive solutions
Revamping supplier management and engagement to streamline processes and drive quality outcomes
Balancing rapid innovation with regulatory compliance to safeguard patients and trust

4:20 pm - 4:55 pm WELCOME DAY SPECIAL CONTENT

Designing Agile Supply Chains to Rapidly Adapt to Regulatory Changes, Market Disruptions, and Shifting Demand

Session Details

Embedding flexibility in supply planning to pivot quickly during demand surges or drops
Leveraging real-time data and predictive analytics for faster decision-making
Creating modular and scalable manufacturing networks to support rapid shifts
Building cross-functional alignment to accelerate response to regulatory and market changes
Establishing contingency plans and alternative sourcing to mitigate disruption risks

5:00 pm - 6:00 pm WELCOME DAY SPECIAL CONTENT

Panel: Scaling AI For Manufacturing Excellence: A Leader’s Checklist For Business Transformation

Sajid Kunnummal

SVP & Chief Procurement Officer

Session Details

Leaders’ decision checklist – Assessing organizational readiness, including infrastructure and data maturity, to enable AI-driven transformation
Building executive confidence with a clear vision and a strategic roadmap for scaling AI
The critical role of leadership in championing AI as a business change, not just a technology or tool deployment
Integrating robust change management practices and trainings to engage and prepare the workforce for AI adoption
Building cross-functional collaboration to foster ownership and drive sustainable AI initiatives
Piloting AI in real-world settings while managing cultural and process changes effectively
Establishing governance frameworks that support ethical, transparent, and auditable AI use across the enterprise

6:00 pm

Drinks Reception

6:30 pm

Executive dinner

(by invite only)

February 24th

Stream 1 Chair

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

Stream 2 Co-Chair

Beth Crandall

Solution Delivery Director

Medical Engineering Consultants

7:30 am - 8:15 am

registration & breakfast

8:15 am - 8:20 am

Opening Remarks and Important Announcements

8:20 am - 8:30 am

Chair’s Welcome Address

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

8:30 am - 9:05 am KEYNOTE

Importance of Building Resilient Supply Chains to Safeguard Continuous Patient Access

Viju Menon

Group President, Global Quality & Operations

Stryker

Session Details

Diversifying sourcing strategies to reduce dependency on single suppliers and regions
Adapting production planning to respond swiftly to disruptions without compromising delivery timelines
Modernizing legacy systems to support agile operations and real-time decision-making
Enhancing end-to-end visibility across the supply chain through integrated digital technologies
Localizing or nearshoring manufacturing to mitigate global logistics and geopolitical risks
Ensuring uninterrupted patient access by building supply chain strategies around product availability and delivery reliability

9:05 am - 9:40 am KEYNOTE

Regulatory Update: Key developments and priorities to drive innovative, safe, and effective medical devices

Michelle Tarver, M.D., Ph.D.

Center Director, Center for Devices and Radiological Health

U.S. Food and Drug Administration

9:45 am - 10:20 am Workshops

Stream One

Unlocking Manufacturing Intelligence: The AI Advantage in Regulated Environments

Matt Lowe

Chief Strategy Officer

MasterControl

Session Details

Tips for identifying high-value AI opportunities in regulated manufacturing environments
Recommendations for balancing innovation with compliance for successful AI implementation
Strategies for implementing “human-in-the-loop” AI systems that maintain regulatory compliance while delivering operational improvements
Methods to keep sensitive manufacturing data secure while leveraging AI insights
Opportunities to gain more insights from data captured across your manufacturing processes

Stream Two

Meeting the Moment in MedTech Manufacturing: A Look at Digital Thread Maturity and Industry Trends to Adopt

Dave Hadfield

Director, Kalypso MedTech Practice Lead

Kalypso: A Rockwell Automation Business

Session Details

Learn valuable insights from research on digital thread maturity to understand how connected systems and processes provide transformative value in MedTech manufacturing
Hear how MedTech companies are leveraging AI, digital health, data infrastructure, supply chain resilience and other models to future-proof their manufacturing operations
Take away valuable ideas and steps on advancing your company’s digital thread maturity to accelerate time to patient

