In an increasingly globalized healthcare landscape, the importance of accurate and effective language translation cannot be overstated, particularly in the life sciences sector. With this focus, Argos Multilingual recently convened a distinguished panel of experts for a webinar entitled “Building and Growing Language Operations in Life Sciences.“
The panel delved into the intricacies and challenges of achieving comprehensive and compliant localization within life sciences organizations. Addressing core themes such as the pros and cons of centralization, the critical role of global teams, the labyrinthine landscape of regulations, and the transformative potential of AI, the discussion provided nuanced insights for professionals in fields ranging from product development and regulatory compliance to marketing. As the industry navigates a globalized world, these insights are instrumental for anyone involved in shaping and executing localization strategies.
Meet our webinar guests:
- Tara Baer is an accomplished consultant with a focus on medical device and pharmaceutical labeling. She has previously served as the Head of Labeling for Takeda and has had roles at industry giants like AbbVie, Boston Scientific, Wyeth, and Intervet. Specializing in translation management, workflow, and content development, Tara is also a founder of Leaders in Labeling, a group committed to thought leadership in the labeling of regulated products.
- Kristina Cole is the Senior Localization Program Manager at Medtronic, overseeing EU MDR–related localization strategy across different business segments and functions at Medtronic. With more than two decades of experience in localization, Kristina also handles translation strategy for Medtronic’s Cardiovascular and Medical Surgical portfolios.
- Nikole Gross, a Principal Localization Specialist at Stryker, brings 30 years of experience to the field. Starting her career at Microsoft in the early ’90s, she now focuses on localizing defibrillation and monitoring devices at Stryker. Her responsibilities span software, voice prompts, data solutions, product documentation, packaging, and labeling.
- Sandrine Lardit serves as the Senior Manager for Translation/Localization at Becton, Dickinson and Company (BD). With over 25 years in the localization industry, Sandrine manages two specialized teams at BD focusing on the life sciences segment. Her roles include project planning, tool implementation, quality management, and stakeholder education.
The discussion was moderated by Nadège Young, VP of Customer Success at Argos Multilingual, whose first-hand experience with life sciences clients provides a unique vantage point for understanding industry-specific challenges.
- Centralization of Localization Programs: Exploring whether medical device buyers commonly employ centralized localization programs, along with the inherent benefits and drawbacks.
- Quality Assurance: Strategies for achieving “Quality at Source,” ensuring translations are accurate the first time while meeting complex regulatory compliance criteria.
- Impact of Regulations: An in-depth look at the labyrinth of regulations affecting the localization process in life sciences and effective strategies for navigating them.
- AI in Localization: The emerging role of artificial intelligence in localization, with insights into how it could reshape content generation, quality checks, and regulatory compliance.
This article aims to distill the critical takeaways from this insightful webinar, and is targeted at professionals in the pharmaceutical, medical device, and healthcare industries who are grappling with the complexities of global translation and localization.
Centralization in localization is a nuanced strategy that can offer significant benefits but also poses unique challenges. Companies considering this approach need to weigh both the tangible and intangible benefits against the specific needs and challenges that come with their industry, size, and global reach.
The benefits of centralization
Centralizing localization programs can yield substantial cost-saving benefits, with “volume discounts” and “economies of scale” often cited as primary advantages. Another benefit of a centralized approach is the capability to “maximize recycling, minimize translation costs, and ensure scalability,” offering a more sustainable and efficient way to manage translation needs.
One of the most compelling benefits is the consistency it brings to an organization’s global efforts. Through the use of shared Translation Memory Systems (TMS) and standardized glossaries, companies can ensure uniformity across different business units and regional markets. This is particularly important in life sciences, where the terminology needs to be precise and consistent to meet regulatory standards.
Beyond cost and consistency, streamlining administrative processes is another attractive benefit. With a unified approach, companies can move from “hundreds of POs to just one annual PO for a vendor,” reducing the administrative load considerably. A centralized system also provides a unified way to address quality, which is invaluable in audits and investigations.
The challenges of centralization
However, centralizing localization programs is far from straightforward and comes with its unique set of challenges. The “cost of implementation” and the time required to align internal departments with the new approach are significant obstacles. It’s not just about using machine translation or other technological tools; it requires a deep understanding of the technical and administrative resources necessary to implement a robust TMS solution.
