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2027 Agenda

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February 22nd

3:00 pm

REGISTRATION

3:30 pm - 4:20 pm WELCOME DAY SPECIAL CONTENT

Panel: Supply Chain and Manufacturing Crisis Roadmap for Disruptions Shortages and Geopolitical Events

Session Details Arrow Icon
  • Capturing key lessons learned from recent disruptions, highlighting what has improved and what still consistently fails under stress
  • Identifying recurring breakdowns in both manufacturing and supply chain execution during crisis events
  • Exposing structural bottlenecks such as inflexible capacity, constrained supplier networks, and slow decision escalation
  • Understanding where coordination between manufacturing, procurement, and logistics breaks down in real scenarios
  • Translating lessons and gaps into clear priorities for building a more responsive and resilient end-to-end operating model
4:25 pm - 5:00 pm WELCOME DAY SPECIAL CONTENT

Cost, Risk, or Service: What Actually Drives Manufacturing & Supply Chain Decisions Today?

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  • Why traditional “cost optimization” models are no longer sufficient in a world shaped by geopolitical volatility, supplier fragility, and regulatory intensity
  • How leading executives are reframing decisions from cost vs. service trade-offs to enterprise risk-adjusted value creation across the network
  • The growing reality that service performance is now a competitive differentiation, but only when it is resilient, not just fast or flexible
  • Why functional silos (finance, operations, quality, supply chain) still distort enterprise decision-making and how this leads to suboptimal global network outcomes
  • How top-performing organizations are moving toward integrated, scenario-based decision frameworks that dynamically balance cost, risk, and service in real time across the value chain
5:05 pm - 6:00 pm WELCOME DAY SPECIAL CONTENT

Panel: When Quality Fails: Managing Recalls, Shortages, Systemic Risk and Other Vulnerabilities

Kevin Rooney

VP of Product Quality

Intuitive

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  • Root causes behind recent quality failures including process drift, supplier variability, and control breakdowns
  • How contamination events and recalls expose deeper fragility across interconnected supply networks
  • Addressing the compounding impact of quality issues on shortages, service levels, and patient access
  • Examining where quality systems break down between manufacturing, suppliers, and distribution
  • Why traditional compliance approaches are not enough to prevent repeat failures
  • Building proactive risk detection systems that identify issues before they escalate into recalls
  • Strengthening end-to-end quality ownership across manufacturing, supply chain, and regulatory functions
6:00 pm

Drinks Reception

6:30 pm

Executive dinner

(By Invite Only)

February 23rd

Stream 1 Chair
Stream 2 Co-Chair

Executive to be Announced

Veeva MedTech

Stream 3 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 & Important Announcements

8:20 am - 8:30 am

Chair’s Welcome Address

8:30 am - 9:05 am KEYNOTE

From Breakthrough to Scale: Building Confidence in Innovation from Development Through Global Reach

Scott Cundy

Senior Vice President and Chief Quality, Development, and Innovation Officer

Medtronic

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  • Designing innovation for scale from day one by resolving the tension between speed, manufacturability, and global execution readiness
  • Treating quality as a continuous, connective system across development, manufacturing, operations, and post-market performance to ensure consistency, reliability, and trust at global scale
  • Aligning innovation velocity with manufacturing capacity and supply chain readiness to reduce late-stage friction, avoid delays, and prevent redesign driven by execution constraints
  • Turning real-world performance, operational data, and supply signals to continuously refine design decisions and strengthen product reliability and lifecycle outcomes
  • Driving enterprise-wide alignment across innovation, quality, manufacturing, operations, and supply networks to enable faster decisions with shared accountability for risk, safety, and performance
9:10 am - 9:45 am Case Studies
Stream One - Manufacturing & Operations

Rewiring the MedTech Manufacturing Footprint: Resilience, Cost, and Control

Dale Pease

Group VP, Supply Chain Operations, Orthopaedics

Stryker

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  • Rebalancing manufacturing footprint decisions across cost, control, and resilience imperatives to avoid over-indexing on any single objective
  • Reassessing nearshoring vs. global manufacturing specialization based on true total cost, service levels, regulatory complexity, and risk exposure
  • Optimizing production network design and plant utilization to improve cost efficiency while maintaining flexibility and redundancy
  • Strengthening operational control across multi-site manufacturing networks through standardization, visibility, and tighter execution discipline
  • Integrating supply-side resilience into operations planning to ensure material availability, reduce bottlenecks, and improve production stability
  • Embedding scenario-based decision-making into manufacturing and operations governance to proactively manage tariffs, disruptions, and shifting demand patterns
Stream Two - Supply Chain

