E-Labeling: A Global Reality

The topic of electronic labeling (e-labeling) appeared on many conference agendas and in a variety of journals throughout 2006. Yet, from a regulatory standpoint, the year was one of discussion but little action. A world of difference exists between a directive that specifies that labeling must “accompany” a device and a directive that specifies that labeling must “be provided.” Such distinctions were the focus of last year's discussions, creating an opportunity for EU regulatory and legislative bodies to clarify e-labeling standards, as well as explore the technological possibilities that e-labeling presents.

When original labeling regulations were written, information technology (IT) was in its infancy. With advances in technology and the increasing sophistication of users, the shift toward paperless labels has gained momentum. Now the medical device industry is poised to bring together technology, regulatory approval, and customer acceptance to make e-labeling a viable, cost-effective, and care-effective option.

It's time for medical device companies seeking to maximize their global position, particularly in the U.S. and European markets, to understand the business advantages and pitfalls of adopting an e-labeling system. Although there are inherent risks in the transition, the potential rewards, for both patient care and profit, are significant. Companies must carefully weigh the benefits before going forward.

Regulatory Primer

The December 2005 revisions to the EU Medical Devices Directive (MDD) further opened the door to electronic formats for product labeling, moving beyond the “leaflet” requirement specified in the previous version of the MDD. Also in 2005, the list of languages required for product labeling of EU–marketed devices was expanded to 20 languages. E-labeling allows manufacturers to

But the revised language has also been problematic. The European Medical Technology Industry Association (EUCOMED), the primary European lobbying group within the medical device sector, believes that one complication comes from sections of the proposed revisions that would require labeling to “accompany” a product. In the era of e-labeling, labeling can move beyond the traditional boundaries of printing and packaging to encompass anything from a CD-ROM to complex software to Web-based seminars for access-on-demand. To require that such new formats accompany a product restricts the ability of manufacturers to better serve caregivers and patients by providing more content-rich labeling at a lower cost.

EUCOMED has proposed—and initial reports indicate that the European Parliament will approve—revised language to the effect that labeling must “be provided.” Although this language would be vague, the revised requirement would enable manufacturers to take advantage of new technology and increasing user willingness to embrace e-labeling for certain kinds of products.

In fact, user adoption will be one of the highest hurdles to clear in successfully introducing e-labeling. The few published studies to review user acceptance of e-labeling are hardly unanimous in their conclusions regarding its acceptability. Although a majority of users (mostly physicians) indicate that they are at least willing to try e-labeling in some situations and with some products, some users remain intransigent.

A Medtronic pilot study in 2004 surveyed 637 physicians in 11 EU countries and found that 35% preferred CD-ROM manuals for implants; 28% regarded CD-ROM manuals as equivalent; and only 4% of respondents would not accept a CD-ROM. On the other hand, a study conducted by the German Federal Institute for Drugs and Medical Devices (BfArM) in March 2004 concluded that the majority of users would prefer paper-based instructions for use and regarded an electronic version as a supplement to, rather than a replacement of, traditional formats.

Since 2004, companies have not gone public with the results of more recent studies. Anecdotal evidence suggests that the major manufacturers continue to slowly gauge user perspectives and requirements vis-à-vis e-labeling, and more controlled data will likely be released when regulations are finalized.

The Labeling Challenge

It's important to note that e-labeling does not come without challenges, albeit a different set of challenges than paper-based labeling. Regulatory bodies, product users, and manufacturers share the responsibility of addressing these challenges without compromising patient safety. Critics of e-labeling contend that

Gaining Ground in the United States

Still, the EU can look to the U.S. regulatory community's experience for reassurance that e-labeling does not compromise patient safety and that it improves a user's experience with products. The Medical Device User Fee and Modernization Act, signed into law in the United States in October 2002, explicitly permits e-labeling for prescriptive devices (as defined in the amended Section 502(f) of the Federal Food, Drug, and Cosmetic Act) used in healthcare facilities.

Users may request—and must be provided with—paper-based labeling if they prefer. Manufacturers submit e-labeling to FDA during the approval process. Companies have provided labeling on CD-ROM, via secure Web sites, and through other media.

Pharmaceutical Parallels

Medical device manufacturers might well look to the pharmaceutical industry for clues to the future. FDA has already begun requiring electronic submissions in the form of structured product labeling (SPL) for regulatory approval. The transition is well under way in the EU as well.

