Agenda - Medical Device Manufacturing Excellence Summit

5:00pm - 6:00pm

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

Session Details

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

6:00pm

7:30am - 8:15am

8:15am - 8:20am

Opening Remarks and Important Announcements

8:20am - 8:30am

Chair’s Welcome Address

8:30am - 9:05am

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

Viju Menon

Group President Global Quality & Operations

Stryker

Session Details

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

9:05am - 9:40am

Evolving Medical Device Landscape: The Path of Digital Transformation

Paul Connolly

President of Global Operations

Smith+Nephew

Session Details

Aligning IT strategies to tackle regulatory, organizational, and market hurdles
Streamlining fundamental processes for quality management, FDA compliance, and value chain mapping
Partnering with industry leaders to drive successful projects on a global scale.
Realizing advantages such as optimized time-to-market, increased agility, and heightened innovation

9:45am - 10:20am

Supply Chain Resilience: Strategies for Mitigating Disruptions and Ensuring Continuity

Paudie O’Connor

SVP Global Supply Chain

Boston Scientific

Session Details

Vendor Diversification: Minimizing Dependency Risks Through Multiple Supplier Partnerships
Digital Supply Chain Solutions: Improving Visibility and Transparency for Better Risk Management
Scenario Planning and Contingency Strategies: Preparing for and Responding to Unforeseen Events
Collaborative Risk Management: Strengthening Partnerships Across the Supply Chain

9:45am - 10:20am

Riding the Regulatory Wave: Navigating the Latest in Medical Device Compliance

Scott House

Senior Vice President, Quality Assurance, Regulatory and Engineering Services

Abbott

Session Details

Explore the dynamic landscape of evolving regulations to ensure seamless compliance amidst recent changes
Engage in collaborative industry efforts to share best practices and insights, fostering a collective approach to navigating regulatory updates effectively
Discover and implement agile strategies for integrating regulatory changes swiftly while upholding the highest standards of product quality
Harness the potential of tech-driven regulatory alignment through AI and IoT, revolutionizing compliance practices to achieve enhanced transparency and efficiency

10:25am - 12:05pm

Pre-Arranged One-to-One Meetings

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

Innovative Production Solutions: Enhancing Efficiency and Quality in Medical Device Manufacturing

Session Details

Advanced Automation: Streamlining Production Processes for Improved Efficiency
Digital Twin Technology: Optimizing Design and Testing for Faster Time-to-Market
Sustainable Manufacturing Practices: Reducing Environmental Footprint While Boosting Productivity
Smart Factory Integration: Implementing IoT and AI for Predictive Maintenance

12:10pm - 12:45pm

Regulatory Intelligence: Staying Ahead in a Rapidly Changing Landscape

Session Details

Global Regulatory Updates: Navigating the Latest FDA, EU MDR, and ISO Requirements
Proactive Compliance Strategies: Anticipating Regulatory Changes and Planning Accordingly
Compliance as a Competitive Advantage: Leveraging Regulatory Excellence for Market Success
Regulatory Intelligence Platforms: Harnessing Data Analytics for Regulatory Insights

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.

Prioritizing Human-Centered Design for Enhanced Device Usability

Embracing the Growth of Telehealth and Remote Patient Monitoring

Addressing Sterilization Challenges in Complex Device Designs

Utilizing Continuous Monitoring and Predictive Maintenance

Excelling in Software Medical Device Design Quality and Compliance

Facilitating Remote Patient Monitoring and Data Collection Efforts

1:45pm - 2:20pm

Fortifying Your Supply Chain: Dynamic Strategies for Unwavering Resilience

Session Details

Delve into robust supplier qualification processes and targeted audits to maintain strict adherence to quality and regulatory standards
Understand the significance of material traceability, risk mitigation, and contingency plans for product integrity
Discover the power of supplier collaboration, incident response, and planning for quality and safety
Emphasize proactive risk management and quality commitment for sustained compliance and resilient supply chains

2:25pm - 3:00pm

Streamlining Compliance for Global Diagnostic Companies

Session Details

Investigating the importance of adopting a comprehensive regulatory platform to maintain a competitive edge
Strategies for expediting international submissions to enhance market access
Exploring access to submission-ready templates tailored to specific countries’ regulatory requirements

2:25pm - 3:00pm

Maximizing Workflow Efficiency with Data Intelligence

Session Details

Strategies for enhancing signal generation efficiency in wideband multi-channel applications
Exploring emerging technologies and standards in electronic design and testing to stay ahead
Implementing workflow automation to seamlessly integrate design, emulation, and testing processes

3:05pm - 4:15pm

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

4:20pm - 4:55pm

Forging Strategic Partnerships: Leveraging Collaboration for Market Expansion and Innovation

