One of the many steps involved in selling a medical device internationally is what’s known as in-country review (ICR) -- the process of having translated material reviewed for accuracy in language, localization, and brand communication. ICR seems like a completely reasonable step, but even a cursory internet search will show that it’s a source of frustration for many companies. A major reason for this is that companies often use internal employees to review their translated medical device material. In a best-case scenario, these employees speak the target language fluently and like a local (for instance, someone who speaks Spanish from Spain wouldn’t be involved in ICR for the Mexican market). They also understand what constitutes a good translation. But this is rarely the case. For instance, when asked to correct something, especially something important, many in-country reviewers will end up playing “spot the error”, even if a translation technically contains no errors at all. This creates significant delays while the translation is “corrected” and approved. The opposite issue can also be true. Those involved in ICR should be checking for accuracy as well as more subtle things like effective localization and branding. But because employees may not know what they’re looking for, if copy seems accurate, they won’t look any further. The more frequent of the two scenarios is usually the former, giving ICR a reputation as a major cause of delays. These delays can start even before any documents are checked. In many cases, employees have other professional responsibilities and assignments to handle as a priority before they can look at every bit of translated material and give their feedback. Because of this, in some cases, the process could end up taking months. Localization expert Michael Oettli points out that ICR is not required by most medical regulatory organizations, but because it’s considered a best practice by the medical device industry, it might as well be. So, ICR is probably here to stay. But can it be fixed? Since ICR is such a pain in the neck, there are many translators and other industry experts who have proposed solutions. One common suggestion is to hire a second, outside language services provider to check the translation, localization, and branding quality of material, rather than relying on employees. Of course, this could also create delays, since the second team may have difficulties communicating with the first translation team through the company that hired both. Cost is likely an even bigger issue. While internal employees could perform ICR for free, an outside source means a higher budget. So, the best solution might lie in improving ICR within a company. One way to do this, Oettli suggests, is to use translation tools like a TM (translation memory) terminology management. These would allow internal reviewers to verify that terms are compliant with a company’s branding and that words used are approved medical terminology for the target market. This would essentially eliminate a large amount of the guesswork and inaccurate error spotting that could otherwise go into ICR. Using these tools would probably require training, and this is the overarching solution that Oettli and many of his colleagues propose. If a company is planning to regularly release products overseas, training employees for ICR is an initial investment of time and possibly budget that could ultimately pay off in a significant way, by making it a far more efficient and accurate process down the road. ICR training could include how to use translation tools and getting familiar with or memorizing a company’s style guide. But, Oettli advises, it should also involve learning about translation itself, as well as which mistakes should or shouldn’t be focused on or corrected. Hopefully, ideas like these will become the norm, not a novelty. Until then, ICR will continue to be a major challenge to companies around the world.
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