The Talent–Automation Gap: Addressing Talent Shortages and the Reality of Automation in Regulated Manufacturing

Miguel Aldana

Sr. Vice President Global Supply Chain and Manufacturing

Siemens Healthineers

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  • Confronting persistent skilled labor shortages and their direct impact on throughput, quality, and scalability in regulated manufacturing
  • Closing the gap between automation ambition and operational reality, particularly in highly controlled, compliance-driven environments
  • Understanding where automation breaks down, from validation constraints to variability that still requires human expertise
  • Balancing workforce strategy: upskilling critical talent versus redesigning roles alongside automation
  • Integrating automation without disrupting quality, compliance, or existing workflows
  • Building a future-ready workforce model that aligns talent pipelines with increasing digital and automation demands
Stream Three - Quality & Regulatory Compliance

Global Regulatory Strategy: Building a Scalable, Integrated Compliance Advantage

Dina Justice

Vice President, Regulatory Affairs

Terumo Medical Corporation

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  • Shifting from fragmented, country-by-country compliance to a unified global regulatory strategy that accelerates multi-market access
  • Embedding regulatory intelligence early to anticipate policy shifts and shape portfolio and market-entry decisions proactively
  • Standardizing core submission structures (modular dossiers, reusable evidence packages) to reduce duplication and speed approvals
  • Redesigning the operating model to balance global governance with regional execution and authority engagement
  • Integrating regulatory planning into the full product lifecycle, from design and development through post-market surveillance, to enable continuous compliance and portfolio velocity
9:50 am - 10:25 am Workshops
STREAM 1 WORKSHOP

CI at Scale: Moving from Reactive Improvement to Built-In Performance in Manufacturing Networks

Executive to be Announced

MasterControl, Inc

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  • Shifting Continuous Improvement from a reactive model driven by failures and KPI misses to a proactive system designed for continuous learning and prevention
  • Reframing recurring operational issues as signals of underlying system and network design gaps, rather than isolated site-level execution failures
  • Moving from local optimization to end-to-end network thinking, where performance outcomes are shaped by how processes, flows, and governance structures are designed
  • Elevating operational data from reporting output to structured feedback that informs system learning and decision-making
  • Building mature CI environments that continuously convert everyday operational signals into structural improvements in work design, governance, and operating models
STREAM 2 WORKSHOP

Multi-Year Road Mapping for Supply Chain Modernization and ROI

Executive to be Announced

RQM+

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  • Outlining the strategic vision: modernize supply chain capabilities to drive resilience, agility, and measurable business impact
  • Prioritizing initiatives based on ROI and risk to target greatest efficiency, cost reduction, or service improvement
  • Developing a phased, multi-year roadmap balancing quick wins with foundational investments
  • Leveraging technology for end-to-end visibility and predictive insights to proactively manage disruptions and optimize performance
  • Ensuring executive sponsorship to align priorities, allocate resources, and maintain accountability
  • Addressing barriers: resistance to change, legacy systems, skills gaps, and interdependent processes
  • Embedding governance and CI mechanisms to track ROI, course-correct, and sustain long-term outcomes
STREAM 3 WORKSHOP

US FDA Inspections, QMSR, VIP, and MDSAP: Trends, Triggers, and Building Continuous Quality Readiness

Executive to be Announced

Rockwell Automation

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  • What is driving FDA inspection trends today, including key triggers such as data integrity, CAPA effectiveness, supplier control, and post-market signals
  • How QMSR alignment with ISO 13485 is changing documentation expectations, audit readiness, and global regulatory harmonization
  • The role of FDA’s Voluntary Improvement Program (VIP) in shifting from reactive compliance to proactive, system-level quality improvement
  • What MDSAP audits consistently reveal about gaps in quality system maturity across manufacturing, suppliers, and global operations
  • How leading organizations are building continuous inspection readiness through real-time quality signals, risk-based monitoring, and integrated QMS visibility
10:30 am - 12:10 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.