10:25 am - 12:05 pm Pre-Arranged One-To-One Meetings

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

10:30 am – 10:50 am: Meeting Slot 1/Networking
10:55 am – 11:15 am: Meeting Slot 2/Networking
11:20 am – 11:40 am: Meeting Slot 3/Networking
11:45 am – 12:05 pm: Meeting Slot 4/Networking

12:10 pm - 12:45 pm Case Studies

Stream One - Manufacturing & Supply Chain

Optimizing Our Global Footprint and Supply Chain in a Changing Business Landscape

Terry Walsh

SVP Global Operations

Beckman Coulter

Session Details

How can we make long-term decisions about where we operate in a time of disruption and frequent change? To what extent can we build resiliency into our industry through interconnected regional and local networks?
Keeping the patient at the core of what we are doing, even as we redesign and transform how we do it
Delivering the value and variety of the world market while transitioning to distributed sourcing, procurement, manufacturing, and fulfillment
Maintaining oversight and visibility in an ever-expanding and potentially decentralizing supply chain organization through a new generation of tools and technologies
Discussing the people part of all this: The leaders, the workforce, the partnerships, and how we all need to grow and develop together as an industry to meet the challenges and opportunities disruption brings

Stream Two - Quality & Regulatory Compliance

Managing a Harmonized Network Quality System and Driving Quality Expense Efficiencies

David Kunz

Senior Vice President, Global Quality & Regulatory Affairs

Zimmer Biomet

Session Details

Establishing a unified quality structure by defining and implementing standard Global Quality KPIs across all sites
Leveraging common software tools and harmonized processes to ensure consistent metrics and streamlined operations
Highlighting top dashboard metrics to provide leadership with clear, actionable insights and real-time visibility
Driving operational efficiency through the integration of MES, standardized Master Data, common tools, and AI

Stream Three - Product Development & R&D

Accelerating Innovation: From Early Customer Insights to AI-Driven, Scalable R&D

Dr. Andrew Omidvar

Vice President Government R&D

Philips Healthcare

Session Details

Capturing customer and clinical insights early to validate real needs before design lock
Using AI and data analytics to identify trends, predict risks, and guide R&D priorities
Shortening development cycles through rapid prototyping and agile cross-functional teams
Building scalable test and development frameworks that adapt as products evolve
Leveraging digital twins and simulation tools to accelerate design decisions and reduce rework

12:45 pm - 1:45 pm

Executive Lunch Seating

12:45 pm - 1:45 pm THEMED LUNCH DISCUSSIONS

Explore this year’s themed lunch discussions led by industry leaders, where executives engage in focused conversations over a meal, discussing topics they’re passionate about alongside their peers.

From Skepticism to Ownership: Engaging Plant Managers to Build Frontline Accountability, Reduce Downtime, and Drive CI

Kara Carter

VP Quality

Boston Scientific

People focus/human element of Continuous Improvement!

Gary Lopez

SVP, Operations

Integer Holdings

Unlocking Enterprise Decision Power with Integrated Supply Chain Intelligence

Philip Tocco

Head of Supply Chain

Johnson & Johnson

Managing Diverse Regulatory Requirements, Consistent Quality Standards and Data Integrity Across Multinational Manufacturing Sites

1:45 pm - 2:20 pm Case Studies

Stream One - Manufacturing & Supply Chain

F.A.C.E. It Together: Driving CI and Sustaining Lean Gains to Modernize Legacy Manufacturing Facilities

Hany Mikhaiel

CVP Continuous Improvement & Central Services

B Braun Medical Inc.

