2026 Agenda

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February 23rd

4:30 pm

Registration

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

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

MODERATOR

Paul Arrendell

Chief Quality Officer

Jabil

Rosaleen Burke

SVP, Global Quality & Regulatory

Boston Scientific

Mizanu Kebede

Chief Quality & Regulatory Officer

Smith & Nephew

Robbie Roark

SVP Quality & Regulatory Affairs

Cordica Medical

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

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

Building and Fortifying Resilient Supply Chains to Strengthen Healthcare

Matthew Smith

Group Vice President, Supply Chain Operations for MedSurg and Neurotechnology (MSNT)

Stryker

Session Details

Diversifying sourcing strategies to enable resilience across geographies
Adapting production planning to respond swiftly to support growth and minimize disruption
Enhancing end-to-end visibility across the supply chain through aligned processes and platforms
Ensuring continued access to life-saving and life-improving technologies through supply chain strategies

9:05 am - 9:40 am KEYNOTE

FDA Regulatory Landscape : Driving Innovation, Quality, and Resilience in Medical Devices

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

Center Director, Center for Devices and Radiological Health

U.S. Food and Drug Administration

Session Details

Regulatory Update: Highlighting recent FDA policy shifts and strategic priorities aimed at accelerating access to innovative, safe, and high-quality medical devices
Supply Chain Resilience: Exploring FDA expectations for building diversified, transparent, and risk-mitigated supply chains to prevent disruptions
QMSR: Clarifying implementation expectations for the new Quality Management System Regulation and alignment with ISO 13485
VIP (Voluntary Improvement Program): Emphasizing how VIP participation enhances manufacturer maturity, continuous improvement, and regulatory flexibility
Advanced Manufacturing: Discussing FDA’s support for digital, automated, and AI-enabled manufacturing technologies, along with advancements in sterilization methods and PFAS reduction, to enhance quality, safety, and production agility
Industry–Agency Collaboration: Highlighting opportunities for strengthened collaboration between FDA and industry to advance innovation, improve quality systems, and address evolving challenges

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

Navigating the Tariff Tides: Optimizing Your Supply Chain's Course Through Global Complexity

Terry Walsh

SVP Global Operations

Beckman Coulter

Session Details

Triage and Stabilize: Mastering Operations Within Current Constraints
Chart the Terrain: Understand your competitive landscape and maximize
Forge Powerful Alliances: Are there known partners who can help?
New Normal: Establish your “flywheel” and activate in 2026

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

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.

Strategic Sourcing Programs Driving Gross Margin Improvement, Tariff Mitigation, Resiliency, and Speed to Market

Stephanie O’Sullivan

Divisional Vice President, Operations Structural Heart

Abbott

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

Kara Carter

VP Quality

Boston Scientific

How Can Early‑Stage Medical Device Companies Strategically Reduce Cost Without Compromising Quality or Regulatory Compliance During Commercial Ramp‑up?

Jahnavi Lokre

COO

Diality

People focus/human element of Continuous Improvement!

Gary Lopez

SVP, Operations

Integer Holdings

QMS in Practice: Lessons Learned and Open Questions

Raghu Aditham

Senior Director Quality

JenaValve Technology, Inc.

New Product Introductions: Bridging the gap between R&D and Manufacturing

Philip Tocco

Head of Supply Chain

Johnson & Johnson

How to Create a Culture Where Organizations Eagerly Exercise their CAPA Process to Achieve Continuous Improvement

Donald Bracken

Senior Director of Production Operations

Penumbra, Inc.

Transforming Regulatory Affairs in the Age of Artificial Intelligence. How to Empower and Enable Global Teams to Solve Challenges at Scale.

Sabyasachi Roy, PhD

Head of Regulatory Affairs (Sr. Director) - Enterprise Informatics, Innovation & Design

Philips

Creating a Culture of Continuous Improvement

Quraish Baldiwala

President Direct Supply Manufacturing & Group Vice President Supply Chain

Direct Supply inc.

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 Product Development to Proactive Postmarket Oversight

Jason Busch

VP Quality Assurance & Regulatory Affairs

Medtronic

Session Details

Navigate the evolving regulatory landscape for AI to understand current global requirements and emerging industry standards.
Leverage AI across the medical device lifecycle to strengthen design controls and enable earlier detection of quality signals with appropriate human oversight.
Examine practical examples of AI integration to shift from reactive problem-solving toward proactive, data-driven quality management.
Exploring “agentic compliance” to see how AI can autonomously monitor and verify adherence to regulations and internal quality standards.

2:25 pm - 3:00 pm Workshops

Stream One

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

Bart Reitter

Vice President of Sales, 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

Partnering with FDA to Improve Quality Culture and Business Resiliency in MedTech

Kim Kaplan

Senior Product Manager

MDDAP, LLC.

