As a medical device manufacturer, your organization faces challenges that companies in other industries may not face, especially when it comes to the closely related areas of patient safety and regulatory compliance.

Expanding beyond your home country comes with extra wrinkles: Medical device translation must meet the same high standards as preparing documentation in your original language. Creating a localization workflow that achieves compliance with speed and accuracy is a high bar to clear, but it’s necessary to help ensure leadership in the medical device space.

What are some challenges around medical device translation?

To understand why medical device translation is difficult, let’s examine the process. In fact, it may be the accumulation of so many individual issues that makes medical translation a more complex proposition than other types of localization. These factors include:

• Adherence to multi-country regulations: Medical device documentation must comply with complex regulations from many jurisdictions. Two sets of examples are the European Union Medical Device Regulation (EU MDR) and the Hazard Communication Standard (HCS) issued by the Occupational Safety and Health Administration (OSHA). Staying compliant with these and other continually updated requirements is a job in itself.
• The need for comprehensive and consistent medical device translation procedures: Medical device documentation includes numerous pieces of content, all of which must stay completely aligned with the device’s user interface. From user manuals and product packaging to “stylistic” content like marketing materials, everything must match. This need for accuracy and consistency is driven by the sheer importance of accurate information for patient safety, combined with legal frameworks designed to protect those patients.
• Tight timelines for localization: The need to translate every piece of content accurately and consistently leads to a related problem: A company that manufactures medical devices must turn around new translations on a tight timeline. Releasing a user interface update without fully localized accompanying materials won’t work, and it’s impossible to get a head start on translating related medical documents, because they must reflect the finalized version of the updated UI.
• Limited ability to use time-saving tools: Technical translation in many industries has been revolutionized by the introduction of high-tech utilities such as artificial intelligence and machine learning. These smart algorithms can translate large volumes of content at high speeds with less human intervention. However, due to the direct relationship between medical documents and patient safety, quality assurance carried out by human experts is an essential step in the medical device industry, one that limits the use of tech-based time-savers such as machine translation.

An experienced medical device translation service can put together a localization workflow that will overcome these challenges and deliver reliable results.

Which documents require translation?

The regulations are still evolving around the exact requirements for medical device documentation. The EU MDR is a good stand-in for the kinds of regulations medical device manufacturers must comply with in many jurisdictions, even outside Europe. The 2021 update included many of the rules for devices paired with medicines. It also outlines the ways companies must make comprehensive safety documentation about their medical products clearly and publicly available. For instance, the EU recommends companies follow ISO standards to make sure their documentation is widely accepted by international authorities.

The kind of safety performance documentation required by international bodies is only the beginning of your medical device manufacturing obligations. This adds complexity to medical device translation efforts. On top of these publicly accessible disclosures, you must make sure you’re providing localized versions of:

• Device UI: Medical equipment that contains a built-in interface must be usable in a target market’s language with prompts, terminology, and more localized for easy comprehensibility.
• Product instructions: Manuals that go into depth about how to use a device must reflect the latest updates and be in sync with the terminology used in the UI.
• Packaging inserts: The printed materials that accompany a medical device should be comprehensive and accurate within the space provided.
• Marketing materials: Stylistic content comes with a different approach to writing than a device’s manual and UI, but they can’t contradict those more technical documents.

The key ingredient across these many documentation types is consistency. While every content type comes with its own style and requirements, they can’t contradict one another, either in the information presented or the terms and acronyms used.

What is an optimized medical device translation process?

Your medical device translation procedures are usually not one workflow, but rather multiple processes moving in parallel. Once a UI update is completed in the original language, localization efforts can start for every target language, with separate teams of expert translation professionals working to complete the job quickly and accurately. Within each of these teams, a few important steps will take place between the release of the new UI update and the final submission of the completed, translated medical device documents.

1. Expert translation of every element, starting with the UI: Consistency is key when it comes to medical device translation procedures. This means each term, acronym and instruction related to a medical device must match the interface of the equipment itself. Expert translators with subject matter expertise set to work, starting with translating a new or updated device UI into the target language, followed by every other piece of content. Even items such as marketing collateral, which demand technical translation instead of stylistic localization, should be handled by the same translation process, to make sure they’re in line with the rest of the materials.

2. A check by the medical device manufacturer’s internal team: No matter how skilled a translation service team is, these professionals don’t work in a vacuum. After translating the device UI and every related material, it’s then customary to pass the results back to the manufacturer’s team in the target market for a check. These personnel can verify that the new documents are clear and easily comprehensible in the new language and fit the company’s branding in that market, making any suggestions or corrections.

3. One more quality assurance pass: In a highly regulated space like medical device manufacturing, where patient safety can hinge on translation accuracy, there’s no room for error. This is why medical translation service providers should offer another round of QA, to make sure every document, digital or physical, is up to demanding standards.

This process can best be accomplished with a team of expert translation professionals who both understand medical device subject matter and have experience translating content into the target language.

What’s the right balance of technology and expertise?

The importance of the human element means that these translation workflows are much less friendly to tech breakthroughs such as AI algorithms and heavy automation. With that said, expert translators can improve their effectiveness with a tool used by humans and algorithms alike — custom bilingual glossaries.

These glossaries are lists of terms that need special attention, along with the exact preferred translations for them. In the world of medical device translation, glossaries can include scientific medical terminology, the names of chemicals and compounds, and acronyms, among other important details. In some cases, medical terms and acronyms aren’t translated into new languages, and are left as-is. Whether they are localized or remain the same, however, using them correctly and consistently is essential for compliance and patient safety.

Building and developing a custom bilingual glossary is a process that can occur when a medical device company works with a translation service for the first time. Experts can then consult the same document every time a new UI update rolls out, demanding more translation work. They can also add to this data set over time.

With these kinds of ever-expanding resources at their command, subject matter experts are the fulcrum of medical device translation, and it can pay to work with the same highly qualified team over time.

What is the ideal approach to compliance?

Building the necessary translation capabilities within your own organization can represent a large, complex, and costly undertaking. But your company can’t afford to fall short in accuracy or speed. The simplest resolution is to work with a highly qualified medical device translation service.

A translation provider with access to trained subject matter experts can deliver a level of repeatable, fast, and accurate translation to meet compliance standards across regions. This usually requires professional translators with a knowledge of medical products as well as the stylistic needs of a chosen content type in each target language.

Working with the same highly qualified translation service for each product release and update can pay repeating dividends for a medical device manufacturer, as learning curves are shortened and your organization can reuse materials such as custom bilingual glossaries. A collaborative workflow, with translators and internal medical device experts all signing off on translations, can deliver results that meet industry standards, year after year.