What is life sciences localization?
What is the value of life sciences localization?
The importance of localization in life sciences is self-evident. With the advancement of globalization, an increasing number of life science companies face challenges in international markets.
Different countries and regions have significant differences in regulations, language, culture, and customs, posing great difficulties for companies.
The need for life sciences localization can be critical even within a single country. For instance, in the United States alone, at least 60 million people don’t speak English at home. Among this population, an estimated 25 million people have limited English proficiency.
Furthermore, medical errors are among the leading causes of death in the U.S. The most significant errors occur in diagnosis, prescription, and the utilization of medical drugs. Some studies show that up to 80% of these errors are preventable.
Given the critical role of language in delivering effective healthcare, it is evident that language barriers play a crucial role in these circumstances.
Localization also ensures compliance with various regulations in different countries and regions, avoiding legal issues and risks. It enhances the company’s brand image and reputation, establishing trust and loyalty in the local market. Localization serves as a foundation and support for companies to expand into global markets, creating more business opportunities and profits.
Big pharma and localization
Drug trials come hand in hand with a long suit of documents, and depending on the region, the requirements will change.
In this field, localization involves translating clinical study reports, research plans, patient consent forms, medical records, patient information, labels, etc. And it requires considering factors such as drug naming conventions, drug interactions, etc., ensuring that the translated content matches the culture and medical system of the target audience.
If a pharmaceutical company starts a clinical trial in the U.S. and plans to expand it in E.U. countries. They must translate clinical trial documents into (many) E.U. languages to communicate with local research institutions, regulators, and patients.
Medical devices and localization
Localizing medical devices involves translating and adapting user manuals, product labels, technical specifications, and other related documents.
Countries and regions have different regulatory requirements and standards for medical devices and need corresponding translation and adaptation. For instance, in the U.S., the main regulatory body is the FDA, while in the E.U., manufacturers must contend with the relatively new MDR.
These differences require considering factors such as regulations, units and measurements, product labeling, and safety warnings specific to the target market to ensure that the translated content complies with local rules and usage requirements.
For example, when an Asian medical device manufacturer introduces their cardiac pacemaker into the European and American markets, they undertake comprehensive localization translation efforts to successfully promote the product. During the actual translation process, important information such as the product manual, product labels, warning signs, and user guides of the cardiac pacemaker are localized to ensure that European and American patients and healthcare professionals can understand the product’s usage, functionality, and safety precautions.
It is crucial to understand and comply with the local regulations of each country and region regarding medical devices, ensuring that the translated content meets legal requirements and remains consistent with the local regulatory texts.
Life Sciences Localization's 5 Challenges
The life sciences industry faces five significant challenges in localization: dealing with increasingly complex and varied documentation, managing the tightening regulatory landscape, keeping costs down and addressing language diversity in patient populations.
These issues intertwine, creating a complex landscape that requires innovative, comprehensive solutions.1. Document complexity
Life sciences localization is a complex task. It requires translators who are more than just linguistically proficient. They should possess a deep understanding of scientific domains. Precision is vital in this field, as translators must adhere to stringent guidelines to align with industry standards.
At times, translators alone might not be enough. The involvement of medical professionals is often necessary to ensure the use of up-to-date terminology. As discussed in the previous sections, failing to tackle this complexity accurately can have disastrous consequences. Moreover, the challenge grows when dealing with terms named after individuals, such as certain medical conditions or procedures (Asperger’s syndrome, Crohn’s disease, Down syndrome, etc.). It’s not merely a matter of direct translation but also grasping the context of the original term. This aspect further underscores the need for experienced, knowledgeable translators in life sciences.
Choosing a language service provider with relevant certifications is a critical decision. An ISO 17100 certification is generally suitable for most projects; we encourage you to seek providers with an ISO 13485 certification. Although not a requirement, it indicates the company’s commitment to the industry. It is a good sign that they have the resources to tackle even the most challenging project.
2. The scope
Life science industry documentation can span a diverse spectrum, adding to the complexity of the translation process. These documents can be grouped into a few categories: patient-centric documents, medication guides, medical device manuals, and research documentation.
Patient-centric documents
This group consists of documents related to patient care, such as billing statements, privacy policies, insurance details, consent forms, and medical records. The primary objective is to ensure that the patient understands the information and contributes to their care process.
Of course, some documents from the categories below may also be patient-centric, either as is or slightly modified.
Medication guides
This category is centered around documents that facilitate medication administration, including package inserts, patient information leaflets, and even prescriptions when appropriate. While the information could be technical for medical professionals, it must be accessible to the average patient as well.
