Automation Strategies IIoT Management

Four Regulated-Industry Disruptors

EP Editorial Staff | July 19, 2023

Manufacturers in the highly regulated industries face significant disruptive forces in the near future that will affect their entire operations, including label making and modification.

The industrial metaverse, cybersecurity, the looming sustainable packing deadline, and data centricity will be the near-future focus in pharmaceutical, food, and related industries.

By Bob Tilling, Kallik

Businesses and manufacturers in highly regulated markets, such as pharmaceutical, food and beverage, cosmetics, and consumer packaged goods (CPG), have experienced huge change in recent years, most significantly in the technologies they use, the regulations they face, and changing demands from their customers. These macro-level, technology-driven changes are having a serious impact, right down to the packaging, labeling, and artwork used when manufacturing each individual product. In the near future, four areas will be most affected.

Industrial meta verse

The global metaverse market is set to grow at an annual compound rate of 39.8% between 2022 and 2030. As part of the wider metaverse umbrella, the industrial metaverse combines a mix of immersive technologies, including physical-digital fusion and human augmentation, to create digital representations of physical environments. Early adopters are already seeing benefits in terms of streamlining logistics and processes, achieving tangible return on investment (ROI), and delivering high-quality products across multiple industrial applications.

Many companies are still trying to envision the future of the industrial metaverse, but its potential to transform design, manufacturing, and interactions across global ecosystems is gaining significant interest. We have already seen the introduction of digital twins, a virtual model designed to accurately represent a physical object. When supported by technologies such as artificial intelligence (AI), Internet of Things (IoT) and 3D rendering, the true power of digital twins can be realized.

In conjunction with digital twins, we can expect to see increased use of 3D rendering, which is the process of using a computer to generate a 2D image from a digital three-dimensional scene. 3D rendering for artwork and labeling generates labels or artwork to put on a product and produces a 360-degree view of what it will look like on the product or even the shelf before it goes to market.


Sophisticated hackers are increasingly finding ways through business security defenses, making cybersecurity a top priority. For the healthcare sector, cyberattacks have been a long-standing issue. Its vast amount of personal data, combined with a reliance on outdated, legacy technology has made the healthcare market a sought-after target and, unfortunately, medical devices have become an easy entry point for attackers. Medical-device manufacturers are on the front line and must integrate an effective cybersecurity plan throughout the entire product-development lifecycle, from pre- and post-market phases to device disposal.

Prevention comes down to data management—companies stand a much higher chance of warning off unwelcomed attackers by putting data at the core of operations. This applies to access control for critical recipes and formulas in the manufacturing supply chain, including the label and artwork management (LAM) solution. LAM solutions are accessed by multiple parties across the manufacturing and distribution process, so product owners need to hold one single source of truth and be sure there is no unwanted data sharing.

They must ensure that only platform users are able to see information relevant to them and that out-of-date files are inaccessible. This will provide reassurance that a consistent audit trail has been followed and minimizes the likelihood of data leakage.

Sustainable packaging

Environmental, social, and governance (ESG) may not be a new phenomenon, but it requires urgent action as pressure mounts daily from investors and an eco-conscious society. Organizations can even expect to lose their competitive edge or market share if ESG is not taken seriously. In a recent report by Kantar, 97% of consumers globally reported that they are prepared to act and live a more sustainable life, with another 79% keen to purchase more sustainable products.

Most recently, microplastics have found themselves under the microscope. Every minute, more than 15 lb. (7 kg) of microplastics from cosmetics and personal-care products end up in the environment. The cosmetics industry is at the forefront of this issue, as 87% of products from the top ten cosmetics brands contain microplastics. The growing issue has sparked major interest and consumers have called upon regulators to create new laws against the use of microplastics. If approved, the restrictions will have huge implications for manufacturers in terms of product composition and a major overhaul of existing labels to reflect ingredients changes.

Exacerbating these pressures is the real and unavoidable 2025 deadline for sustainable packaging. Although market challenges, such as cost of living increases and supply-chain shortages, will wreak havoc for organizations, nearly 70% of consumers are willing to pay more for products with sustainable packaging. This will require business leaders to rethink operations and timeframes, including the use of sustainable materials. Technology will reduce long manufacturing development lifecycles and waste in label and artwork management by easily allowing adaptability to fit new packaging sizes and types.

Data centricity

More organizations will realize the true power of data when analyzed and used at scale. Despite investment of trillions of dollars by U.S. companies into data analytics integration at scale, up to now only 8% of organizations are capturing real value. From a labeling and artwork management perspective, effectively harnessing data can unlock a whole host of opportunities and help prepare for changes in regulations, product updates, and reaction in the event of product recalls.

In the artwork and labeling space, being able to react to changing market conditions will be pivotal to staying compliant. As a result, operational companies must invest in a data-heavy system, capable of quickly examining, storing, and printing mass amounts of data. Consider the move to sustainable packaging, in which companies will need to alter recycling symbols for each product based on the material type, regional recycling regulations, and storage and recycling instructions for every region and every language.

Analyzing data at scale and implementing cross-organizational change across thousands of product lines will be a long, arduous, and error-prone task with a manual or paper system. It is simply impossible now to adapt to change and to grow without the help of technology.

Whether it is the rise of the industrial metaverse, preparing for upcoming regulations, tightening cybersecurity defenses, or increasing focus on ESG, manufacturers will experience an additional reliance on digital LAM solutions to ensure product packaging and labeling keeps pace with these developments. For all manufacturers, particularly businesses in regulated industries, the label may be the last part of the production cycle, but it will be one of first parts to cause regulatory issues and affect consumer safety. EP

Bob Tilling is Vice President of Global Sales, at Kallik LLC, Birmingham, UK. Kallik is an enterprise labeling and artwork management software company that produces Veraciti, a full end-to-end software system covering the entire labeling lifecycle of highly regulated industries. Learn more at


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