In an increasingly patient-centered world, regulatory agencies like the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and others globally are placing greater emphasis on how information is communicated to patients. Whether it’s clinical trial documents, drug instructions, or digital health tools, usability is no longer optional—it is a regulatory and ethical imperative.
Patients today are more involved in their care than ever before. However, medical jargon, overly complex instructions, or poorly designed interfaces can create critical gaps in understanding. These gaps can lead to medication errors, protocol non-compliance, or disengagement from trials. Regulatory bodies are recognizing this and incorporating usability as a cornerstone of compliance and patient safety.
The EMA highlights the importance of health literacy in its guidance documents, particularly when it comes to patient information leaflets (PILs) and informed consent forms. Usability testing with real patients is not only recommended but often required. Methods such as structured user interviews, comprehension tests, and iterative prototyping are encouraged to ensure that content is both readable and actionable.
The EU’s Clinical Trial Regulation (CTR) also emphasizes the importance of clear, accessible information for patients, placing greater onus on sponsors to prove that materials are fit for purpose before trial initiation.
The FDA’s Center for Devices and Radiological Health (CDRH) has long acknowledged usability as a safety issue. Human Factors Engineering (HFE) is now a standard requirement in the development of combination products, medical devices, and digital health tools. FDA guidelines specifically call for summative and formative usability testing, with validation studies required to ensure that intended users can use the device safely and effectively under expected conditions.
For pharmaceutical and biotech sponsors, this has implications not only for labelling and packaging but also for eConsent forms, recruitment materials, and digital interfaces.
Beyond the EMA and FDA, countries such as Canada, Australia, and Japan are also tightening standards around user comprehension and digital accessibility. The ISO 62366 standard for the application of usability engineering to medical devices is increasingly recognized across borders. This global movement indicates a broader shift from regulatory "box-ticking" to truly patient-first design thinking.
Sponsors need to anticipate usability testing at multiple points in the development cycle—early in design, pre-submission, and even post-market. This means budgeting for usability services, integrating them into timelines, and working with partners who understand both design and regulatory expectations.
At Clynn Health, we specialize in bridging that gap. We work with life sciences organizations to ensure their patient-facing and regulatory documents are not just compliant, but effective and empathetic. Our user testing methodologies are aligned with global regulatory frameworks, helping clients derisk submissions and enhance patient outcomes.
In a globalized clinical landscape, language can no longer be an afterthought. With clinical trials expanding into diverse regions and medical devices reaching multilingual populations, the clarity of communication is as important as the science behind it. At Clynn Health, we champion multilingual usability testing to ensure that every participant — regardless of language or literacy level — can understand, engage, and act safely.
Traditional translations often fall short when tested against real-world patient understanding. A perfectly translated informed consent form may still confuse patients if idiomatic expressions, regional differences, or health literacy challenges aren’t addressed. Informed consent, recruitment flyers, eDiaries, and digital platforms must not only be linguistically accurate but also culturally relevant and functionally usable in every market.
Without multilingual usability validation, sponsors risk:
Delays in ethics approval or regulatory submissions
High dropout rates due to misunderstanding
Patient safety incidents caused by misuse or misinterpretation
Non-compliance with regional regulatory requirements
Our process goes far beyond standard back-translation or proofreading. We offer:
Localized User Testing: We engage native speakers from your trial regions to test translated materials in real-life contexts — ensuring your message is not just readable but actionable.
Cultural Validation: We examine tone, metaphors, design layout, and even iconography to adapt content for local norms and cultural expectations.
Cross-Language Comparative Analysis: We assess whether users in different regions derive the same understanding from the translated versions as from the original, ensuring consistency and fairness.
Digital Platform Localization Testing: For eConsent, mobile apps, or wearable device interfaces, we test user interaction across languages, accounting for screen fit, flow logic, and user behavior differences.
Both the EMA and FDA emphasize clarity and comprehension in patient-facing materials. Regulatory authorities in Asia-Pacific and Latin America are increasingly scrutinizing translated documents for usability and accuracy. Health Canada and the TGA (Australia) now expect documentation that accommodates minority languages and Indigenous populations.
Failing to adapt documents for multilingual contexts is not just a communication issue — it’s a compliance risk.
Multilingual usability is not just a regulatory checkbox — it’s a marker of respect. When trial participants or device users see that materials are written for them, in their language, and reflect their culture, trust increases. So does engagement. This leads to higher retention, lower risk, and a stronger ethical position.
Whether you're preparing trial documents in Hindi, Swahili, Japanese, or Brazilian Portuguese, Clynn Health ensures that every version of your material is optimized for comprehension, accessibility, and regulatory success.
Because in health communication, how you say it is just as important as what you say.
When clinical trials or medical technologies expand globally, it might seem logical to simply translate patient-facing materials into local languages. After all, translation is fast, scalable, and cost-efficient. But here’s the problem: translation alone is not enough. In health and clinical research, clarity isn't just desirable — it’s critical for safety, ethics, and compliance.
At Clynn Health, we believe translation is just the first step. Usability testing is what makes language work for people.
Translation converts words from one language to another. But understanding comes from how people interpret those words, within their cultural, social, and emotional context. For example, a consent form translated from English to Mandarin may use accurate vocabulary, but it may still confuse users because of unfamiliar medical analogies or overly technical phrasing.
Imagine asking an elderly rural patient in Brazil to interpret an app that says, “Select the dropdown to submit your adverse event.” If the interface and language aren’t tested for usability, you might get blank stares — or worse, incorrect data.
Usability testing ensures your translated documents and digital tools are:
Clear: Does the participant understand what’s being asked?
Actionable: Can they take the right steps after reading?
Culturally Sensitive: Are examples, visuals, or metaphors appropriate for the region?
Safe: Does the information prevent error, misuse, or misunderstanding?
Cognitive debriefing, user interviews, and comprehension assessments uncover gaps that literal translations never catch. A poorly worded diary question could lead to a missed symptom. A confusing interface could delay reporting of a side effect. Usability testing prevents these risks.
Agencies like the EMA, FDA, and MHRA increasingly expect that patient-facing content be both comprehensible and usable — not just correctly translated. FDA guidance on eConsent and the EMA’s focus on informed decision-making emphasize user understanding across all languages.
A translated document that fails to communicate effectively may lead to:
Ethics committee rejection
Delays in patient recruitment
Patient withdrawal or protocol deviation
Post-approval audit findings
In other words: translation without usability can cost you.
One Clynn Health client translated a pediatric trial guide into five languages. But parents still didn’t understand dosing instructions — until we conducted localized usability sessions. The revised layout and plain-language rewrite reduced confusion by 87%. This saved the sponsor weeks in re-submissions.
In consumer products, translation failures might cost a sale. In healthcare, they can lead to misdiagnosis, poor adherence, or trial failure.
That’s why usability testing isn’t a luxury — it’s a critical quality and compliance safeguard.
We combine linguistic expertise, behavioral testing, cultural nuance, and regulatory alignment to ensure that your message is understood, not just translated. Because people don’t just read your materials — they live with them.
Why not just translate? Because clarity can save lives.