Aligning for Growth: The Evolution of Medical Device Labeling
Page 1 of 8 Version 140224 Aligning for growth: the evolution of medical device labeling How label lifecycle management can accelerate growth A Whitepaper from PRISYM ID Page 2 of 8 Version 140224 Aligning for growth: the evolution of medical device labeling How label lifecycle management can accelerate growth The introduction of Unique Device Identification (UDI) regulations signals a seismic shift in the labeling of medical devices. Over the past twenty years, the development of labeling solutions for the highly regulated devices sector has been a steady evolutionary process – but not everybody has taken the journey. While some companies have recognized the commercial benefits of introducing more scalable solutions – driven by data, not label outputs – others remain on the lower rungs of the evolutionary ladder. But the introduction of a common UDI mandate is a once-in-a-generation game-changer that gives medical device organizations no choice but to change. What’s more, it will also have significant downstream implications right across the supply chain. The onset of UDI is genuinely seismic: it charts the move from evolution to revolution. But its introduction could also provide a powerful opportunity for companies to accelerate efficiency and productivity, and drive profitability. As the new FDA requirements finally take hold, the questions for global medical device organizations are clear: is your current labeling infrastructure aligned with the new UDI regulations? Moreover, is it aligned to your business objectives? It can be. Fully integrated label lifecycle management solutions not only provide a mechanism to ensure regulatory compliance, they can also provide an engine for growth. It’s time to get the engine started, before the wheels come off. The theory of evolution In the past twenty years, systems for medical devices labeling have been through three distinct stages of evolution. Stage one: the local solution In terms of medical device labeling systems, the Darwinian ‘origin of species’ was largely a localized solution managed at a site level. Under this silo approach, every single production site within a global organization had its own individual system, its own templates and, more often than not, its own static documents for every product it produced. Such systems focused almost entirely on the provision of outputs – labels – and were generally run from basic software, held on an individual’s PC. They offered very little standardization and no centralized control. Stage two: the regional approach Moves to a more advanced approach started to take shape from around 2005, when systems evolved to provide greater regional or divisional control. Using this approach, clusters of operations in geographical Page 3 of 8 Version 140224 regions (such as the EU), or in business divisions (such as orthopedics), began to centralize and standardize the label design, review and approval processes. Although this methodology was still highly focused on the label, there was an incremental increase in emphasis on the data, highlighted by the emergence of template driven solutions where label designs were used across multiple products. From a technology perspective, the software to support the regional/divisional approach sat on a regional server, accessible only to narrow cohorts of individuals at specific sites. Stage three: the global approach The latest rung of the evolutionary ladder is the development of integrated label lifecycle management solutions that provide transparency and accessibility right across global organizations. Unlike their predecessors, these systems have a laser focus on data – recognizing that the effective management of content can enable standardization and ensure that processes are controlled centrally and distributed locally and regionally including requirements for local language and country specific requirements. Despite these three clear phases of evolution, there remains significant variability across the industry. Some companies are implementing advanced global labeling solutions, and reaping the rewards; while others are still stuck at stage one. But, as the regulatory environment for medical devices continues to shift, and the business landscape responds to ever-changing global conditions and challenges, the principles of Darwin’s Theory of Evolution could have a painful truth for the devices sector. Only those that adapt will survive – while those that don’t risk becoming extinct. To thrive, a Label Lifecycle Management solution is the natural selection. What is Label Lifecycle Management? Label Lifecycle Management (LLM) refers to the provision of discipline and control throughout the lifetime of the label. This includes: • Security controls • Auditing • Editing tools • Maintenance of data integrity • Support for review and approval • Supply of objective evidence • The ability to represent customer processes • The storage of historical content for future reference Data is the key focus of LLM – with the label considered to be the final output, and the product of robust, validated and visible data integrity. Fully optimized LLM is best underpinned by leading edge technology. A LLM solution gives companies a 360° view of all of their data assets, enabling a fully integrated organization-wide approach to production processes. Effective LLM provides a centralized global platform Page 4 of 8 Version 140224 that can be leveraged across all sites, regions and divisions – and that is interoperable with existing enterprise systems. These powerful web-based tools provide comprehensive, scalable and validatable solutions that offer medical device manufacturers complete label integrity – from data management to design and approval, through to label production and inspection – to meet the strictest compliance requirements. Moreover, with both the regulatory and commercial environments fast-paced and dynamic, LLM solutions can provide a robust platform for future system expansion, underpinned by standardization, holistic visibility and widespread accessibility. Drivers for Label Lifecycle Management The rationale for LLM is varied, combining both commercial and regulatory drivers. Despite great technological advances in recent years, labeling and packaging defects still remain responsible for a high percentage of voluntary recalls of medical devices. The commercial implications are significant; efficiency, productivity and ROI take a major hit, whilst the potential damage to brand reputation and patient safety is equally severe. Alongside this, the financial penalties for non-compliance are