Healthcare & Life-Science Translation
If you are a subcontractor supplying equipment, parts or consumables, or if you are a consultant providing services to life-science companies, hospitals, and clinics, then you are most likely familiar with the stringent quality standards for products and the complex regulatory affairs. But are you also aware of the need for precise documentation and clear communication with healthcare professionals and patients?
Accurate and clear documentation and communication are essential components of the products and services delivered to the life-science and healthcare sectors. This page contains information about what it takes to achieve flawless translation of life-science and healthcare documentation and communication.
First, some categories of life-science organisations and healthcare companies where this is particularly important:
Pharmaceutical companies. Both those that develop and sell human medicinal products as well as those that manufacture and sell veterinary medicinal products. Some of these have integrated biotechnological processes and are in fact biopharma companies.
Biotechnological companies. They manufacture medicinal products derived from living organisms, for instance vaccines.
Medical device companies. A huge industry that delivers surgical instruments, dental instruments, surgical implants, prostheses and diagnostic technology, including software and imaging solutions, to hospitals, clinics and laboratories.
Contract Research Organisations (CROs) are companies that assist in the development of pharmaceuticals, medical devices and biotech products, providing research with clinical trials and tests.
Hospitals and clinics. With their treatment facilities, equipment, healthcare professionals and other staff, they are the pivots of patient care. Another associated group consists of laboratories handling analyses of samples for diagnosis, treatment evaluation and scientific research.
Life-science education & research institutions play a crucial role in educating the next generations of healthcare professionals, scientists and researchers.
Challenges in Translating Healthcare and Life-Science Texts
Translating life-science texts involves several significant challenges. Among these, adherence to regulatory requirements, precise use of terminology and appropriate integration of machine translation and AI technologies are particularly important. These factors illustrate the complexity of translating life-science texts. It is necessary to strike a balance between accuracy and fluency to ensure that the meaning is conveyed correctly, and the text is comprehensible to the readers.
Regulatory Compliance
Compliance with regulatory requirements is key to ensuring the accuracy and reliability of translations in the life sciences, particularly for pharmaceuticals and medical devices.
Translated instructions for use for a pacemaker must adhere to regulatory standards so the manufacturers can meet legislative requirements and obtain marketing approval.
Translated product information for pharmaceuticals, Summaries of Product Characteristics (abbreviated SmPC or SPC), Patient Information Leaflets (PIL) and label texts, must adhere to regulatory requirements to obtain marketing approval in the EU member states where the product is or will be marketed.
The regulatory affairs section in a medical company has an important role in ensuring this. However, knowledge about the product and the regulatory affairs surrounding it must be combined with linguistic expertise to obtain marketing approval. The European Medicines Agency (EMA) has set out specific linguistic requirements for the translation of texts about pharmaceuticals, and knowledge about for instance Quality Review Documentation (QRD) templates is indispensable when translating product information about pharmaceuticals.
Precise Terminology
Using correct terminology is crucial. But correctness is more than just conveying the same meaning in another language. The target audience should also be familiar with the terms.
If the readers are patients, they may not understand medical terms and may for instance sign an informed consent form for a clinical trial without comprehending its content. Similarly, if they struggle to understand instructions in a medical device translation or a translation of a patient information leaflet for medication, they may not use the product correctly. Even if they manage to use it correctly, they may feel insecure, which could result in a loss of confidence in its effect.
If the readers are healthcare professionals, the translation should use the medical terminology specific to the medical field and a professional writing style to maintain the credibility of the source language text and ensure that the readers feel that they can rely on its content.
Machine Translation and AI
Machine translation and AI usage in translation have increased exponentially in recent years within life sciences and healthcare. Previously, translation automation consisted only of using a Translation Memory (TM) in a Computer-assisted Translation (CAT) system. A TM is a database containing separated sentences in the source language (e.g. English), each paired with the corresponding sentence in the target language (e.g. Danish) from previous translations. A CAT system or tool is a writing and editing tool for translation. It looks up phrases in TMs, termbases and glossaries.
