Stream One Chair

Dina Justice

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

Stream Two Chair

John Daley

John Daley

VP SME

Compliance Architects LLC

5:30pm

6:00pm

7:30am - 8:15am

8:15am - 8:20am

Opening Remarks and Important Announcements

8:20am - 8:30am

Chair’s Welcome Address

Dina Justice

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

8:30am - 9:05am

Fireside Chat: Transforming Supply Chains into Competitive Advantages: A Strategic Vision for Medtronic

Greg Smith

Greg Smith

Executive Vice President, Enterprise Operations

Medtronic

  • End-to-End Efficiency: Streamlining integrated processes and operations for seamless global coordination and responsiveness
  • Cost Optimization: Balancing cost efficiencies with value creation through innovative financial strategies
  • Quality Commitment: Upholding robust quality systems to exceed regulatory and customer expectations
  • Empowering Talent: Promoting collaboration, continuous improvement, and leadership development within the supply chain
  • Customer Focus: Aligning supply chain strategies with customer needs, enhancing agility, and delivering superior service
9:05am - 9:40am

Are Sustainable Supply Chains a Myth?

Paudie O’Connor

Paudie O’Connor

Senior Vice President, Global Supply Chain

Boston Scientific

Carbon neutrality, Science Based Targets, ESG, VPPA. The world is a buzz with the goals, terms and actions intended to help preserve the environment. In this discussion, Paudie O’Connor will share the ways Boston Scientific is debunking the myth that supply chains are not sustainable and demonstrate how business goals and environmental goals can co-exist to create a healthier planet. With a focus on minimizing the company’s impact on the environment, he will detail Ideal Product Flow, which is focused on driving more efficiency and sustainability in how Boston Scientific’s products are sourced, manufactured, packaged and distributed. He will also address how the company is working to deliver a sustainable future for its employees as well as the customers and patients his team proudly serves.

9:45am - 10:20am

Maximizing Return on Automation: Benchmarking Operational and Business ROA

Brian Curran

Brian Curran

SVP Manufacturing Excellence Success

MasterControl

William Darcy

William Darcy

Manufacturing Quality Engineer

Carestream

Attendees will see actual customer metrics and leave with a better understanding of:

  • How modern MES and QMS systems can work together to automate a significant portion of your end-to-end production processes
  • The areas where digital process and equipment automation have significant impact and how that translates to the bottom line
  • How digital systems can improve the work experience for operators and ‘automate the human element’ that is critical to production
  • How to clearly demonstrate the ROI of a digital system
9:45am - 10:20am

Improve Device Quality and Business Performance with the Voluntary Improvement Program

Kim Kaplan

Kim Kaplan

Senior Product Manager

ISACA

  • Use a third-party approach tailored to meet your business needs
  • Leverage a proven maturity model to better understand, measure, and improve capabilities
  • Foster a culture of continuous improvement across the organization
  • Boost employee morale and buy-in to reduce rework and turnover for faster innovation
  • Shift to a more collaborative relationship with US FDA
  • Access US FDA opportunities to reduce regulatory burden and accelerate innovation. See Final Guidance “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program”
10:25am - 12:05pm
  • 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

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.

12:10pm - 12:45pm

Regulatory Strategy: A Comprehensive Guide to Navigating the Global Market

Dina Justice

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

In the ever-evolving landscape of the medical device industry, having a solid regulatory strategy is crucial for success. It goes beyond simply choosing a pathway to market; it involves carefully selecting the best markets and pathways for both your device and your business.
  • Navigating the global market with confidence – developing a comprehensive regulatory strategy
  • How to stay updated on regulatory requirements, engage with regulatory exerts and prioritize quality, safety and compliance throughout the development and commercialization of your medical device
  • How can we develop the right strategy to achieve regulatory compliance efficiently and effectively, and bring safe and innovative medical devises to market
12:45pm - 1:45pm

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.

