Glossaries and Termbases for Medical Device Companies
As social, political, and economic ideologies shift and evolve throughout the world, so too do terms, acronyms, and phrases within businesses and across industries. And, as the world continues to globalize, these terms, acronyms, and phrases must now be accurately translated into multiple languages to ensure effective communication with partners and customers alike. In the life sciences arena, this is especially true.
Advances in medical device (and in-vitro medical device) technologies along with advances in diagnosis, treatment, and care often lead to new vocabulary that needs to be professionally translated, captured, stored, communicated, and shared with key stakeholders. Since the safety and well-being of patients depend on how well they — or their medical care team — understand the instructions for use (IFUs) and operating manuals for medical devices, particular attention must be given to the creation of an effective terminology management system (TMS). In short, a TMS identifies, stores, and manages company- and product-specific terminology that requires professional translation.
Before the translation process takes place, however, it is imperative that medical device companies develop a comprehensive list of the terms that apply to their company as well as to each of their medical device products. This list might consist solely of text but might also include images and reference materials. A thoroughly and properly established glossary and termbase work to remove any ambiguity while enhancing translation consistency and accuracy (especially if your content contains a number of niche terms).
Understanding Termbases and Glossaries
Languages are complex and are continually changing. From industry to industry and company to company (and sometimes from product to product), the same words can carry different meanings. This is certainly true of the life sciences industry. In fact, one could argue that with regulatory changes and medical advances, the language that encompasses all-things-life-sciences is one of the most complex, everchanging, and challenging. When we look through this life sciences lens, we see how critically important it is to avoid language confusion in life sciences. For medical device manufacturers, ensuring a consistent and accurate use of their company’s (and product’s) terminology mitigates the risk of misusing, underusing, or even overusing medical devices. In this way, termbases and glossaries play a particularly critical role in ensuring the right terms are applied at the right time.
A glossary is a specialized list of words and their corresponding definitions that companies use to clarify meaning. Readers check glossaries to better understand and apply company-specific vocabulary. To enhance this understanding and increase the likelihood of appropriate application, glossaries can also contain illustrations, sound, and video. Think of glossaries as a collection of terms and their corresponding meanings, oftentimes related to a specific company, subject, or product line.
When medical device companies partner with language services providers (LSPs) well-versed in life sciences translation, these glossaries are further developed to include the full list of approved translations of specified words and phrases. At this level, glossaries can contain a list of the terms in the source language along with approved translations in multiple languages. By adhering to the approved translations in the glossary, translators ensure that each time a defined term appears in a translation project, it is translated consistently and accurately. By their very nature, glossaries, then, greatly reduce translation time and the overall cost of translation.
In simple terms, termbases (terminology + database) are more sophisticated databases containing all the approved terminology for a given company or for each product a company places on the market. Unlike a glossary’s simple list of words, however, termbases function as a system that manages the terms. For instance, termbases work to standardize word usage by permitting or excluding the use of certain terms and their variants, among other factors. And, since termbases are often shared among several individuals and groups, they play a particularly key role in enforcing terminology consistency. The more consistent and accurate the content, the easier, faster, less expensive, and more accurate the translation.
In other words, a well-built termbase and glossary will help companies remain consistent in their messaging in any language.
Terminology Challenges Faced by Medical Device Manufacturers
From the costs associated with product design and research and development to security vulnerabilities, product safety and efficacy, and regulatory compliance, today’s medical device companies face a great many challenges. And, while all of these challenges can be viewed as separate and distinct, they are intricately connected by language. After all, the impact of a product’s design, the overall success of a product’s efficacy, and its longevity on the market all depend on how effective, accurate, and consistent the company communicates.
One need only look at Regulation (EU) 2017/745 (MDR) which now requires “instructions for use [to] be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.”1 The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) follows in much the same vein requiring “clear and precise” language for all technical documentation as well as all patient information materials. To put this into greater perspective, Heather Riah, Assistant Vice President of CRICO Strategies believes that “[c]ommunication difficulties are not isolated to providers lacking ‘people skills’ or patient[s] with language or comprehension deficits. Every mode and system by which patients and caregivers share health-related information is vulnerable to failure.”2 In their 2015 Malpractice Risks in Communication Failures, the company highlights just some of the common departments where miscommunication in healthcare occurs.
Data Source: CRICO Strategies
The life sciences regulatory ecosystem in the United States and in Europe holds effective communication central to a medical device company’s roles and responsibilities. Communication is central to all industries, of course, but when it comes to life sciences, effective communication with internal and external stakeholders is critical to public safety and paramount to the wellbeing of the patients using their medical devices. Therefore, creating, updating, and maintaining a TMS to ensure consistent and accurate communication across languages is likely one of the highest priorities but also one of the toughest challenges medical device companies face today.
Ingenuiti Has You Covered
Whether you already have an established glossary or require support in creating your glossary and termbase, Ingenuiti has you covered. Ingenuiti not only provides unparalleled translation services of client-supplied glossary terms but also collaborates with clients to help build and maintain glossaries and termbases, extracting terms and starting the process on our clients’ behalf. Ingenuiti helps brands:
✓ Determine their objectives (identifying key terms — including noun and verb usage, product names, and more)
✓ Extract product literature in the English source (ex., terms, existing glossaries or terminology lists to establish a baseline)
✓ Identify termbase and glossary terms, as well as definitions of each as needed
✓ Translate by using any existing translation memory (TM), and perform editing and quality assurance (QA) checks
✓ Assist with performing an in-country review process to ensure the terms and glossary are agreed upon prior to implementation
✓ Create a continuous process, with updates to your glossaries, adding new terminology for every project (when and where necessary) to ensure the most current and agreed-upon company terms are used.
By building and maintaining glossary and terminology consistency, Ingenuiti helps medical device companies save money and lessen the time to market. As experienced language services providers within the life sciences industry, Ingenuiti works closely with our medical device clients to build and maintain consistent, professionally established terminology in multiple languages. Our proven, advanced TMS coupled with our in-country, native-speaking linguists offer secure solutions to ensure terminology consistency every time, regardless of short deadlines or project scope. In short, Ingenuiti will help guide you throughout the translation process. With Ingenuiti, you’ll reduce miscommunication, lower translation costs, and get your products quicker to market.
We have the technology. We have the subject matter expertise. We have Project Management Specialists. Place your trust in Ingenuiti.
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1 Regulation (EU) 2017/ 745 of the European … – EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745.
2 Strategies, CRICO. “Failures in Communication Contribute to Medical Malpractice.” Failures in Communication Contribute to Medical Malpractice, 29 June 2018, https://www.prnewswire.com/news-releases/failures-in-communication-contribute-to-medical-malpractice-300212716.html.