Medical device manuals
Medical devices range from simple tools to incredibly complex ones like the da Vinci Surgical System. However, regardless of its complexity, each device must be accompanied by an understandable manual detailing its assembly and usage.
Furthermore, these manuals require translators with different backgrounds. A translator adept in pharmacological terminology will struggle with the documentation of an advanced prosthetic.
Research documentation
Last but not least, this category includes any documentation that must be submitted for clinical trials or publishing academic papers. From the forms submitted by the participants of a clinical trial, to the data submitted to a journal.
Lastly, clinical trials and academic papers come with unique documents. This includes forms completed by clinical trial participants and data submitted to scientific journals, which may require different translators.
Life science localization is not a one-size-fits-all field. Each category demands a specific understanding and expertise, accentuating the importance of specialized translators in this domain.
3. Compliance
In this industry, products and services must navigate a complex labyrinth of stringent regulations and compliance rules. These regulations aren’t static—they differ across geographical boundaries and evolve with time. Your life sciences localization team must keep up.
A prime example is the EU MDR. First instituted in 2017, it brought about tighter control over the medical industry, particularly impacting the manufacturing, distribution, and usage of medical devices. This has necessitated producing and translating new documents to align with its requirements. Translators working in this space need an in-depth understanding of these stipulations to ensure accurate translations that meet the regulatory requirements.
However, when the destination for a medical device is the US instead of the EU, the translators must also be well-versed in the FDA’s specific templates. Let alone if your goal is Chinese territory, then the NMPA’s rule must be religiously followed. Achieving this level of precision requires adopting rigorous processes and collaboration with experts in medical and legal domains.
4. Crippling costs
Navigating the vast landscape of life science localization can be a costly endeavor. Undeniably, the quality needed in healthcare, given its life-critical nature, can be pricey. Every penny counts in an industry already strained by the heavy financial weight of medical equipment and pharmaceuticals. Yet, compromising your translation budget could have disastrous consequences.
Luckily, specialized language service providers offer effective solutions to keep your budget in check. You can cut costs without sacrificing quality by employing automated translation for recurring text and harnessing translation memories. These reputable providers grant you access to comprehensive glossaries and translation databases, helping you cut down on costs over time.
The longer you collaborate with a language service provider, the more benefits you reap. With their extensive database, they can increasingly minimize your expenses. Indeed, our experience shows a potential savings of up to 40% for our long-standing partners.
5. National diversity
The need for multi-lingual medical documentation and interpretation intensifies as nations become more diverse. As we discussed before, the US alone is home to millions of non-English speakers requiring different linguistic services.
But it’s not just the US. In Canada, a significant portion of the populace, about 7.1 million, prefers to converse in French, their mother tongue. Among these, a subset, which includes Haitians, Belgians, Swiss, Lebanese, and Moroccans, use unique French dialects, adding another layer to the linguistic challenge.
In Nigeria, which boasts over 500 native languages, English is the common thread for 60 million of its 213 million citizens. Other widespread languages include Pidgin, a local English dialect, and Hausa, which is spoken by 31% of the population.
In France, the scenario is intriguing. While French is the primary language for most, approximately 55.81 million people, sizable linguistic communities exist. The number of non-French natives is around 8.5 million. Within this diverse group, the largest subgroup speaks Arabic (2.3 million), followed by Portuguese (960,000), Spanish (770,000), and Italian (640,000).
Considering that these trends are unlikely to shift in the opposite direction, the life science industry must keep up as best as possible and provide appropriate materials and healthcare services to its patients.
Key Takeaways
The intersection of technology, patient safety, and language diversity is a pivotal challenge and opportunity for the life sciences industry. As we have seen, patient safety remains a crucial concern in healthcare, with adverse events being one of the leading causes of death and disability worldwide. The role of communication and understanding in these events cannot be overstated, and language diversity, particularly in the context of the world’s ever-growing multicultural societies, adds another layer of complexity.
Meanwhile, the technological revolution in the industry, epitomized by innovations such as the da Vinci Surgical System, offers promising solutions for improving patient safety. These systems incorporate sophisticated design, simulation, and execution tools that can reduce human error and enhance the quality of care.
However, to fully capitalize on these advancements, it is essential to overcome the language barriers that can hinder their effective implementation and use. By recognizing and addressing these challenges, the industry can ensure that high-quality, safe, and accessible care becomes a global standard, regardless of the language spoken by the patient.