Driving Key Business Results for Patients: Optimizing Production Systems: Assessing Site Strengths/Opportunities, and Leading Benchmark Excellence

Michael Ingles

Michael Ingles

Director of Business Excellence

Edwards Lifesciences

Navigating The Evolving Landscape of Quality and Compliance

Laxmismita Sreedasyam

Laxmismita Sreedasyam

Director, Quality Engineering

Imperative Care

Building a Quality System for the Future: Strategies for Embracing Change, Innovation, and Excellence

Linette Torres

Linette Torres

Chief Quality Officer

Integra LifeSciences

Leadership Strategies for Cultivating a Patient-Focused Manufacturing Culture

Mario Barquero

Mario Barquero

Plant Manager - Alajuela Costa Rica

Philips Healthcare

Continuous Improvement in Quality Management: Strategies for Operational Excellence

Shibu Korula

Shibu Korula

EVP, Quality & Regulatory

Tecomet

1:45pm - 2:20pm

Transforming Supply Chain Quality Processes in the Digital Era

Aileen Barreto

Aileen Barreto

VP Supply Chain Quality, MedTech

Johnson & Johnson

  • Exploring the Supply Chain Quality current state and the benefits of digitally optimizing manual processes
  • Identifying how to evaluate your current state and design a future digital ecosystem’
  • Implementing key strategic tactics that will automate your processes, integrate data and reduce burden on your employees
  • Realizing the benefits for customers, patients, employees and beyond
2:25pm - 3:00pm

From Complaints to Patient Breakthroughs: Harnessing AI to Capture Voice of Customer and Accelerate Medical Device Innovation

Zillery A. Fortner

Zillery A. Fortner

Industry and Business Development Director, SM

Honeywell Life Sciences

In the highly regulated and rapidly evolving medical device industry, capturing and leveraging the Voice of the Customer (VoC) is essential for enhancing product quality, ensuring compliance, and fostering patient-centric innovation. Traditional complaint-handling systems often struggle with the volume, variability, and complexity of feedback, leading to missed insights and reactive approaches.

This session examines how artificial intelligence (AI) is transforming complaint handling by enabling proactive, data-driven strategies. Attendees will discover how AI-enabled systems analyze unstructured data, identify trends, and extract actionable insights from customer feedback while ensuring compliance with regulatory standards. Through examples, we will demonstrate how AI can turn complaints into opportunities for innovation, improve customer satisfaction, streamline reporting processes, and ultimately enhance patient outcomes.

Join us to

  • Understand the Role of AI in Complaint Handling: Explore how AI-enabled tools can transform traditional complaint handling by automating data analysis, identifying trends, and ensuring adherence to regulatory standards.
  • Learn to Capture and Leverage the Voice of the Customer (VoC): Discover strategies for utilizing AI to extract actionable insights from customer complaints, transforming feedback into opportunities for product and process innovation.
  • Drive Innovation While Enhancing Compliance: Acquire practical knowledge on implementing AI-enabled solutions that meet regulatory requirements and promote a culture of continuous improvement and patient-centric innovation.
2:25pm - 3:00pm

Fireside Chat: Pathways to Accelerated Innovation: Navigating Regulatory Strategy for Regenerative Devices

Peggy Hansen

Peggy Hansen

General Manager & Senior Vice President

Regenity Biosciences

Jessica Swanson

Jessica Swanson

VP of Marketing

Regenity Biosciences

  • Navigating the Regulatory Landscape: Discussion of safety and efficacy standards for regenerative devices, recent updates impacting approval pathways, and how companies can turn regulatory strategy into an innovation enabler
  • Addressing Manufacturing Challenges: Strategies to proactively tackle regulatory concerns during design and production, best practices for integrating new technologies, and lessons from overcoming regulatory hurdles to achieve industry success
  • Achieving Regulatory and Operational Harmony: Tips for engaging with regulatory bodies, balancing compliance with scalability, and aligning agile development with complex requirements
  • Shaping the Future: Emerging trends in the regulatory environment and how collaborative efforts between manufacturers and regulators can drive faster innovation
3:05pm - 4:15pm
  • 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

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.