Session Details

F – Focus: Identify key initiatives to drive impact, and develop a roadmap that aligns resources, capabilities, and leadership in line with long-term objectives
A – Alignment: Ensure enterprise-wide alignment by connecting corporate strategy with functional goals, fostering cross-functional collaboration, and creating measurable objectives that accelerate adoption and accountability
C – Culture: Embed a culture of CI as a strategic enabler, shaping behaviors, decision-making, and leadership practices across the organization to sustain transformation
E – Execution: Translate strategic initiatives into measurable results by tracking progress, overcoming obstacles, and using feedback loops to refine approaches continuously
Evolve CI by building adaptable roadmaps, reassess priorities during internal and external changes, and continuously refine processes to sustain long-term improvement

Stream Two - Quality & Regulatory Compliance

Transforming Quality with AI: From Enabled Search to Agentic Compliance Verification and Root Cause Analysis

Jason Busch

VP Quality Assurance & Regulatory Affairs

Medtronic

Session Details

Understand how AI can streamline quality data search, helping teams quickly identify trends, risks, and recurring issues across large datasets
Explore the concept of “agentic compliance”, using AI to autonomously monitor and verify adherence to regulations and internal quality standards
Learn how AI-driven root cause analysis can identify underlying problems faster and more accurately than traditional manual methods
Examine practical examples of integrating AI into quality systems to move from reactive problem-solving to proactive quality management

Stream Three - Product Development & R&D

Designing for Manufacturability (DFM): Making Devices Production-Ready From Day 1

Session Details

Integrating DFM thinking at concept stage to prevent downstream redesigns and bottlenecks
Simplifying parts, materials, and assemblies to reduce production complexity
Aligning tolerances and design features with real-world manufacturing capabilities
Incorporating supplier, fabrication, and automation feedback into early design cycles
Ensuring smooth design-to-production transfer through cross-functional collaboration and structured reviews

2:25 pm - 3:00 pm Workshops

Stream One

Applying Innovation Strategically to Accelerate Performance, Simplify Complexity, and Maximize Value in Manufacturing

Joe Goodman

GM Americas

Honeywell Life Sciences

Session Details

Explore the challenges and trends shaping medical device manufacturing, including regulatory pressures, rising costs, and faster product delivery demands
Learn strategies to manage the growing complexity of global operations while maintaining quality, compliance, and patient safety
Understand the most critical outcomes organizations can achieve by addressing these challenges, from stronger supply chains to improved efficiency and competitiveness
AI is not the answer for everything, but it can be a powerful enabler to optimize processes and drive innovation when applied strategically

Stream Two

A Journey into Smart Factory Implementation

Executive to be Announced

ISACA

Session Details

Highlighting the significance of integrating advanced technologies to streamline production processes
Offering practical solutions for real-time monitoring and data analytics enable quick decision-making
Utilizing smart sensors at various stages of the production line ensures consistent quality control by continuously monitoring critical parameters like temperature, humidity, and ingredient proportions
Integrating AI-powered tools in the manufacturing process to enhance worker productivity and safety

3:05 pm - 4:15 pm Pre-Arranged One-To-One Meetings

3:05 pm – 3:25 pm: Meeting Slot 5/Networking
3:30 pm – 3:50 pm: Meeting Slot 6/Networking
3:55 pm – 4:15 pm: Meeting Slot 7/Networking

4:20 pm - 4:55 pm KEYNOTE

Leading Through Challenges to Transform Culture, Drive Performance, and Build Global Trust

Steve C de Baca

Chief Patient Safety & Quality Officer

Philips

Session Details

Recognize the value of diverse experiences and taking risks in leadership
Build and leverage professional networks to grow and problem-solve
Apply effective strategies for leading teams and individuals across cultures
Understand the role of vulnerability, mentorship, and continuous learning in leadership
Develop strategies to communicate clearly and foster alignment within teams

4:55 pm - 5:30 pm KEYNOTE

Unleash the Power of IBP: Empowering Your People to Drive Strategic Decisions Through Advanced Scenario Planning

