The development and market launch of a new drug or medical device is a highly complex, time-consuming undertaking. Did you know that several linguistic procedures will be needed over the course of the entire process?
In simple terms, the overall progression of producing and marketing a new healthcare product or service is shown in the diagram in Figure 1.
Figure 1: The development of a new healthcare product or service can be represented by five overall steps, from opportunity assessment to risk analysis, market launch and post-launch analysis. Linguistic services are needed in various stages of this process. Key: FMEA – Failure Mode and Effect Analysis; IQ – Installation Qualification; OQ – Operational Qualification; PQ – Performance Qualification. Diagram adapted from Ashfaq A., 2018 1.¹.
In this article, we will present seven linguistic services potentially needed by a medical or pharmaceutical company to successfully reach the market.
Medical and pharmaceutical translation involves interpreting medical and pharmaceutical documents or texts and subsequently converting the entire message into another language.
A company that develops medical devices (MDs) to be marketed in Europe must obtain CE marking for each one – Figure 2. According to European Union regulations ², the manufacturer must provide the label and instructions for use on the device itself, on the packaging and at the website (if applicable), together with an EU declaration of conformity and technical file (see all details in this article). Each country requires information on the MD to be written in the language of local users. Therefore, some products may require the translation of these items into 24 languages.
Figure 2: General steps of activities in compliance with European regulations for the affixing of CE marking on medical devices (adapted from Freitas, A. S. B. - Medical Devices: Regulatory Framework and Technical Documentation²).
When a Contract Research Organization (CRO) conducts a clinical trial, it needs a series of documents translated into the official languages of each participant, namely informed consent documents, clinical protocols, packaging and labels (for further details, please see this article). This is the phase that requires pharmaceutical translation processes to be carried out.
2. Revision and correction by a native speaker
Since translation may be done by different persons or entities within medical and pharmaceutical companies, the translated documents should undergo verification. Therefore, a translation done by a professional from the CRO or local branch, without formal training in translation, should be revised and corrected by a native-speaking translator specializing in healthcare, with a command of scientific and medical terminology.
Sometimes, a document can be written directly in a given language by a non-native speaker, such as an article written in English for publication in journals. In this case, the document should be revised by a native speaker of the language who specializes in the area in question. Learn more about these services here.
3. Adaptation to local language - localization
Linguistic localization goes beyond translating a document’s content into another language, and adapts it to the social and cultural specifications of the local market. In practical terms, this service is important, for example, in the stages of:
Submission of regulatory documents to the regulatory authorities: each country has its own local regulations for the sale and distribution of drugs. Anything out of line may result in delays in regulatory authority approval, higher costs or even having to entirely redo the clinical trial.
4. Linguistic validation
Linguistic validation consists of evaluating the translation’s accuracy from the standpoint of content and the country’s culture, by means of an examination done by native speakers of the language who reside in the required region.
In the medical sector, using ounces or grams, miles or kilometres, can make all the difference in properly understanding the content. Since misinterpretations may have serious consequences, it is extremely important to not underestimate this process which, technically speaking, is comprised of three stages, as shown in Figure 3 (learn about the entire process in this article).
A CRO may be required to perform linguistic validation at the time of the clinical trials. Some Ethics Committees require informed consent documents to be back-translated into the original language as a means of extra linguistic validation to ensure that the document has been properly translated and localized to its target audience, for the purpose of avoiding misinterpretations and serious problems.
Figure 3: Stages of the linguistic validation process.
5. Terminology management
Every sector/specialized area has its own lingo. If we use two different terms to refer to the same concept, will the audience perceive that they are synonymous, or that we are intentionally talking about two different things? Take this example: “Beta thalassemia is characterized by a deficiency or lack of beta globin chain synthesis. The diagnosis of Cooley anemia is based on a haemoglobin analysis.” Will the reader understand that “beta thalassemia” and “Cooley anemia” are synonyms for the same illness?
To keep the audience from being confused, the process of terminology management is essential. This consists of identifying, recording and translating into the desired language all specific key information on the company’s business area, product or services (for further details, please see this article).
6. International Multilingual Marketing
When launching a new medical or pharmaceutical product, a number of different marketing and communication materials must be produced, including content for websites, brochures, online ads, brand manuals, advertising and educational content for social networks in written and audiovisual format, press releases and much more.
A business wanting to expand internationally must reproduce these materials in the native language of the country where the product or service will be marketed. This phase requires a major multilingual marketing effort, which goes far beyond the “mere translation” of words. The message must be relevant to the country or audience in question, conveying emotions in this language, while upholding a high degree of communication quality regardless of the language.
7. Software and website debugging
This quality assurance process troubleshoots programming and graphic problems at the website of a medical or pharmaceutical company, or in the software of a medical device prior to its launch. It is possible to find menus with linguistic errors, links which do not work or open the wrong page, or images in the wrong language.
How can one successfully complete these processes in practical terms?
To this end, you can:
¹Ashfaq, A. Understanding the 5 phases of medical device development. Disponível em https://www.greenlight.guru/blog/5-phases-of-medical-device-development, 2018.
²Regulamento (EU) 2017/745 para Dispositivos Médicos, disponível em https://eur-lex.europa.eu/eli/reg/2017/745/2017-05-05, accessed in September 2021.