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 it 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.