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January 31, 2022


The Top 4 Labeling Challenges Facing Medical Device Manufacturers – And How To Address Them

by Laura Hindley

PR & Content Manager

The medical device market has been growing at a compound annual growth rate of five percent and with an aging population, the COVID-19 pandemic, and the prevalence of chronic disease, it’s showing no signs of slowing. It’s a challenging time for medical device manufacturers. They are forced to balance demands for quality and compliance with operational efficiency – at times it can seem like a never-ending battle to remain competitive.

Let’s take a look at four challenges medical device manufacturers are facing right now and how Enterprise Labeling helps to effectively overcome them.

Challenge 1: The rising tide of regulations

Regulatory compliance has been identified as the most significant challenge facing medical device manufacturers. Labeling accuracy, consistency, and traceability are hugely important, as is the speed with which they need to comply. This paired with the constantly changing scope of regulations and the regional differences involved, require the implementation of a modern Enterprise Labeling solution. An Enterprise Labeling solution provides the transparency and traceability that regulatory bodies require.

 Challenge 2: Reduce costs and maintain high-quality standards

Quality and cost controls are both paramount in the medical device industry, where manufacturers have found themselves operating in a marketplace that is becoming increasingly price sensitive. To compete, they must find ways of making production more efficient and getting more done while spending less, and all without compromising the quality of their products. Modern Enterprise Labeling helps organizations create more efficient workflows, make the best use of internal resources, and eliminate costly errors.

 Challenge 3: Expanding into new markets

Expanding into new markets whether adding new regional facilities or adopting existing locations through acquisition is a fundamental aspect of many device manufacturers’ business strategies. Yet, with growth comes risk. To successfully expand into new markets, device manufacturers need the solid foundation that an Enterprise Labeling solution provides. This will ensure that they can smoothly incorporate new products, languages, and suppliers into their existing production workflows while extending existing quality control measures to newly- acquired production sites.

 Challenge 4: Streamlining the receipt of inbound goods

When suppliers don’t comply with labeling standards, medical device manufacturers are forced to use more manual processes to offset challenges like inventory miscounts, missed production deadlines, the relabeling of inbound goods, and the need for more warehouse space to store the goods. An inefficient supply chain plus increased labor costs, excess inventory, and warehouse space equals slower time-to-market, decreased competitive advantage, and the inability to scale across the enterprise. By extending labeling to suppliers, manufacturers receive inbound goods with compliant labels which meet corporate standards while also improving those valuable relationships.

By rethinking the way you handle labeling and taking advantage of the latest technology within Enterprise Labeling solutions, you can effectively and efficiently comply with industry regulations, cut costs, improve quality, expand operations, and scale.

To learn more about how to address these challenges, download our white paper, 'Turning Roadblocks into Pathways to Success'.