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2026 Agenda

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February 23rd

3:15 pm

Badge Pick Up

3:55 pm - 4:55 pm WELCOME DAY SPECIAL CONTENT

Powerful Alliances: Working with Our Supply Chain Colleagues to Streamline Manufacturing Processes

Session Details Arrow Icon
  • Illustrating just how many ways supply chain capabilities impacts manufacturing performance
  • Discussing the intersection of manufacturing planning and consumer demand as a path to more agile supply chain transformations
  • Working with upstream suppliers and downstream distributors and retailers to support informed and collaborative decision-making
  • What does a true manufacturing-supply chain partnership look like in real-time on a day-to-day basis?
5:00 pm - 6:00 pm WELCOME DAY SPECIAL CONTENT

Panel: Five Big Issues We Need to Discuss in Medical Device Manufacturing

Laxmismita Sreedasyam

Director, Quality Engineering

Imperative Care

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

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  • Technology: How is it changing the way we work, and what should we be doing to better serve patients?
  • Leadership, Talent, and Workforce Development: How are the needs and wants of the people who make their careers with us changing, and what are we doing as an industry to attract and retain the people we need to succeed?
  • Product Development and Manufacturing: We build things that make people’s lives better, but how we create these products is growing ever-more challenging, exacting, and fast-paced. How can we continue to get better even as what we do becomes more complicated?
  • Regulatory Environment: What does exceeding expectations look like in a regulatory environment that is undergoing a time of disruption and turbulence? How do we keep our organizations and our patients safe and happy?
  • Controlling Costs: The world is getting more and more expensive, and we are being asked to do more with less while improving end results. How are we individually and collectively rising to meet this challenge?
6:00 pm

Drinks Reception

February 24th

Stream 1 Chair

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

Stream 2 Co-Chair

Executive to be Announced

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

Medical Device Manufacturing Leadership as an Art, as a Science, and as a Heavy Responsibility

Viju Menon

Group President, Global Quality & Operations

Stryker

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  • Remembering that whatever our day-to-day looks like, or how the business landscape changes, we do what we do for patients. We never get to take a break or cut corners, so how do we continue to improve and excel in our work no matter what?
  • Discussing how the new generation of tools and technologies is changing both how we work tactically and what we can achieve strategically. What are we doing to get the most out of these new capabilities?
  • Incorporating the experiences, best practices, and lessons learned in other manufacturing sectors to improve the productivity, quality, and reliability of our medical devices
  • How are we positioning and futureproofing our organizations for long-term success? What should we be learning about and thinking about and starting right now so we will be ahead of the curve on what comes next?
9:05 am - 9:40 am KEYNOTE

Focusing on the ‘How’ as We Improve Our Manufacturing Performance Through Standardized Global Operating Systems

Chester Zelaya

Senior Vice President Implant Network Global Operations

Edwards Lifesciences

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  • As we rethink our supply chains and add regional autonomy into our business strategies, let’s remember good ideas found anywhere can work everywhere. How do we make sure our best practices are applied throughout our organizations?
  • Creating and implementing a scientifically rigorous model to control both short- and long-term planning and execution of work
  • Highlighting the role of people as the catalysts and drivers of change within an organization
  • Standardizing business practices across global operations and encouraging a culture of Continuous Improvement
  • Illustrating process optimization in action and discussing what the next steps will look like
9:45 am - 10:20 am Workshops
Stream One

Maximizing Return on Automation: Benchmarking Operational and Business ROA

Executive to be Announced

MasterControl, Inc

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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
Stream Two

Speed to Market: The Power of Centralized Data and the Promise of AI

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  • Understanding the challenges Medical Device companies face to develop, build, and deliver the right products on time every time, and building a robust and resilient system to rationalize and strategize that process
  • Centralizing data from various systems, teams and locations to minimize business, quality and technical risk
  • Harmonizing data to enhance collaboration, scalability and data integrity
  • Leveraging advanced analytics and AI to gain rapid, data-driven insights
10:25 am - 12:05 pm Pre-Arranged One-To-One Meetings Arrow Icon

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

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

Adolfo Amador

Operational Excellence Manager

ICU Medical

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  • 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

