Feature Article

Innovations in medical technology have global relevance. It is important that language and cultural barriers do not impede a product’s access to new markets. Translation is a vital part of this complex process, yet it can create many stumbling blocks. Here are some key factors to consider as you navigate the translation process.

Douglas Adams, author of The Hitchhiker’s Guide to the Galaxy, created the famous Babel Fish, a remarkable creature that can instantly translate any language. Science has not yet produced a universal language comprehension tool— human intervention is still required—and the challenge for translation remains unchanged: Ensuring unambiguous, culturally relevant communication to everyone involved in the process from key decision makers to end users. Translation and localisation are important tasks for any company targeting a multinational market; that is doubly true for manufacturers of medical devices who must adhere to stringent legislation.

As well as meeting regulatory requirements, successful translation also means quicker time to market. That is why it is imperative to start thinking about translation requirements, and specifically who is going to do the work for you, in the early stages of a project.

What needs to be translated?

Medical devices require a multitude of translated documents from clinical trial consent forms and instructions for use (IFU) to marketing and training materials.

Clinical trials can be a key element of the product development process. When they are conducted on a multinational basis, they require a vast amount of translation. Patient-facing communications are usually a priority. These can include informed consent forms, patient-reported outcome documents, applications, and legal documentation on patient rights.
Partners and legal bodies involved in the process also require documents that need to be translated such as correspondence between different countries’ research teams, study guidelines, funding letters, and insurance documentation.
Before the product can be taken to market, the company will need IFU translations for its target regions. Needless to say, it is essential that technical information be conveyed accurately in all languages. Training and marketing materials are also a priority. These need to adapt to cultural as well as language differences.

Regulatory requirements

Compliance with relevant regulatory bodies is imperative, and flaws in the translation process can significantly slow down time to market.

Legislation varies greatly from country to country, and there are also translation guidelines with global reach to consider. For instance, Good Clinical Practice (GCP), the international scientific and ethical standard governing clinical trials that involve human subjects, requires that information given to a patient should be in language that is 'understandable”.
IFU translation is a key concern, as well. The Medical Devices Directive makes it illegal to put a medical device on the market without making available an IFU in the local language. The directive also highlights the importance of having translation-related quality assurance processes in place.

Finding the right partner

Choosing the right partner to provide translation services requires careful forethought. For this specialist service, look for companies with proven expertise in the sector that use only native speakers for translation work. Membership in a recognised industry body, such as the Association of Translation Companies, is a good indicator of quality; so is use of state-of-the-art computer-aided translation (CAT) tools such as the SDL Trados translation memory system.
Most importantly, ensure that your partner can access individual translators who are qualified experts in your field.
Detailed medical knowledge is as important as the language skills of the translator. It will enable them to spot medical errors in a text and produce the most effective translation.

There are a number of ways to choose and validate a competent translation partner.
* Research company websites. A word of caution, however: never rely on a website alone. Always take the time to phone the company directly and ask detailed questions about its experience. Ideally, you should ask to speak with other med-tech customers with whom the company has worked.

• Tap into a network of your peers. Word of mouth recommendations are a powerful and helpful way to locate a new supplier.
• Ask companies on your shortlist to produce a sample translation. This can be an excellent way to establish the quality of a company’s work, as well as help you to decide whether you will be able to work well with them.

Why back translation matters

It is important for the translated text to retain the precise meaning of the source text. One way to achieve this is by carrying out so-called back translations. Indeed, for some local regulatory authorities, such as medical ethical committees or institutional review boards, back translations are a prerequisite.

Back translation is a quality assessment procedure: a second translator translates an already translated text back into its original source language. The back translator usually does a very literal translation, as the purpose is to test the accuracy of the translation rather than the style. By comparing the two versions in the original source language, any errors or ambiguities can be easily identified.

For example, in one IFU the English text contained the phrase “aches and pains”. When translated into Spanish—one of the most commonly requested languages—the two English words were condensed into one new word: “Dolores”. The back translation highlighted this fact. Once the issue had been identified, the writers were able to decide whether it needed rephrasing.
For obvious reasons, it is essential that back translation be carried out by a different translator than the person who worked on the original.

As well as revealing discrepancies in meaning, back translation can also highlight sentence or phrase constructions that could be open to different interpretations. It is also a useful method for ensuring that the language used in the original and the translation is as clear, concise, and reader friendly as possible.

How to prevent getting lost in translation

Here are five key pointers to a successful translation.

• Factor in a project’s translation requirements as early as possible.
• Choose the right partner. Be sure your supplier has specific medical knowledge and language skills, and a proven track record.
• Be rigorous. When it comes to critical documents, consider doing two sets of back translation for extra peace of mind.
• Be sensitive. Let your translation partner guide you on local and cultural differences that may affect your documentation.
• Look at the big picture. A good translation partner can translate words “in situ” within your chosen design or format.

Conclusion

Effective translation is a critical requirement for the successful launch of a medical device. Get it right, and you will not only ensure that your product reaches the global marketplace, but you will reduce time to market by meeting strict regulatory requirements. Get it wrong and you risk costly delays and legal issues.
Until Douglas Adams’ Babel Fish becomes a reality, the best way to achieve success is to plan your translation requirements well in advance, make them an integral part of your strategy, and choose the right partner.

About the author: Steve Wilde is Managing Director of The Translation People (www.thetranslationpeople.com), a successful and well-established translation-services company based in the United Kingdom. A member of the Association of Translation Companies, the company provides a comprehensive range of services in more than 100 languages to clients across the globe. It has worked extensively across the medical technology and pharmaceutical sectors, supporting AIDS research, translating medical device IFUs, and localising marketing material for new product launches. He can be contacted via e-mail at steve.wilde@thetranslationpeople.com.