Soapbox

How Labeling Plays a Critical Role in Mitigating Supply Chain Disruptions

By Laura Johnson
March 1, 2021


• Categories: 03-Manufacturing Execution, 04-Product Design & Development, 05-Quality/Regulatory, RC - Medical Device Labeling, Soapbox

Unexpected supply chain disruptions impacted nearly every industry since March 2020, and medical device companies have needed to withstand particular challenges. Although your mind may immediately think of PPE, ventilator, vaccine and syringe manufacturers in this scenario, companies across every vertical—not just those that are COVID-specific—have been affected.

Largely, the challenge has been shifting both production and supply, which has multidimensional aspects. In an industry where precision and quality are paramount, supply chain resources and quality assurance teams have been impacted by COVID protocols, including having limited access to sites. Additionally, every time a medical device manufacturer shifts production, they need to shift labeling to meet demand. Suppliers, meanwhile, must rapidly integrate with new medical device companies in a compliant manner—otherwise their parts and materials will never reach the customer.

With this understanding, enterprise labeling has become the glue that must hold a rapidly changing medical device supply chain together. People depend on this equipment for surgical intervention, lifesaving care, drug delivery and pain management. Labeling is as critical as quality for medical device products. If a manufacturer can’t shift labeling to meet production in a timely manner, their products may not get to where they needed in a critical timeframe.

As such, medical device companies need to anticipate and manage labeling risks. For example, if a company changes suppliers, their raw materials or components may arrive with a different label structure or label content then the previous supplier—which means that these materials cannot be incorporated into the assembly process until they are relabeled, which costs time, money, and effort. This is why it is critical to have a centralized system with controlled access for suppliers to print approved labeling templates and content at their facilities.

Lastly we need to consider that more than 80% of medical device manufacturers have fewer than 100 employees in the United States, and that more than 60% have fewer than 20. In an era of relatively static supply chains, these companies could get away with passing paper in order to create labels and packaging artwork. Now that the supply chain flexibility is no longer optional, smaller enterprises must rapidly digitalize the vital paperwork that powers their logistics.

Medical Device Manufacturers Must Cope with Supply Chain Uncertainty

Let’s start by looking at a short case study.

Early in the pandemic—and continuing as of this writing—medical device manufacturers began experiencing a shortage of nitrile, which is used most notably in gloves but also in many other medical devices.

This shortage was due to the fact that major manufacturers of nitrile were all in China, and that the material was quickly requisitioned by the Chinese government. Medical device manufacturers had to find other sources of nitrile quickly.

Let’s say that you need to rapidly switch your nitrile supplier from a company in China to a facility in South America. This means that the supplier has to create a label that includes:

• A new point of origin
• Different shipment routes
• Different languages
• New customer requirement(s)
• Potentially altered formatting

If these parameters are incorrect, then you (or at least the next manufacturer in the supply chain) can’t use their materials or components to create your product. In this case, you’ll need to work with the supplier to get a label printed correctly. Language barriers, time differences, and email chains can stretch this process out interminably during a time when there needs to be efficiency.
Each change can cause delays, especially if your organization isn’t changing one supplier at a time. Based on the overall map of shortages, many companies have had to make multiple changes simultaneously.

Even if you’re eventually able to switch back to your original supplier, you may not be able to quickly resume your operations. The pandemic has been going on for a long time—If you can’t pick up where you left off, then your supply chain still isn’t agile.

How Can Medical Device Manufacturers Shift Production More Efficiently?

So, based on all of the above, what’s the right way for a medical device company to shift labeling from one site to another? Even though the administering of a vaccine means that the immediate necessity of maintaining a flexible supply chain could be drawing to a close, there are plenty of other reasons why it could be helpful to maintain this capability.

A multi-site labeling approach is designed to ensure continuous operations while realizing the benefits of both centralized and decentralized deployments. Business users at remote facilities can independently manage labeling, while accessing standard and approved label data and templates from a company’s central location. If connectivity to headquarters is disrupted, remote facilities failover to a local instance, synchronizing transactional data later when the connection is restored—ensuring uptime and reducing risk. Companies can quickly and easily shift labeling from one location to another if there is a break in continuity or a disruption at any point across their enterprise. This is critical in maintaining business operations in the case of any outages, shutdowns or supply chain disruption. Additionally, multi-site empowers remote facilities to run without reliance on a full-time connection to company headquarters while maintaining compliance with corporate labeling standards.

Cloud-Based Labeling Solutions Provide Convenience, Compliance and Security

By obtaining visibility and control over supplier labeling, it becomes much easier for medical device manufacturers to shift to suppliers in new locations, enabling much more efficiency in maintaining business continuity. Instead of providing a new supplier with data and hoping that they create the correct label with it, the user can manage the template they need.

What’s more, your supplier no longer need specialist knowledge to generate a label. International shipping regulations can be difficult to manage, but by using enterprise labeling, they can generate compliant labels programmatically. As long as they can correctly identify what is being shipped, along with its origin and destination, your solution can generate documentation and labeling with the correct languages, the correct pictograms, and even the correct font and lettering size. This allows medical device companies to focus on their core competencies—designing and building high-quality medical devices—without forcing them to become experts on international commerce.

Many medical device companies are receiving an unexpected windfall of orders this year—which is why the abilities of enterprise labeling have become even more important. Companies aren’t just replacing suppliers, in other words. Instead, they need to rapidly add new capacity to keep up with demand. In this scenario, the ability eliminate relabeling and improve the commitment to just-in-time manufacturing is a critical component of the ability to scale.

Lastly, medical device manufacturers take security seriously. Your chosen enterprise labeling solution should have the ability to offer role-based security. This means that your system administrators can choose who can access labels, content, and printing devices. They should also have the ability to understand printing activity across the entire facility network. This helps ensure that your printing architecture meets privacy and security standards without allowing bad actors a toehold into your organization.

The Need for Flexible Medical Device Supply Chains Extends Beyond COVID-19

As the vaccination campaign for COVID-19 continues to roll out, the medical device industry will most likely endure additional supply shocks. For example, demand for syringes is expected to increase dramatically. What’s more, it’s important to be ready for the next medical crisis. Even if your company has gotten through the pandemic without serious inconvenience to date, you’re not immune to changing demands.

The best hedge against a changing logistics landscape is to implement an enterprise labeling solution. This solution provides access to accurate and compliant labels to meet demand, while extending access to suppliers without spending weeks trying to reinvent the wheel as far as labeling processes are concerned.

No one can truly predict the next event that will disrupt medical device supply chains—the only thing that businesses can control is how well they are prepared to respond. Whether you’re shifting production, switching suppliers, introducing a new product, selling devices in a new country, or preparing for the next pandemic, enterprise labeling will streamline your ability to scale and adapt. Apart from saving your bottom line, this shortens the time it takes for you to help people in need.