Additionally, in larger corporations, there’s often “a lack of support and knowledge in localization at higher levels,” making it difficult to garner the support needed for a centralized approach. It is a complex task that necessitates “corporate support” and “collaboration from various departments within a company,” especially from procurement teams who must understand the “intricacies of translation.”
A customized approach
While the idea of centralization sounds appealing, it’s clear that there isn’t a one-size-fits-all approach. Companies with a significant global footprint may find it easier to standardize their procedures, but even then, it’s important to recognize that “there are specific niche needs in different parts of the business.” Especially in the face of frequent acquisitions in the life sciences sector, integrating a new company into an existing centralized framework is a complex task.
Furthermore, the term “centralization” doesn’t necessarily mean relying on a single translation vendor; it implies a unified approach to localization efforts. A smart strategy often starts with smaller, more manageable steps such as “having consolidated translation memories or understanding your target markets.”
Quality in the realm of global localization is a nuanced subject that extends far beyond simple linguistic accuracy. It intersects with various business objectives, such as risk mitigation, time management, and customer satisfaction, and involves a deep-rooted collaboration between LSPs and in-house subject matter experts.
One pivotal factor in maintaining high-quality translations is the initial definition of what quality means to an organization, which you need to research “before you even put a plan in place.” This points to the importance of aligning an organization’s localization efforts with its unique definitions of quality. The focus varies across industries: in life sciences, the emphasis is not solely on linguistic quality but also heavily on “risk-based” considerations: “it’s more about being able to correctly use the product and not introduce risk to the user. ” Understanding this allows localization teams to prioritize accordingly, maintaining an equilibrium between linguistic “correctness” and functional usability.
The role of in-country review
The traditional approach of utilizing in-country reviewers for quality assurance has been a subject of intense debate. While these reviewers bring an invaluable perspective on cultural and local nuances, their role can become a “bottleneck,” contributing to delays and even added costs. More worryingly, in-country reviews can sometimes lead to “adding errors versus reducing errors.” Therefore, it’s crucial to strike a “balance between the knowledge of your internal resources and the checks and balances with the LSP,” ensuring the most effective quality checks.
Prioritizing critical content
With tight schedules and diverse deliverables, organizations often face the challenge of deciding which content should undergo rigorous review processes. “The device elements are the most critical to be reviewed by your in-country reviewers because that’s actual usage of the device and what the person’s using, and it really affects that user experience.” Zeroing in on critical content areas like user interface and device labeling ensures the highest quality where it matters most, enhancing user experience and reducing risks.
Leverage glossaries and translation memories
One universally acknowledged cornerstone for quality assurance in localization is a well-curated glossary. “Your glossary should be really solid and you should have that proactively put in place” so that it acts as the “foundation” of all translation activities. Coupled with robust translation memories, these tools become indispensable in maintaining consistent and high-quality translations.
Risk analysis and regional nuances
The complex landscape of global localization also demands a thorough risk analysis to determine where the focus should be. One panelist states that “understanding where you’re putting your focus and time and not just ticking the box” of in-country review is crucial, emphasizing the need to understand the intricacies of language variations within regions, especially in sectors like pharma and healthcare where a mistranslation could have severe consequences.
Quality is not a monolithic concept but a multi-layered framework requiring a blend of technology, human expertise, and strategic foresight. By taking a more nuanced approach, businesses can ensure that their localization efforts meet the highest standards, fulfilling both their operational objectives and market needs.
The ever-evolving regulatory landscape is a dominant force shaping the way companies in life sciences approach localization. The need for global compliance imposes an intricate tapestry of obligations, spanning not only the traditional realms of label and package insert translation but also extending into newer requirements such as Summary of Safety and Clinical Performance (SSCP) under Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Complexity and unique requirements
Companies now operate under the increasing weight of market-specific stipulations, making single-source localization strategies less feasible. “As much as we try to be global… it’s impossible,” reflects one panelist, underlining the need for unique baselines that target individual market requirements. The necessity of understanding what is truly required versus what is optional or preferential adds another layer of complexity, forcing companies to adopt a more nuanced approach to interpreting regulations.