Peter Bennett

Senior VP Global Supply Chain

Cardinal Health

Arthur Leach

Senior VP Global Manufacturing

Cardinal Health

Session Details

Gain hands-on experience creating and analyzing multiple business scenarios using IBP tools
Learn to interpret scenario results to make practical, actionable decisions that impact performance
Apply scenario planning techniques to real-world business challenges and forecasting needs
Use IBP to identify potential risks, uncover opportunities, and allocate resources effectively across functions
Build skills to align cross-functional teams around data-driven insights and strategic decision-making

5:30 pm - 5:35 pm

Chair’s Closing Remarks

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

5:35 pm

Drinks Reception

6:05 pm

Executive dinner

(by invite only)

February 25th

7:30 am - 8:20 am

registration & breakfast

7:45 am - 8:20 am breakfast workshops

Stream Two

Electronic Enterprise Quality Management Systems: Protecting Patients, Maintaining Compliance, and Positively Impacting the Bottom Line

Executive to be Announced

Veeva MedTech

Session Details

Creating a collaborative production environment that communicates with business IT
Moving your production models from individual machines to holistic processes
Enabling existing infrastructure for the next generation of tools and technology
Monitoring, documenting, and electronically archiving performance and production data
Examine how improved quality control creates not only safer products, but also creating efficiencies and measurable cost savings

8:25 am - 8:35 am

Chair’s Opening Remarks

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

8:35 am - 9:10 am KEYNOTE

Smarter, Faster, Leaner: Evolving Manufacturing & Supply Chain for Tomorrow’s MedTech Challenges

Mark Brosius

Chief Manufacturing & Supply Chain Officer

Intuitive Surgical

Session Details

Connecting global ecosystems to overcome legacy silos and long lead times by creating digitally connected networks that enable faster, more coordinated responses to change
Simplifying operations through automation, digitalization, and lean workflows to address complexities, enhance efficiency, streamline processes, and maintain regulatory compliance
Turning data into enterprise decision power by integrating manufacturing and supply chain intelligence to provide real-time insights for smarter, proactive decisions
Building resilient and sustainable supply networks to respond to global disruptions by deepening collaboration, improving traceability, and embedding long-term risk and sustainability practices
Empowering people to lead transformation by investing in digital upskilling, fostering innovation, and cultivating a culture that embraces continuous improvement

9:10 am - 9:45 am KEYNOTE

Enabling Successful Design and Manufacturing Transfers of Medical Devices

Raghu Jainapur

Vice President Quality, Healthcare Systems & Technologies (HST)

Baxter Healthcare Corporation

Session Details

Addressing real-world challenges and common pitfalls during design and manufacturing transfers, and effectively managing transfer milestones
Architecting and executing a quality and regulatory submission strategy
Translating design specifications into clear, actionable manufacturing instructions
Using pilot runs and iterative builds to identify and resolve manufacturability issues early
Aligning validation plans with real-world production conditions and conducting hands-on training
Building a structured knowledge transfer process to support smooth and scalable production scale-up

9:50 am - 10:25 am Case Studies

Stream One - Manufacturing & Supply Chain

Transforming Complex Operations: Lessons from Network Rationalization, IBP and Portfolio Impact on Complexity

Eamonn Nestor

Senior Vice President, Orthopaedic Operations

Smith+Nephew

Michael Jacene

VP of Quality

Smith + Nephew

Stream Two - Quality & Regulatory Compliance

Panel: Cultivating a Strategic Quality Culture: Aligning leadership, Vision, and Metrics for Long-term Excellence

