In the medical device industry, translating is not a choice―it is a requirement. Medical device translation can be a difficult task due to a number of different factors. These must be taken into account by a translation provider in order to produce accurate, reliable translations that meet all the necessary requirements and industry regulations.
Some factors contributing to the challenging task of medical device translation are:
- Medical terminology / lexical and colloquial differences between languages
- Regulatory requirements for medical device labeling by region and country
- Sheer volume of content to be translated for medical devices
- Ongoing device improvements and periodic regulatory changes
- Medical device packaging updates
Due to the critical stakes involved in making accurate translations for the medical device industry, meticulous attention to detail on every piece of content is vital. That means that how a medical device manufacturer prepares its content for translation is equally important.
The Staggering Need for Medical Device Translation
Due to the life-and-death issues involved in health care, it is one of the most highly regulated industries. This directly affects medical device translation because of the sheer volume of material that must be translated for every involved audience.
Regulations vary from country to country, but they all require that materials and content that accompany a medical device be translated for every possible audience. This includes such items as medical device packaging and medical device labeling, user interfaces and software, instructions for use (IFUs), patient-focused and/or caregiver-focused documentation, and marketing materials.
Beyond this user-facing content, product-related documentation that will be used by regulators to assess the device and its effect on end users must also be translated. This can include studies, tests, clinical trial documentation, quality management system files, and various other administrative documents.
Preparation and Planning for Medical Device TranslationM
The first steps in any successful project are advance planning and preparation. The following suggestions will help companies prepare important content for medical device translation.
Select What Is to Be Translated
As outlined above, there is much content involved in medical device translation, including both outward-facing and inward-facing documents. This should include all product documentation, medical device packaging, hardware, user interfaces, software, research material, and other important content.
Including all of the components is essential to avoid unexpected cost overruns and project delays. Also, some files, such as instruction manuals, may build on previously completed translations, such as user interfaces. Work with your translation provider if you are unsure about how to prioritize.
During this phase, you will need to determine the exact regulatory requirements applicable to each device and its content. Answer the following questions as you prioritize content:
- Does anything need to be changed for a specific market?
- Are there specific regulations that will require the product and its documentation be modified for one or more countries or regions?
- Are these region-specific documents available now for translation?
- What are the legal requirements for translation or testing in each country or market?
Legal experts who specialize in helping companies with regulatory issues should be consulted to ensure the correct content is provided for translation.
Write for Translation
Get your material ready for professional medical device translation by making sure your source documents are professionally written and edited in their original language.
If your source language is English, all content should be in simple English with short, clear sentences. Limit dependent clauses. Using only one thought per sentence helps translators easily determine your meaning and aids in building your translation memory.
Eliminate cultural references and idiomatic expressions that may not translate well across cultures. Symbolic language can cause confusion outside the English language and related cultures, so eliminate any symbols that do not cross cultural barriers well.
Prepare for Text Expansion
The same content in most other languages will be 20 percent longer, or more, than English. That means you must allow space for text expansion when designing or creating your original print layout in English, including artwork, graphics, charts, or medical device labeling.
Provide Editable Source Files
Providing editable source files is a critical part of preparing your content for translation. Use common file formats for text and images whenever possible. Original files are simple to edit and format, making for labor and cost-saving translation efforts that help guarantee accuracy.
Create a Product Glossary
A product glossary contains specific terminology that is critical to your product. A glossary speeds up the translation process by helping translators quickly comprehend your exact meaning. Translators will not experience delays waiting for clarification of terms that have been defined in advance.
Items to Clarify With Your Medical Device Translation Provider
Often, medical device OEMs are using an internationally recognized set of symbols to communicate important information in the place of words. Sources such as the ISO 15223-1:2016 standard list symbols used for a wide array of medical devices in many countries.
This is an effort to provide consistency and prevent errors in translation that may seriously harm patients or caregivers. It also reduces the amount of text requiring translation and the resulting text expansion, speeding the process by standardizing layouts for documents and labels.
Also, as medical devices and technologies evolve, the accompanying software and documentation must be revised in all the previously translated languages. Manufacturers retain liability for their devices throughout the product’s lifespan, including any upgrades or mandated regulatory changes.
Therefore, it is important for manufacturers to partner with a translation services provider that is experienced in all aspects of medical device translation. Since this will be an ongoing, long-term partnership, companies must choose a translation partner with native language translators that are also subject matter experts in the medical device industry.
When it comes to medical device translation, you cannot afford to choose an inexperienced translation services partner. Lives and your company’s reputation and liability hang in the balance.