Varian, a Siemens Healthineers company, strives to create a world without fear of cancer. For more than 75 years, Varian has developed, built, and delivered innovative technologies and solutions that help its clinical partners around the globe treat millions of patients each year. Headquartered in Palo Alto, California, U.S.A., and with offices in 70 locations around the world, Varian supports every step of the cancer care journey – from screening to survivorship. The company offers everything from advanced imaging and radiation therapy to comprehensive software and services, to interventional radiology, in addition to pursuing clinical research to create a more efficient, personalized care pathway.
Varian combined with Siemens Healthineers in 2021. Prior to that, the company used Loftware LPS to manage its medical device labeling. Varian wanted a modern cloud-based labeling solution that would help them create a standardized labeling process. After the acquisition, it was important that they selected a state-of-the-art, cloud-based labeling solution that could address the needs of the entire Siemens Healthineers company. Varian worked with the Loftware team to upgrade from Loftware LPS to Loftware Cloud which was seamlessly integrated into their SAP system. By adopting Loftware Cloud, the labeling team can ensure that label output matches label design, without the need for any manual adjustments when printing the label.
Wir können nun den globalen Marktzugang für unsere Medizinprodukte sicherstellen und den Etiketteninhalt nach Bedarf anpassen, was zu einer schnelleren Produktzulassung und weniger regulatorischen Verzögerungen führt.
Mark Illgner
Senior Labeling Development Engineer
Varian needed to comply with local regulations regarding medical device labeling in all the countries where it does business. However, the combination of long product lifecycles and inherited issues from previous labeling systems and templates forced Varian to manually create more label versions, increasing complexity and confusion. This resulted in inconsistencies in label layouts and meant that business rules couldn’t be applied across the label database. Instead, the IT team developed custom scripts with logic built specifically for each template. This was a time-consuming and resource-intensive process. With Loftware Cloud, Varian can now use business rules to create variable label content, such as the manufacturing date, serial number, and Unique Device Identifier (UDI), based on a country’s regulations. The company can thus comply with localization requirements, distributing its medical devices across markets while tailoring label content as necessary.
Varian also wanted to address previous challenges that impacted regulatory approval. With former labeling solutions, there was inconsistency between label templates and the final printed labels, resulting in discrepancies in the new label versions. This made it difficult to get regulatory approval for the validation of label prints due to compliance concerns. Loftware Cloud streamlines the labeling process by automating label layout adjustments, eliminating the need for manual intervention when printing labels to ensure seamless adherence to specifications.
For Varian, Loftware Cloud serves as a strategic label content management system. Integrating Loftware Cloud with SAP empowers the labeling team to locate all instances of a specific symbol quickly and easily across various label templates, enabling agile adjustments to meet evolving regulatory requirements and avoid penalties or fines. The team uses this information to conduct an impact analysis on the content change and to ensure they consider the entire population of impacted label templates. This helps Varian comply with changing medical device regulations and maintain label consistency.
The more consistent label template design and layout process means that Varian has fewer labeling issues and an easier review process. Now that Varian can create standard business rules, the company hopes to consolidate some of its label templates and further streamline label creation.
