#1: Multilingual Labeling – Does it really have to be so difficult?
As medical device, pharmaceutical and clinical trial organizations seek to leverage existing products in new markets, or look to extend product ranges in existing geographies, the requirement to ensure that packaging is accessible to the population in that particular market has become increasingly important.
Sourcing, recording, controlling, designing and using language-specific information is now critical to accessing a number of emerging markets for medical devices whether they are manufactured locally or imported to a specific geography.
Medical materials are shipped across many countries and many continents. For the sake of patient safety, the ability to control these materials’ labels at a global level is paramount. Labels must therefore be safely and accurately customized not only so that they are in the appropriate local languages, but also so that country-specific labeling requirements are met. Labels must ensure nuances of country specific designs and regulatory requirements are understood sufficiently to communicate coherently with users. Any local language labeling errors can create the risk of brand damage, especially during product recalls.
At PRISYM ID, we recently polled our customer base to see what the biggest challenges have been when it comes to label production. Not surprisingly, out of nine major issues, language management or multilingual labeling was the most prevalent one - across the board. Why is that? Most of the time, language management is viewed as a difficult task due to many perceived complexities. Companies may often struggle with outdated, manual processes. This then creates difficulties in dealing with the translation of individual phrases, country-specific requirements, specific local language differences… the list goes on and on.
Not surprisingly, label lifecycle management solutions have become an important weapon in the language management arsenal. A proven, validated labeling software system will remove the perceived complexities of local language labeling and facilitate the management of source data for labels, all while meeting country-specific requirements.
#2: Expansion and global labeling – Controlling the chaos
The medical device industry landscape is constantly in a state of flux with billions of dollars changing hands on a daily basis. Expansions. Mergers. Acquisitions. Restructuring. Spinouts. Downsizing. New regulations. Emerging markets. It’s all enough to make your head spin.
As medical device companies like yours expand by experiencing growth or through mergers and acquisitions, the affect on packaging and labeling operations can be significant. Perhaps a new geography is being introduced. Or, a new range of products is making its debut in the market. Or, perhaps your manufacturing operations are moving to 24/7 and changing to adhere to a raft of import restrictions.
Regardless of the method of growth your company is experiencing, you will need to always be prepared to extend and maintain control of your manufacturing labeling process throughout and after the growth period. Many companies have chosen to standardize on a Label Lifecycle Management system in order to maintain some control throughout corporate expansion activities. Besides offering you improved label integrity and consistency, a labeling software system can help you unify and integrate your labeling efforts across new, global business units and acquired companies. A labeling software system can also improve standardization efforts on a global basis and reduce the need for manually monitoring the labeling process.
#3: Managing the complexities of global labeling requirements
All global manufacturers, including medical device manufacturers, wrestle with country of origin labeling requirements in one way or another. It can be especially confusing and complex in an environment where kits or packs are assembled, such as instrument manufacturing, or where complex devices are sold – which may include supply components from many territories.
As companies like yours expand into new manufacturing territories, country of origin labeling requirements can slow your business down if you are not adequately prepared. How can you be confident and fully prepared to meet country of origin requirements head-on? The best way is to make sure that the appropriate processes and procedures are built into the packaging and labeling process ahead of time, rather than leaving the interpretation of regulations to the production line.
One way to alleviate the complexity is to be proactive about moving to a lifecycle labeling system if you haven’t done so already. A labeling software system will help you manage your data more effectively and assist with every aspect of your overall labeling process, including adherence to country of origin requirements.
Issue #4: Reduce waste and spend - Insert management on demand
It is a constant struggle for medical device, pharmaceutical and clinical trial organizations to keep on top of all the newest regulations, certifications and required updates in a timely fashion. In this day and age of ever changing policies and country-specific labelling requirements, maintaining booklets has become a cumbersome manual process ̶ and they are expensive to produce.
Multipage booklets are costly for organizations to manufacture because any required change means the entire booklet needs to be updated and reprinted. The ability to print single page instructions on demand is more economical and efficient and can be version controlled. Printing IFUs on demand helps ensure you include the right information with the right product in the right language – every time.
Proven benefits from current case studies show:
- Stronger version control processes
- Reduction in waste and space
- Ease of new market adaption management
- Up to $8 million in annual savings
#5 Label Defect Control - Achieving zero-defect labeling
With the introduction of UDI, the need for medical device manufacturers to examine systems, processes and operations is intensifying. Product recalls in the medical device industry are increasing – impacting operational efficiencies and profitability. Labeling errors are a common cause of recall, but they can be easily avoided. The introduction of automated vision systems means there are more effective, efficient and secure ways of ensuring zero-defect labeling.
By integrating automated vision inspection with label lifecycle management software, medical device manufacturers can manage and document labels through design, approval, print and inspection. This end-to-end approach gives greater visibility and control of the entire process, and supports FDA compliance.
To find out more, watch our best practice guide to achieving zero-defect labelling. This webinar presents best practices to help:
- Understand why print verification systems are becoming an essential part of the production line
- Discover why your medical device label production may not be meeting FDA compliance requirements
- Achieve insight into best practices for managing defect control
#6 The 3 Cs of Label Production
Recent UDI requirements have persuaded many medical device companies to review their labeling capabilities. This, alongside other regulatory, technological and market drivers, has led to a growing number of companies issuing Requests for Proposals (RFPs) to labeling solution vendors to address this key operational activity. However, many organizations still overlook the strategic importance of labeling and underestimate its impact right across the supply chain.
Companies need to take an enterprise-level approach to determine the impact a label lifecycle management system can have in terms of operational efficiency, risk management, regulatory compliance, consolidation and in some cases expansion.
All instances of production label prints across manufacturing lines, distribution centers, as well as by 3rd party manufacturers must Consolidate, Control, and Capture the entire process.
The three C’s enable companies to manage electronic reconciliation across all printing operations within the system to satisfy regulatory auditors and management accountability, ensuring a “single version of the truth” to meet current and evolving regulatory requirements including UDI.
By incorporating the three C’s in label lifecycle management software, medical device manufacturers can manage and document labels through design, approval, print and inspection. This end-to-end approach gives greater visibility and control of the entire process, and supports FDA compliance.
#7 Three key considerations for implementing UDI
In the ever increasing interests of patient safety and efficient protection of public health, the FDA has adopted a rule for UDI in support of enhancing safety, with the aim of identifying errors involving medical devices and providing more rapid resolution of device problems.
The standardization of a common UDI mandate is designed to increase visibility and improve the quality of information in medical device adverse event reports, improve traceability and security within the supply chain. It will also reduce the potential for medical errors through consistent, unambiguous, harmonized data. Furthermore, UDI will facilitate the storage, exchange and integration of data and systems between suppliers and providers.
3 key questions for medical device manufacturers are; based on your current system capabilities:
- Are you able to properly control the elements and execution of your print jobs and then capture the data elements of every label printed?
- Will you be positioned to efficiently capture and submit the necessary UDI data to the Global UDI Database?
- Have you factored in the training of your staff and allocated sufficient time to integrate this additional labeling requirement to your current processes?
If you can’t give a definitive yes, then you need to think about how you will manage this in the future. By planning and implementing a label lifecycle management strategy with the right processes and right solution, you will guarantee UDI readiness for your organization without derailing your production.
This recent whitepaper from PRISYM ID and GS1 walks you through the necessary steps and processes to keep you on track when implementing UDI.