The medical device industry is heavily regulated. Industry standards can vary significantly from country to country, and documentation and customer material require localization.
In the European Union, for example, Medical Device Directives specify the translation of labels and user instructions. A company selling a medical device into the EU single market must ensure its quality management system delivers “accurate and up-to-date” translations.
In Canada, regulations state that a medical device manufacturer, whose product directions for use are only available in one official language, must provide them in the other official language as soon as possible at the request of the purchaser.
In China, localization is a core part of the initial registration process. The application dossiers must be in Chinese and all non-Chinese documents supporting the application have to be translated.
In the ramp-up to marketing, medical-device organizations must localize product development and manufacturing documents, as well as information on packaging and labels.
Moving along the process, the content type shifts again when marketing and sales materials come into play. Everything from websites to ads, from training documents to tutorial videos must be localized.
Finally, in the post-marketing stage, the focus goes back to technical content. Now, organizations must localize materials on medical device safety and performance, as well as reports and studies.
Medical device manufacturers, who want to keep tight control over their content to satisfy regulators while also staying nimble to get their message across to customers, better look for a state-of-the-art localization platform. Let us discuss this through the case of MED-EL, a worldwide leading manufacturer of hearing implants headquartered in Innsbruck, Austria.
A Look at MED-EL
MED-EL Medical Electronics employs over 1,700 around the world.
In 1977, MED-EL’s Austrian founders created the world’s first microelectronic multi-channel cochlear implant. Since then, MED-EL has continuously invested in research and development to produce state-of-the-art medical devices to overcome hearing loss.
MED-EL has established a strong international presence with over 30 offices worldwide and the company’s website is available in 40 languages and language variants.
“Even one small error or wrong term can delay the approval of a medical device by authorities”―MED-EL Translation Manager
So how did MED-EL meet all its translation requirements? MED-EL has various departments that handle translations, each specializing in a specific text type (e.g., marketing text, rehabilitation material, and so on). While each department identifies and manages its own translation needs, they all work closely together.
With close cooperation between departments, the translation managers in charge worked on implementing a translation infrastructure that would facilitate translation management and knowledge exchange via a single, centralized platform.
Bells and Whistles: Baseline Requirements
MED-EL team members went ahead and defined a strict set of baseline requirements for the localization platform, which was to be selected in a competitive process.
- Distributed architecture – A central server is used to control and manage linguistic data, issue temporary licenses
- Intuitive user interface – A short learning curve for in-house and external resources to use the localization platform quickly
- Information exchange – Interoperability to deal with the variety of file formats MED-EL uses
- Built-in terminology management tools – To avoid misunderstandings and registration issues, terminology had to be maintained throughout the entire workflow. A central term base, shared and managed by all departments, had to assure consistent use of MED-EL terminology across writing and translation projects.
- Centralized translation memories – Previously approved translation segments needed to be leveraged to allow quick turnaround.
- Full unicode implementation for Asian-language support – MED-EL localizes into Asian languages (Korean, Chinese, Cantonese, and Japanese) as well as some Indian dialects. To enable this, the localization platform had to offer flexible segmentation rules to adapt to Asian and double-byte or right-to-left languages such as Arabic and Hebrew.
- Change-tracking functionality – Version control, especially when content can change quickly due to new data and information
- Inline QA tool – Translation managers need to check the text against certain predefined criteria.
- Workflow design – The localization platform had to be flexible enough to be immediately implemented in the current workflow.
“To us, a 100% match means it’s linguistic data that has already been approved. It’s text we can trust”―MED-EL Translation Manager
All Boxes Ticked
The translation team analyzed and tested various translation productivity and translation management tools. They also solicited reviews from colleagues. And, ultimately, MED-EL’s translation managers came to a decision: They would implement Kilgray’s memoQ.
For MED-EL, memoQ met all the requirements. It was also the technology of choice of the three language service providers that perform selected translation tasks for MED-EL.
The memoQ version MED-EL chose to implement was memoQ server. MED-EL opted to use memoQ WebTrans, a version of memoQ that works in any web browser and is ideal for assigning proofreading work to external resources.
WebTrans is integrated into the memoQ server, which has a customized filter to extract content from MED-EL’s CMS and import it to memoQ.
What’s more, memoQ WebTrans has proved especially useful for revisions, because subject-matter experts (typically in-country MED-EL staff) do not have to manipulate files. They use WebTrans for proofreading by simply accessing the text through the WebTrans website, applying the corporate linguistic QA model, and marking errors.
MED-EL also decided to implement the memoQ server add-on QTerm, which centralizes terminology management, providing a single point of access for up-to-date terminology. The result: coherent wording throughout communication channels and support to comply with local standards.
Using WebTrans in the revision process, subject-matter experts can use QTerm to access the terminology database and contribute to terminology without having to install or license a specific tool.
For the translation managers, it is important to have one central point to exchange information. They explain, “Sometimes, during the prelaunch stage, other colleagues may have already worked on the terminology. We need to ensure coherence within all documents. Even one small error or wrong term can delay the approval of a medical device by authorities.”
“We hit break even three months after implementation”―MED-EL Translation Manager
Making Decentralization Work
A fair share of MED-EL’s translation volume is run in-house, with translation managers and in-house proofreaders performing proofreading and QA tasks. Via direct access to translation memories and terminology repositories, colleagues from worldwide offices can conduct in-country reviews.
MED-EL’s original workflow substantially changed for the better, according to the translation managers, who explained, “We now have one platform in memoQ to work more efficiently and exchange texts more easily with all stakeholders. That has led to an enormous increase in language combinations covered and also in overall workload handled, even though human resources remain the same.”
MED-EL did experience a major change: New, extended centralized translation memories and terminology database. The most important new feature is the pre-translate function.
These days, translation memories are leveraged for reliability, not necessarily for 100% matches. One translation manager articulates it this way: “To us, a 100% match means it’s linguistic data that has already been approved. It’s text we can trust.”
Costs Down, Compliance Up
MED-EL relies on translation memories for the consistency they provide as well as their ability to save time. After implementation, the company saved on turnaround time and localization costs―and they broke even on the investment three months after implementation.
So what has been the most important benefit of introducing a centralized translation memory repository and term base? “Greater inherent consistency, because terminology is, of course, key to meeting the strict international standards of our quality management system,” as pointed out by one responsible translation manager.
The new translation platform has also allowed traceability in the localization process as well as version control; the two basic requirements of any quality-management program.
Completing the picture, the company’s control of licensing costs is a major benefit as well. Now, translators and proofreaders can log into the translation system via a copy of memoQ, whether it is a desktop version or memoQ WebTrans; meanwhile, reviewers and subject-matter experts can use browser-based interface WebTrans and QTerm.
With memoQ, MED-EL’s translation team now has the technical foundation in place to support the company’s growth while being compliant and customer-centric in a highly regulated and complex market.