1. Meeting Regulatory Requirements – Nothing is more time consuming than working with government agencies. Add language complications to the mix and it can derail your company’s timeline by months, if not years. Every country has its own legal requirements for language, testing, and production. If you’re marketing your medical device in Europe – where 30% of world revenues are spent on medical devices – the CE mark is essential. Obtaining that certification requires that manufacturers provide all labeling, information for usage, documentation, and marketing materials in the official language(s) of the end-user’s country. The European Union has 22 official languages, so defining your target market is step #1. Most companies try to make the most use of languages like French, German, Spanish, and Portuguese, which are spoken in multiple European countries as well as some South American countries. If your market extends to areas where community languages are spoken or if you wish to reach Asian markets, the need for linguists broadens. Look for language providers that have an extensive list of translators from around the globe as well as detailed experience with agencies and directives such as the FDA, European Union Directives, and Japanese Pharmaceutical Affairs Law (PAL) and your business will be in good hands.
2. Product Development, Testing & Usage – One of the biggest mistakes medical device companies make is waiting to hire translation specialists until a product is in its final stages of development. Establish a relationship early and you’ll have a partner who is intimately connected throughout the stages of development and one who can address translation needs along the way. Everything from patient information leaflets (IFUs and DFUs), packaging labels, consent forms, authorizations, scientific articles, case report forms, and adverse event information needs to be translated. Failure to translate these documents, or to do so clearly, could result in seizure of products, recalls, or exposure to liability lawsuits. All of which cost time and money.
3. Marketing – Nowhere is a native speaker more important than in the arena of marketing, where understanding the market culture is the foundation for better sales. An experienced language provider can supply your company with a linguist who is both an expert in medical terminology and in acceptable ways to speak to local consumers. Also, it’s very important that promotional materials don’t exaggerate the claims made on materials attached to the packaging. Translation of website material, literature, CDs and videos can all be handled by language providers to ensure consistency and to avoid scrutiny from regulators abroad.
4. Software – Recent changes to global regulations now define a medical device to include software (according to a 2007 revision of Medical Device Directives 2007/47/EC). Because traditional documents like user manuals and instructions increasingly include software-driven requirements, it’s imperative that software is not only translated properly and clearly, but that it is also localized to ensure usability, accuracy, and functionality. Neglecting these issues could cause misuse of the product and lead to damaging lawsuits. Ask potential translation agencies about these issues to ensure that you’ve found the right company for the job.
5. Creating A Glossary Of Terms & Setting Correct Terminology – A good translation glossary facilitates a product’s success, makes translation more consistent, and speeds up the translation process. Creating a glossary or establishing correct terminology should involve a medical translator as well as someone in the field to validate the terms being defined. Also, many Directives encourage the use of medical device symbols – used to denote everything from Sterile Product to Batch Code to Date of Manufacture – because the medical world is very familiar with these symbols. One last note, a language provider can also ensure that all written documentation accommodates special characteristics or marks such as tildes and umlauts, or accurately used Asian characters.
6. Post-Market Translations – Once a product makes it to market, translation demands don’t disappear. Any updates or changes need to be incorporated into the literature so that all information is conveyed accurately and professionally. Typically, this can be done quickly and rather inexpensively, especially if you’ve remained with your original language provider.
7. Communications – Written documentation is only one aspect of a language provider’s services. There’s nothing more tragic than losing a great sale because you smiled when you should have been serious or you shook hands when you were expected to bow. An experienced language provider can take the guesswork out such situations by providing diversity training and cultural consulting. And, if an interpreter is needed to make sure all aspects of a business meeting are understood, that can be arranged as well. Good communication skills encompass much more than language and using those skills will help to open doors around the world for your product.
If you still have questions about how a translation company can help your medical device company, we’d love to hear from you. Or, if you have good stories about your language experiences, we’d love to hear about those, too. Send us your questions or stories and we’ll address them in another post!