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 Are Medical Devices?

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 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 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!

The post The Localisation of Medical Devices appeared first on Comunica.

This means that translation and localisation play a huge role in facilitating communication and making these trials possible. It also means that huge demands are placed on the quality of this translation work. After all, miscommunications could literally set back the advancement of health and prosperity on our planet.

So for today’s edition of the blog, we would like to take a closer look at the fascinating area of clinical trial localisation. We will look at some key considerations and the extra steps that are normally included to ensure accuracy and quality in the translation of trial materials.

What Is a Clinical Trial?

A clinical trial is when a new treatment – whether it be a vaccine, a medication, a supplement, a medical device or something else entirely – is tested on humans. The aim is to study any behavioural or biomedical changes in the trial participants and ultimately to bring the product one step closer towards approval.

Clinical trials can vary generally in scope and size but typically they are divided into four different phases. It can take as long as a decade for a drug or therapy to make it through all four phases.

Often trials are focused on what are known as PROs or patient-reported outcomes. This is where patients report their own experiences of a drug or therapy by completing a questionnaire or an assessment form.

Clinical trials can be centred at one single institution or they might be multi-centre, spread across many different institutions and even countries. Increasingly, global trials can also be conducted virtually as so-called decentralised trials, which means they are less bound to a single location or language.

When Do Clinical Trials Require Translation?

Translations are often required to aid clinical trials for a number of different reasons. In the case of multi-centre studies or decentralised trials, for example, the scientists working on a trial may speak different languages and require assistance creating documentation in a common language.

In other cases, a clinical trial might be focused on a particular region of the world. Think Zika or Ebola, for example. These were outbreaks that occurred in localised parts of the world where various different languages were spoken – Spanish, French, Portuguese but also many indigenous and minority languages.

In such cases, translation is needed in order for researchers to communicate with each other, but it is also essential in allowing scientists and study volunteers to interact and exchange information. This is especially the case in urban settings where multiple languages are spoken and where proficiency may vary across different languages.

Why Not Just a Straight, Word-for-Word Translation?

Clinical trials are expensive and translation may seem like one area where costs could be cut. But there are many reasons why clinical-trial texts are almost always localised professionally rather than simply translated by a lay person or run through a machine-translation programme.

Perhaps the most obvious is the need for precision. Questionnaires completed by study participants usually ask very precise questions and any vagueness or ambiguity in the questions may be reflected back in the answers given.

If it seems as if respondents in one language have interpreted a question differently to respondents in another, this may invalidate the entire trial. Linguists therefore need to consider exactly how different readers may interpret certain words and pick their translation accordingly.

Another reason is cultural sensibilities and stigmas relating to how we perceive ourselves and others. Words that are neutral in one context or language may feel loaded or negatively charged in another. Consider synonyms like lazy, inert, sluggish, lackadaisical or bone idle. These all have similar meanings but may be interpreted or perceived differently. Some may feel insulting while others may feel more neutral but still have different associations that make them less suitable.

What is Full Linguistic Validation?

You may also have heard the term full linguistic validation in reference to clinical trials. This is an additional step in the translation and localisation process that has been recognised as best practices when translating PROs and similar documents to be used by study volunteers. Essentially, the idea here is to make sure that the final translation matches the original as closely as possible in meaning while also being adequately adapted to the target.

One component of this is back translation whereby the translation produced is then translated back into the source language by another linguist who has not seen the original text. This back translation is then compared against the original text so that any potential discrepancies can be caught and remedied by the team who produced the original translation.

This can then be supplemented by a clinician review or through a process known as cognitive debriefing. This involves testing the translated questionnaire or assessment with a group of people from the target language to ensure that they would understand its questions in the same way as the original. Again, any discrepancies can be logged and used to inform further editing of the translation.

Years of Experience with Clinical Trial Localisation

Here at Comunica, we have plenty of experience working with the translation and localisation of clinical trials. We understand the process and the importance of both accuracy and adaptation within this field, and we can work with you to incorporate full linguistic validation into the translation and localisation process if desired.

If you would like to learn more about how we could help you with your translation and localisation needs within clinical trials and PROs, please do not hesitate to get in touch for a no-obligation consultation or quote.

The post Localising for Clinical Trials appeared first on Comunica.