  • 10:35 am – 10:55 am: Meeting Slot 1/Networking
  • 11:00 am – 11:20 am: Meeting Slot 2/Networking
  • 11:25 am – 11:45 am: Meeting Slot 3/Networking
  • 11:50 am – 12:10 pm: Meeting Slot 4/Networking
12:15 pm - 12:50 pm Case Studies
Stream One - Manufacturing & Operations

The Smart Factory Gap in MedTech: Why Digital Capability Isn’t Becoming Operational Performance

Marc Gelnett

Executive Vice President of Operations

CooperSurgical

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  • The widening gap between smart factory investment and measurable operational performance in MedTech manufacturing, and why it persists despite heavy digital spend
  • Why visibility, AI, and analytics have not translated into faster execution or better frontline decision-making, despite improved data availability
  • How structural fragmentation across OT, IT, Quality, and labour models is undermining end-to-end manufacturing control and consistency
  • Why pilot success fails to scale, and what changes in standardization, governance, and replication are required to industrialize digital across sites
  • What leading manufacturers are doing differently: embedding digital into operating rhythms, redefining decision rights, and aligning accountability across the manufacturing system
Stream Two - Supply Chain

Supply Network Architecture: Transitioning from Linear Chains to Dynamic Ecosystems

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  • Redefining competitive advantage at the network level: shifting from optimizing individual supply chain nodes to architecting end-to-end networks that drive speed, resilience, and strategic optionality
  • Embedding structural flexibility into design: building supply networks that can reconfigure sourcing, production, and distribution pathways in response to geopolitical, demand, and capacity shifts
  • Aligning network design with enterprise strategy: ensuring supply chain architecture directly supports growth markets, margin strategy, and service differentiation
  • Moving from efficiency-first to resilience-led models: balancing cost optimisation with built-in redundancy, diversification, and risk absorption capacity
  • Establishing governance for dynamic network management: enabling continuous re-optimization of supply networks through integrated decision-making, data, and scenario planning
Stream Three - Quality & Regulatory Compliance

Enabling Successful Design and Manufacturing Transfers of Medical Devices

Raghu Jainapur

Vice President Quality

Minimed

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  • Addressing real-world challenges and common pitfalls during design and manufacturing transfers, and effectively managing transfer milestones
  • Architecting and executing a quality and regulatory submission strategy · Translating design specifications into clear, actionable manufacturing instructions
  • Using pilot runs and iterative builds to identify and resolve manufacturability issues early
  • Aligning validation plans with real-world production conditions and conducting hands-on training
  • Building a structured knowledge transfer process to support smooth and scalable production scale-up
12:50 pm - 1:50 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.

Smart Factories in MedTech: Hype vs. Operational Reality

Executive to be Announced

Rockwell Automation

Global Trade Friction: Tariffs, Export Controls, and Supply Chain Redesign

The Governance Gap in Quality: Why Control Structures Are Failing Complex Manufacturing Networks

The Anatomy of a Plant Shutdown: Managing Risk, Compliance, and Continuity While Reshaping the Global Manufacturing Network

Leading Enterprise-Wide Supply Chain Transformation with AI and Advanced Analytics

Regulatory Intelligence: Turning Inspection Data into Strategic Foresight

1:55 pm - 2:30 pm Case Studies
Stream One - Manufacturing & Operations

Where AI is Delivering Real Impact in Manufacturing and Operations

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  • Sharing real production-floor examples where AI has improved throughput, reduced downtime, and stabilized operations under variability
  • Highlighting predictive maintenance use cases that have meaningfully reduced unplanned equipment failures and improved asset utilization
  • Exploring AI-enabled optimization of scheduling, capacity planning, and workforce allocation in real-time operations
  • Identifying how AI is improving end-to-end operational visibility and enabling faster, more coordinated decision-making across sites
  • Discussing what it actually takes to move AI from pilots to scaled deployment across multi-site manufacturing and operational networks
Stream Two - Supply Chain

Practical AI Wins in Supply Chain Operations

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  • Sharing real-world examples where AI has improved forecasting accuracy, reduced stockouts, or stabilized demand variability in live operations
  • Highlighting where AI has meaningfully improved decision speed and exception handling in planning and execution environments
  • Exploring practical deployments of AI in production, such as predictive maintenance, quality inspection, and yield optimization
  • Identifying where AI has successfully enhanced visibility across fragmented supply chain data and improved cross-functional coordination
  • Discussing what has actually worked in scaling AI beyond pilots into embedded, day-to-day operational decision making
Stream Three - Quality & Regulatory Compliance

