Optovue

RFgen features built-in integration capabilities to major enterprise barcode labeling solutions, including BarTender and Loftware Label Manager^®. Optovue uses RFgen’s integration with BarTender to populate barcode labels with their ERP data for full compliance with the FDA’s UDI requirement.

RFgen can generate many types of custom barcode labels and RFID tags, or allows companies to simply scan pre-printed labels and attach product information to the unique identifiers. Optovue opted to use RFgen to print its own custom barcode labels. The RFgen interface to BarTender is seamless, so workers only interact with RFgen.

Using RFgen, Optovue met the deadline for FDA compliance with new UDI packaging labels. “We flew through with flying colors because we went through a very in-depth validation and verification process. Being FDA controlled, it is crucial that any change to our system, our processes or equipment be very well documented,” Barth said.

Optovue uses RFgen to manage parts inventory as well as finished products. According to Barth, using RFgen has enabled his teams to improve upon inventory management that was already well-controlled. “RFgen has allowed me to move from a 99% accurate inventory to a near-perfect inventory level. It is rare that we do an inventory adjustment since full implementation,” he said.

“We use RFgen to manage the receipt of incoming materials used to produce our product, both components and purchased assemblies from our contract manufacturer,” Barth continued. “We run a tight inventory control system as well as a FIFO system. We are able to accurately scan in the receiving and put away information, pull kits using the barcode labels, perform cycle counts and any adjustments, and transfer inventory from one location to another. And we also use RFgen for our shipment transactions as far as scanning what goes out the door and validating it against the UDI label.”

The employees at Optovue had no trouble learning to use RFgen on their mobile devices. Barth said, “The ease of use of RFgen helps to naturally produce a more accurate inventory by allowing our employees to key in fewer numbers and instead scan barcodes. I am now in the process of reconfiguring our warehouse space for workflow improvement to reduce kitting time and production. RFgen is an invaluable tool.”

After the FDA imposed the UDI requirement, many foreign governments decided to improve labeling for medical equipment. As a global business, Optovue must reconfigure many of its packaging labels again so that they will be compliant not only with FDA, but other regulatory bodies around the world.

There is also another FDA deadline looming. While the first phase of the regulation required labeling the packages the products ship in, the August 2018 deadline requires labels to be affixed to the product directly.

“It is designed so that after equipment or a part is unwrapped, installed and the packaging thrown away, people can still find out where it came from and when it was developed by a label on the product itself. I will be working with the RFgen team for that requirement,” said Barth.

Whatever new Oracle transaction or labeling requirements arise, Barth is confident the RFgen solution will help Optovue rise to meet the challenge. “I would definitely recommend RFgen. We would not have been able to ship product over the last ten months unless things worked correctly–RFgen made it possible.”