Weak in the Knees: Managing Regulatory Translation

Throughout 2006 and 2007, Sankt Hedwig Hospital in Germany performed at least 47 failed knee replacement surgeries, the root cause of which has since been identified as the mistranslation of a single word on product packaging. As a result, in addition to the cost of remedial surgery, Sankt Hedwig and the US device manufacturer incurred multi-million dollar compensation claims.

This incident illustrates some of the most common translation speedbumps along the medical device development process, including:

International differences in regulatory requirements. German law requires that US manufacturers translate the Instructions for Use (IFU) into German, but it does not require the translation of product packaging. Meanwhile, in the US, the Food and Drug Administration (FDA) requires the translation of all labels and labelling into English.

Using an employee for translation. A Sankt Hedwig employee incorrectly translated the phrase “non-modular cemented” into “zementfrei,” which means “not requiring cement” or “without cement.”

Lack of oversight. The hospital printed labels with the incorrect translation and then adhered them to product packaging, bypassing both the European Medicine Agency (EMA) and The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).

In cases such as these, it’s important to note that translators and the companies hiring them may also be held accountable for any resultant adverse outcomes, which include more than the medical issues. Additional adverse effects of inferior translation services include:

• Submission Delays: Inaccuracies will lead to questions from the regulatory reviewer, requests for clarification, or even the rejection of the submission, delaying the product launch.

• Recalls and Safety Alerts: For example, if translated documents fail to clearly communicate contraindications or side effects, it may lead to adverse events, which in turn can trigger a recall of the device from the market.

• Compliance Violations: Non-compliance – for example, marketing based on translated documentation that doesn’t meet the specific legal and regulatory requirements of a particular country – can lead to regulatory sanctions or fines.

• Cost Overruns: Indirect costs resulting from translation errors include the need for retranslation, additional rounds of regulatory review, and delayed product launches, each of which significantly increase the overall cost of bringing a medical device to market.

The Intricacies of the Regulatory World

The FDA and its international counterparts have similar – though not identical – objectives and breadth of jurisdiction and there are notable differences between agencies in the application and execution of stated requirements.

For example, even classification of devices and technologies in each country may differ – specific devices like joint prostheses are classified differently in the US and the UK, and depending on risk classifications, even the quality and quantity of clinical data – required for market approval – can differ.

Regulations, too, are always evolving. In our blog, The Top 3 Translation Requirements in Medical Device Manufacturing, we focus on the constantly changing regulatory landscape, most recently illustrated by the EU’s adoption of revised Medical Devices Regulation (MDR) requirements starting in May, 2024. That changeability adds a layer of complexity to the product development lifecycle, including translation requirements, which the MDR now holds to ISO standards.

In fact, the most successful translation management plan (TMP) tracks along the entirety of the development lifecycle, from research and development to global marketing and commercialization, according to Michael Drues, President of Vascular Sciences and a guest on The Global Marketing Show podcast. At the same time, he adds, the “root cause” of an unsuccessful product launch is building a TMP based on regulatory requirements.

Instead, pick three-four locales in which to launch, pool the regulatory requirements of each country – benchtop testing, animal or clinical testing, reimbursement – and derive a holistic view across departments. “Put them together in a way that makes sense,” he says. Listen to the full episode to learn more about creating a TMP for your product.

Translation Quality Matters

Mitigate risk by hiring experienced translators who specialize in medical devices, conduct thorough review and validation of translated documents, and maintain documented quality control processes. High-quality language services providers (LSPs) will also be transparent about their use of technology – computer assisted translation, translation memory – relying on it less for translation than to ensure consistency and accuracy across documents and departments.

Look for an LSP that utilizes a holistic approach to project management in order to avoid the most common translation pitfalls. A qualified agency will stress the following quality markers:

Accuracy and Precision: The terminology used in medical device regulatory documents is highly specialized. Accurate translation prevents the rejection of regulatory submissions and, more importantly, ensures patient safety. Even small errors can have significant implications; for example, device misuse – suppositories mistaken for oral medication – or incorrect dosages.

Translators with industry experience will also understand how to use the proper “voice” for various regulatory content – IFUs, for example, are written with an eye toward readability for the lay person, as opposed to a Summary of Product Characteristics (SmPC), a document required by the FDA and its international counterparts prior to the authorization of any medicinal product. The SmPC is intended solely for healthcare professionals so that they understand how to use a product safely and effectively. It includes information such as: the qualitative and quantitative composition of the medication, its pharmaceutical form, clinical particulars, and other technical aspects of the product.

Consistency: Consistency in the use of terminology and presentation is crucial, particularly when the same device is being marketed in multiple countries. Discrepancies can lead to confusion among regulatory reviewers and might raise questions about the reliability or safety of the device. In addition, high-quality LSPs guarantee consistency across updates and revisions due to changes in regulations, technology, or clinical practices.

Cultural and Linguistic Adaptation: Effective translation accounts for cultural nuances and local practices, particularly around global marketing. It includes appropriate formatting – dates, measurements, and colors, for example – but more importantly, it means tailored messaging and branding that aligns with cultural sensitivities. An industry-experienced translator knows to address the unique needs of each market while accounting for local healthcare practices – the role of healthcare professionals in influencing purchasing decisions, for example, or a country’s level of reliance on non-traditional medicine.

Qualified Personnel: There is high demand for translators who not only understand both source and target languages fluently but who also have a deep understanding of medical and technical terminology, including regulatory affairs. The pool of such qualified translators is relatively small; a high-quality LSP acts as your partner, pairing you with industry-experienced translators and maintaining the most beneficial client-translator pairings over time.

Error-free translation is key to moving any product through the manufacture-to-market pipeline, but more importantly, it’s essential to optimizing efficacy and ensuring patient safety. And it’s safe to say that the unifying, overarching goal of the FDA and every one of its international counterparts is the same – to “first, do no harm,” while continually improving product safety and patient outcomes.