Guest Blog post by Andres Heuberger, CEO and Founder of ForeignExchange Translations.
While any software localization can be challenging, medical device software adds yet another layer of complexity to the equation. This complexity comes from the fact that software is so integral to the functioning and therapy of a device that is keeping a person alive. Regulators are acknowledging this and device companies have to deal with new rules and new challenges.
With the advent of the new Medical Device Directive (MDD) amended by Directive 2007/47/EC and implemented six months ago, software is now included in the definition of a medical device. It does not matter whether the software is integrated into the actual device or is a stand-alone product. Software validation will also be an Essential Requirement (ER 12.1a) under the MDD. Annex I, Essential Requirement 12.1 has been amended to include that software must be validated, taking into account the principles of development lifecycle, risk management, validation and verification. In this context, proper software internationalization is even more important.
Software code needs to be able to handle different characters such as diacritical marks, as well as user inputs. User prompts need to be unambiguous and clear, especially since the prompts can be presented at times of user stress and emergency situations. Some device companies have started to use cognitive debriefing techniques which were, until now, reserved for the validation of pharmaceutical patient-reported outcomes, in order to evaluate the effectiveness of software interfaces. Having to carry this out in multiple languages and geographies can complicate development projects, not to mention the costs involved. On the translation side of medical device software, there is a narrow skill set for linguists, who must be able to translate software strings out of context, understand medical terminology and, in many cases, be savvy enough to test localized software on different platforms.
All is not bleak though. The companies who are most successful with their software localization are the ones who build projects specifications with localization in mind from the start and who lean on their translation providers for support from project inception through to final testing. It’s a brave new world, and medical device companies have no choice but to embrace it and understand the regulations and implications while devising new ways of working.
ForeignExchange Translations provides specialized medical translation and localization solutions to pharmaceutical and medical device companies. For more information, visit www.fxtrans.com.
