Life science translation encompasses a very wide range of services. In fact, the life sciences themselves span a wide range of scientific disciplines. Life sciences are concerned with the study of living organisms, which includes not only plants, animals, and humans, but also microorganisms.
In this article, we will look more at the life sciences in the context of the medical world and the role that medical translation plays in that world. Medical translations cover a vast range of topics such as medical devices, pharmacology and pharmaceutical products, and clinical research and testing.
At Lexitech, we primarily deal with translations in the field of medical devices. Each of these subfields is so specialised that it requires special skills to handle it with the required precision.
As we will explain later in this article, the risks are so great – both for the companies and ultimately for the patients – that extreme care must be taken in all the processes involved, including communication, whether monolingual or multilingual. This applies to pharmaceuticals and clinical research, but also to medical devices.
What makes life science translations so special?
There are a few characteristics that stand out. First, life sciences are a major industry. In many developed economies like ours, the life sciences and medical world as a whole account for between 10% and 15% of the GDP (gross domestic product). It is understandable that the population expects the best possible quality of medical services, given the budgets involved. Most of this budget goes to care and medicine, but all services throughout the value chain must be of the highest quality. Where medical translation is concerned, this means that not only must the source material be accurate and comprehensive, but that the translators must also be knowledgeable and experienced in the field of the document they are translating.
In addition, the world of life sciences is highly regulated. This is a logical consequence of the quality that patients and the public in general rightly expect from medical care. Many national and international organisations set standards and are charged with protecting and promoting public health and evaluating and monitoring the quality of medical products and services. The volume of regulations in place is constantly increasing from year to year, requiring ever-greater specialisation from all the professionals involved, from nurses to translators.
In addition, the medical sector is expected to grow in the coming years, and its need for innovation and resources will only increase over time. As the average population continues to age, the demand for medical services will also increase. In addition, the medical world will necessarily be called upon to face unexpected situations, as the world recently saw with the recent Covid-19 pandemic.
The medical world is also very research intensive, and new companies are being created all the time. The biotech world is a very vibrant and active industry, not only in Western Europe and North America, but all over the world. This generates a huge volume of scientific content that researchers and investors around the world want to share.
Lastly, all patients have the right to access information in their own language about the drugs and medical devices they use. In reality, this right goes even further, because in many cases, regulators and supervisors require the use of plain language that is appropriate for the intended audience.
The impact of medical device translation
The quality of medical device translation services has a direct economic impact for several reasons. First, poor or inaccurate translation can result in risk to patients, which is unacceptable from a human-centric perspective. Second, manufacturers and distributors can face financial consequences if regulatory or supervisory authorities conclude that the information was not accurate enough for patients, doctors, or caregivers. Likewise, when the translation and localization process for medical devices is inadequate, new products cannot be brought to market in a timely manner and manufacturers or distributors must forgo revenue and suffer a financial loss. In extreme cases, product recalls can occur. Clearly, all these situations have an impact on the company’s reputation. Therefore, risk to reputation, though difficult to quantify, is an important factor in choosing the right quality for medical device translation services.
When all is said and done, low quality can often end up costing companies more than they bargained for.
The European Union’s Medical Device Regulation
In replacing the 1993 medical devices directive with Regulation (EU) 2017/745 on medical devices (“MDR”), European authorities appear to have opted for a much more direct form of regulatory intervention. Their aim has been to adapt medical device regulation to the changing world, promote competitiveness and innovation, and achieve a number of important benefits, including better protection for patients. One of the most important issues is the translation of documentation pertaining to medical devices, and, in particular, the availability of accurate and understandable information for users in all countries of the European Union – or, more precisely, in all countries where manufacturers and distributors want to offer their products.
A number of safeguards are in place to protect users and patients. One is EUDAMED, a medical device database that inventories all the products available on the market. It contains relevant information about medical devices and the companies responsible for them (manufacturers) and provides overall transparency for the public and health professionals in the different Member States of the United European Union. EUDAMED identifies medical devices throughout their life cycle and includes information such as the registration of manufacturers, the representative on a given market, and the declaration of conformity. In other words, large amounts of data must be made available, all with a high degree of precision in the different languages in which economic operators operate. Every product and device can be traced using its unique device identifier (UDI). Implants are marked with a unique number on a so-called implant card that allows them to be individually traced. For translation and localization companies, this means that information sometimes has to be provided in many languages on a single label or document.
