The life science industries are highly regulated for good reason. Without proper guidelines and control mechanisms to ensure safety and quality, dangerous products could be marketed to unassuming customers.

Life science companies, especially larger ones like Merck, PPD, Icon, and Hologic, do business in a global environment. Life science companies’ commercialization of products in different global regions requires information to be understood by the targeted markets in the local language. In addition to this, with clinical trials increasingly being conducted overseas, the need for culturally-sensitive marketing material for patient recruitment and engagement, clear communication between coordinator and participant, as well as in-depth knowledge of local regulatory policies is critical for global market access and success.

Every industry has unique terminologies and jargon, and the life science industries are no exception. In addition to specific jargon use, the life sciences are also considered a knowledge industry. In fact, some of the terminologies used in the life science industries can be quite challenging to someone outside of that industry, making translating life science content more complex and, at times, rather difficult. In other words, if the content is not well understood, it cannot be translated well. To provide the highest-quality translations, not only do translators need to be professional linguists, but they must also possess subject matter knowledge of the content. 

In addition to having knowledge of the content, translators also need to understand various regulations and guidelines pertaining to information security, confidentiality, and quality assurance practices. One example would be that before a translation can take place for a Patient Information Leaflet, a “Readability” test must be performed. The “Readability” testing is a method (could be an interview or survey) to assure that the intended target consumer understands the intent of the content. Many regulatory bodies, like the FDA for example through the Plain Writing Act of 2010, requires that any informative medical documentation for patients must be broken down into easily digestible way, without needing to understand industry-specific knowledge and jargon.

For those reasons and more, many Language Service Providers (LSPs) have stringent requirements when qualifying translators for life science content. Further, LSPs are either certified or have quality assurance measures in place conforming to ISO 9001 standards. Some even have ISO 17100 certifications which is specific to the translation industry.

Adding to the complexity of translating life science content mentioned above, many times documents received by the LSPs come in the form of scanned documents. This requires additional effort to either reproduce the source document manually or to convert the documents into an editable format via an optimal character recognition (OCR) application. To make matters even more complex, depending on the nature of the content, sometimes specific templates are required which cannot be altered, like for example, translating labeling content.

Lastly, errors in translation can have enormous consequences.  Lives could be lost and a company’s reputation could be damaged. Translation errors can delay a launch of a product, recall of a product, and can lead to legal proceedings. One of the most famous examples of the potential dangers mistranslation can cause for patients and life science companies comes from Germany in 2007, when a US-manufactured knee prosthesis used an LSP to translate the information for use (IFU) on the inside of the package, and left the words on the outside in English. This minor error caused 47 patients receiving knee replacement surgery serious complications when a bilingual staff member, instead of a professional linguist with subject matter expertise, incorrectly translated “non-modular cemented” as just “non-cemented” based on the labeling on the outside packaging. Patients who received the initial surgery were then required to have another one to amend the original mistake, ultimately creating an unnecessary extended recovery time, as well as added pain and suffering. As a result, multiple lawsuits against both the medical device company as well as the hospital caused both life science businesses to lose millions of dollars trying to remedy what was originally one small translation error.

Due to the severity of the consequences, and the necessary details, only qualified professional translators take on these types of projects within the life science industries. Taking shortcuts or trying to save a few dollars by using non-qualified translators can have a long-lasting negative impact on the company and patients receiving the treatments in general. To avoid potential lawsuits, or risking patient’s safety and health, life science businesses must look for LSPs with the proper experience, qualifications, technology, and systems in place to ensure the highest-quality translation for their products when expanding into foreign markets.

About CSOFT Health Sciences

CSOFT Health Sciences provides end-to-end medical translations for all phases of the product lifecycle, from pre-clinical to post-launch. We also specialize in market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.

About CSOFT

CSOFT International is a leading provider of cross-border communications for enterprises seeking growth in global markets. Our expertise in localization, documentation, and branding encompasses a full range of end-to-end content and consulting services that we deliver in over 250 languages. With a focus in health sciences and smart technology, we work closely with our clients to deliver precision solutions to the challenges of engaging markets, consumers, and regulatory environments worldwide.