Quest Medical, Inc. is a United States medical device manufacturer. Founded in 1979, the company designs, engineers, and manufactures medical products for three key markets: Cardiology, Infusion Therapy, and Ophthalmology. One of Quest Medical’s main objectives is regulatory compliance and product safety and performance. As an FDA-regulated manufacturer, the company must comply with UDI regulations and produce GS1-compliant labels. Quest Medical was looking for a template-based labeling solution that would speed up their labeling process by enabling business users to update label templates without having to involve the IT department.
Quest Medical used a homegrown labeling solution to manage product labels for over 100 products. However, the labeling solution wasn’t template based. Instead, the IT department created individual labels for each product and each label contained different symbols. Whenever a symbol needed to be changed, either because of a new regulatory or customer requirement, the IT department needed to reprogram the application. A label change request could have a turnaround time of a week or more – a costly delay which had a significant impact on the business.
Loftware Spectrum enabled Quest Medical to move the entire label creation and maintenance process away from the IT department and place it in the hands of business users. Using Spectrum’s built-in label templates, the company consolidated 98 labels into 20 templates. Since FDA regulation changes typically apply to a product group, Quest has organized label templates in the same manner. This helps them streamline label changes, as they can now change one template and those changes will apply to all products in that group.
With the previous labeling system there were obstacles around achieving full GS1 compliance. The IT department struggled to get Device Identifier (DI) and Production Identifier (PI) data into the barcode. With Spectrum’s GS1-ready label templates, Quest Medical was able to convert over 20 templates in one day. This process would have taken weeks with the previous system.
Loftware Spectrum is entirely user-based. No IT help needed for routine day-to-day processing or changing label data or format, and that is a huge benefit
Randy Cochran
Project Manager, Quest JDE implementation
Another important criterion for Quest Medical was finding a label solution provider with a history of successful integrations with the JD Edwards (JDE) business system. The company selected JDE as its new Enterprise Resource Planning (ERP) system and they wanted to integrate labeling and use JDE as the front-end system. Unfortunately, this integration wasn’t possible with their homegrown labeling solution. However, Loftware Spectrum for Medical Device is designed to easily integrate with any ERP system and offers pre-built integration with JDE. The fact that other customers have successfully integrated Loftware Spectrum with JDE provided Quest Medical with the confidence that they had found the right labeling solution for their unique labeling demands.