Transforming Post-Market Signals into Strategy: Evaluating Complaints, Trends, and Off-Label Use to Guide Product Decisions

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  • Turning fragmented field data into decision-grade intelligence by integrating complaints, trend signals, & off-label use into a unified post-market view rather than siloed reporting streams
  • Distinguishing signal from noise in real-world data, with emphasis on identifying patterns that meaningfully indicate product performance, safety drift, or evolving clinical behavior.
  • Understanding off-label use as a system signal, using it to evaluate unmet needs, design assumptions, and potential gaps in intended use validation
  • Strengthening product lifecycle decisions through closed-loop feedback, ensuring post-market insights actively inform design updates, risk controls, & next-generation product development
  • Building organizational responsiveness to emerging risk indicators, enabling faster escalation pathways, clearer ownership, and more proactive regulatory and quality decision-making
2:35 pm - 3:10 pm Workshops
STREAM 1 WORKSHOP

Global Maintenance Optimization: Turning Reliability into a Strategic Cost and Productivity Advantage

Executive to be Announced

Honeywell Life Sciences

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  • Standardizing maintenance strategy across global sites to eliminate variability, reduce duplication of effort, and unlock enterprise-wide cost efficiencies
  • Shifting from localized maintenance decisions to centralized, data-driven asset management that optimizes spend across the full manufacturing network
  • Reducing total operational cost by improving asset uptime, extending equipment life cycles, and minimizing unplanned downtime across all plants
  • Leveraging cross-site performance benchmarking (OEE, downtime, maintenance cost per unit) to identify inefficiencies and replicate best-in-class practices globally
  • Aligning maintenance strategy with production and supply chain priorities to improve throughput, reduce capacity constraints, and strengthen global delivery performance
STREAM 2 WORKSHOP

Transforming Planning: Decision Intelligence, Process Orchestration, Data Visibility, and Embracing Uncertainty

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  • Redesigning planning as a decision-led operating model where choices are continuously optimized, not locked into static cycles
  • Connecting end-to-end planning processes through orchestration across demand, supply, and operations to enable coordinated execution
  • Establishing trusted, real-time data visibility as the backbone for faster, higher-confidence trade-off decisions
  • Embedding scenario-driven thinking to operationalize uncertainty rather than attempting to eliminate it from the system
  • Shifting from forecast accuracy as the goal to decision quality and speed as the primary measures of planning effectiveness
STREAM 3 WORKSHOP

Building a Risk-Driven Audit Strategy: Managing Global Operations, Supplier Complexity, and the Gap in Audit Capability

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  • Examining current audit models and their limitations, where audits remain compliance-focused, retrospective, and weakly connected to operational risk and performance signals
  • Addressing the gap between global operational complexity and audit consistency, where multi-site manufacturing, diverse suppliers, and regional regulatory expectations create variable outcomes
  • Examining the growing mismatch between traditional audit approaches and modern product realities, including SaMD, AI-enabled devices, and cybersecurity requirements that demand deeper technical and lifecycle understanding
  • Addressing capability gaps in internal and supplier auditing, where auditor training often lags behind the complexity of technologies and systems being assessed, leading to inconsistent interpretation and risk evaluation
  • Learning how organizations are shifting toward risk-based, intelligence-led audit strategies, integrating data, supplier performance signals, and real-time operational insights to move from periodic compliance checks to continuous assurance
3:15 pm - 4:25 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.

