Gaining Control in High-Compliance Medical Manufacturing with RFID

In Brief

• Implemented RFID-based Work-in-Progress (WIP) tracking, replacing manual processes to enhance accuracy and efficiency.
• Achieved real-time visibility into production workflows, bolstering traceability and compliance with FDA and ISO standards.
• Integrated RFID asset tracking with existing ERP systems, streamlining data management and reporting.

Navigating the Digital Transformation Imperative

In today's rapidly evolving manufacturing landscape, digital transformation is no longer optional: it's a strategic necessity. According to a Deloitte survey, 79% of CEOs view digital transformation as one of their top three strategic priorities. However, only 22% of companies have undergone significant digital business transformation¹, highlighting a substantial gap between ambition and execution.

For a multinational medical device manufacturer specializing in precision surgical instruments and implantable devices, this gap manifested in the form of manual tracking methods: barcodes and handwritten logs that led to errors, delays, and increased risks of non-compliance with stringent regulatory standards.

Implementing RFID for Enhanced Compliance and Efficiency

To address these challenges, the company partnered with FactorySense to implement an RFID-based WIP tracking system. This comprehensive solution encompassed hardware, software, and consulting services, enabling a rapid and risk-free pilot deployment at the company's primary production facility.

Key components of the solution included:

1. RFID-Tagged Components and Subassemblies: Each item was tagged at the beginning of production, allowing automated tracking through each manufacturing stage.
2. Fixed RFID Readers at Key Production Checkpoints: These readers automatically updated the location of components in real-time as they moved through workstations.
3. Handheld RFID Scanners for Spot-Checking and Compliance Audits: Quality control personnel used portable scanners to verify component history without interrupting production.
4. Cloud-Based Dashboard Integration with ERP Systems: Real-time visibility into WIP inventory was achieved, streamlining compliance reporting and enhancing production scheduling.
5. Custom Dashboards Displayed on Production Floor Screens: Visual dashboards provided real-time tracking of WIP inventory, cycle times, and bottlenecks.
6. RFID Geofencing for Sterile and Non-Sterile Area Monitoring: The system generated real-time alerts when materials moved between controlled sterile areas and general production zones, reducing contamination risks and ensuring compliance with strict manufacturing regulations.

Conclusion

By leveraging FactorySense's RFID consulting and RFID software solutions, the medical device manufacturer transformed its WIP tracking process, achieving enhanced regulatory compliance and operational efficiency. This case exemplifies how RFID asset tracking and inventory management software can serve as pivotal tools in the digital transformation journey, particularly in industries where precision and compliance are paramount.

References

1: https://mitsloan.mit.edu/press/only-22-companies-have-undergone-significant-digital-business-transformation-and-they-have-higher-revenue-growth-and-net-margins