Session Details

Driving market expansion through collaboration and exploring partnerships, distribution agreements, and acquisitions drive market reach and customer diversification
Fostering collaboration innovation by combining diverse expertise and resources, leading to novel product developments and technological advancements
Enhancing technological capabilities through partnerships via shared research, licensing agreements, and acquisitions, strengthening competitive positions
Analyzing growth strategies to empower companies to navigate market shifts and capitalize on emerging opportunities for sustainable growth

4:55pm - 5:30pm

Panel Discussion: Fostering Diversity, Equity, and Inclusion

Session Details

Explore the evolving definitions of diversity, equity, and inclusion, highlighting their importance in ensuring effective and inclusive medical interventions
Examine the shifting landscape of diversity and inclusion in clinical research, considering changing demographics and the necessity for representative participant samples
Review diverse initiatives in the medical device and healthcare sectors aimed at promoting inclusivity in clinical trials, including outreach programs and community engagement efforts
Discuss the utilization of digital health technologies to enhance diversity in clinical trials, exploring how these tools facilitate broader participant recruitment and engagement across diverse populations

5:30pm - 5:35pm

Chair’s Closing Remarks

5:35pm

7:30am - 8:25am

Registration & Breakfast

7:45am - 8:20am

Unlocking Personalized Patient Care through Software Solutions

Session Details

Incorporating strategic insights, intentional design, and innovative engineering to facilitate scalability
Empowering healthcare providers to deliver exceptional patient care through the implementation of software solutions
Fusing diverse insights to drive digital transformation in healthcare delivery and improve patient outcomes

8:25am - 8:35am

Chair’s Welcome Address

8:35am - 9:10am

Unleashing the Potential of Additive Manufacturing in Medical Device Innovation

Session Details

Exploring how additive manufacturing, or 3D printing, is revolutionizing the medical device manufacturing landscape, offering customization and precision
Discussing the effect of additive manufacturing on the industry with traditional manufacturing methods being replaced, enabling the creation of innovative medical device designs
Showcasing how additive manufacturing processes allows us to maximize CAD capabilities, improving precision, scalability, and cost-effectiveness in manufacturing
Highlighting the importance of staying informed about advancements in additive manufacturing, navigate regulatory considerations, and embrace collaborative opportunities for innovation in healthcare

9:10am - 9:45am

Ensuring Cybersecurity in Medical Devices: Compliance Strategies for Industry Leaders

Session Details

Analyze the critical fusion of cybersecurity focusing on regulatory intricacies and proactive compliance measures
Provide a comprehensive overview of existing regulatory parameters, highlighting key guidelines and standards relevant to cybersecurity
Offer pragmatic approaches to achieve compliance with cybersecurity regulations, emphasizing patient safety as a paramount concern
Anticipate future regulatory trajectories and empower executives to navigate forthcoming compliance challenges in the medical device arena

9:50am - 10:25am

Driving Innovation in Medical Device Manufacturing: Technologies Shaping the Future

Session Details

Additive Manufacturing Advancements: Exploring the Potential of 3D Printing in Healthcare
Robotics and Cobots: Enhancing Precision and Safety in Production Lines
Material Science Innovations: Developing Next-Generation Biomaterials for Enhanced Performance
Augmented Reality Applications: Revolutionizing Training and Maintenance Processes

9:50am - 10:25am

Navigating Regulatory Landscapes: Ensuring Compliance and Quality Assurance in Manufacturing

Session Details

Regulatory Compliance Strategies: Adapting to Evolving FDA and International Standards
Quality Management Systems: Implementing Robust Processes for Consistent Product Quality
Risk Management Best Practices: Mitigating Risks Across the Supply Chain
Validation and Verification Procedures: Ensuring Product Integrity Throughout the Lifecycle

10:25am - 11:15am

Pre-Arranged One-to-One Meetings

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

11:20am - 11:55am

Investing in Tomorrow: Funding Trends and Opportunities in Healthcare Technology

Session Details

Explore current trends in funding and investment within the healthcare technology sector, encompassing a wide range of innovative solutions and platforms
Discuss emerging opportunities for investment in healthcare technology, from digital health startups to established companies developing groundbreaking technologies
Provide insights on key factors influencing investment decisions, including market trends, regulatory landscapes, and technological advancements, and strategies for securing funding to drive innovation and growth in the healthcare industry

11:20am - 11:55am

Optimizing Testing and Inspection Processes with Automated Quality Control Systems

Session Details

Explore the cutting-edge technologies powering automated quality control systems, revolutionizing testing and inspection processes in medical device manufacturing
Learn how these systems improve efficiency by automating repetitive tasks, reducing manual intervention, and minimizing the risk of human error
Discover how automated quality control systems enhance accuracy through precise measurement capabilities, real-time data analysis, and advanced algorithms
Understand the reliability benefits offered by these systems, including consistent performance, traceability of results, and adherence to regulatory standards

12:00pm - 12:35pm

Streamlining Your Product’s Path to Success with Manufacturing Solutions

Session Details

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

12:00pm - 12:35pm

Continuous Improvement in Quality Management: Strategies for Operational Excellence

Session Details

Lean Six Sigma Applications: Driving Efficiency and Eliminating Waste in Manufacturing Processes
Quality Culture Development: Empowering Employees to Champion Quality Initiatives
Real-Time Quality Monitoring: Leveraging IoT and Big Data Analytics for Proactive Quality Assurance
Agile Quality Management Methodologies: Adapting Quickly to Changing Business Needs

12:35pm - 1:35pm

Overflow Lunch Seating

12:35pm - 1:35pm

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.