  • 3:15 pm – 3:35 pm: Meeting Slot 5/Networking
  • 3:40 pm – 4:00 pm: Meeting Slot 6/Networking
  • 4:05 pm – 4:25 pm: Meeting Slot 7/Networking
4:30 pm - 5:05 pm KEYNOTE

Risk as a Design Principle: Embedding Quality into Every Operational Decision

Steve C de Baca

Chief Patient Safety & Quality Officer

Philips

Session Details Arrow Icon
  • Reframing risk as a core input to enterprise strategy and execution, where decisions in product development, sourcing, and manufacturing are shaped by upfront risk understanding, not downstream correction or compliance response
  • Embedding risk intelligence into capital allocation, portfolio prioritization, and operational trade-offs, enabling leaders to explicitly weigh speed-to-market, cost efficiency, innovation ambition, and quality exposure in a structured way
  • Building an enterprise capability to convert fragmented signals from design, suppliers, manufacturing sites, and field performance into a single, decision-ready view of risk across the value chain, rather than siloed functional reporting
  • Establishing a unified enterprise risk language that aligns quality, supply chain, operations, regulatory, and commercial leadership, ensuring consistent interpretation of risk and eliminating localized or conflicting decision logic
  • Moving from periodic risk assessments to continuous, real-time risk governance, where live operational and supply chain data actively informs decisions, allowing the enterprise to anticipate disruption rather than react to it
5:05 pm - 5:10 pm

Chair’s Closing Remarks

5:10 pm

Drinks Reception

5:45 pm

Executive dinner

(By Invite Only)

February 24th

Stream 1 Chair
Stream 2 Co-Chair

Executive to be Announced

Veeva MedTech

Stream 3 Co-Chair

Executive to be Announced

Medical Engineering Consultants

8:00 am - 8:45 am

registration & breakfast

8:10 am - 8:45 am breakfast workshops
Stream Two

Digital Quality: Myth vs. Maturity

Executive to be Announced

Veeva MedTech

Session Details Arrow Icon
  • Why “going digital” hasn’t automatically improved quality performance: Understanding the gap between digitizing quality processes (QMS tools, eDHR, eQMS) and actually improving decision quality, speed, and consistency
  • Where digital quality systems break down in real operations: How fragmentation across ERP, MES, QMS, and supplier systems creates hidden disconnects in traceability, deviation handling, and CAPA effectiveness
  • Why data integrity risks are evolving, not disappearing: Moving from paper-based errors to system-level risks like poor master data governance, uncontrolled interfaces, and inconsistent validation across platforms
  • What true audit readiness looks like in a digital environment: Shifting from “audit preparation mode” to continuous inspection readiness with always-on, retrievable, and context-rich digital evidence
  • How to embed quality into day-to-day operational decision-making: Making quality signals actionable in real time, so deviations, supplier risks, and process drift influence manufacturing and supply chain decisions before issues escalate
8:50 am - 9:00 am

Chair’s Opening Remarks

9:00 am - 9:35 am KEYNOTE

Operationalizing Resilience: Identifying and Leveraging Key Drivers in Supply Networks to Strengthen Resilience

Peter Bennett

Senior VP Global Supply Chain

Cardinal Health

Session Details Arrow Icon
  • Defining and prioritizing the core resilience drivers such as supply diversity, capacity flexibility, inventory strategy, and lead time robustness
  • Translating resilience from concept into measurable network levers embedded in sourcing, manufacturing, and distribution decisions
  • Building end-to-end visibility across suppliers and nodes to understand where resilience is gained or lost in the network
  • Embedding risk sensing and scenario planning into operational decision-making to activate resilience drivers early
  • Aligning cost, service, and resilience trade-offs through deliberate network design and governance mechanisms
9:40 am - 10:15 am Case Studies
Stream One - Manufacturing & Operations

Cost Pressure vs. Innovation: Operating in a Margin-Constrained Environment

Carlos Soto

Head of Manufacturing - Americas

Telelfex

Session Details Arrow Icon
  • The shift from cyclical inflation to sustained structural margin pressure reshaping manufacturing strategy
  • Moving from cost reduction to cost transformation across product design, engineering, and operations
  • Establishing clear executive frameworks to decide when to redesign, absorb, or pass through cost pressure
  • Strengthening collaboration between operations, supply chain, and finance leadership to ensure aligned margin ownership and decision-making
  • Assessing today’s capability and performance gaps across cost, efficiency, and agility to identify where value leakage and structural weaknesses exist
  • Building resilient, flexible manufacturing networks that balance efficiency with risk, volatility, and disruption
  • Protecting innovation while driving efficiency through aligned governance, incentives, and cross-functional accountability
Stream Two - Supply Chain

Why Supply Chain Transformation Requires Operating Model Change, Not Technology Alone

