January 10, 2023
Why medical device manufacturers are embracing cloud-first labeling strategies
Director of Sales, Life Sciences
The medical device industry requires precision and quality to operate effectively, and this is no different in its supply chains. The protocols brought on by the COVID-19 pandemic heavily impacted production, in large part due to supply chain disruptions and although this is easing, many have realized their systems need to be future-proofed to prepare for the next potential event that could impact medical device supply chains. With merger and acquisition (M&A) activity continuing to increase, companies are looking for a solution allowing them to scale supply chains and easily extend controlled access to validated solutions to providers and partners.
One specific pain point felt by the medical device industry has been shifting production and supply, with both having multidimensional aspects. While the pandemic sparked many of these issues, recent worker shortages and facility shutdowns have exasperated the situation. Every time a medical device manufacturer shifts production, labeling must shift to meet demand. However, without a centralized solution that’s effective in a remote setting, this becomes increasingly difficult, posing issues for the company and the people depending on medical devices for surgical intervention, life-saving drug care, drug delivery, and pain management. For this reason, labeling is as critical as quality is for medical device products because if manufacturers can’t shift labeling to meet production in a timely manner, they could incur hefty fines and their products won’t get where they’re needed when they’re needed.
So, how do medical device manufacturers mitigate this risk? The answer lies in the cloud.
Labeling simplified with the cloud
Cloud-driven labeling solutions are the most effective way to help medical device supply chains run at peak efficiency – even with a remote workforce.
The need for more cloud-based systems in today’s digitized environment is well recognized. According to Gartner, by 2026 public cloud spending will exceed 45% of all enterprise information technology (IT) spending by 2026, up from less than 17% in 2021. Furthermore, Loftware’s 2022 research reveals 73% of companies believe the cloud will be their preferred method for labeling applications in the next three years because of the huge potential to scale, standardize practice, and drive improvements across their enterprise.
Even if a company has made it through the pandemic without serious inconvenience yet, this doesn’t mean they’re immune to changing demands. The best hedge against a changing logistics landscape is implementing a cloud-based Enterprise Labeling solution, which will provide medical device manufacturers with several business-boosting benefits.
A cloud-based solution reduces the risk of mislabeling and enables regulatory compliance. According to a Loftware report, recalls and lawsuits, largely caused by labeling errors, cost the medical device industry up to $5 billion annually. Preventing errors is of utmost importance for medical device manufacturers operating across an ever-changing regulatory landscape. For example, manufacturers can create labels that include the unique device identifier (UDI) device and production identifier information that’s required by FDA UDI and EU MDR (medical device reporting) regulations. They can store these labels in a catalog, clearly document actions, and print manufacturing history to respond to regulatory audits as required. This is critical because one misstep can severely hamper a product’s route to market, impact patient health and safety, incur fines from regulators, and damage brand integrity.
Additionally, with the cloud, maintenance is greatly simplified, and upgrades are seamless thanks to the on-demand provisioning of software. It provides a high level of financial predictability since it shows up as an operating expense versus a capital expense. With no IT infrastructure to purchase or maintain, medical device companies can allocate budgets to other core operating expenses and focus on running their businesses.
Tearing down barriers
With cloud labeling, medical device companies improve regulatory compliance and avoid costly labeling errors, while maintaining a crucial level of safety customers and supply chains require. Additionally, organizations can be up and running quickly, benefit from automatic software updates, pay on a subscription basis, easily scale their printing operations when needed, reduce infrastructure costs, obtain advanced IT security, and improve their sustainability credentials.
Many medical device manufacturers are lean outfits relying on either pre-printed label stock or analog systems to create labels for products. In an era of relatively static supply chains, these companies could get away with antiquated labeling systems because operations were fairly rigid. Now that supply chain flexibility is no longer optional, enterprises must rapidly digitalize the vital paperwork that powers their logistics. This process can prove to be difficult for some organizations who may not allocate as much time or resources to this transformation. The cloud removes these barriers and puts world-class enterprise systems into the hands of companies of all sizes – even those that may be resource-constrained.
Using a system that can handle a complex web of regulations and shifting suppliers is imperative for medical device manufacturers. As the labeling and supply chain ecosystems continue to evolve, companies continuing to think more strategically about addressing both current and future challenges will turn to cloud-first labeling strategies to help them achieve their goals.
*This thought leadership article was first published by Today’s Medical Developments
- Supply Chain