Planning the language route
A document that will reach readers in more than one language needs decisions while its source is still being written: which kind of language work each passage needs, from translation through localisation and adaptation to transcreation, what has to be settled in the source before it is approved, and what travels with the source when it is handed over for translation.
Kinds of language work
A source is whatever comes in for translation and the target whatever comes out, and the source need not be English.
All of this work is often called translation, although in practice it may be of different types. Writing creates content for a specific purpose, audience and context, and a sentence written for a patient leaflet is not the same as one written for a regulatory document, even where the medical topic is the same. One experienced medical translator sorts the work into four routes.
| Route | Purpose and boundary |
|---|---|
| Translation | Transfer meaning accurately while preserving intent. Content that is regulatory or critical for safety, such as safety instructions, instructions for use and summaries of product characteristics, and content derived from them, requires full equivalence: a controlled transfer of meaning, not creative improvement. |
| Localisation | Adapt content to a market, audience, healthcare system, format or regulatory context. Reserve it for content with market-specific references or conventions, such as units, formats, healthcare references, local contact points and examples, keeping the content as close as possible to the approved version while adapting what surrounds it. |
| Adaptation or rewriting | Change structure, wording or explanation when the source's structure or content will not work for its audience, for example when an accurate source is too dense, too expert-oriented or not structured around the reader's needs. Translating such a source as it stands reproduces the problem. |
| Transcreation | Recreate tone, impact or a desired emotional or behavioural response when literal translation would keep the words but lose their effect. Recruitment taglines, disease-awareness campaigns, adherence messages and engagement-focused marketing copy may need this route. |
One project may need one or several of these routes. A patient-facing campaign can include safety information that needs translation, local healthcare references that need localisation, a complex and dense explanation that may need rewriting, and campaign lines or slogans that need transcreation.
Asked to choose routes for three texts, the same translator assigns translation to a warning in instructions for use not to exceed the stated dose, and adds localisation of formats such as units for the instructions for use as a whole. A recruitment tagline such as "be part of something bigger" she assigns to transcreation, which would also have to comply with the target market's recruitment regulations, because not every region has the same ones. A clinical-trial lay summary, in her account, may combine translation, localisation of numeracy, healthcare context and local conventions, and rewriting where plain language in the source market needs adjusting to plain language in the target market, because health literacy levels are not global.
Not every document fits neatly into one route, so the options should be considered deliberately, ideally with input from the translation and localisation provider before the project is locked into an established workflow. Nor should it be assumed that everything needs translation: the provider, involved early, helps identify what needs adapting, what is fixed, and when the source itself needs adjusting before the next step. The routes differ in cost, timeline, ownership of the materials, review expectations and quality criteria. If the route is not agreed early in the process, the service provider and the client work with different expectations.
Decisions settled before approval
The choices made when writing the source can affect what happens later in translation, review, adaptation, usability and regulatory fitness across markets. Content meant to travel across several markets should be written with that journey in mind, and with the next stage in mind rather than in the hope that it will work out.
Translation issues and questions often begin before the translation process starts. Translation should be considered at kickoff or during the first draft, when there is still time to make the source more translatable, clarify terminology, identify market-specific references and anticipate what may need adaptation later. If translation first comes up during review, some decisions can still be adjusted but the window is smaller. If it first comes up at handoff, the source is already locked, and the result can be avoidable queries from the translation vendor, disagreements on terminology, layout issues and problems adapting the content to the local environment. Not every translator needs to be involved in every source document from day one, but content clearly intended for multilingual use should not leave translation and localisation as an afterthought.
One experienced medical translator holds that writing with translation in mind has operational value. In her account, it supports faster market launches because fewer issues need resolving after approval, and it reduces query and review cycles because the source is clear and better briefed. It reduces the impact on medical and legal review because fewer local questions arise from unclear or unstable wording, supports stronger testing for materials that need it, reduces regulatory risk because claims, terminology and local references are handled more deliberately, and supports safer content for patients.
Content is best developed and finalised in one language before it is translated into another, and not developed in two languages at once, because that streamlines the process and ensures quality. The language the original is developed in should depend on the medical writing resources available and on the reviewers' language preferences.
