By Richard Sikes, special to The Content Wrangler; Reprinted with permission, MultiLingual magazine, Copyright March 2006, issue #78

If two localization professionals begin to chat about the special problems that their work entails, a fair amount of energy is developed. Get five or six on the phone in a conference call, and the energy abounds. Multiply that by six or seven in a round table setting, and a synergistic “wow factor” really sets in.

Professionals responsible for localization work in the pharmaceutical and medical-device industries deal with a special set of problems that those in the “classical” localization industry do not. When they have an occasional chance to meet under the auspices of the Localization World conference in a round table setting just for them, they discover through that forum that they and their peers share many top-of-mind concerns. Such sharing is unique and contrasts starkly with other industries. The Medical Localization Round Table is the only forum for pharmaceutical and device companies to discuss translation and localization issues.

Medical localization shares many attributes with other realms of the industry such as software localization, and there are many areas of overlap, such as medical imaging software, for example. But there are also profound differences. A poor or inaccurate translation may generate a smirk factor when it occurs in the context of a consumer software program. It may be annoying if it is in a business application. But when the subject matter has to do with human life, the stakes are much higher.

For this reason, there is a great deal of regulation that pertains to the translation of medical source material, whether that material is instructions for patients regarding consumption of medication or for medical professionals — for example, how to use life supporting equipment such as a ventilator, defibrillator or heart-lung machine. Localization takes place within the context of a strict regulatory environment. These rules not only govern what can or cannot be said, but also influence workflow. Localization workflow takes on a whole new dimension when the component of approval sign-off is added. One medical localization professional says, “We proof everything to death!” Timeframes lengthen, and feedback mechanisms must be implemented.

Furthermore, tracking and documentation of the sign-off trail must support squeaky-clean auditing to a degree that is unthinkable in the fast-paced consumer software world. Gören Nordlund, a project manager for user information and education at Sweden’s MAQUET Critical Care AB, states, “It is not only the sign-off trail that has to be auditable. As soon as a document has been released, any change has to be approved and documented. In medical-device localization the worst thing you can do is to do anything without having supporting documents showing who did it, why was it done, who checked it and, maybe even more important, who said that it should be done. Imagine the number of documents and sign-offs required for a change in a user manual!” Multiply this by the differing regulatory requirements of different target jurisdictions, and you have a logistical headache that makes consumer software localization look positively simplistic.

Some target jurisdictions add headaches of their own. For certain locales, it is extremely difficult to anticipate delays that may come from regulatory authorities. For example, such an authority may decide that results from clinical trials are inconclusive or otherwise insufficient. Approval can essentially never be circumvented just to keep a marketing schedule, so process schedules must change accordingly. Making up for lost time can put a lot of squeeze on localization tasks and can put inordinate pressure on the individuals carrying out those tasks.

Another type of regulatory headache can be caused by ambiguity within a target jurisdiction. Inna Geller from Medtronic says, “In certain parts of Asia that are expanding markets for us, regulatory requirements are subject to frequent change, and practical interpretations are also influenced by individual preferences of individual partners and counsel. This puts us in the position of trying to hit a moving target. This can cause delay and additional work on components that we had sometimes assumed to be finished. This kind of iterative spin obviously impacts our scheduling and productivity.”

Because human health and safety are involved, medical product companies tend to move slowly and cautiously. This causes medical localization as a branch of the greater localization industry to lag behind technologically by a factor of a number of years. Medical companies are slow to adopt new processing technologies such as state-of-the-art content management tools or emerging standards such as XML-based authoring.

Competitive pressure on several levels will drive medical companies to greater localization technology adoption in the future. There is a finite supply of translators who combine mastery of translation tools such as TRADOS with specialized subject matter expertise prerequisite for medical translation. This dearth of human capital is proportionately greater with regard to smaller language groups such as the Baltic languages. Nonetheless, European Union regulations now stipulate that certain document types must be translated into these languages.

Lack of supply relative to demand generally pushes prices upward; however, localization professionals in the medical industry experience the same pressure as those in other industries to keep costs down. In other industries, quality can sometimes become a variable in the delivery equation; however, variability in quality cannot be tolerated due to the aforementioned regulatory and ethical constraints. The only place that there is potential give is in process efficiency through technological advance.

A key component of technological progress is benchmarking. One cannot measure progress without knowing where one was and is. To be of optimal value, though, benchmarking must be industry specific. The round table forum allows participants to get a sense of what measures other medical industry players have adopted and what kind of numbers they have managed to achieve through process improvement.

There are a few classical, non-technological opportunities for efficiency improvement. One of the most effective areas of improvement potential lies in the realm of reusable source language. But optimization of reusability implies (PDF), among other things, communication across departmental borders, and this is sometimes uniquely difficult in the medical environment.

Many medical companies, especially pharmaceutical manufacturers, are very large and geographically distributed. There are not only corporate silos, but also regional silos to be connected. Companies such as these have often grown through acquisition, and processes can be very different from one branch to another. Localization professionals in large companies repeatedly note that they experience great difficulty in finding out who their peers in other corporate groups are, not to mention what kinds of processes and best practices prevail.

The agendas of past medical round tables show an eclectic mix of classical localization industry topics and specialized variants. In 2004, the agenda was dominated by topics such as vendor management, vendor training, value-added services and review cycles, plus human resource issues such as localization personnel hiring criteria and organizational structures. But there was also a spattering of specialized topics with a niche slant, such as auditing of work and compliance, comparison of medical translation pricing as opposed to information technology pricing, and quality thresholds in the medical context.

Half a year later at Localization World San Francisco in 2004, there was discussion of strategies for working with multilanguage, single-language and regional-language vendors. This, plus the pervasive quality issue dominated the morning. In the afternoon, however, the focus turned closer to the cutting edge of the overall industry with a session on the impact of content management systems on medical localization processes.

In the 2005 Localization World Bonn Medical Round Table, the group spent a morning session examining the importance of defined localization procedures in the context of regulatory environments and brainstorming about which processes are the most relevant to codify. Later, discussion turned to vendor selection and retention. This would be “classical” subject matter, were it not for the subtopic addressing what characteristics define an ideal medical translation vendor. This topic was discussed both in the clients-only morning session and in the afternoon session, which was open to client and vendor representatives alike. In the afternoon session, vendors also described how they go about qualifying translators for medical work.

The 2006 Medical Round Table enhanced the overall Localization World Barcelona conference theme of “Working – Together” by focusing on bridging of functional differences and corporate silos through greater collaboration.

Beginning with brief statements from participants about how things currently work — or don’t work — in their companies, participants drilled down on some of the positive and negative attributes of different corporate organizational forms as they apply to localization. After lunch, there was a presentation from a major manufacturer about how the company has achieved a unique degree of collaboration. Participants brainstormed together about observations made and lessons learned during the day, with the goal of creating a set of best practices that they could take away to their own corporate environments.

All in all, medical localization is a complex potpourri of classical and niche industry requirements, strongly seasoned with a variety of regulatory concerns. Opportunity to achieve and maintain human health must not be impacted by language and culture. Thus, localization practitioners in the medical industry bear enormous responsibility as our world copes with the despair of disease and the hope of medical discovery.

About the Author

Richard Sikes has been immersed in localization since 1989. He is the Principal Consultant for Localization Flow Technologies.