Life Science Localization
Regulated industries might be slower than other to adopt AI but that does not mean that they are not encountering changes and new challenges for translation and localization. This issue we are going to take a bit of a step away from the AI scene (don’t worry it is not going anywhere) to dig a bit further into some of the issues facing Life Science companies today.??
This month, we are highlighting topics and ideas from experts in the life science industry who participated in the "Building and Growing Language Operations in Life Sciences ” roundtable.??
Kristina Cole, Senior Program Manager | Global Translation & Localization, Medtronic
Tara Baer, Consultant
Sandrine Lardit, Senior Manager for Translation/Localization, Becton, Dickinson and Company (BD)
Nikole Gross, Principal Localization Specialist, Stryker
Key discussion points?
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.?
Centralization of Localization Programs in the Life
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 Global Localization: A Multifaceted Approach?
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.?
Understanding quality?
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.?
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The Impact of Regulations on Localization in Life Sciences?
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.?
Looking ahead?
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.?
The Transformative Potential of AI in Localization?
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.?
Making the Most of Life Sciences Localization Resources
Multilingual Magazine
MDR info for Localization Managers
IVDR info for Localization Managers
Thank you for joining us for another issue of localization insights!