It’s generally accepted that in the highly regulated medical device industry labeling plays a critical role. The introduction of the FDA’s Unique Device Identification (UDI) system, the creation of the European Commission’s (EU) Medical Device Regulation (MDR) recommendation this past year, and the implementation of similar processes in other regions and countries have helped put labeling front and center. Organizations must not only grapple with compliance, but also continually explore new ways to improve efficiency in getting their product to market.
The global rollout of UDI-type regulations has helped ignite some new industry trends in labeling that are also providing unique opportunities for companies to reduce costs, save time, improve time to market (i.e., gain a competitive advantage). Here are just a few of the trends we’re seeing and how medical device manufacturers, as well as their supply chain partners, may benefit from a more strategic approach to enterprise labeling.
Trend 1: Adopting a Centralized, Standardized Approach
Standardizing on a single labeling solution certainly isn’t a new concept, but for larger medical device organizations dealing with complex regulations, it just doesn’t make sense to rely on disparate, disconnected labeling solutions. When you isolate labeling to the production lines at remote sites, it’s hard to ensure label accuracy and brand consistency across the global supply chain. Plus, you greatly limit the visibility into labeling for key stakeholders at corporate, especially your regulatory affairs or compliance teams.
Today’s powerful, enterprise-class labeling solutions make standardization a practical, viable reality. And when you can centralize control of labeling and provide secure access to regulatory, quality and other functions within the organization, you can systematically manage the design, review and printing of UDI labels—whether for product, packaging or shipping—across all your facilities. You also reduce the number of templates you need to store. Plus, new cloud-based capabilities make it easy to extend labeling to contract manufacturers, suppliers and distributors.
New wrinkle: Multi-site labeling. In the past, medical device companies often had to choose between deploying labeling systems centrally to maintain consistency and streamline management versus implementing locally to maximize uptime and reduce risk. In an ideal world, organizations should be able to manage labeling centrally and ensure alignment with corporate standards while enabling geographically dispersed locations to run autonomously without relying on an uninterrupted connection to headquarters.
New advancements in enterprise labeling allow companies to realize the benefits of centralized and decentralized deployments at the same time. “Multi-site” functionality offers the best of both worlds for companies that cannot afford a stoppage in mission-critical labeling but also require greater control and consistency over global labeling. Now business users at facilities like manufacturing plants, contract manufacturer sites, warehouses and distribution centers can manage labeling independently when required, while accessing standard and approved label data and templates from a company’s central location. This empowers facilities to run without depending on a full-time connection to headquarters while ensuring that they comply and stay current with corporate labeling standards.
Trend 2: Achieving a Tighter Workflow and Approval Process
With so many stakeholders involved with medical device labeling these days—and with accuracy and brand integrity more vital than ever—a well-defined workflow has grown to be a vital part of the process. Factor in the equally complicated and often parallel process of managing packaging artwork and it’s easy to see how product gets delayed in getting to market. The manual or disconnected approaches of the past create too many cycles and increase the risk of errors. And if you can reduce cycle times on labels and artwork from months and weeks to days that can represent a huge cost savings as well as increase agility when new products are introduced or major changes are needed.
Create a “closed loop” for approval. Today’s enterprise labeling solutions can automate workflow to streamline the review and approval of labels, content and packaging artwork, helping to ensure that the right people are included. You can also manage version control and easily apply user access based on role and department. This is key in the medical device industry where validation, traceability and compliance are essential. It’s important to look for solutions in which workflows are easily configurable to match your way of doing business. It’s also critical in the medical device space that workflow support e-signatures for 21 CFR Part 11 compliance.
Trend 3: Gaining More Insight for Reporting and Auditing
Medical device companies in particular understand the value of obtaining important business metrics across supply chain operations. Given the increasingly critical role of labeling, it’s only natural that stakeholders are asking for advanced analytics and reporting from their enterprise labeling solution. This is especially true because labeling has a direct impact on production and supply chain activities, and in validated environments, users want to keep up with all labeling activity and changes as they happen. Who knows when the FDA or another regulatory body will audit your operation?
Today’s enterprise labeling solutions provide built-in business intelligence (BI) to pull data and create customized reports that address a wide range of requirements. When users have access to analytics and real-time reporting they are able to gain insight into constantly changing and vital information including labels, printers, print jobs, users and audit data. This helps drive improvements to labeling processes faster and more efficiently—whether it’s responding to printer performance or unused templates.
Leverage real-time dashboards. Further visibility and agility is realized through graphical, interactive dashboards that offer real-time status of labels, workflows, print requests, configurations and user actions—from creation and approval to publication and print. Now both labeling professionals and auditors have assurance that processes are operating in accordance with key performance indicators as well as strict regulatory guidelines.
Trend 4: Increasing Number of Labeling Stakeholders
As labeling has become increasingly vital for medical device companies, many more people, groups, departments and even regions are becoming involved. Each of these constituents has their own interests and requirements that must be appropriately represented on the label. For this to happen, there needs to be more cross-functional collaboration across the enterprise—including third-party partners—to ensure accuracy and streamline mass label changes. It’s also important to simplify maintenance and support of global labeling operations by being more proactive and designating resources to coordinate and execute labeling throughout the supply chain.
With so much attention now on labeling from various departments, medical device companies are looking to empower stakeholders in the labeling process beyond just the approval stage. New advancements in enterprise labeling are making it easier to bring interested parties into the design phase by providing “layers” to segregate and manage the real estate on a label. This enables collaborative efficiency by allowing different groups (e.g. regulatory, marketing, product management) to “own” and control specific layers of a label. This not only shortens approval time but also allows faster updates to relevant label templates, reducing the time and effort needed to manage large numbers of label templates.
Stick to the “rules” of labeling. Another way to empower stakeholders and more easily keep pace with changing requirements—both regulatory or customer—is to take advantage of built-in business logic found in enterprise-class labeling solutions. This lets medical device companies create business rules as they pertain to users, labels, workflow, printers, etc. For example, you can create a rule as to which labels receive a certain symbol or language change. This logic can be applied without complicated coding and IT involvement.
These are some of the emerging trends we’re seeing with medical device labeling. More regulations, more stakeholders, more global expansion all point to the need for a powerful, scalable labeling solution. New innovations in enterprise labeling are making it faster and easier for medical device companies to sustain compliance while driving significant operational gains across their global supply chain.