Streamlining Operations and Simplifying Regulatory Compliance

David Kunz

Senior Vice President, Global Quality & Regulatory Affairs

Zimmer Biomet

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  • Identifying where ‘the way it has always been done’ is holding your organization back
  • Automating processes to track assets, inventory, throughput, and schedule preventative maintenance
  • Connecting business systems to eliminate duplicate data entry and unnecessary overlaps in departmental responsibilities
  • Customizing data collection and reporting to meet specific business, quality, and regulatory compliance requirements
  • Upgrading systems for new functionality while minimizing downtime
12:45 pm - 1:45 pm

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.

Strategies for Tariff Disruption: What is Everyone Else Doing?

Adjusting Just-in-Time Supply Chain Models to Accommodate Today’s Disruptions

The Many Hats of a QA/QC Leader in a Smaller Business

Always Prepared: Building an Organization that is Ready for Unannounced Audits

Application of AI in Quality: Approaches, Challenges, and Case Studies

Quality and Compliance Considerations: Comparing and Contrasting Large Versus Small Organizations

The Labor and Talent We Need Now, Tomorrow, and in the Decades to Come

Getting the Most ROI Out of The Tools and Technologies We Buy

1:45 pm - 2:20 pm Case Studies
Stream One - Manufacturing & Supply Chain

Moog MDG Costa Rica’s Transformation Road Map, Our Results, and Where We Are Going Next

Adriana Quesada Miranda

Sustainability Program Manager

Moog Medical Devices

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  • Where did we begin, and how has our Operational Excellence journey shaped out story?
  • Sharing how our facility thinks about its people, the safety, health, and environment, quality standards, productivity, financial performance, and operational excellence. How does Moog invest its resources to foster a culture of Continuous Improvement that drives us to do better across all of these important issues?
  • Illustrating how leaders shape the conversation, drive change, and make new ideas and innovations permanent best practices
  • Highlighting examples of success with lessons learned from our experiences that other organizations can apply to their own projects and processes
  • What is next for us?
Stream Two - Quality & Regulatory Compliance

Promoting Quality Excellence and Cultivating a Culture of Proactive Operations

Jason Busch

VP Quality Assurance & Regulatory Affairs

Medtronic

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  • Implementing strategies to motivate teams to prioritize quality, fostering a culture centered around excellence
  • Exploring seamless methods to integrate stringent quality standards into manufacturing processes
  • Implementing robust monitoring and control measures to ensure quality standards are upheld throughout operations
  • Employing strategies to empower workforce members to take ownership of quality control measures
2:25 pm - 3:00 pm Workshops
Stream One

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

Executive to be Announced

Honeywell Life Sciences

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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.
Stream Two

A Journey into Smart Factory Implementation

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  • 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 Arrow Icon

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.

  • 3:05 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

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

Max Urbini

Senior Vice President Operational Performance

BD

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  • 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?
4:55 pm - 5:30 pm KEYNOTE

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

Terry Walsh

SVP Global Operations

Beckman Coulter

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  • 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
5:30 pm - 5:35 pm

Chair’s Closing Remarks

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

5:35 pm

Drinks Reception

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

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  • 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

Encouraging Ambition: What Does the Future of Medical Device Manufacturing Leadership Look Like?

Chuck Medovich

VP & Chief Quality Officer

Johnson & Johnson

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  • What is the next “Big Idea” for our industry? Where should we go from here?
  • Re-examining the accepted wisdoms and sacred cows of how we should organize and manage a medical device manufacturing organization
  • Setting far-reaching goals that challenge us about people, performance, sustainability, and marketshare
  • Building bridges between our manufacturing and technical operations leadership teams and other facets of the company
  • Taking local innovations and initiatives and translating them up into the global culture of our companies
  • Do you know who your successors will be? What are you doing to prepare the next generation to step into your shoes and then be able to walk even further in them?
9:10 am - 9:45 am KEYNOTE

AI and Medical Device Manufacturing — What Are We Doing, and What Comes Next?