One result of these regulations and requirements is that a greater volume of content must be managed, updated, translated, and distributed to the right audience. The EU’s MDR is four times longer than the directive it replaced. In all areas, the volume of content is increasing, so a strong translation process is needed to keep everything under control.
What the MDR says about translation
(include link here: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=uriserv:OJ.L_.2017.117.01.0001.01.ENG)
1. General obligations of manufacturers, authorised representative, and technical documentation (Article 10, Article 11, and Annex II). These sections describe the minimum requirements for selling a medical device in the EU. This includes providing all information and documentation demonstrating the conformity of the device in an official language of the European Union. All appropriate instructions for use and packaging in the language of the country in which the product is sold must be supplied with the product itself.
2. Importers, distributors, and private label distributors (Article 16). If a distributor intends to label, repackage, or even modify a manufacturer’s product as a private label and then resell it, all MDR restrictions apply here as well. There must be an adequate quality management system in place to ensure that all business units comply with the procedures for translation. If a distributor does not comply, it can be fined.
3. Implantable devices (Article 18). Key information must be provided in the language of the Member State where the product was sold. This information includes the product, the manufacturer, the lifetime of the product, and any special steps or instructions for medical personnel and/or the patient.
4. EU Declaration of Conformity (Article 19). The actual declaration of conformity must be translated into an official language of the European Union.
5. Summary of the safety and clinical performance of the device (Article 32 and Article 41). All information about the safety and clinical performance of the device must be written in a way that is understandable to the intended user and this information must be made available through EUDAMED. This, of course, begs the question of what is “understandable” to the intended user…
Translations of medical devices are required in all 24 EU languages
In the past, individual states could choose the languages in which information about devices or products was made available. This was consistent with the nature of a European directive. Today, the MDR requires that information about medical devices be available in all 24 official languages.
In addition, the MDR requires not only that all 24 languages be made available, but also that the text be easily understood by all users and the general public. For products that are solely used by a specific audience, such as medical personnel, there is room for interpretation. But if the information is written specifically with the needs and background of healthcare professionals in mind, does it also need to be provided in a language that the general public can understand?
The new regulatory scheme also has an impact on the approval process, including where translation is concerned. Today, translations must be made available early on in the process as part of the technical dossier required by regulators for the conformity assessment. In the past, translation was done after the assessment, when manufacturers could decide for themselves what basic information they wanted to provide, depending on the requirements of different markets. That process has now been turned on its head. The instructions for use (IFU), labelling, and safety information are all included in the information that needs to be translated into multiple languages.
Because EUDAMED must contain information on medical devices translated into every official European Union language, your translation partner must use an appropriate content management system and have its own translation management system to ensure that your medical device translations continually remain accurate, consistent, and traceable.
Medical device translation: new developments
Medical device translation must be seen in the context of new developments in the market as a whole. Telemedicine is one of the most important developments in recent years, and it has only been accelerated by the Covid-19 pandemic. With telemedicine and virtual consultations, new devices and tools have been developed. New wearables, kits, and software have been brought to market, and even mobile phones now play a role in the delivery of medical services. Nearly everyone has a mobile phone that they carry with them at all times, making it an ideal vehicle for new services. This means that when translating content related to these new developments, disciplines and content overlap and our medical device translators must have a solid understanding of how they work.
Medical device translation: new risks
These developments compound the novel risks and opportunities that exist under the new system created by the MDR. The liability of all manufacturers has increased, patient confidentiality requirements are higher than ever before, and cybersecurity risks must be factored in more than in the past.
Your ideal medical translator
What should you look for in a medical device translation agency?
The best-performing medical device translation companies have a standardised and rigorous process that complies with common standards such as ISO 17100:2015 for translation services or, more generally, the ISO 9001:2015 standard for quality management systems. ISO Certifications are sometimes criticised, but they do offer the advantage of providing a minimum standard for buyers to assess the processes of your translation company.
In addition to ISO standards, translation companies involved in medical device translation should implement various levels of quality control, some of which are human and some of which are supported by technology.
Translators must have in-depth knowledge of vocabulary related to drugs, medical devices, or medical tests. Not only does this enable them to produce accurate translations, but it also ensures that the language used matches the characteristics and knowledge of the target users.