Brian Schultz

Vice President – Quality, Safety & Regulatory Affairs

Fisher & Paykel Healthcare

Session Details

Discover common challenges facing the MedTech industry
Learn how FDA wants to collaborate with industry on solutions
Understand why a compliance-only approach can limit your organization

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

Understand the “what, why & how” of transformations
Recognize and respect the journey
Recognize the value of diverse experiences and taking risks in leadership
Apply effective strategies for leading teams and individuals through transformations
Develop strategies to communicate clearly and foster alignment within teams

4:55 pm - 5:30 pm KEYNOTE

Fireside Chat: Future of Manufacturing & Operations Leadership: Leading Complex Operations in an Era of Constant Disruption

Reginald Mingot Blanc

VP Integrated Supply Chain

Session Details

How the role of manufacturing and operations leaders is evolving from execution to enterprise strategy
Leading global operations through volatility: managing risk, resilience, and trade-offs in real time
Building organizations that can adapt at speed without sacrificing safety, quality, or cost discipline
Developing the next generation of operations leaders: skills, mindset, and succession planning
Making high-stakes decisions with imperfect data, balancing urgency, judgment, and accountability
Lessons learned from leading large-scale transformations across networks, systems, and cultures
Aligning technology, people, and process to drive sustainable performance, not just short-term wins

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

The Heart of Compliance: How Women Leaders Cultivate a Sustained Culture of Quality

Amra Racic

VP, Government Strategy

Veeva MedTech

Anna Burla

Global Senior Director, Quality System Compliance and Inspection Readiness

Novocure GmbH

Michael Jacene

VP of Quality

Smith + Nephew

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

Session Details

Moving organizations beyond “checkbox compliance” toward a proactive quality culture
Leveraging how women leaders use transformational leadership to bridge regulatory gaps
Utilizing empathy and cross-functional collaboration to manage the “human element” of compliance
Fostering psychological safety so employees feel empowered to speak up about risks
Examining how inclusive leadership styles prevent recalls and improve operational behavior

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

Practical Insights from the Frontlines of the Digital Mfg Revolution

Mark Brosius

Chief Manufacturing & Supply Chain Officer

Intuitive Surgical

Session Details

What do the rapid evolution of robotics and AI mean for digital transformation in manufacturing?
Are there straightforward ways to cut through the hype and gain real value in your own operations?
Is your traditional Mfg Infrastructure, such as business systems for planning, ERP, and Mfg execution obsolete?
The Chief Mfg Officer of robotics pioneer, Intuitive, will share insights and prescriptions for success

9:10 am - 9:45 am 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

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

Session Details

Leveraging alignment between manufacturing, supply chain, and the business as a trigger to drive meaningful operational transformation
Identifying key sources of operational complexity and applying network rationalization to eliminate redundancies, streamline site footprints, and enhance responsiveness while reducing overall costs
Using IBP to create connected planning process for more accurate forecasts and better resource allocation
Managing portfolio complexity to streamline offerings and enhance operational agility
Leading teams through transformational change while keeping employees engaged and motivated
Turning operational insights into actionable strategies that balance short-term change with long-term growth and innovation

Stream Two - Quality & Regulatory Compliance

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

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

Medha Trivedi

Worldwide Vice President of Quality, Peripheral Intervention

Chandresh Thakur

Head Regulatory Compliance Robotics and Digital Solution

Johnson and Johnson MedTech

Anna Burla

Global Senior Director, Quality System Compliance and Inspection Readiness

Novocure GmbH

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

Closing the Gap Between Planning and Execution in Medical Device Supply Chain

Mark Carleton

General Manager Manufacturing Execution Systems

Eyelit Technologies

Stefano Alfonsi

CEO & Board Director

Elos Medtech

Session Details

Discover the essential capabilities for effective planning and scheduling
Accuracy vs Granularity: how to be “Roughly Right” instead of “Precisely Wrong”
Bridging the gap between S&OP and S&OE
How to move from ensuring your plan is plausible to confidence that it is optimal
Learn where AI helps today and where the focus should be on other foundations

12:00 pm - 12:35 pm Case Studies

Stream One - Manufacturing & Supply Chain

Culture Eats Strategy for Breakfast-- Driving Collaboration Across Various Organizational Cultures

Jesse Freeman

Senior Vice President of Global Operations

Globus Medical

Max Poeske

Sr Director of Global Supply Chain

Globus Medical

Session Details

Exploring an organization’s cultural profile
Strategies across cultures
The role of leadership
Influencing the change; a case study

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

12:35 pm - 1:35 pm

Executive Lunch Seating

12:35 pm - 1:35 pm Interactive Think Tanks

These are Informal and unmoderated networking opportunities for like-minded attendees to get together in small groups to brainstorm and discuss issues of common interest. Icebreaking questions and topics of possible conversation will be provided but are by no means mandatory.

TOPIC ONE

Leading Large-Scale Operational Transformation and Change: Lesson Learned

TOPIC TWO

Managing Risk Across Complex, Global Supply Networks

TOPIC THREE

Managing Supplier Quality Risk in Complex Supply Chains

TOPIC FOUR

Building Regulatory Resilience in Medical Device Manufacturing

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

Necessity for EU Regulations for Medical Devices
Device Manufacturing from the New Regulations Perspective
Critical Subcontractors & Crucial Suppliers
EU Regulations – Impact on Virtual Manufacturers
Manufacturing as Integral Part of Technical Documentation
Microbiology/Sterilization Assessment
Manufacturing Changes – Substantial/Non-Substantial

2:10 pm - 2:45 pm KEYNOTE

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

Jamie Kinzer

VP E2E Operations ISC

BD Medical – Advanced Patient Monitoring

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