Advancing Performance Enhancement with Innovative Training Practices

Excelling in Patient Data Management and Workflow Technology Integration

1:35pm - 2:10pm

Innovating Training and Education Strategies to Revolutionize Staff Training and Development

Session Details

Engage in immersive workshops, simulation training, and virtual reality experiences to keep teams at the forefront of the evolving medical device landscape
Foster a culture of collaboration and innovation, enabling seamless adoption of new technologies and methodologies
Harness the power of AI and machine learning to personalize training modules according to individual learning styles and job roles
Tailor programs to meet the unique requirements of various departments, including R&D, quality assurance, production, and regulatory affairs, ensuring comprehensive skill development across the organization

1:35pm - 2:10pm

Key Takeaways: Unveiling Quality Control Essentials

Session Details

Delving into the core principles of quality control, exploring its essential role in ensuring product safety and efficacy
Examining the reactive nature of quality control processes and their focus on product inspection and testing
Learning about the metrics and methodologies employed in quality control, including acceptance criteria and corrective actions
Highlighting the importance of trained personnel in accurately assessing product defects and maintaining quality standards

2:10pm - 2:50pm

Panel: Looking Backwards, Looking Forwards: Maximizing Our Impact on the Future of Medicine

Session Details

Reflect on Industry Evolution: Assess the changes in the medical device manufacturing ecosystem and their impacts on innovation, R&D, and regulatory processes
Collaborative Strategies: Address fragmentation challenges by enhancing communication, collaboration, and idea consolidation for collective success
Future Business Ecosystem: Discuss reasons for establishing new companies and envision the growth of the industry
Production Platforms for New Modalities: Debate on suitable production platforms for emerging modalities and meeting evolving market demands efficiently
Next Steps for Established Platforms: Explore strategies to efficiently serve large markets while ensuring regulatory compliance and patient safety using existing platforms

2:50pm - 3:00pm

2025 Agenda

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

Opening Remarks and Important Announcements

Chair’s Welcome Address

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

Viju Menon

Evolving Medical Device Landscape: The Path of Digital Transformation

Paul Connolly

Supply Chain Resilience: Strategies for Mitigating Disruptions and Ensuring Continuity

Paudie O’Connor

Riding the Regulatory Wave: Navigating the Latest in Medical Device Compliance

Scott House

Innovative Production Solutions: Enhancing Efficiency and Quality in Medical Device Manufacturing

Regulatory Intelligence: Staying Ahead in a Rapidly Changing Landscape

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.

Prioritizing Human-Centered Design for Enhanced Device Usability

Embracing the Growth of Telehealth and Remote Patient Monitoring

Addressing Sterilization Challenges in Complex Device Designs

Utilizing Continuous Monitoring and Predictive Maintenance

Excelling in Software Medical Device Design Quality and Compliance

Facilitating Remote Patient Monitoring and Data Collection Efforts

Fortifying Your Supply Chain: Dynamic Strategies for Unwavering Resilience

Streamlining Compliance for Global Diagnostic Companies

Maximizing Workflow Efficiency with Data Intelligence

Forging Strategic Partnerships: Leveraging Collaboration for Market Expansion and Innovation

Panel Discussion: Fostering Diversity, Equity, and Inclusion

Chair’s Closing Remarks

Registration & Breakfast

Unlocking Personalized Patient Care through Software Solutions

Chair’s Welcome Address

Unleashing the Potential of Additive Manufacturing in Medical Device Innovation

Ensuring Cybersecurity in Medical Devices: Compliance Strategies for Industry Leaders

Driving Innovation in Medical Device Manufacturing: Technologies Shaping the Future

Navigating Regulatory Landscapes: Ensuring Compliance and Quality Assurance in Manufacturing

Investing in Tomorrow: Funding Trends and Opportunities in Healthcare Technology

Optimizing Testing and Inspection Processes with Automated Quality Control Systems

Streamlining Your Product’s Path to Success with Manufacturing Solutions

Continuous Improvement in Quality Management: Strategies for Operational Excellence

Overflow Lunch Seating

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.

Advancing Performance Enhancement with Innovative Training Practices

Excelling in Patient Data Management and Workflow Technology Integration

Innovating Training and Education Strategies to Revolutionize Staff Training and Development

Key Takeaways: Unveiling Quality Control Essentials

Panel: Looking Backwards, Looking Forwards: Maximizing Our Impact on the Future of Medicine

Chair’s Closing Address

Sessions From PMWS

Download The Agenda PDF

Summit Floorplan

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