Translation memory software also helps to draw on content that has already been translated in the past, enabling translators to achieve a style and vocabulary that is coherent with prior translations. In addition, significant time and cost savings can be achieved if translation memories are kept up to date and all feedback is consistently processed in the translation memory.
The role of project management cannot be underestimated. A dedicated project manager who oversees the project, monitors progress, and ensures that projects are delivered on time and with good quality is a key part of any project.
In certain cases, machine translation can improve the quality and speed of the translation process. Strict terminology management and style control can make machine translation a viable option. This requires that authors, terminologists, translators and project managers work together very closely to establish efficient workflows and a smooth, streamlined process.
The complexity of medical device translation and the constant stream of new regulations mean that all professionals involved need regular training, including technical writers, copywriters, medical device translators, project managers, and desktop publishing experts. The entire process, from A to Z, must be rooted in a strong concern for strict quality management, both at the human and technological levels. This ensures that the results generated showcase consistently high quality, from writing, to translation, to post-editing.
This concern for quality also extends to the technological environment used. An IT environment certified to ISO 27001:2013 (Information Security Management) is a minimum requirement for companies looking to ensure that document flow and communication between translation companies and clients remain secure at all times.
What can be done at the source?
First, translation buyers can ensure that all documentation is produced to demanding standards such as those set out in ISO 15223. And for good reason: the quality of a translation is often largely dependent on the quality of the source text it is based on.
Second, medical device manufacturers should always work with human translators with medical translation experience to ensure consistently high quality. Although technologies such as translation memory software or machine translation can increase the efficiency and speed of the process, ultimately, a human must be at the helm to ensure that the right decisions are made regarding the methods and processes to be used, particularly in terms of content, budget, target audience, scope, etc. This guarantees that output quality will always meet the expectations and requirements of manufacturers and users.
Lastly, all stakeholders must be kept abreast of regulatory changes. This is, of course, quite a challenge given the tsunami of new regulations, which in itself argues for greater specialisation among all the professionals involved.
What types of documents do we translate?
Here are just a few of the different types of documents we frequently translate.
If you would like to learn more, contact us now.
• Product information
• Summary of product characteristics
• Patient information and labelling
• Package inserts and labels
• Investigator brochures
• Consent forms
• Clinical protocols
• Case report forms (CRF)
• Patient recruitment materials
• Pharmacological studies
• Product catalogues
• Installation manuals
• Training brochures
• Clinical trials
• Preclinical and clinical evaluation reports
• Device labelling
• Product labels
• Clinical trial reports
• Regulatory documents
• Manufacturing process descriptions
• SOP Procedures
• Master batch records
• Material safety data sheets
• Marketing materials
• Company websites and portals.
How should you choose your medical device translation agency?
The first thing a medical device translation buyer can look for is ISO standards, such as ISO 17100 and ISO 9001 (mentioned above). A more accurate source of information, however, is the translation company’s quality manual. While ISO standards prescribe certain minimum quality requirements, the quality manual of a company specialised in medical device translation often gives a much better picture of how the necessary level of translation quality is achieved from day to day and maintained at all times in a constant and predictable way.
The manual alone will tell you something, but if you want to take it a step further, you can also look at the company’s latest audit reports. Is every step in the process traceable? Can everything be verified? Were corrective actions taken when deficiencies were identified? And were those corrective actions properly documented? With this type of analysis, you can get an accurate picture of the quality level of your potential translation company.
In addition, a service level agreement (SLA) can allow customers to make specific arrangements with their translation customer regarding delivery times and service quality. An SLA is also a place where the process can be explained in detail so that all steps are fully understood by both the buyer and the service provider and, in the event of a deviation from the agreed translation process, appropriate corrective action can be taken with full understanding and transparency for all parties involved.
A complete service package is another feature that can make one company stand out from the competition. Services such as translation, terminology management, revision, and desktop publishing can all be provided in one place by translation companies. It goes without saying that the efficiency of your processes will be increased if you can get all the services you need from a single company.
Lastly, there is the issue of the readability of medical device translations. Regulations are very demanding in this regard, but this is also a significant challenge for translators who can be called upon to deal with content that, while very technical, still needs to be accessible and readable for a wide audience. Ask potential medical device translation providers for their view on this point, and see where they stand on the issue compared to the competition.