Writing for translation and core labels
One viable approach to offsetting this complexity is writing for translation. Organizations are urged to prepare their foundational documentation not with a single market in mind but as a template for multiple markets. A concept from the pharmaceutical industry that could aid medical device manufacturers is that of a ‘core label,’ serving as a baseline document focused on key safety and use components. This core label can be integrated into glossaries and translation memories, allowing companies to “look at it more holistically.”
Risk mitigation and quality assurance
Interpreting regulatory requirements correctly the first time is crucial for risk mitigation. As one expert notes, “until you really have something locked in, you don’t want to move forward with localization” to avoid the cost and time involved in rework. The concept of Quality at Source gains prominence here, underlining the importance of getting translations right the first time to save on subsequent correction efforts.
Local expertise and partnerships
Companies are increasingly relying on local regulatory expertise to navigate specific market demands. Sometimes it’s about “physically walking the information into their health authority,” while at other times, it’s about interpreting what the regulations truly necessitate. A strong emphasis is placed on partnering with language service providers and regulatory agencies as one would with a contract manufacturer. A transparent, auditable relationship with these partners ensures not only compliance but also efficient adaptation to new regulatory challenges.
Regulations in localization are no longer just about adhering to different languages and cultural norms but are increasingly connected to intricate, market-specific rules and medical protocols. With countries layering additional requirements on top of global mandates, such as MDR and IVDR, a one-size-fits-all approach is increasingly becoming a relic of the past. Companies must adopt more dynamic strategies, leveraging technology and local expertise to keep pace with these evolving demands.
The takeaways are clear: mastery of the regulatory landscape is not merely advisable but essential. It calls for meticulous planning, robust quality assurance systems, and a commitment to continuous adaptation. “At the end of the day, you’re responsible for your products,” a panelist aptly concludes, underlining the gravity of the challenge and the need for unwavering attention to detail.
As the world navigates an increasingly digital landscape, artificial intelligence’s influence on the localization industry is becoming a subject of pivotal importance. No longer just a buzzword, AI is seeping into various stages of the localization process, sparking both enthusiasm and cautious optimism among experts.
One of the earliest forms of AI in localization is the ubiquitous “translation memory,” which leverages previous translations to inform new ones. As noted, “the translation memory in and of itself is a form of AI,” since it employs fuzzy and direct matches to improve efficiency. Building upon this, the industry is shifting from merely “translating” to “generating content” customized for each market. The emphasis is on creating not just a one-size-fits-all translation but content that resonates with the local audience. One panelist observed that “instead of transcreation, you might be looking at more customized content for each market through AI,” echoing the need for more personalized, market-specific communication.
AI’s transformative potential is particularly noticeable in areas where high volumes of data and quality checks are involved. For instance, a well-trained AI model could significantly “improve the quality and turn things around more quickly.” Whether it’s about refining product descriptions or ensuring consistency in medical literature, AI can offer practical solutions for tasks that were traditionally time-consuming. Furthermore, structured content is emerging as a pivotal theme. “Understanding what we’re doing and how we’re doing it is part of it. And once you understand that, then you can build the structure, which allows you to automate,” observes one panelist, highlighting the need for a more methodological approach to content creation.
However, integrating AI into the localization process is not without its complexities. The technology remains in its “early days,” and “fine-tuning is really critical to ensure accuracy.” Especially in sectors like life sciences and medical devices, where the stakes are high, the “human element of verification” cannot be wholly eradicated yet. AI might offer “a lot of territory to cover,” but it requires a large volume of data for training and substantial internal discussions to arrive at a reliable solution.
While LSPs are “at the drawing board on AI and solutions,” the panelists believe that businesses will follow suit only after a thorough understanding of the potential benefits and limitations. “Your key role, if you’re leading localization within your organizations, is helping them understand that and where they can benefit from that and what’s realistic.”
In conclusion, AI holds the promise to revolutionize the localization industry, but its full impact is yet to be realized. This technology challenges traditional notions but also invites organizations to be part of an exciting, albeit complicated, future. As one panelist aptly summed it up, this is “a very exciting field,” and perhaps, the next discussions will be solely focused on the transformative power of AI in localization.
Watch the on-demand recording of “Building and Growing Language Operations in Life Sciences” for additional insights. We welcome your engagement and your feedback! Write to us at firstname.lastname@example.org.