Complex manual business processes made meeting stringent regulatory requirements difficult for Mentor Worldwide LLC, a leading supplier of saline and silicone breast implants and other products for the global aesthetic medicine market.
The company’s implant products are Class I, Class II, and Class III medical devices tracked to comply with U.S. Food and Drug Administration (FDA) regulations. Mentor documents the movement of each implant through a complex consignment sales process to the doctor who uses it.
Mentor needed an automated data capture solution that would easily integrate with their installation of JD Edwards EnterpriseOne to generate serialized labeling, automate complex manual processes and meet rigorous validation requirements. That’s why Mentor chose DSI® to optimize their business processes.
DSI provided pre-built applications for accurately tracking inventory, assets and time using RFID and barcode technology, as well as pre-built integration with JD Edwards to provide access to real-time data.
“The DSI applications we use have been validated and documented,” said Fred Schulte, Information Technology Manager for Manufacturing and Distribution, Mentor Worldwide LLC. “DSI saved us many hours of effort in fulfilling this requirement.”
DSI’s codeless, rapid development platform enabled project managers to quickly tailor the pre-built mobile apps to meet Mentor’s unique business requirements and allowed Mentor staff to easily modify and enhance apps as needed. DSI provided Mentor the self-sufficiency to meet their current and future needs.
“Working with DSI was a very positive experience,” said Fred Schulte, Information Technology Manager for Manufacturing and Distribution, Mentor Corporation. “DSI consultants took the time to understand our company and our business processes to tailor apps to meet our specific needs.”
DSI mobile apps generate unique, non-repeating serial numbers for the product classes that require them.
“The unique serial number enables us to access the product’s entire history. It is linked to data in our enterprise application that enables us to track a number of variables, from sterilization date and lot number to consignment, sales and billing history,” Schulte said.
DSI automated transaction processes in Mentor’s consignment sales channel.
“Consignment inventory isn’t invoiced until it is used. Automating manual processes simplifies our tracking and billing processes,” Schulte said. “Now we can bill more quickly and accurately.”
In addition to requirements for product labeling and tracking certain products, Mentor must also validate software and apps with extensive documentation. DSI preserved Mentor’s investment in an existing labeling system and more than 500 templates, which helped Mentor simplify validation of the labeling system.
“The DSI applications we use have been validated and documented,” Schulte said. “DSI saved us many hours of effort in fulfilling this requirement.”
“Barcode scans of the serial number using DSI are critical to our ability to streamline many of our in-house business processes,” Schulte said. With DSI, Mentor has achieved several key business benefits:
“The DSI applications we use have been validated and documented,” said Fred Schulte, Information Technology Manager for Manufacturing and Distribution, Mentor Worldwide LLC. “DSI saved us many hours of effort in fulfilling this requirement.”Download PDF