unforgiving. With regulatory scrutiny further intensified by the recent introduction of the UDI directive, the catalyst for change is compelling. Commercial challenges The medical device industry as a whole faces numerous general challenges as it seeks to adapt to a changing business and economic climate. The market is now truly global, with companies developing an international customer-base and building a global infrastructure to support it. Medical device organizations have established local operations in all of the world’s mature and developed markets – and, moreover, many have identified emerging and developing nations as a key engine for long-term growth. Device companies are now multi-national, multi-region and multi-site operations – and, as a result, are having to confront all of the common business challenges of communication, brand consistency and system integration. With operational efficiency and productivity an industry-wide imperative, the need for collaboration, data visibility and interoperability across countries and regions is paramount. Consolidation has become a major priority – not least in the production and manufacturing environment. Companies are operating multiple systems across their facilities – each with different operating procedures and capabilities. This, in turn, is leading to a multiplicity of label designs, a duplication of skills and, of course, increased costs. The need for standardization is growing. Likewise, the ever-sprawling geographical expanse of the medical devices sector also means that companies increasingly need to adapt to evolving country-specific regulations. As regulation in mature markets shifts, requirements in the developing nations are also changing. There is a growing trend for multi-language and language-specific labeling, while import restrictions in countries such as China mean that companies may not be able to label products in the local market, they must instead be labeled prior to shipment. Page 5 of 8 Version 140224 At the same time, in line with ongoing global expansion, commercial demands and shareholder expectations are such that companies are now manufacturing products around the clock. The challenges of delivering new products to existing markets and existing products to new markets is placing renewed pressure on facilities, and increasing the risk of manufacturing or production errors. The need for system expansion is great. But for economies of scale, the standardization of processes and centralization of control enabled by LLM solutions is undoubtedly a more sustainable and cost-efficient option. Regulatory challenges The recent introduction of the FDA’s directive for UDI is just the latest in a long line of regulations designed to enhance patient safety and improving the recall process in the event of issues. But it is also the most significant regulatory change of its generation, and promises to have far-reaching downstream implications for the industry and the supply chain. The directive aims to improve the ability to trace and track medical devices at a global level. Until now, there has been no single global regulation for uniquely identifying devices in the supply chain – making product recalls less efficient and more complex, and negatively impacting patient safety and confidence. A UDI is a unique numeric or alphanumeric code that allows the unambiguous identification of a specific product or product batch. It represents the “access key” to device-related information stored within a publically available Global UDI Database (GUDID), allowing users to look up information about that particular product. The main framework for the production of a Unique Device Identifier is the combination of the UDI located on the label or directly on the product, and the storage of the UDI and additional device related information in the GUDID. The UDI itself contains two parts: the Device Identifier and the Production Identifier, both of which must be individually recognizable. The new UDI requirements provide a way of presenting information in a standard format or barcode, making trade, distribution and usage more secure. The standardization of a common UDI mandate will increase visibility and improve the quality of information in medical device adverse event reports, improve traceability within the supply chain and reduce potential errors through consistent, unambiguous and harmonized data. To work effectively, it must also facilitate the storage, exchange and integration of data and systems between all healthcare stakeholders. Broad adoption and use amongst manufacturers, suppliers, distributors, providers and patients will be central to the directive’s success. As a result, the manufacturing and labeling industry faces the potentially daunting task of improving current processes in time with the incremental implementation timetable. Talk about an evolution Compliance with the new UDI directive does of course present challenges for the industry. For many, it will require a comprehensive program of change management, involving a detailed review of current infrastructure and the development of a robust strategy to meet the new requirements quickly and effectively. The three stages of labeling evolution outlined at the start of this paper could give the Page 6 of 8 Version 140224 impression that the medical device sector as a whole has adapted its production processes in line with shifting regulatory and market dynamics. This would be misleading. Across the industry, the way in which many companies approach the design, creation approval, printing and inspection of labels is variable and fragmented. Commonly, organizations regard labels as individual documents that present fixed pieces of content – and when changes are required they are forced to go back to the master file, modify individual content-rich documents and then reprint them. It’s a primitive process that’s not only inefficient and costly, but also resource-intensive, a hostage to product updates and country-specific regulatory requirements, and prone to human error. And worse still, label data rarely integrates with other organizational business systems and other key aspects of the production process. In some organizations, data is maintained off-line or uploaded from a spreadsheet ahead of a batch print. Incredibly, some companies still import data using ‘copy and paste’. And in many cases, labeling processes sit in their own operational silos, ready to be married with the product only at the final stage of the production line. In a competitive global marketplace where brand reputation is a key commodity, such archaic and disjointed approaches leave companies