For translation tasks where the TM contained no or very little usable text, some language service providers (LSPs) started using machine translation (MT) for generic texts around 2015 when neural machine translation (NMT) was introduced. Gradually, the usage spread to specialized subject fields, including life sciences.
Today, LSPs often prepare the translation by propagating content from the TM and then running an AI tool to translate the sentences with no or very inequivalent (sometimes called low fuzzy) TM matches. The result is reviewed and edited afterwards. This is called machine translation post-editing (MTPE).
It may sound like this is an almost fully automated solution for translating even highly complicated text. Still, in reality, a thorough review is necessary in most cases. AI for the translation of life-science & healthcare has many limitations, and a language specialist with experience in the field must edit the translation afterwards.
Advantages of AI in healthcare & life-science translation
AI can be useful in the translation of generic texts without complex medical terms and phrases. AI tools can translate any text, but when taking a closer look, you will see that the terms have not been translated consistently and that the most fluent translation is achieved when the source text is well-written and fluent. In other words, for the translation of texts for general information within healthcare, using AI can be a solution when the source language text is well-written by experienced writers.
An AI translation of such generic texts must of course always be reviewed and edited. If complete native-language fluency is required, and the translation of the terminology must be consistent, then a thorough review and full edit of the translation is needed. If not, for instance if the lifetime of the text is short, then light editing may be sufficient.
Limitations of AI in healthcare & life-science translation
Life-science and healthcare texts often cover very specific topics and are aimed at healthcare professionals and scientists. Correct translation may in some cases be a matter of life and death, in other cases regulatory compliance may be jeopardized. Details that may seem insignificant to a layperson could profoundly influence the comprehension of the text.
Despite all its awe-inspiring qualities, AI has significant limitations in translating life-science documentation and healthcare communication. Due to the way it works, AI cannot perform consistent and accurate translations of medical terminology. The large language models have been trained to use linguistic variation. Moreover, AI-based text generators tend to hallucinate, leading to a risk of changing the meaning of the text.
In my experience, instructions for use, maintenance manuals, etc. for medical devices and medical technology are often written in English by technical specialists who are non-native speakers. The large language models have been trained with the common language usage of native speakers. Consequently, AI translation of texts written by non-native speakers with varying linguistic proficiency will most likely be flawed and sometimes parts of it will be incomprehensible.
The best solution is to translate the texts in a CAT tool using relevant Translation Memories, termbases and glossaries. Moreover, the translator must be proficient in the source and the target languages as well as have knowledge about the medical subject field. This will ensure that the terminology is consistent and that the translation conveys the meaning correctly, is fluent and easy to understand for the intended readers.
Finally, the wording in patient records and laboratory results can be incomprehensible to others than the treating physicians due to internal jargon and special abbreviations that AI cannot handle. Space constraints in tables may also result in unusual abbreviations that only humans with knowledge about the field can understand.
Patient records and laboratory tables are not easy to convert and fit into a CAT tool, so a manual translation in Microsoft Word or Excel may be the only option. Only an experienced, professional translator can tackle this and obtain a satisfactory result through meticulousness and attention to detail.
A solution for Danish-English and English-Danish translation and language services
If you deliver products or services to life-science companies or hospitals, clinics or laboratories, finding the right professional for Danish-English or English-Danish translation or Danish or English writing tasks can be challenging.
I offer professional translation, writing and editing services. Since 2007, I have translated a substantial number of documents, including patient information, information about pharmaceutical products, marketing copy about pharmaceuticals, medical technology documentation and medical device user guides. My experience spans working for prominent brands, small and medium-sized companies, and the public sector in Denmark.
I am committed to delivering high-quality work that meets the rigid standards of the life-science industry, as well as clinical trial translation and regulatory affairs.