IV Sets - MDR

Led a comprehensive European Union Medical Device Regulation (EU MDR 2017/745) compliance program for ICU Medical's global portfolio of intravenous (IV) infusion and administration sets. This large-scale regulatory transformation initiative required simultaneous management of 25+ product families, coordination of cross-functional teams across 4 time zones, and establishment of enterprise-level governance structures to ensure continued market authorization across all EU member states under the most stringent medical device regulations in history.
 

Strategic Program Leadership & Portfolio Management:
Directed a cross-functional Core Team of 30+ members spanning R&D Engineering, Regulatory Affairs, Quality Assurance, Clinical Affairs, Manufacturing Operations, and Marketing to execute comprehensive MDR rebaselining activities. Established program governance structure including steering committee oversight, weekly technical working groups, and monthly executive leadership reviews. Managed portfolio of 25+ IV set product families representing $120M+ annual revenue across infusion therapy, oncology administration, and critical care applications.

Regulatory Gap Analysis & Compliance Planning:
Conducted systematic gap assessments comparing existing Technical Files against new EU MDR requirements including enhanced clinical evaluation, post-market surveillance, unique device identification (UDI), and risk management documentation. Identified 150+ compliance gaps across product portfolio requiring remediation activities spanning updated design documentation, additional verification testing, clinical data compilation, and manufacturing quality system enhancements. Developed detailed compliance roadmaps with prioritization matrix based on market impact, regulatory risk, and resource availability.

Design Control Documentation & Traceability:
Led comprehensive update of Design History Files (DHF) ensuring complete traceability from user needs through design inputs, design outputs, verification protocols, and validation studies for all product variants. Coordinated preparation of 80+ Design Input Requirements (DIR) documents, 120+ Design Output Specifications (DOS), 200+ verification test protocols, and 50+ validation study reports. Implemented electronic Quality Management System (eQMS) enabling real-time documentation tracking, version control, and audit trail compliance.

Verification & Validation Program Execution:
Managed execution of 45+ new verification test protocols addressing updated MDR performance requirements including mechanical integrity, biocompatibility (ISO 10993), sterilization validation, particulate matter analysis, and compatibility testing. Coordinated 12 validation studies with external test laboratories and clinical sites, including human factors usability assessments, clinical performance evaluations, and real-world evidence generation. Ensured all test methods aligned with harmonized standards (ISO 8536, ISO 1135) and Notified Body expectations.

Process Optimization & Efficiency Improvement:
Architected streamlined project tracking system utilizing Microsoft Project, SharePoint, and custom Power BI dashboards enabling real-time visibility into 500+ project tasks across concurrent workstreams. Standardized workflows for design change control, verification protocol development, technical file updates, and regulatory submission preparation—improving execution efficiency by 35% through elimination of redundant reviews, parallel processing of independent activities, and automated status reporting. Reduced average design change approval cycle time from 45 days to 28 days through process reengineering.

Data-Driven Program Metrics & KPI Development:
Developed comprehensive portfolio dashboards and Key Performance Indicators (KPIs) enabling Senior Leadership Team visibility into cost, schedule, performance, and risk across all MDR compliance activities. Established metrics tracking including: design documentation completion rates (87% complete at program midpoint), verification testing progress (45 protocols completed on schedule), budget variance (<3% deviation), resource utilization (95% efficiency), and risk mitigation effectiveness (12 critical risks retired). Presented monthly executive briefings utilizing data visualization tools to communicate complex program status in actionable formats.

Cross-Functional Collaboration & Stakeholder Management:
Facilitated collaboration across 6 functional departments spanning 8 global office locations including Irvine (USA), San Clemente (USA), Salt Lake City (USA), Austin (USA), Halstead (UK), Uppsala (Sweden), and manufacturing sites in Mexico and Dominican Republic. Conducted 200+ stakeholder meetings including technical working sessions, risk review boards, design review committees, and senior leadership updates. Addressed team questions, resolved technical conflicts, and escalated critical issues requiring executive decision-making or additional resource allocation.

Risk Management & Regulatory Strategy:
Updated risk management files (ISO 14971) for entire product portfolio, conducting comprehensive hazard analyses, risk control evaluations, and residual risk assessments. Identified 180+ potential hazards spanning use errors, manufacturing defects, environmental factors, and clinical complications—implementing risk controls including design improvements, labeling updates, user training enhancements, and post-market surveillance protocols. Coordinated Notified Body interactions including BSI, TÜV SÜD, and DEKRA ensuring technical file acceptance and CE Mark maintenance.

Clinical Evaluation & Post-Market Surveillance:
Directed preparation of Clinical Evaluation Reports (CER) compiling 15+ years of clinical data, post-market surveillance records, literature reviews, and equivalence analyses demonstrating continued safety and performance under MDR requirements. Established enhanced post-market surveillance (PMS) and post-market clinical follow-up (PMCF) plans including periodic safety update reports (PSUR), trend analysis protocols, and clinical investigation triggers. Implemented vigilance database integrations enabling real-time monitoring of adverse events and field actions.

Business Impact & Market Continuity:
Successfully maintained EU market authorization for 100% of IV set product portfolio, avoiding potential revenue disruption of $120M+ annually. Enabled continued supply to 500+ European hospitals and healthcare systems serving critical care, oncology, neonatal, and general infusion therapy applications. Established scalable compliance framework supporting future product development, regulatory changes, and portfolio expansion initiatives.