The electronic submission requirement is predicated on the need to standardize data submissions in ways that are accessible and searchable. At the same time, electronic submissions have enabled FDA and pharmaceutical companies to streamline the approval process, speed time to market, and improve patient care standards.

By combining electronic submissions on the front end with e-labeling on the back end of the regulatory approval process, companies are able to reduce the human errors that can easily be introduced along the way. Reduced costs, shorter approval times, and improved safety are the main benefits.

Examining the Technology

While the regulatory world turns at a rate that can make geology seem like a thrill ride, technology evolves almost as quickly as one can blink. Companies ready to move toward technologically enhanced labeling mechanisms are already discovering capabilities that were not available just three years ago. With smart planning and timely technology deployment, manufacturers can position themselves to pounce as soon as more markets open up to e-labeling.

In addition to the user benefits of e-labeling, manufacturers achieve enormous benefit from the underlying e-labeling translation and production technology. For example, FDA's SPL electronic submissions requirements are based on extensible markup language (XML) technology. Companies using XML can share information easily with partners, suppliers, and customers, in addition to FDA. Clinical researchers and practitioners can communicate more closely through shared XML data, and even translators and other service vendors can gain faster access to the most up-to-date information to move projects (such as updates) along more quickly. XML technology can help manufacturers lower costs as well as shorten project cycles.

Other kinds of technology also form a natural fit with e-labeling. More and more manufacturers are looking to manage their massive data resources through content management systems (CMS) and enterprise management systems (EMS). Whether relying on proprietary systems or the ever-growing options for off-the-shelf applications, manufacturers using robust CMS and EMS systems can have single-source control over everything from print manuals to PDFs, Web content, and CD-ROM files and training curricula.

These systems ensure that users—both internal and external—always have the most current and accurate information. New publications, translations, updates, and releases can be managed through a central administrative system, and multiple outputs (paper-based, electronic, or a combination) can be generated off the same source materials.

Although proper implementation of a CMS or EMS requires strategic planning and resource allocation, companies that use these systems will find themselves ready to embrace e-labeling as well as traditional labeling, depending on the needs of their users and markets.

Staying Ahead of the Curve

Step by step, regulations worldwide are moving toward implicitly or explicitly allowing e-labeling. Companies that wait too long might find themselves left behind the adoption curve. Manufacturers can stay ahead by employing several strategies.

Feasibility Review—Legacy Products. For each product already in the marketplace, carefully consider the pros and cons of moving toward e-labeling. Some products may perform best with traditional labeling, and others may be suited for e-labeling in specific circumstances, such as professional use. Also consider your update schedule for legacy products. When the labeling is updated, does it make sense to provide an e-labeling version?

Feasibility Review—New Products. For each product in the pipeline, do a similar cost-benefit analysis of implementing e-labeling. Pay particular attention to the number of markets, languages, and user types to come into contact with the product. Also consider your expected number of labeling updates. Products with few updates may be managed best with traditional labeling; products with multiple updates in several languages may benefit from e-labeling.

User Feedback. Regardless of current e-labeling implementation plans, start a dialogue with customers and users concerning their attitudes about and expectations of e-labeling. Try to find out how much potential users know about it, how comfortable they are using electronic labels, and their technical capabilities for accessing e-labeling information.

Technology Updates. Few companies have truly up-to-date technology capabilities for CMS and EMS. Take time to conduct a thorough information management audit to learn what your firm's information assets are and how close the company is to maximizing their use. Identify any gaps in IT capabilities and develop a strategic plan for technological evolution that takes into account regulatory requirements, labeling needs, translation, and data access.

Regulatory Activity. The EU is expected to publish the final draft in the Official Journal by the end of 2007. When it does, expect a flurry of new activity as companies that have been waiting to act make their strategically planned moves. As these firms tip their hands, the next few years should be fascinating for industry observers as well as the players.

Conclusion

Although e-labeling presents a variety of opportunities for medical device manufacturers, it's important not to underestimate the complexity and depth of an e-labeling initiative. The biggest challenges rarely arise in the technological sphere. There are often underlying problems with business processes that must be addressed before an e-labeling project can move forward. By taking a collaborative approach that cuts across company divisions and includes service partners, technology, and regulatory groups, manufacturers can successfully plan, implement, and measure the benefits of e-labeling on global markets.

Kristen Giovanis is managing director of KJ International Resources Ltd. (KJI; Minneapolis ). She can be contacted at [email protected].

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