Since March 2020, medical device companies have needed to withstand unique challenges; companies across every vertical — from PPE, ventilator, vaccine and syringe manufacturers to those that are not COVID-specific — have been affected by the pandemic and consequent supply chain disruptions
A key challenge has been shifting supply and production, notes Laura Johnson, Director of Sales, Life Sciences, at Loftware. When medical device manufacturers change suppliers, for example, their raw materials or components often arrive with a different label structure or content than the previous supplier.
As a result, these materials cannot be incorporated into the assembly process until they are relabelled, which costs time, money and resources. Additionally, language barriers, time differences and email chains can stretch this process out interminably during a time when there needs to be efficiency.
In today’s world in which supply chain flexibility is no longer optional, companies of all sizes must streamline their processes — not only to survive but to provide patients with the products they need within a critical time frame. In this industry, people depend on efficiency for vitally important surgical intervention, lifesaving care, drug delivery and pain management.
One of the most important parts of developing a new medical device is ensuring that it’s labelled properly. Labelling the device involves a variety of details, including instruction regarding its proper use, requirements to safely operate the device, storage, maintenance and installation requirements.
All devices are required to have a Unique Device Identification (UDI) that identifies the general type of device and a specific product identifier. Common symbols are used to communicate properties that occur for a variety of devices. Although the standards in the US, the EU and Canada all vary slightly, the basic principles remain the same.
For some devices, this is a fairly straightforward process, especially with those that are similar to ones already developed. Others take more time because they are based on a new type of device or an innovation that was not regulated before. Labelling is a very precise process and the complications that result from new safety or security concerns can jam up the works.
With this in mind, the best hedge against an ever-changing regulatory, logistical and business landscape is to implement a cloud-based enterprise labelling solution. Forward-thinking companies are already turning to automated and digital solutions to manage and control the process to achieve compliance, ensure flexibility and speed time-to-market.
This was illustrated in our annual “Top 5 Trends in Labelling and Packaging Artwork” report, which polled nearly 1000 professionals from organisations across all major industries and 55 countries.1 Of those surveyed, 85% said that having an enterprise labelling solution helps to eliminate the risk of non-compliance, whereas 83% said they would generate significant cost savings by consolidating under a single labelling solution.
One of the biggest benefits of implementing a cloud-based enterprise labelling solution is that medical device companies can shift labelling from one site to another while ensuring continuous operations. This allows companies to realise the benefits of both centralised and decentralised deployments.
As such, business users at remote facilities can independently manage labelling while accessing standard and approved label data and templates from a company’s central location.
Additionally, a multisite approach empowers remote facilities to run without reliance on a full-time connection to company headquarters, while maintaining compliance with corporate labelling standards. If connectivity to headquarters is disrupted, remote facilities failover to a local alternative, synchronising transactional data later when the connection is restored — ensuring uptime and reducing risk.
Companies can quickly and easily shift labelling from one location to another if there is a break in continuity or a disruption at any point across their enterprise. This is critical to maintain business operations in the case of any outages, shutdowns or supply chain disruption.
Medical device manufacturers are under constant pressure to comply with new regulations, reduce costs, expand into new markets, improve quality and scale their enterprises. To flourish, medical device makers must change the way they innovate, design for manufacturability and differentiate their products in the market. One way they can do this is by harnessing the benefits of the cloud.
As they rethink existing methods and innovate processes, medical device manufacturers need to improve quality while spending less and tracking more. That’s where cloud-based enterprise labelling can help.
By rethinking the way they handle labelling, and taking advantage of the latest technology within enterprise labelling, medical device manufacturers can effectively and efficiently comply with industry regulations, cut costs, improve quality and expand their operations and scale.
Nobody 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, a cloud-based enterprise labelling solution will streamline your ability to scale and adapt.