Medha Trivedi

Worldwide Vice President of Quality, Peripheral Intervention

Robert Popp

Vice President, Quality

Cook Medical

Chandresh Thakur

Head Regulatory Compliance Robotics and Digital Solution

Johnson and Johnson MedTech

Session Details

How to translate organizational vision and values into measurable quality objectives that drive long-term performance
Exploring methods to engage leadership and cross-functional teams in building accountability for quality outcomes beyond compliance
Learning practical strategies to embed quality thinking into everyday decision-making, from design to manufacturing floor operations
Identifying key performance metrics that reflect culture, not just process compliance (e.g., behavior-based indicators, ownership, responsiveness)
Examining real-world examples of how continuous leadership reinforcement and transparent communication sustain a culture of quality over time

10:25 am - 11:15 am Pre-Arranged One-To-One Meetings

10:30 am – 10:50am: Meeting Slot 8/Networking
10:55am – 11:15am: Meeting Slot 9/Networking

11:20 am - 11:55 am Workshops

Stream One

Vertical Integration Versus Contract Manufacturing – How to Select the Right Fit for Your Product and Business Needs

Executive to be Announced

Eyelit Technologies

Session Details

Conducting a structured risk-benefit analysis based on product complexity, regulatory classification, and IP sensitivity to guide your model choice
Developing cost and capacity models to compare in-house manufacturing investment versus contract manufacturing scalability and lead times
Mapping out quality and compliance requirements (FDA, EU MDR) and determine how each model supports traceability, audit readiness, and lifecycle obligations
Building a robust framework for selecting and managing contract manufacturers, including performance metrics, QMS alignment, and escalation protocols
Align manufacturing strategy with long-term commercial goals by integrating inputs from operations, RA/QA, R&D, and supply chain leadership
Staying ahead of common pitfalls such as loss of process visibility, delayed tech transfers, or compliance gaps and implement safeguards to prevent them

Stream Two

Managing Diverse Regulatory Requirements, Consistent Quality Standards and Data Integrity Across Multinational Manufacturing Sites

Session Details

Harmonizing quality systems across sites to comply with FDA, EU MDR, ISO 13485, and market-specific regulations, while maintaining operational flexibility
Embedding regulatory intelligence processes to proactively monitor global changes and translate updates into actionable manufacturing and quality system improvements
Ensuring data integrity and traceability by applying ALCOA+ principles across digital systems (eQMS, MES, ERP) and aligning records with regulatory expectations
Establishing centralized governance and global training programs to drive consistency in process validation, documentation, and inspection readiness
Managing regional variation in PMS, change control, and supplier oversight while preserving product quality and compliance

12:00 pm - 12:35 pm Case Studies

Stream One - Manufacturing & Supply Chain

From Incremental to Transformational: Building the Foundations for Sustainable Excellence

Eric Mixon

Senior Director Business Excellence

Edwards Lifesciences

Michael Ingles

Director Business Excellence

Edwards Lifesciences

Session Details

Discover where transformation truly begins– Identifying transformation entry points through internal assessments that uncover the right diagnostics and opportunities for impact
Leading and culture:Understand how leadership commitment and cultural alignment create a powerful top-down cascade that empowers employees and fuels change
Operational Excellence:Rely on standard best practices in manufacturing and operations to ensure consistency
Performance Management: Learn how structured performance systems enable continuous improvement, accountability, and measurable progress
How to sustain the shift? Walk away with strategies to move beyond incremental changes and build a resilient foundation for long-term transformational growth

Stream Two - Quality & Regulatory Compliance

Post Market Regulatory Considerations: Continuous Improvement and Design Controls

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

Session Details

Regulatory strategy for post-market design changes
Sustaining engineering and regulatory considerations
Continuous monitoring and reporting review
Design changes and design controls
How to address global registration effects of design changes

Stream Three - Product Development & R&D

Transforming R&D: Agile Methods, Early Risk Strategy, and Scalable Testing

Session Details

Embedding agile workflows to speed iteration and improve cross-functional alignment
Identifying and mitigating risks early to prevent late-stage redesigns
Building scalable, modular test systems that grow with product complexity
Integrating customer and clinical insights upfront to reduce rework and improve outcomes

12:35 pm - 1:35 pm

Executive Lunch Seating

12:35 pm - 1:35 pm THEMED LUNCH DISCUSSIONS

Explore this year’s themed lunch discussions led by industry leaders, where executives engage in focused conversations over a meal, discussing topics they’re passionate about alongside their peers.

