Light Resistant
IV Sets

Spearheaded the design, development, and regulatory compliance of innovative light-resistant intravenous (IV) administration sets specifically engineered to protect photosensitive oncology drugs and parenteral nutrition solutions from UV-induced degradation. This Class II medical device project required simultaneous management of new product innovation, EU Medical Device Regulation (MDR) rebaselining, and global supply chain coordination across multiple manufacturing sites.
 

Product Innovation & User-Centered Design:
Led comprehensive user needs research through structured interviews with oncology nurses, pharmacists, and clinical practitioners across 12+ hospital systems. Identified critical pain points including drug potency loss, workflow inefficiencies, and patient safety concerns related to light exposure during chemotherapy administration. Translated 25+ user requirements into detailed technical specifications covering material opacity, transmission rates, mechanical performance, and clinical usability. Developed Design Input Requirements (DIR) documentation ensuring traceability from user needs through verification testing.

Material Science & Engineering Excellence:
Conducted extensive material selection analysis evaluating 8+ polymer formulations for UV-blocking efficacy, biocompatibility (ISO 10993), extractables/leachables profiles, and manufacturing scalability. Collaborated with material science experts and third-party testing laboratories to validate light transmission properties, demonstrating >95% UV protection across critical wavelength ranges (290-400nm). Optimized amber-tinted tubing formulations balancing light resistance with clinical visibility requirements for fluid flow monitoring and air bubble detection.

Global Supply Chain & Manufacturing Integration:
Identified and qualified 3 strategic suppliers across North America and Asia for critical components including UV-resistant tubing, injection-molded connectors, and specialty films. Led technical transfer initiatives with ICU Medical's Costa Rica manufacturing facility, establishing production-ready processes including extrusion parameters, sterilization validation (EtO and Gamma), and automated assembly line configuration. Reduced material costs by 18% through supplier negotiations while maintaining quality specifications and delivery timelines.

EU MDR Compliance & Regulatory Strategy:
Managed comprehensive EU MDR rebaselining effort for existing IV sets portfolio, updating Technical Files to address new regulatory requirements including clinical evaluation reports, post-market surveillance plans, and unique device identification (UDI). Coordinated cross-functional teams spanning Regulatory Affairs, R&D, Quality Assurance, Clinical Affairs, and Marketing to ensure 100% traceability of design inputs, outputs, verification, and validation activities. Successfully navigated gap analyses, risk management updates (ISO 14971), and Notified Body interactions to maintain market authorization.

System-Level Integration & Program Management:
Orchestrated system-level integration for Class II oncology infusion platform, ensuring seamless compatibility between light-resistant IV sets, infusion pumps, electronic medical records (EMR), and pharmacy workflow systems. Managed 15-month project timeline across 4 development phases (Concept, Design, Verification, Validation) while balancing aggressive cost targets, quality requirements, and market launch deadlines. Established portfolio dashboards tracking 50+ project milestones, 12 verification protocols, and 6 clinical validation studies.

Cross-Functional Leadership & Stakeholder Management:
Presented monthly program updates to Senior Leadership Team, highlighting project progress, risk mitigation strategies, and resource requirements. Facilitated collaboration across 6 functional departments including R&D Engineering, Regulatory Affairs, Manufacturing Operations, Supply Chain, Quality, and Clinical Affairs. Addressed technical challenges through structured problem-solving, including design-for-manufacturing (DFM) optimization that reduced assembly time by 22% and improved first-pass yield to 97%.

Business Impact & Clinical Outcomes:
Delivered innovative product solution addressing $45M+ market opportunity for photosensitive drug delivery in oncology and neonatal intensive care settings. Enabled hospital pharmacy departments to eliminate expensive light-protective foil overwraps, reducing material costs and nursing preparation time by an estimated 8-12 minutes per infusion. Enhanced patient safety through reduced medication errors and improved drug efficacy preservation.