"Ask your healthcare professional if a drug is right for you" looks short, clear and familiar, but it carries several hidden decisions. "Healthcare professional" assumes a particular healthcare system, and the relevant one might be a general practitioner, specialist, pharmacist or nurse, which can vary from market to market. "Right for you" is not neutral: it has a slightly persuasive function, encouraging the reader to consider whether the product may suit them, which may be appropriate in some contexts and in others may raise concerns that it is promotional. English can leave "you" unmarked for formal or informal address, singular or plural, and sometimes masculine, feminine or non-binary forms, while many languages force a choice. These decisions need to be made at the source writing stage, because otherwise someone else has to make them later, usually under more pressure, with less context and across several languages.
A language team can review the source while it is being drafted. The in-house translation and localisation department of one large medical-technology company offers writers a source review: the writer sends the document they are working on, and the department reviews the English to flag ambiguous or unclear text, missing units, and areas that need attention from a regulatory perspective. The department's own analysis found that projects that go through a source review are completed about 80% faster than projects that do not, because there are fewer linguist questions and fewer projects stop. A source review helps avoid changes to the English in the middle of the translation workflow, which arise when a document sent to in-country subject-matter experts turns out to contain content that is not accepted, goes back to the writer, and is changed in a source change round that is hard to manage with so many people in one project.
The company, increasingly aware of this problem and its cost, had begun bringing the department in very early to make sure content is ready for translation. In one case a department project manager attended an on-site meeting where documentation for a new medical device was authored under a live source review, with feedback such as that a text was ambiguous or should be reworded as a complete sentence, done to save time in the translation workflow.
For technical documentation, the department does not alter the content sent for translation: the writer is expected to have already reviewed all of the content, the regulatory information to be correct and up to date, and units of measurement to have been added and updated as needed. As essentially a supplier, it cannot be responsible for source content creation or direct a writer to delete a paragraph because a particular market will not accept it. Having worked so much with the material, it can still suggest that the writer check a passage with that country's regulatory authorities, and translation starts regardless.
The same company has further controls that lessen the risk of a source not being ready for translation. Every operating unit has a style guide that sets its tone, how it references things and how it lists. A content management system helps ensure consistency in both the English and the translations, because writers reuse content instead of always creating new content, which always risks being unclear or unsuitable for the audience. Writer education had become a strong focus, through a course called Writing for a Global Audience in which the trainer works through with a writing team how to author text clearly and in a translation-friendly way. The course began with technical writing and instructions for use, was branching out to marketing and corporate communications and to formatting for publication, and was being extended to writing for machine translation, meaning text clear enough to come out of an engine with as few errors as possible.
Context in the handoff
Writers, medical and legal reviewers, clients, local affiliates, translators, local reviewers, designers and sometimes usability testers touch the same material without necessarily sharing its context. The handoff is where that context usually disappears from the translator's perspective. Translators often do not receive enough context, sometimes receiving only the text, and may not know the audience, the target market or the rationale behind the terminology. For apps and medical device software, they may also lack the screenshots, the layout information and the context in which each part of the user interface appears. So the handoff should carry the context about audience, market and intent, together with the glossary and the screenshots.
Given only the text, translators have to fill the gaps, which means more questions, more review rounds and more room for interpretation; given the audience, purpose, screenshots, a glossary and other relevant context, many of those questions disappear before they become a problem. The same sentence can be translated differently depending on where it appears and who it is for, so context changes the quality of the work. Missing context surfaces later as query rounds, missed timelines, layout and readability problems and rework that is attributed to translation, although the root cause may lie upstream. If, for example, the explanation of timing, risk or study procedures in a clinical-trial lay summary turns out to be ambiguous only after the summary has been approved in English and translated into several languages, it has to be corrected in every language, which costs much more than resolving it in the source. Translators who ask for this information are not being difficult: the problem is missing context, and context is part of quality assurance.
The source file at handoff
Whether a source file is ready for translation depends on factors such as its type, for example a word-processor file, a page-layout file or a spreadsheet, whether formatting problems inside it, such as hard returns in the middle of a paragraph, have been removed, and whether the table of contents is linked so that page numbers update automatically.