Is your translation process reliable and repeatable?
For medical devices to fulfill their important roles safeguarding patients’ health, medical professionals and individual users must understand how to operate them. But what if those using the devices aren’t native speakers of the device manufacturers’ printed instructions? This highlights the profound importance of medical device translation best practices.
Every medical device manufacturer must keep translation accuracy top of mind. By setting up a reliable, repeatable process around medical device translation and localization, it’s possible to streamline the process of translating essential relevant content. But what qualities should this translation process focus on, and what’s the best way to ensure high standards are met?
What matters most in medical device translation?
Medical device translation is just one specific area of medical translation, simply because of the life-saving nature of medical equipment and because of regulatory requirements. Quality standards are very high, as they typically require compliance with various governmental agencies around the world.
While it can seem daunting to comply with regulations from multiple jurisdictions, the general requirements for medical equipment translation best practices come down to a few priorities:
- Accuracy: The most important facet of any health care translation or localization effort is accuracy. Translation is the process used to convert one language to another (e.g., U.S. English to Latin American Spanish). Localization is a further step that might adapt the expressions or style of the translated language to the norms of a particular country or culture (e.g., Latin American Spanish localized differently for Mexico, Chile, Argentina, or Puerto Rico). Transcreation is a further step where translated content might be rewritten by a fluent native speaker in-country or in-market to make it seem as though the content originated there. For all of these methods, it’s essential that the target language documentation precisely retains its source-language (medically reviewed) meaning.
It is a good idea for medical device manufacturers to work with their translation services provider(s) to determine which translation method best fits their situation. This allows users of varied language skills to safely work with the device, without ambiguity or questions. This absolute need for accuracy also means translation or localization partners probably can’t settle for machine translation (MT) alone, or even MT plus human post-editing. Full human translation is often the method providing the base level of acceptable quality, further augmented by subject matter experts in the appropriate field.
- Consistency: Medical device translation includes many pieces of documentation, even when dealing with a single device. For example, the user interface must match the manual, any accompanying documents, and even the marketing materials.
An important tool for maintaining consistency and high standards over time is the creation and use of custom bilingual glossaries. These are important libraries that offer rules and examples of how to translate medical or industry terms, acronyms, product and company names, personal names, locations and other outlier expressions. This includes what to translate, or not, and when. It’s often appropriate to leave these words as is. Custom bilingual glossaries can be used by machine translation engines and human translators alike, and they become a corporate asset that saves time and increases in value with each successive use.
- Speed: Despite the absolute need for accuracy, medical device manufacturers are often tasked with translating or localizing documentation in a short time frame. This is especially prominent when regulatory authorities require accurate translation of all documentation around a user interface change before that update can go live in a specific territory. In these cases, manufacturers need to produce multiple language translations in a matter of weeks to roll out updates worldwide.
The need to achieve all these requirements together creates pressure on device manufacturers and their translation service providers. Working with expert translation and localization providers who offer deep expertise in medical device translation is the quickest way to meet all the required quality standards.
What types of information need translation?
When ensuring that you have best practices in place for your medical device translation, it’s important to remember just how many elements need to be translated. A single device can come with numerous pieces of documentation, all of which have to be accurately translated into each new target language on a tight timeline. These include:
- User interface: The device itself may contain digital elements that have to be localized into new languages. Translation of these prompts must be accurate and consistent, and should typically come first, before the related documentation is localized.
- Operator manuals: Users of medical devices need to have manuals they can consult to make sure they’re operating the technology correctly. Therefore, these user manual documents must be translated to match the UI localization for each language exactly.
- Development safety update reports (DSUR): These standardized reports on the safety of medical items are required under the European Union Medical Device Regulation (EU MDR). They let users know about any adverse reactions to a product discovered during clinical trials.
- Safety data sheets (SDS): Safety data sheets are designed to comply with the Hazard Communication Standard (HCS) issued by the Occupational Safety and Health Administration (OSHA). They contain information about possible risks of various chemicals.
- Product packaging inserts: Any materials placed into the physical packaging of medical devices may need to be localized to suit the new markets where those devices are being released, matching the translated UI.
- Medical marketing collateral: Marketing materials should be translated to be consistent with other medical device documents, ensuring they accurately represent the devices. This holds true even though this content is “stylistic” rather than purely descriptive.
Localizing all of this documentation to high standards of accuracy, consistency and speed is a job for a highly specialized translation partner experienced with medical device translation best practices.
What are the best practices of medical device translation?
Finding an ideal and comprehensive medical device translation and localization workflow is essential for manufacturers to keep their product releases and updates on schedule. Considerations that go into a medical equipment translation process can include:
- Use of personnel with subject matter expertise: Translation and localization professionals working in the medical device industry can improve the accuracy and completeness of their work if they understand the concepts involved. This is why it pays to work with translation teams with a high number of advanced-degree holders.
- Collaboration between teams: A comprehensive localization process often involves handoffs between teams. For instance, a third-party localization team might take the first pass at a document, then pass it on to the manufacturer’s in-house experts for verification, with one more subsequent pass to catch any new typos or errors.
- Creation of custom bilingual glossaries: Glossaries of terms can make translation faster and more efficient in the future. They can also aid consistency, ensuring important technical terms and acronyms are always used in the same way across all related documents for a target language.
- Overlap on documentation and stylistic translation: Despite the different purposes of factual medical device documentation and marketing materials, translation and localization of all these deliverables should be handled by the same teams, to impose accuracy.
- Parallel work across multiple languages: When a new product debuts or a UI update goes live, there’s a scramble to convert necessary documentation into multiple languages. Working with a translation services partner that can scale up and take on all these requirements on a short schedule is a major advantage for any manufacturer.
An effective, repeatable professional translation workflow that meets all these standards can give medical device manufacturers the performance they need to deliver their devices across regions, maintaining compliance and hitting deadlines.
How can you secure the best translation services for your business?
If you’re a medical device manufacturer, the easiest way to bring a new level of effectiveness, maturity and overall translation quality to your localization workflow is to team up with an expert partner for medical device translation services. This is where Linguistic Systems can help.
Working with a network of 7,500 localization professionals and holding four ISO certifications, Linguistic Systems delivers the kind of hands-on expert translation and language services experience that can help manufacturers in the medical industry reach and maintain high standards of accuracy, consistency and compliance. Contact us to get started.
EDITOR’S NOTE: Linguistic Systems uses a combination of advanced proprietary technology and 7,500 skilled, certified translators to deliver high-quality translations in 120+ languages. With 55+ years and billions of words of experience serving 25,000 clients, including many Fortune 100, AmLaw100, and top medical and life sciences firms, you can trust us with your foreign language translations.
