It is not enough to simply write your medical device instructions and labels. To garner regulatory approval, you must ensure that your Instructions for Use (IFUs) and labels are readable and understandable, passing stringent usability testing standards.
Proper use of your device is vital to end-users’ success. Clear IFUs, proven and tested, reduce the capacity for user error. Well-written IFUs and labels, along with rigorous testing of those instructions in every language that they are offered, are integral to remaining in compliance with ongoing changes to international laws.
With over 6,500 languages spoken across the globe, it could be tempting to use a simple translation service, hoping this is a quick and sufficient way to localize vital documents for delivery to international markets. However, while technically making a document like an IFU readable, such services rarely go the extra step in making that same document understandable. This is especially true when your end-user is a general consumer instead of a technically proficient healthcare industry worker.
At CQ fluency, we deliver translation services that include cultural adaptation of your communications. This goes further than merely translating a document from one language to another. Words serve only as vehicles for ideas, which means that no matter how exhaustive or comprehensive a given document might be, that information may fail to reach the target if it is incompatible with the user’s ability to receive and process it.
Addressing and resolving linguistic barriers is just one part of the job any translation service must undertake. In many respects, cultural barriers to information exchange are even more challenging to overcome than linguistic barriers. To understand more about our usability and readability-compliant translations, as well as cultural adaptation services, we will provide an example product of a vaginal microbicide gel, a product that can protect against sexually transmitted infections, including HIV.
our usability and readability testing process at work
At CQ fluency, we are fluent in over 170 languages, and we work with over 2,500 certified in-country linguists. Translating medical device information can be a lengthy process, requiring all relevant instructions, guidelines, dosages, contraindications, etc., to be adapted and effectively tested for the localized market. Our experts have both cultural and subject matter expertise, ensuring your IFUs exceed your expectations in any language.
Readability tests have been required in the European Union for years, and reveal missing information, as well as vague language. A step that seems like standard protocol to a medical professional needs to be explicitly detailed when the end-user is a not a subject matter expert. Our rigorous process will reveal any gaps so regulatory approval is simple and the device’s use is as safe and effective as possible.
Readability testing also evaluates the reading level for the instructions. Language used, the complexity of the sentence structure, and other factors can create IFUs which are hard to comprehend. 45 million people in the United States read below a fifth-grade level. According to the National Assessment of Adult Literacy, approximately 50% of Americans cannot correctly read a prescription drug label. In terms of health literacy, 36% of Americans have basic or sub-basic health literacy skills. In Europe, 1 in 2 citizens report low levels of health literacy with a big knowledge gap between countries. Varying factors contribute to someone’s level of health literacy, but vulnerable groups with low health literacy are at higher risk for poor health outcomes.
Properly labeled diagrams, along with clear, plain language and exhaustive step-by-step instructions, help to close the gap on medical device IFU comprehension. Governmental regulations require companies to hit this mark, and CQ fluency is here to make sure your users understand every point of your IFU.
Additionally, coordinating the appropriate interviews is crucial to verifying readability of IFUs. Readability in this case is measured by interviewing patients and/or their caregivers on their ability to understand key concepts in the text. CQ fluency appoints specialists for the pilot testing to prepare and administer the interview questions. The results are then summarized/quantified with recommendations on how to re-phrase or modify the language.
By covering these bases through robust verification processes, we generate a holistic measure of how the readability of IFUs perform in a real-world context. This lays the groundwork for a device with which end-users find success.
how cultural adaptation reduces confusion
A strictly literal translation is not the only challenge medical companies face when adapting their IFU for other languages and markets.
This information we’ve discussed is comprehensive and often lengthy, especially for medical supplies like surgical suite equipment. Our previous example microbicide gel is significantly less demanding in this regard.
Instructions for applying the gel are straightforward and can be formulated using simple language or diagrams. One might think that simple ‘localization’ of this information would be sufficient. However, real-world researchers in Ghana encountered unexpected questions from study participants when conducting clinical trials on this same product. Chief among those questions was whether application of the product before intercourse would diminish sexual pleasure for involved parties.
This information was not initially thought necessary to include in the initial presentation to the study’s participants, but at CQ fluency, this is the sort of cultural difference we anticipate. This oversight was a natural consequence of the study taking place in a primarily patriarchal society, a difference we will help you identify. We can provide suggestions like including the information requested by Ghanian participants at the outset. In a case where this factor had not been anticipated, it would have been identified early in our readability and usability testing process.
Considering the most effective medium to communicate information is vital to ensuring it reaches the consumer in a format they can understand. In the case of our microbicidal gel example, a simple paper insert with printed instructions, contraindications, and even a few visual diagrams for applying the product would be prudent. A short video presentation might even be helpful. But what if the target market is a majority Muslim country? At CQ fluency, we account for Islamic concepts of modesty and other religious factors, incorporating them into the presentation to ensure the consumer optimally receives it. It is critical to remove as many obstacles as possible in the path of the information to its intended recipient, and many of those obstacles are cultural as well as linguistic.
the bottom line
A combination of shifting cultural demographics in countries such as the USA, and low literacy (including health literacy) requires tailored communication. To ensure IFUs and other materials are linguistically and culturally digestible, implementing strong readability and usability testing is vital.
Companies are looking to not only stay ahead of the regulatory curve but are also concerned with ensuring their products are properly utilized. The most proactive companies are racing to incorporate cultural adaptation into their development process for critical documents like IFUs. Forward-thinking companies view our service as both an extension of customer service and an extra layer of liability protection. They know that as the globe continues to shrink due to ever-increasing international commerce, providing culturally adapted documentation is not only the financially responsible choice; it’s also the ethical one.
questions? we’re eager to answer!
CQ fluency goes beyond simply translating. We recognize cultural obstacles to communication We partner with producers to connect with their customers by developing messaging that truly resonates, and together with our expert pool of clinicians and regulatory experts help our clients anticipate problems long before they impact the bottom line, and meet highly regulated requirements.
Ideally, CQ fluency is engaged early on in your planning. We perform a translatability assessment on patient-facing instruments before they are final. This is to ensure that future translations can all be conceptually and linguistically equivalent while also being culturally and linguistically appropriate for your target markets. This prevents any future issues in pooling and comparing equivalent data for statistical purposes
Our holistic approach includes a review of culture cues such as tone, images, gender implications, food, humor, sequence, acronym, idioms and descriptions of medical terms that don’t exist in target languages. We also prepare our subject matter expert linguistic teams on what to look out for and provide the rationale. This helps eliminate unintentional ambiguities or unnecessary complexity.
Contact us for more real-life examples of our comprehensive process in action.