Building, Leading and Retaining a Skilled MedTech Manufacturing Workforce: From Talent Pipelines to Leadership Readiness

Balancing Control and Flexibility: Making the Right Call Between Contract Manufacturing and Vertical Integration

How to Master Inspection Readiness with Risk-Based Audits, Good Change Control and Documentation Practices

Strengthening Supplier Quality by Closing Compliance Gaps and Ensuring Accountability Without Compromising Production

1:35 pm - 2:10 am Case Studies

Stream One - Manufacturing & Supply Chain

ICU Medical’s Experience Embracing the Shingo Model and Our Operational Excellence Journey

Adolfo Amador

Operational Excellence Manager

ICU Medical

Session Details

Offering an overview of our plant’s 25-year story as a Costa Rican-based medical device manufacturing facility that is committed to successfully serving patients’ needs while embracing change to enhance our capabilities and productivity
Why did we choose the Singo Model in 2018, and how have the three pillars of Operational Excellence —a Culture of Respect and Humility, a commitment to Continuous Improvement, and the embracing of Alignment in our purpose and decision-making— shaped who we are and how we work
Demonstrating the impact Operational Excellence has had on our metrics and deliverables in terms of quality, productivity, cost and employee engagement and morale. What have we achieved, what are we achieving, and what are we working towards now?
Showcasing our people as the real catalysts of change, and how everyone contributes to ongoing, incremental, self-reinforcing positive change
What can other medical device manufacturers learn from ICU Medical Costa Rica’s experience that can be applied to everyone’s operations, processes, and teams?

Stream Two - Quality & Regulatory Compliance

Manufacturing Expectations Through the Lens of a Notified Body: Risk, Quality, Process and Supply Chain Under EU MDR

Prabhu Gubbi, Ph.D.

Technical Specialist & Scheme Manager (Orthopaedics & Dental)

BSI Group America Inc

Session Details

Opportunities to better align manufacturing risk controls general gaps with the device’s overall risk management file
Considerations for strengthening process validation and documentation consistency across manufacturing lines
Key factors to improve oversight of suppliers and subcontractors, including quality agreement practices
Observations on inconsistencies between global manufacturing sites impacting quality system robustness
Common nonconformities related to process validation and production control during audits
Emerging patterns on post-CE marking changes, where the missteps occur and reflections on best practices
Ways to improve manufacturing documentation to better support clinical evaluation and PMS activities

Stream Three - Product Development & R&D

Managing Product Development Risks: From Concept to Market Exit

Session Details

Identifying technical, regulatory, and market risks early to prevent late-stage setbacks
Integrating structured risk reviews throughout the development lifecycle
Using real-world data and customer insights to validate assumptions and reduce uncertainty
Planning for end-of-life risks, including supply continuity, obsolescence, and responsible product retirement

2:10 pm - 2:45 pm KEYNOTE

Driving Operational Excellence in Medtech: BD's Journey to Innovation, Accountability, and Performance

Max Urbini

Senior Vice President Operational Performance

Session Details

Understanding where we were as an organization at the start of our transformation, what we said we wanted to achieve in the beginning, and how we took the first steps of our journey
Illustrating our progress with examples of how we evolved and grew along the way. Where and when did our original goals change? How did we learn by doing and adapt our tactics to achieve and hold onto what works?
Discussing the importance of accountability in Operational Excellence to both celebrate and share what works and learn lessons and adapt strategies when things do not turn out as expected
How has an organization as big as BD taken individual innovations and applied them across our company? What can other medical device manufacturers take from our examples and apply to their own organizations?

2:45 pm - 2:50 pm