3:15pm - 4:15pm

4:20pm - 4:55pm

Panel Discussion: Navigating the Journey to Quality and Regulatory Mastery

Jessica Smith

Jessica Smith

Corporate Vice President, Global Quality and Chief Regulatory Officer

Integra LifeSciences

Ian Purdy

Ian Purdy

Sr VP of RAQA

Intuitive Surgical

Shibu Korula

Shibu Korula

EVP, Quality & Regulatory

Tecomet

  • Evaluating the effects of new regulations on the medical device sector
  • Providing guidance on creating and deploying efficient quality management systems
  • Examining the careful balance between innovation and safety mandates
  • Sharing approaches for conducting quality risk assessments and taking proactive measures
  • Charting a future course for the medical device industry with best practices and learned insights
4:55pm - 5:30pm

Performance Management Beyond Limits: Elevating Operations Excellence Globally

Chester Zelaya

Chester Zelaya

Senior Vice President Implant Network Global Operations

Edwards Lifesciences

  • Driving simultaneous performance gains across the Manufacturing Network
  • Implement a standardized performance management system rooted in lean principles to ensure consistent improvement across multiple manufacturing sites, enabling organizations to achieve synchronized progress and scale operational excellence globally
  • Push the limits of performance management to create value and drive innovation
  • Create a culture of collaboration by leveraging data driven insights and communication platforms to share best practices across plants, empowering teams to collectively address challenges, innovate and accelerate performance improvements
5:30pm - 5:35pm

Chair’s Closing Remarks

Dina Justice

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

5:35pm

6:15pm

7:30am - 8:25am

Registration & Breakfast

7:45am - 8:20am

Panel: Enabling Patient Safety & A Culture of Quality

Vishaka Rajaram

Vishaka Rajaram

Senior Director, Quality

Veeva MedTech

Jessica Smith

Jessica Smith

Corporate Vice President, Global Quality and Chief Regulatory Officer

Integra LifeSciences

Ian Purdy

Ian Purdy

Sr VP of RAQA

Intuitive Surgical

Executives in Quality, Regulatory, Operations, and Supply Chain play a critical role in shaping and sustaining a company’s culture. This panel will explore how leaders are driving cross-functional collaboration from the top down—breaking down silos, leveraging technology, and empowering teams to prioritize patient safety and a culture of quality.

8:25am - 8:35am

Chair’s Welcome Address

Dina Justice

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

8:35am - 9:10am

How a Global MedTech Leader Operates to Unlock the Future Medical Device Manufacturing

Viju Menon

Viju Menon

Group President, Global Quality & Operations

Stryker

  • Highlighting Stryker’s strategy to maintain strong growth while impacting more than 130 million patients globally
  • Exploring how Stryker works closely with its customers to improve healthcare while ensuring lifesaving and life-improving technologies remain available
  • Devise strategies to enhance operations efficiency and elevate standards to gain a competitive edge in an evolving industry
  • Discussing the evolution of manufacturing plants, technology initiatives and the importance of procurement transformation
9:10am - 9:45am

The Journey from Quality Remediation to Quality Excellence

David Kunz

David Kunz

Senior Vice President, Global Quality & Regulatory Affairs

Zimmer Biomet

  • Review Zimmer Biomet’s multi-year quality journey case study in transforming a global organization’s quality and compliance framework.  Faced with FDA Warning Letters and the need for significant remediation, the company embarked on a structured and disciplined approach to achieve sustained quality, compliance, and patient safety
  • Explore the key elements for a quality remediation playbook including leadership essentials, company culture, structured program management, and establishing a sustained go-forward quality system
  • Highlight the essential elements in a harmonized quality system supporting over 30 network sites driving quality excellence performance with improved efficiencies
9:50am - 10:25am

Supply Chain as the Enabler to Deliver on the Zero Unserved Patients Promise

Cory Resler

Cory Resler

Vice President Operations & Supply Chain

Philips Healthcare

  • We want to empower our customers with innovative solutions to support them in delivering exceptional care
  • Supply chain has a crucial role in delivering those innovative solutions. Every move counts
  • Cory will take you along the supply chain journey with a focus on Zero Unserved Patients leveraging the capabilities of the team
9:50am - 10:25am

Mastering Quality Control Essentials: Elevating Product Excellence

Robert Popp

Robert Popp

Vice President, Quality

Cook Medical

  • Unveil the core principles of quality control, illuminating its pivotal role in guaranteeing product safety and effectiveness
  • Explore the proactive nature of quality control processes, emphasizing their dedication to product inspection and rigorous testing
  • Dive into the metrics and methodologies that drive quality control, from establishing acceptance criteria to implementing swift corrective actions
  • Shine a spotlight on the critical role of trained personnel in meticulously assessing product defects and upholding impeccable quality standards
10:25am - 11:15am
  • 10:30 am – 10:50 am: Meeting Slot 8/Networking
  • 10:55 am – 11:15 am: Meeting Slot 9/Networking

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.