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  • Examining how legacy operating models limit the impact of even advanced digital tools, where fragmented processes and siloed decision rights prevent end-to-end visibility from translating into better outcomes
  • Learning that technology amplifies existing system design rather than fixing it, meaning inefficient workflows, unclear ownership, and misaligned KPIs are often scaled rather than solved
  • Examining the gap between process ownership and digital enablement, where tools are implemented without redefining who decides, who acts, and how exceptions are managed across the network
  • Leveraging operating model redesign to align structure, governance, and incentives with digital capabilities, ensuring data, decisions, and accountability flow coherently across function
  • Learning that sustainable transformation depends on behavioral and governance change, not just system upgrades, embedding new ways of working alongside technology deployment
Stream Three - Quality & Regulatory Compliance

EU MDR through the Notified Body Lens: Expectations, Variability, and MDR 2.0

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  • What Notified Bodies are actually looking for under MDR, and why technically strong products still fail or get delayed in review
  • The most common submission gaps from a reviewer perspective: clinical evidence depth, technical documentation consistency, and weak PMS integration
  • Why timelines slip in practice, misalignment between manufacturer assumptions of “complete submissions” and Notified Body readiness expectations
  • What a “reviewer-ready” submission truly means, and how manufacturers can redesign internal processes to reduce cycles, rework, and delays
  • What a future “MDR 2.0” would need to address to better balance patient safety, innovation speed, and Europe’s global competitiveness
10:20 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 1 WORKSHOP

The Hidden Drivers of Manufacturing Underperformance

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  • Reframing underperformance from a “site execution problem” to a system design outcome shaped by how processes, flows, and governance are structured
  • Identifying how fragmented decision-making across functions and tiers creates hidden friction that accumulates into chronic performance loss
  • Moving beyond lagging KPIs to recognize early operational signals that reveal stress points in flow, capacity, and variability
  • Understanding how local optimization unintentionally drives global underperformance by improving siloed metrics at the expense of end-to-end efficiency
  • Building the capability to convert operational data into structural insight, enabling continuous redesign of how work is planned, governed, and executed
STREAM 2 WORKSHOP

Empowering Supply Chain Decisions Through Actionable Metrics and Real Time Data Analytics

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  • Moving from lagging reports to real time, decision ready visibility across the end-to-end supply chain
  • Focusing on a small set of high impact metrics that directly drive operational, quality, and commercial decisions
  • Enabling end to end integration of manufacturing, quality, inventory, and logistics data for a single source of truth
  • Leveraging AI and advanced analytics to improve prediction, anomaly detection, and decision support at scale
  • Embedding insights directly into daily operational workflows to improve speed, alignment, and execution consistency
STREAM 3 WORKSHOP

SaMD and AI-Enabled Medical Devices: Cybersecurity Pressures, Validation Challenges, and Evolving Quality Systems

Executive to be Announced

PTC

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  • Examining where quality systems are effectively supporting rapid AI and software-driven development, and where legacy validation approaches are still constraining agility
  • Addressing the growing cybersecurity expectations across the product lifecycle, and the gaps between design-stage risk controls and real-world threat management
  • Examining how well post-market surveillance is capturing real-world performance of adaptive and learning systems, and where visibility is still limited
  • Addressing inconsistencies in regulatory interpretation and evidence expectations for AI-enabled and software-based medical devices across global markets
  • Learning how quality organizations must evolve from compliance enforcement models to continuous, data-driven systems that integrate software, AI behavior, cybersecurity, and clinical feedback loops
12:00 pm - 12:35 pm KEYNOTE

Navigating Trade and Tariff Landscape by Integrating Trade Compliance into Decision-Making and Strengthening Partnerships

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  • Developing a decision framework that embeds trade, tariff, and regulatory variables into sourcing, manufacturing, and network design choices
  • Using scenario-based modeling to assess tariff exposure, policy shifts, and geopolitical risk across end-to-end supply flows
  • Treating compliance as a strategic input into cost, footprint, and market access optimization rather than a downstream control step
  • Building shared visibility and governance frameworks with suppliers and logistics partners to coordinate responses to trade volatility
  • Aligning commercial, supply chain, and regulatory functions around a unified framework for faster, more consistent decision making under uncertainty
12:35 pm - 12:45 pm

Chair’s Closing Remarks Followed by Lunch

12:45 pm - 1:45 pm

Networking Lunch