Managing the information that appears on medical device labels traditionally involves huge amounts of repetitive manual data collection and input. At the same time, this information is subject to stringent and changing regulation which leaves little room for error. Using human resources for this process can be inefficient and costly. What if there was a better way?

Labelling and artwork management expert Kallik introduces its Rules Engine, a specialised module for the Veraciti label management platform. The Rules Engine leverages automation to transform how data is incorporated into label design, replacing costly manual data entry with something innovative, more efficient and more reliable.

“It’s all about automating data population to reduce the amount of time users spend inputting data,” says chief technology officer Rob Woodall.

Automating the process

Fast, accurate and flexible, software has the potential to manage data population far more effectively than a human user could.

“It’s about making life easier for the end users,” explains Woodall. “The system makes decisions for them and automatically inserts the necessary logo or phrase.” The administrator just inputs the rules, which define the words, phrases or symbols that must appear on the label. The Rules Engine then automatically populates labels with this data.

“It’s really about taking the human error out of it,” Woodall explains. With medical device labels subject to strict regulation, accuracy is crucial. “There are various regulations that mean certain pieces of data need to be on labels,” says Woodall. For example, the recent EU MDR (Medical Device Regulation, effective since 26 May 2021) demands that medical device labels contain the date of manufacture and a standardised symbol to indicate that the device is medical, among many other pieces of information.

The Rules Engine can be programmed to automatically apply this information to every label without the need for it to be entered manually. “We get the system to manage these decisions to automate the process to reduce data collection times and increase accuracy. The idea is that you can review a set of regulatory guidelines, build a set of rules linked to those guidelines and speed up the work creation process,” says Woodall. This way, manufacturers can guarantee that their labels meet regulatory requirements.

As is so often the case, automation increases the speed and efficiency of the process. “If mistakes are made by humans as part of the data collection process, then the labels have to be pushed back through the process and then sent for approval,” Woodall explains. “You get more incremental changes to the artworks which means that it’s going to be a slower process to get the work approved. What you’re looking for is as few minor version iterations as possible.” The Rules Engine removes people from the data collection stage and allows them to focus on the review process, saving a step and reducing the chance of delays.

“And it’s not just about the initial creation of the labels, it’s the subsequent change of those artworks,” Woodall adds. “If the artworks change over time, because regulations or branding requirements change, the system allows users to change the labels en masse and then reapply a new set of rules to regenerate the labels with the new data requirements. This is a much quicker way to create and change your artworks as opposed to manually, as you would in a legacy process.”

All this can be carried out from the comfort of the Veraciti platform, which is designed for user accessibility and has the flexibility to handle even complex demands. “Some customers have some quite specific needs. They might need to have certain prefixes or textual changes made that would historically be done manually,” says Woodall. “With the Rules Engine, you can switch into advanced mode, which enables you to write codes to do almost any type of transformation.” This includes defining specific rules for certain sets of labels – for example, labels in different languages.

Market impact

Manufacturers can use the Rules Engine to reclaim valuable time and resources. “When you’re building artwork in Veraciti, if you’re automatically populating 40% of your data, you’re making a saving there,” Woodall points out. “Medical device customers have already been using it to speed up their MDR compliance projects for this year.”

Their feedback is key to the continued development of the platform, he explains, “because it’s quite a complicated piece of software that we want to build and improve over the following years. We run a customer advisory board every few months and we use that as a way to get feedback from our customers to improve on the system.”

The highly regulated and high-volume nature of label management means that this market stands to benefit hugely from leveraging automation. Kallik is uniquely positioned to lead the way, Woodall asserts, because of its data-centric approach: “If you’re all about the data, you have the ability to plug in something like a Rules Engine, because it works on data.”