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  • Taking the hype out of the Artificial Intelligence conversation to focus on the science, not the science fiction
  • Demonstrating the real use cases where AI is already producing positive results. What are we learning from these projects and programs?
  • Talking about the people part of making these new tools and capabilities work. How are we as leaders handling the soft skills of change management to win hearts and minds and get buy-in from our teams?
  • Making the business case for rational, realistic, and impactful transformations in our processes to leverage what the next generation of Data Analytics tools with intuitive and interactive UI can really offer us now and in the near future
  • What is success going to look like in the short term, and when are we going to allow ourselves to set ‘big goals’ based on the results we are seeing?
9:50 am - 10:25 am Case Studies
Stream One - Manufacturing & Supply Chain

Proactivity – the Future of Quality

Natalia Mendez

VP of Operations - Ultrasound ISC Leader

Philips

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  • Using Human and Organizational Performance (HOP) in designing quality into the end-to-end supply processes, and describing how to implement effectively
  • Adopting risk-based approaches to identify and mitigate potential issues, maintaining a focus on critical processes and regulatory compliance
  • Fostering a culture of Continuous Improvement, leveraging digital tools to optimize processes and enhance overall quality management
  • Establish a proactive approach to regulatory compliance and production effectiveness using appropriate problem solving and conducting regular self-assessments
Stream Two - Quality & Regulatory Compliance

Mastering Clearance and Approvals: A Guide to Navigating Regulatory Waters

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  • What is involved today to navigate the evolving regulatory terrain involved in medical device clearance and approvals that spans multiple regulatory bodies and compliance benchmarks?
  • Comparing and contrasting innovative methodologies to accelerate approval processes without compromising regulatory integrity
  • Exploring strategies such as pre-submission consultations and technology-driven documentation management systems
  • Highlighting the pivotal role of manufacturing quality in securing regulatory greenlights, with a focus on robust quality management systems and adherence to good manufacturing practices
  • Delivering insights from real-world examples that offer tangible solutions for meeting and exceeding regulatory expectations while preserving manufacturing efficiency and compliance standards
10:25 am - 11:15 am Pre-Arranged One-To-One Meetings Arrow Icon

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 – 10:50am: Meeting Slot 8/Networking
  • 10:55am – 11:15am: Meeting Slot 9/Networking
11:20 am - 11:55 am Workshops
Stream One

Digital Machine Health: Listening to the Heartbeat of Your Business

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  • Hear how Machine Health enables leading manufacturers to harness the power of AI and machine learning to reduce unplanned downtime, improve OEE, and increase plant collaboration and productivity
  • Why Machine Health is the key to digital transformation in manufacturing and how leading manufacturers are seeing exponential value within weeks of deployment
  • How is Industry 4.0 changing the way manufacturers interact with their equipment?
  • Going beyond the ordinary reactive to proactive/preventative transition to truly understand the heath of your machinery throughout its lifecycle
  • Harnessing the power of AI and Machine Learning to improve overall equipment effectiveness (OEE), reduce unplanned downtime, and increase plant productivity
  • Bringing real-time visibility to what is happening in your plant at every stage of your processes
Stream Two

Demand Modeling and Service Planning in the Age of Analytics

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  • Learn how demand modeling is quickly supplanting demand forecasting
  • Understand the power of your inventory – It’s an asset
  • See how forecasting aligns with demand planning to support an executable S&OP vision
  • Balancing demand and supply to make agile trade-offs
  • Ensuring that you, “Get what you plan”
12:00 pm - 12:35 pm Case Studies
Stream One - Manufacturing & Supply Chain

Leading a Technical Organization Through Uncertainty

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  • Discussing the drivers of uncertainty and options to mitigate or circumvent their influence on your operations
  • Managing Launch Demand through multiple scenarios
  • Change Management as the Soft Tool that makes the hard jobs possible
  • Remembering that your company is a collection of people, and engaging and motivating your team and your leaders is the only way to move forward
Stream Two - Quality & Regulatory Compliance

Mastering Quality Control Essentials: Elevating Product Excellence

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  • Refining quality control processes to enhance product safety, compliance, and overall excellence
  • Exploring effective strategies for evaluating current quality control methodologies and pinpointing areas for improvement, ensuring ongoing enhancement and regulatory compliance
  • Highlighting critical aspects of quality control processes, such as role definition, collaboration promotion, and robust change management implementation
  • Discussing actionable tactics for fostering a culture of quality, fostering collective commitment to excellence and continual improvement
  • Gaining valuable insights from real-world examples and time-tested best practices, illustrating successful quality control initiatives driving innovation and excellence in the industry
12:35 pm - 1:35 pm

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.

