> As medical device manufacturer Zimmer Biomet grew through mergers and acquisitions, it sought to harmonize disparate labeling systems across its global facilities. The goals were to improve efficiency through standardized labeling processes and support worldwide regulatory compliance, particularly with the evolving European Union Medical Device Regulation (EU MDR). Zimmer Biomet selected Innovatum’s ROBAR software, with label design and printing powered by BarTender.
The Challenge
Headquartered in Indiana, Zimmer Biomet is one of the world’s largest medical device companies. It designs, manufactures, and markets orthopedic implants and other musculoskeletal technologies and services, with operations in more than 25 countries. The company partners with healthcare providers worldwide. Zimmer Biomet was built through mergers and acquisitions, and each acquisition introduced legacy systems that resulted in different capabilities across facilities. Labeling was a particular concern. Legacy systems were limited in their design and data structures and were not scalable. Many systems could not generate some of the new barcodes essential for medical device labeling, such as 2D Data Matrix codes. The situation was compounded by inadequate vendor support and internal staff attrition.
The company experienced print latency and system-generated downtime and had to invest considerable effort in maintaining accuracy. These inefficiencies affected profitability and made it significantly more difficult to maintain regulatory compliance with the U.S. Food and Drug Administration (FDA) and its global counterparts. “We were unable to process some of the new barcodes,” said Aimee Wright, Global Labeling Manager at Zimmer Biomet. “We had to hard-code the symbologies into our printers. We were managing thousands of SKUs in our system, and every new label design required work from our IT team.” In addition, Zimmer Biomet faced the tsunami of requirements introduced by the European Union Medical Device Regulation (EU MDR).
The Solution
Selecting a labeling system
In 2009, Biomet deployed ROBAR, which includes BarTender, for enterprise labeling at the company’s dental facility in Florida. Additional instances were later implemented at facilities in New Jersey and at the company’s Indiana headquarters. When Zimmer and Biomet merged in 2015, the company needed a system that could keep pace with its rapid growth, provide efficient processes, and support compliance with emerging regulatory standards. After comparing the available systems, its experience with ROBAR proved to be the differentiator. The decision was based on the superior user experience provided by the ROBAR platform, the exceptional support from the ROBAR team, and BarTender’s adaptability. “The system’s ease of use, audit readiness, scalability, and design capabilities were differentiators. It had everything we needed to manage regulatory requirements,” said Wright. ROBAR provided a resilient, agile platform with redundant server architecture and 99.99% availability. “For example, it was remarkable that we could print labels for 30,000 different SKUs using a single template,” Wright explained. The company also printed that template across 75 plants and contract manufacturers, using approximately 50 different printers and brands at multiple resolutions.
Label translation and localization — ROBAR Destination Labeling
At its distribution facility in the Netherlands, Zimmer Biomet deployed ROBAR Destination Labeling in 2019. ROBAR manages SAP-guided smart picking, prints instructions for use (IFUs), and generates all additional language labels required based on the shipment’s final destination. With a single UDI barcode scan on the packaging line, ROBAR determines which languages are already included on the product label, evaluates the languages required at the destination, and prints the additional languages on the label in a fraction of a second. When necessary, it also prints other required documents that are not labels. To ensure accuracy, the barcode on the label and the IFU are then scanned to verify that the correct documentation is included with the correct product.
Unprecedented agility, regulatory compliance, and automated change management
Because of the limitations of its legacy systems, the company previously relied on numerous static elements in label files, requiring an unmanageable number of label templates. Today, labeling is connected to dynamic data stored in the integrated database management system. Integrations with at least 12 different PLM and ERP systems provide appropriate sources for critical label content and manufacturing data. Using BarTender’s conditional printing capabilities, ROBAR merges data into label templates, generating proofs for review and approval through an integrated workflow module. The system is designed to process and automate changes at scale—an essential capability for operating efficiently across multiple regulatory environments. This gives Zimmer Biomet the agility to manage bulk updates, generate required PDFs, automate redline version comparisons, and approve labels electronically. Zimmer Biomet can process very large-scale change controls, such as the Brexit CE mark change, instantly across more than 125,000 labels.
Today, more than 800 users process approximately 9,000 multiprint label requests every day, including users from more than 70 external suppliers. This enables Zimmer Biomet to consistently receive components labeled according to its requirements. Suppliers access the service over the internet through a simple browser-based interface, with no local client or application installed on the supplier’s system. Suppliers do not need access to the Zimmer Biomet network to print Zimmer Biomet labels. The database management system captures a complete audit trail for internal and external print operators, supporting regulatory compliance and operational efficiency. The system delivers the first label in approximately three seconds worldwide, with 99.99% availability enabled by redundant automatic failover architecture.
Complex labeling, simplified
Rather than relying on expensive, customized coding to design labels, ROBAR and BarTender provide a configurable, user-friendly experience. “BarTender has enabled us to take control of our labeling challenges,” said Wright. “We manage all label content and format design within our department, with minimal support from our IT team. The solution has enabled us to apply governance and data structure to this critical function.” BarTender gives Zimmer Biomet the flexibility to explore expanded use cases. Encoding RFID for a smart label is no more complicated than creating a barcode. For use cases requiring special attention, Visual Basic scripts are available.
Preparing for future growth
“I doubt you could get a more user-friendly and responsive labeling and design system than this,” said Wright. “We are able to streamline our processes using layers, Visual Basic scripts, and other standard BarTender features. Printing plays a critical role in Zimmer Biomet’s mission, and the response time we experience is unprecedented. Moving to BarTender has given us limitless opportunities that we did not see with any other solution. It has allowed us to think strategically about the future. It has been a game changer for us.”
