Overview
A leading medical device manufacturer faced challenges in managing high-speed, multi-site assembly and packaging across facilities in the US and Europe. To meet growing demand and comply with strict regulations, they required a scalable, automated solution for component pairing, serialized product identification, automation management, and full traceability. Recognizing the mission-critical nature of this implementation, they sought a trusted partner with the expertise to deliver precision, efficiency, and reliability at scale. With over 30 years of experience in automation, manufacturing, and regulatory compliance, Catalyx was chosen to bring this vision to life.
Challenges
Complexity of High-Speed Component Pairing & Serialization
Managing precise real-time pairing of serialized components across multiple high-speed assembly lines created significant risks of misalignment, production delays, and quality issues.
Regulatory Compliance & Traceability Gaps
Strict FDA and EU MDR regulations required end-to-end traceability, but inefficient tracking systems increased the risk of compliance failures, recalls, and supply chain disruptions.
Inability to Scale Production to Meet Demand
Surging demand for biometric monitoring devices exposed the limitations of manual processes, preventing the company from scaling efficiently while maintaining speed, accuracy, and quality control.
Our Solution
Comprehensive Technical Solution & Operational Support
Catalyx implemented an end-to-end solution, integrating automation, expert engineering, and operational support to optimize pack line efficiency, traceability, and scalability while ensuring regulatory compliance.
Enhanced Data Management & Traceability
A serialized tracking system provided full production visibility, ensuring secure, compliant, and transparent monitoring from assembly to market distribution.
Real-Time Quality Control & Compliance
By integrating real-time process control with edge devices, Catalyx enabled automated defect detection and process optimization, reducing waste while maintaining data integrity and audit readiness.
Scalable & Adaptive for Global Expansion
Designed for multi-site deployments, the solution allowed for seamless scalability, ensuring efficient production growth without disruption.
Comprehensive Operational Support
Beyond implementing advanced technology, Catalyx provided robust operational support to maintain system performance, maximize uptime, and ensure seamless production.
24/7 Remote Support for Continuous Uptime
A dedicated remote support system allowed for immediate issue resolution, minimizing downtime and maintaining peak operational efficiency across all production sites.
Embedded Engineers for Onsite Expertise
Catalyx embedded expert engineers directly into operations, providing real-time troubleshooting, optimization, and hands-on support during critical production phases to ensure seamless transitions and rapid problem resolution.
End-to-End Project Execution & Validation
Managing the entire software delivery lifecycle, Catalyx ensured smooth implementation, full system validation, and seamless workflow integration to eliminate operational disruptions and maintain compliance.
Scalable & Adaptive for Future Growth
Built for long-term scalability, the system was designed to adapt to operational expansions, whether launching new production lines or expanding into global markets, ensuring future-ready flexibility.
By integrating expert engineering, real-time support, and scalable solutions, Catalyx ensured sustained operational excellence, efficiency, and compliance across all production sites.
Outcomes
Market Demand Met
Annual product demand surged from 3 million units at launch to over 50 million units today.
95%+ Yield Rate Achieved
Achieved a 95% yield rate and maintained zero product recalls since launch.
1.5M+ Patients Benefiting Daily
Over 1.5 million patients rely on the device daily for health monitoring.
Regulatory Success
Approval in the US enabled massive expansion and increased production capacity.
10+ Year Global Partnership
Multi-site, multi-year success and recognized as one of the most successful product launches in medical device history.
Global Scalability
On-schedule implementation across multiple manufacturing sites in the US and Europe.
Conclusion
Through a strategic partnership with Catalyx, the medical device manufacturer successfully overcame complex serialization challenges, regulatory compliance hurdles, and production scalability limitations. By implementing advanced automation, real-time quality control, and expert operational support, Catalyx delivered a future-ready solution that enabled seamless multi-site expansion while maintaining efficiency, accuracy, and compliance.