Understanding Asset Lifecycle Management to Control Costs and Maximize Productivity

Becoming a Leader, Growing as a Leader, and Mentoring Future Leaders

Riding the Wave of Disruption by Integrating Data, Decisions, and Operations

Scaling Smart: Strategies for Sustainable Growth in Medical Device Manufacturing

1:35 pm - 2:10 pm KEYNOTE

Qualifying and Validating the Quality Culture and QA/QC Processes of M&A Candidates and New Partners

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  • Identifying the key capabilities and best practices your organization requires of a potential partner
  • Evaluating and making recommendations on the performance of M&A candidates
  • How do we bring new organizations into the fold to improve their capabilities while preserving what they do best?
  • Facilitating communication and collaboration with new partners to ensure Continuous Improvement in productivity, quality, and regulatory compliance
  • Building bridges between their Quality Culture and ours so both sides benefit before, during, and after our organizations come together
2:10 pm - 2:45 pm KEYNOTE

Our Patient-Centric Transformation Journey

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  • Acknowledging that all medical device manufacturers must be patient-centric, and so creating a flexible, scalable manufacturing and supply chain network with our patients’ needs at the core is not a competitive advantage: It is a matter of life and death for our company
  • Discussing the rewards and challenges of building and maintaining a high-performing patient-centric supply chain organization
  • Establishing transparency and visibility throughout our network so we can better communicate, collaborate, and coordinate on delivering what we need where we need it on time, every time
  • Where do we go from here to stay on top and raise what we currently consider to be our ceiling?
2:45 pm - 2:50 pm

Chair’s Closing Remarks

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

Sessions From Previous Years

The Journey from Quality Remediation to Quality Excellence

The Journey from Quality Remediation to Quality Excellence

Mar 3, 2025
Are Sustainable Supply Chains a Myth?

Are Sustainable Supply Chains a Myth?

Mar 3, 2025
Panel Discussion: Navigating the Journey to Quality and Regulatory Mastery

Panel Discussion: Navigating the Journey to Quality and Regulatory Mastery

Mar 3, 2025
Performance Management Beyond Limits: Elevating Operations Excellence Globally

Performance Management Beyond Limits: Elevating Operations Excellence Globally

Mar 3, 2025
Building a Quality Culture and Continuous Improvement

Building a Quality Culture and Continuous Improvement

Mar 3, 2025
Fireside Chat: Chaos to Clarity: Driving Results and Engaging Teams Through Operational Rigor

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

Mar 3, 2025
Panel: Planning for Medical Device Manufacturing of the Future: What are the Five Big Things We Need to Talk About?

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

Mar 3, 2025
How a Global MedTech Leader Operates to Unlock the Future Medical Device Manufacturing

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

Mar 3, 2025
The Data-Driven Future: Leveraging Insights to Stay Ahead in Healthcare

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

Mar 3, 2025
Supply Chain as the Enabler to Deliver on the Zero Unserved Patients Promise

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

Mar 3, 2025
From Complaints to Patient Breakthroughs: Harnessing AI to Capture Voice of Customer and Accelerate Medical Device Innovation

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

Feb 28, 2025
Regulatory Strategy: A Comprehensive Guide to Navigating the Global Market

Regulatory Strategy: A Comprehensive Guide to Navigating the Global Market

Feb 28, 2025
Fireside Chat: Transforming Supply Chains into Competitive Advantages: A Strategic Vision for Medtronic

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

Feb 28, 2025
Maximizing Return on Automation: Benchmarking Operational and Business ROA

Maximizing Return on Automation: Benchmarking Operational and Business ROA

Feb 28, 2025
Transforming Supply Chain Quality Processes in the Digital Era

Transforming Supply Chain Quality Processes in the Digital Era

Feb 28, 2025
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