increasingly vulnerable to mislabeling and voluntary recall. A broader view is required. Although it is a vital component in the production process, the label is merely one of many – a final output that is intrinsically linked, and indeed the product of, all the other variable aspects. Label design and delivery cannot, therefore, sit in isolation. It is only one aspect in a 360° process – and to meet the highest standards of accuracy, it needs to be built upon a 360° view of all the variable data components that influence its content. In the highly regulated medical device environment, these variables include product specifications, country and product-specific regulations, market destination, local language requirements, batch number and expiry dates. And the regulatory landscape, rather like companies’ product portfolios, is evolving all the time. Systems and processes must therefore evolve with it. For those companies stuck on the lower rungs of the evolutionary ladder, talking about evolution is no longer enough. Doing nothing is not an option: what you do today, you cannot do tomorrow. And with the regulations mandating companies to retain documentation for devices for as long as seven years after the last device has been used in a patient, the need for an effective solution to store and manage data is critical. Against the backdrop of a complicated matrix of commercial and regulatory challenges, organizations must implement a system that not only ensures they are compliant with new legislation, but one that can also flex for growth and adapt to future regulatory changes. In return, the investment in such systems can lead to many operational benefits such as producing booklets, Instructions for Use (IFUs)/ Directions for Use (DFUs), as well as the ability to produce materials ‘on demand’ and print on a ‘just in time’ basis. Page 7 of 8 Version 140224 The benefits of Label Lifecycle Management solutions Meeting the challenges of UDI does not need to be daunting. Fully integrated end-to-end LLM solutions can help companies take a more strategic approach to the management of global data, and help companies capture, store and disseminate data quickly, safely and accurately. The benefits are significant. LLM platforms can increase efficiency by reducing the number of unnecessary manual checks, improve quality control with the use of automated validation systems throughout the lifecycle, and accelerate products to market. Centralized data creates a robust platform for a ‘single version of the truth’ that can be used to generate and print labels ‘just in time’ – ensuring that the right information goes on the right product at the right time, every time. And truly holistic systems also allow for post-print verification to ensure no errors have crept into the process at the print stage; vision verification solutions carry out automated audits through the print process, assuring approved imagery and data has been printed correctly on every label, as well as delivering lifecycle traceability. Moreover, the standardization enabled by LLM solutions provides data visibility for stakeholders right across multi-national, multi-site organizations. This not only helps companies manage local language requirements effectively and mitigates the costly risk of product recalls, but it also provides reassurance and control for marketers seeking to maintain brand consistency across global markets. LLM solutions can also help companies tackle some of the wider strategic challenges head-on. The most significant of these, of course, is assuring profitability. This is largely achieved by balancing efficiency and productivity, as well as protecting against the expensive (in both time and money) implications of non- compliance. By taking a greater focus on LLM, and ensuring more efficient operations, companies are well-placed to reallocate manufacturing and drive more products through their facilities. At present, for many organizations, the silo way in which operations are set up means that the cost of making just one global change to a label can be astronomical. Companies must take a step back and look at the number of steps – and the associated costs involved – in executing those global changes, and assess whether they are optimizing technology to consolidate those processes. Are you still working on an individual workstation basis? Are individual errors still creeping in? How long does it take to make a global change, and how much does this cost you – both financially and in terms of speed to market? The additional layer of regulatory evolution, led by the seismic shift to UDI, brings further weight to the argument for immediate change. Inefficient operations and processes have long plagued medical device manufacturers, but the perceived trauma of significant global change has dissuaded organizations from overhauling its systems. But the advent of UDI finally removes the option of choice. Companies can no longer afford to be passive. Without a standardized mechanism for LLM, the costs of implementing UDI controls will undoubtedly be prohibitive. A failure to deliver efficiencies could cost companies a significant amount of money. In the most extreme cases, it could end up costing you your business. Page 8 of 8 Version 140224 For medical device companies grappling with commercial and regulatory challenges, the mantra is therefore simple: it’s evolve or die. In an expanding and changing marketplace, companies must quickly climb the evolutionary ladder and put in place integrated systems that empower their multi-national workforce with data accessibility and visibility, and provide brand consistency, efficiency and operational agility across a global marketplace. It’s the theory of evolution, and the survival of the fittest. And to thrive, a Label Lifecycle Management solution may just be the natural selection. About PRISYM ID Turn-Key Solutions for Global Label Lifecycle Management PRISYM ID designs and delivers turn-key labeling solutions for organizations that need complete product auto- identification and lifecycle traceability. With the continual tightening of labeling regulations and audits, PRISYM ID empowers its clients to safeguard their reputation by ensuring compliance, and significantly reduce costs by eliminating recalls through labeling errors. PRISYM ID is the market leader in world-class label lifecycle management, and is trusted for delivering personalized service excellence to clients in varied sectors including medical device, life sciences, healthcare, automotive, chemical and manufacturing. For further information, please go to: +44 (0) 189364400 | +1 508-948-6100 | | | @prisymid