Heckert, Stacey

Addressing Hidden Risks in Medical Device Labeling Operations

By Chris Heckert, Warren Stacey
Heckert, Stacey

Due to rapidly evolving regulatory landscape and manufacturing demands, label requirements and the information they contain are constantly changing. Here’s how medtech organizations can manage the process.

Many medical device organizations implement labeling on a local level, leaving it to each manufacturing region or division to procure their own system, often from a range of different suppliers and featuring bespoke code to cater for localized policies and procedures. These disparate labeling systems will frequently lack interoperability, resulting in a siloed rather than holistic approach to regulated label management. However, labels are printed, products are shipped—it’s not particularly elegant, but it gets the job done, right?

While this approach might not lead to issues if label content was static, we know that label requirements and the information they contain are constantly changing thanks to the rapidly evolving regulatory landscape and manufacturing demands of the business. It is quite common for revisions to be made to large numbers of labels across an even larger range of product lines—a mass change event—and these are becoming ever more frequent and impactful.

For instance, consider the extensive changes to labels on hundreds of thousands of existing products that will need to be actioned over the next couple of years to ensure compliance with EU MDR following the end of the transition deadlines in 2024 and 2025. A massive exercise for organizations, despite many of the revisions being common in nature. Of course, a seismic regulatory change isn’t the sole instigator of mass change events—something as simple as a change of address for an authorized representative can necessitate amendments to thousands of labels.

The challenge posed by the high frequency of mass change events and lack of central control is compounded by the processes commonly used across the industry. According to a survey conducted earlier this year, two-thirds of medical device companies were relying wholly or partly on manual processes to initiate wholesale changes across all labels, Instructions for Use (IFUs) and other items of regulated content. Therefore, it is not surprising that more than 15% of respondents also expressed a lack of confidence in delivering error-free changes across their product range.

If anything, it’s surprising that only 15% of respondents lacked confidence despite continued reliance on manual scoping exercises. These inherently risky processes conclude in the same way, with someone asking, “Did we get everything?”. By continuing to use manual processes, medical device manufacturers are gambling, and the costs associated with losing are huge.

The financial implications of a recall initiated due to labeling errors are already high when considering the cost of returns, relabeling, repacking and redistribution, but what happens when we factor in potential reputational damage? If a labeling error poses a significant risk to patient safety or even worse, leads to actual harm or loss of life, the possibly irreparable damage to your brand is hard to quantify. We understand these risks and the positions decision makers face.

So, how should we be managing mass change events? While not a panacea, adopting a global labeling system (GLS) means you can ensure consistency in approach and data across all manufacturing sites, with centralized control over labeling functions. The GLS will control the master label data, linking it with your templates for labels, booklets, IFUs and any other piece of regulated content, offering tremendous flexibility and peace of mind when editing a label.

It is the centralized management of the master label data that allows a GLS to offer near-instantaneous scoping of mass change events caused by regulatory change or any other reason. In mere moments you can identify with complete confidence every label that uses regulated content containing a specific phrase, ISO symbol, brand identity, authorized representative, etc. This incredible power at your fingertips is limited only by the data you have in the system.

Migrating to a global labeling system requires financial investment and a change in approach, offering you considerable long-term benefits. There’s often a disconnect between how a process works on paper and then applied to the real world, in terms of both time and money. A two-minute job to change a single label can easily take days or weeks if it is reliant on a manual process with inputs from many different quarters.

One manufacturer, operating over a dozen sites around the world, each using a different labeling system, discovered that the cost of actioning a single mass change event was more than $350,000 and there were four such events already in the pipeline. Adopting a GLS with centralized mass change functionality meant they could simultaneously reduce their risk profile and bring the cost of actioning a mass change event to tens of thousands of dollars. While mass change capability proved to be the decisive factor in their ROI calculation, the greatest value they gained from their GLS was the ability to sleep soundly, knowing that they had eliminated the hidden risks in their labeling operations.

Medical device label changes should be able to be made fast, easy and accurate. As labeling professionals, we understand how exhausting these changes can be due to disparate systems and multiple locations. The right GLS solution will enable to you make mass changes in accordance with ever-changing regulations quickly, efficiently and accurately, accelerating your growth of enable products to reach the global patient population.

About The Author

Chris Heckert, Network Packaging Partners

About The Author

Warren Stacey, PRISYM ID