Medical device companies are under a lot of pressure to design top-quality products that comply with a range of regulatory needs requirements while performing reliably. This focus on the device itself is so strong, that many companies end up underestimating the importance of other aspects of product development.
Label management is one area where, if overlooked, significant delays, inefficiencies and problems may arise.
With the deadline for the new EU Medical Device Regulation (MDR) just recently past, many companies may have learned this the hard way. MDR brings added complexity to labelling processes by enforcing unique device identification (UDI) information on all labels.
The aftermath of cases such as the PIP Breast Implant Scandal, where health bodies struggled to trace who had received unsafe silicone implants, paved the way for the
As manufacturers scrambled to redesign each of their labels under the new requirements, those with inefficient processes were encountering problems. For many, a disjointed approach is at the root of the problem.
From legal and regulatory departments to marketing, trademark and product design, many teams contribute to label creation. Using traditional systems, one person is often left trying to piece it all together, searching through a range of emails and documents from different sources in an attempt to understand whether they have the correct or latest version.
With such a fragmented approach, it’s easy to see how errors can arise. However, when it comes to pharmaceutical and medical device products, there is no room for getting it wrong.
According to Dave Tarbuck, vice president of global customer excellence at label and artwork management specialists Kallik, the consequences can be both financial and fatal.
A lot at stake
“If you’ve got a drug and the packaging or instructions say to take it 23 times a day instead of two to three times, that product has to be recalled because the information is wrong. That error can cost millions and millions of pounds, not to mention create significant reputational damage,” says Tarbuck.
The implant scandal is just one example of this. FDA figures reveal that there has been a large increase in product recalls in the last decade, 15% of which are attributable to labelling errors.
Situations like this are the worst-case scenario. But, by lacking an effective label management system, medical device companies may be suffering in other ways.
“Many medical device companies experience geographical challenges when they have sites across the globe,” says Tarbuck. “They don’t have the level of control they need over both their labelling and their content. Additionally, they have a high level of risk of things being done incorrectly. That means that if something is inaccurate, they struggle to pinpoint where it went wrong in the process. Software like Veraciti centralises all of that.”
How Veraciti can help
Veraciti, Kallik’s cloud-based platform stores and manages each component of the label’s artwork and content, enabling automated artwork generation from a library of assets and phrases. Veraciti simplifies review and approval processes, too, which can be cumbersome over email. Imagine ten different reviewers, making amends on ten different versions of that artwork. You soon lose control.
“With Veraciti, there’s one version of the artwork that everyone looks at. Straightaway, you’re reducing the risk of having out-of-date files sent for review, people commenting on an old version, and everything else that confuses and slows down the process,” explains Tarbuck.
In today’s climate, speeding up supply chains has never been more important to the medical industry. Just think back to last year’s sanitiser shortage. “An unfortunate consequence of Covid was the need for companies to consider how their supply chain works and how to shorten timeframes,” says Tarbuck. “Because our system allows people to collaborate, it means supply chains can actually be expedited. The labelling is already there.”
Veraciti has also been instrumental in helping companies meet MDR’s new labelling requirements on time. According to Tarbuck, one Kallik customer had to rework 90,000 labels for their first Class I product. Veraciti was heavily relied upon in the process and, without the system, the client was unlikely to meet the deadline.
However, it’s not just about speed. Veraciti also plays a big role in ensuring label compliance and offering comprehensive audit trails. “It doesn’t matter where you are geographically, you can go to the system to find out who, what, where, when. Because everything is in one place, you are reducing the risk, removing some of the geographical barriers, and speeding up the process as well.”
To find out more on Kallik and the Veraciti software, visit www.kallik.com