As populations age and the healthcare sector expands, medical devices have increasingly become a part of our daily lives. What’s more, because medical devices are often highly specialised pieces of equipment, they are often manufactured in global hubs and exported across political and linguistic borders.

This means that translation and localisation have a necessary role to play in allowing medical devices to be produced, marketed sold and used. Here at COMUNICA, we have ample experience within this sector and we know what it takes to localise medical device content correctly and accurately. Today on the blog, you can read more about what this service entails, as well as its demands and pitfalls.

What is a medical device?

A medical device is any apparatus, implement, machine, implant, software, material or any other similar article which is used for medical purposes. There are many different categories of medical device and in essence they can be anything from a wheelchair or a set of crutches to a heart rate monitor, a defibrillator or a pacemaker.

Medical devices are often branded and they can be targeted either directly to consumers or to businesses such as hospitals and healthcare providers. Increasingly, they are used not just by medical staff but also by patients themselves as healthcare necessarily become more digital with the rise of virtual wards.

Given their sensitive nature, medical devices are strictly regulated across the world. Exactly what rules and regulations apply varies from country to country. In the EU, medical devices are regulated by the European Medicines Agency and subject to the European Medical Device Regulation (EU MDR).

What is medical device localisation?

By medical device localisation, we mean the process of both translating and localising content related to medical devices from one language and culture into another. Content in this case can be anything from text that forms part of the product itself (such as on-screen text in the case of software) or accompanying documentation, like instruction manuals or product information on the box.

The aim of medical device localisation is to ensure that the text can be understood and used by healthcare professionals or lay users in another country and cultural context. Beyond simply translating words, localisation further implies adapting language so that it makes sense in its new cultural context. Elements that can be localised include date formats, units of measurement, cultural expressions, idioms, conventions and much more.

Medical device localisation can also take regulatory requirements into consideration. For example, the EU MDR sets certain requirements for the instruction manuals that accompany medical devices. These requirements may not be the same as those that apply to a product manufactured and sold in Vietnam or the United States, for example. A bespoke and comprehensive localisation process can take these factors into consideration to help ensure that the finished content will be compliant with the rules and conventions of its target market.

What are some best practices for medical device localisation?

Medical device localisation is not a cheap or fast process. As with medical translations in general, extra quality control steps are usually required in order to safeguard patient safety and reduce the risk of error by as much as possible.

But there are a number of things that clients can do to ensure optimal results:

  • Identify all text to be translated and localised: Make sure to consider all aspects of your product and don’t forget about small or stray items of text. For example, labels that are separate to the main pamphlet, or solitary words that appear next to buttons on the hardware.
  • Compile a glossary: Terminology needs to be consistent. By maintaining internal glossaries and sharing them with your language-service providers, you can make sure the same terms are used across all documents. This cuts down on confusion and helps users understand exactly what you mean.
  • Use an agency that understands back translation: Back translation is an important quality step when it comes to medical translations due to the high levels of precision required. This is a distinct process to regular translation and can go wrong if the translator is not familiar with how this process works.

Follow these steps and your project will be much more likely to succeed.

Is medical device localisation really necessary?

Given that medical device localisation is no walk in the park – and not exactly cheap as chips – you may be wondering if there are shortcuts or certain exceptions where it’s not necessary. Unfortunately, there have been a number of cases over the years which demonstrate just how crucial this process is.

Perhaps one of the most well-known examples is from a hospital close to Epinal in France. The hospital had procured a device for the radiation treatment of prostate cancer, but found that the software had not been translated into French. The hospital decided to use bilingual staff to translate the text on screen in an ad-hoc way, and unfortunately the dosage information was misinterpreted. Four patients died as a result and dozens more were also affected.

Experience you can trust

Here at COMUNICA, we have years of experience working with the translation and localisation of medical devices. We are familiar with the steps involved and we know all the things that have to be considered – from choosing a register that suits the target reader to adapting for cultural and linguistic differences.

So if you are looking for a medical device localisation service you can trust, feel free to get in touch with us for a general chat about the requirements and options.

Our team is always on hand and more than happy to help!