Medical Device Translation

In today’s globalized world, medical device translation has become ever more necessary. Medical devices, ranging from simple thermometers to complex MRI machines, are essential for diagnosing and treating patients worldwide. And in a linguistically diverse world, the information associated with these devices frequently requires accurate translation to guarantee the safety and efficacy of medical treatment for speakers of other languages.

Medical device translation is a critical step in the process of making medical devices available in different countries. It involves translating all documentation related to the device, including user manuals, labeling, and packaging, into the single language or multiple languages spoken in the target market. This process is indispensable for making sure that patients and healthcare providers understand how to properly use devices and follow all related safety precautions.

Risks and Liability

One of the major risks associated with inadequate medical device translation is miscommunication. If a user does not understand how to use a device properly, they could misuse it, potentially leading to injury or even death. For example, a patient who misunderstands the dosage instructions on a medication pump could accidentally overdose, leading to serious health complications.

Furthermore, translation errors can lead to legal liability issues. If a medical device is not properly labeled in the language or languages spoken in a particular country, manufacturers and distributors could end up liable for any injuries or damages that result from its use. Simply stated, the medical field does not allow for a margin of error.

In addition, regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have established guidelines for the translation of medical devices. These guidelines outline the necessary steps for accurate and appropriate translation of medical device documentation.

Appropriately Qualified Translators

Accurate, high-quality translation of medical devices demands professional linguists. It is a critical process that requires appropriately qualified translators with a full command of both English and their native language.

TrueLanguage relies upon linguists with an academic or professional background in medical or scientific fields for all related translation work. Using unqualified linguists for this kind of translation work may be considerably more inexpensive in the short term, but you will pay for it in the long term through negative repercussions resulting from substandard translations.

Glossary and Style Guide Support

While absolutely indispensable, qualified translators by themselves are not enough. The optimal translation of scientific and medical devices also necessitates the support of a glossary and style guide. TrueLanguage can create a glossary and style guide for our clients prior to initiating translation of their materials. Additionally, we can leverage computer-assisted translation (CAT) tools for the consistent implementation of preferred terms throughout scientific and medical device content.

When possible, TrueLanguage strongly recommends the incorporation of a client-review process for the glossary and style guide so that native-speaking staff can sign off on key terminology before it appears in the finalized version of the translated content.

Formatting and Typesetting Challenges

Finally, the translation of scientific and medical devices often involves considerable formatting and typesetting challenges because of GUIs (graphic user interfaces) and other special design features common to this kind of specialized content.

TrueLanguage can work with a client’s original design files and carefully preserve the original layout in translated versions. When original design files are not available, TrueLanguage can also recreate formatting from the files that are available. The lead translator will perform the final review of the formatted translation so that everything looks correct.

Localization vs Generalization

There is often a debate about whether to localize the translation of medical documents for a specific region or create a relatively region-neutral translation. When you localize a translation, you tailor it to a specific region’s language and culture, considering local terminologies and language variations. On the other hand, creating a regionally neutral translation will make the document applicable to various regions and cultures, without favoring any specific one.

There are advantages and disadvantages to both approaches. For example, if you opt for localization, you can make the document more accessible and understandable to its intended audience. This is because localized translation adapts itself to local language and cultural nuances. Such an approach can lead to better patient outcomes, especially when it comes to understanding treatment options and instructions. On the downside, however, it can also be more expensive and time-consuming to produce regionally localized translations, especially if multiple versions are needed for different regions.

Alternatively, creating a region-neutral translation can save time and resources. This is because you can use such translations in multiple regions without the need for extensive customization. But it may also result in misunderstandings or confusion, especially when the translation deviates from key regionally specific instances of language or culture.

Ultimately, the decision to localize a translation or create a regionally neutral one depends on the specific context and needs of the document and its intended audience. It may be beneficial to consider a hybrid approach, where certain elements of the translation are localized while others are kept regionally neutral, to strike a balance between accessibility and cost-effectiveness.

Enlisting the assistance of a language translation provider can help you make that important decision. At TrueLanguage, we offer specific guidelines in accordance with our proprietary LocalVoice™ and TrueGlobal™ processes. Contact us today with any questions you have regarding these important decisions.

Summary

Medical device translation is a critical step in ensuring the safety and efficacy of medical treatment worldwide. As medical devices become increasingly complex and international markets continue to expand, accurate and appropriate translation of all associated documentation is essential. With the potential risks associated with inadequate translation, it is important that manufacturers and distributors take this issue seriously and work with professional translators to ensure accurate and appropriate translations.

TrueLanguage understands that the translation of scientific and medical devices is a complex process that requires qualified translators, a glossary and style guide, and careful formatting and typesetting. We have expertise in all these areas and can provide clients with the highest quality translations for their medical device documentation. By prioritizing these important aspects of medical device translation, manufacturers and distributors can help guarantee that patients and healthcare providers worldwide have access to safe and effective medical treatment.