11:20am - 11:55am

The Data-Driven Future: Leveraging Insights to Stay Ahead in Healthcare

Michelle Menendez

Michelle Menendez

Senior Director Strategic Accounts

Premier, Inc.

Myla Maloney, MBA, BCMAS

Myla Maloney, MBA, BCMAS

Chief Growth Officer

Premier, Inc.

  • Learn how to leverage data to gain a comprehensive view of the market, identify untapped opportunities and optimize growth strategies
  • Explore the role of advanced analytics in enabling data-driven decisions that reduce costs, improve targeting, and accelerate time-to-market for new products
  • Understand how predictive tools anticipate demand surges, mitigate risks, and support inventory optimization for a competitive edge
  • See how data integration facilitates portfolio expansion, identifies growth in adjacent markets, and supports strategic partnerships for long-term success
12:00pm - 12:35pm

Fireside Chat: Chaos to Clarity: Driving Results and Engaging Teams Through Operational Rigor

Mark Mews

Mark Mews

Vice President, Global Supply Chain & Operations Leader

W. L. Gore & Associates

  • Effortlessly scaling production from small to commercial levels
  • Understanding turnkey capabilities that accommodate varying production volumes, from clinical to general use
  • Exploring quality-centric operations within certified manufacturing facilities adhering to FDA and ISO standards
  • Providing comprehensive end-to-end support from design validation through to commercial launch
12:35pm - 1:35pm

Lunch

12:35pm - 1:35pm

1:35pm - 2:10pm

Building a Quality Culture and Continuous Improvement

Anna Burla

Anna Burla

Global Senior Director Quality Compliance and Inspection Readiness

Novocure GmbH

  • Ensuring safety, compliance and innovation – How to build a strong quality culture and implementing continuous improvement practices
  • Successful implementation of quality culture & continuous improvement
  • Overcoming challenges in building a quality culture
  • Embrace quality at every level of the organization and adopt continuous improvement as a core value to stay competitive, compliant, and trusted in the marketplace
1:35pm - 2:10pm

How Smart Factories Can Help the US to meet Pandemic Resiliency

Alison Bagwell

Alison Bagwell

CEO

Nephron Nitrile

  • Leveraging technology for future-proof manufacturing
  • Creating a more resilient and agile manufacturing environment to withstand future pandemics or other global disruptions
  • Using AI/automation to optimize manufacturing processes and enhance resiliency
2:15pm - 2:55pm

Panel: Planning for Medical Device Manufacturing of the Future: What are the Five Big Things We Need to Talk About?

Cory Resler

Cory Resler

Vice President Operations & Supply Chain

Philips Healthcare

David Kunz

David Kunz

Senior Vice President, Global Quality & Regulatory Affairs

Zimmer Biomet

Joseph Koruth

Joseph Koruth

Head of Operations

Straumann Group

Chester Zelaya

Chester Zelaya

Senior Vice President Implant Network Global Operations

Edwards Lifesciences

Mark Mews

Mark Mews

Vice President, Global Supply Chain & Operations Leader

W. L. Gore & Associates

  • Innovation and R&D: Fueling our industry, R&D drives groundbreaking solutions. We will explore strategies to stay ahead in technology and product development
  • Manufacturing Processes and the Future: Optimizing processes for agility and sustainability is key. We adapt to innovations to lead the industry forward
  • Quality in the Age of AI/ML: Exploring the future of medical device manufacturing and how automation will reshape operations while maintaining quality standards and leveraging technologies for risk mitigation and improvement
  • Regulatory Compliance: Employing effective strategies for clearance and ongoing compliance
  • Supply Chain Resilience and Sustainability: Enhancing supply chain resilience and sustainability through strategies that leverage digitization and AI to bolster efficiency, traceability and fortify against unforeseen challenges
2:55pm - 3:05pm

Chair’s Closing Address

Dina Justice

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

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