Medical devices
Guidelines for developing inclusive device usability studies that reflect the diversity of real-world end users and settings.
Inclusive device usability studies must mirror real-world diversity, spanning demographics, environments, accessibility needs, and varying levels of literacy, technology familiarity, and physical ability, to ensure safe, effective medical device use for all patients, clinicians, and caregivers.
August 12, 2025 - 3 min Read
Inclusive usability research begins with a clear, patient-centered mandate that prioritizes real-world variation over convenience. Researchers should map user groups beyond traditional age and gender categories, incorporating socio-economic status, language, culture, disability type, and caregiving roles. Ethical planning ensures informed consent is accessible to diverse literacy levels and languages, while attention to power dynamics between researchers and participants fosters genuine voices. The study design must anticipate setting variability, such as busy clinics, home environments, or rural clinics with limited connectivity. By documenting these factors in preregistration, investigators create a transparent baseline for interpreting usability outcomes and identifying which user segments require prioritized design improvements.
Early stakeholder engagement is essential to align study goals with patient and clinician priorities. Collaborative advisory boards should include patients with mobility impairments, sensory losses, cognitive differences, and low-literacy backgrounds, as well as frontline healthcare workers who operate devices under time pressure. Co-creation sessions help translate clinical objectives into user-centric tasks, avoiding assumptions about how devices are used. Researchers should solicit feedback on terminology, aesthetics, and ergonomic considerations that influence comfort and adherence. Engaging diverse communities from the outset reduces bias, strengthens trust, and yields actionable insights about barriers and facilitators across settings, improving generalizability without compromising scientific rigor.
Structured inclusion strategies ensure broader, fair representation.
When selecting sites, researchers should deliberately include urban clinics, rural health posts, home care environments, and telemedicine workflows to capture the broad spectrum of end-user contexts. Site selection decisions must consider infrastructure availability, such as Wi-Fi reliability, electrical stability, and space constraints that affect device handling. Recruiting strategies should adapt to local norms and barriers, including stigma, distrust, or historical underrepresentation. In parallel, observer roles and data collection methods must be attuned to cultural expectations around modesty, privacy, and interpersonal dynamics. Collecting contextual notes and environmental metrics alongside task performance provides richer interpretation of usability findings.
Task design must reflect realistic activities rather than idealized procedures. Scenarios should account for varying literacy, language proficiency, and numeracy, employing plain language prompts and multilingual support. To counter bias, researchers should pilot test tasks with diverse participants, refining instructions to be universally understandable without diluting scientific rigor. Data captured should extend beyond success rates to cognitive load, time pressure, error management, and frustration signals, recognizing that some users may complete tasks differently yet safely. Finally, consent and debriefing processes must honor participants’ comfort levels, with options for pause, withdrawal, or caregiver assistance where appropriate.
Ethical frameworks guide inclusive study conduct and outcomes.
A robust recruitment plan requires explicit inclusion targets linked to real-world population proportions, with flexibility to adjust for local demographics. Screening procedures must be accessible and respectful, offering materials in multiple formats and languages. Researchers should monitor enrollment to prevent over- or underrepresentation of subgroups, deploying outreach partners from community organizations to reach marginalized populations. Compensation and scheduling should consider participants’ caregiving duties, employment, and transportation limitations, ensuring barriers to participation are minimized. Throughout recruitment, emphasis on transparency about study aims and potential benefits enhances trust and reduces skepticism toward medical research.
During data collection, multimodal methods capture diverse expressions of usability. Think-aloud protocols can be adapted to suit participants who prefer non-verbal feedback, while structured interviews and rapid ethnography reveal subtle interactions with devices in context. Accessibility accommodations, such as screen-reader compatibility, high-contrast interfaces, captioning, and physical supports, must be integrated from the outset. Researchers should also be alert to social desirability bias, creating confidential spaces for candid feedback. Regular debriefs with participants enable timely adjustments to procedures, which preserves data integrity and reinforces participant respect.
Results reporting should emphasize practical implications for all users.
Informed consent processes should be accessible and meaningful. Plain language summaries, teach-back confirmations, and multilingual options support genuine understanding. For participants with cognitive or sensory impairments, surrogate consent or extended discussions may be necessary, always with independent oversight. Data governance practices must protect privacy, especially when video or biometric data are collected. Storage, access, and sharing policies should be transparent, with de-identification protocols that preserve analytic value while safeguarding confidentiality. Finally, the study’s risk-benefit calculus must reflect diverse risk tolerances, ensuring protections are proportional to participants’ lived experiences and contexts.
Research teams should reflect diversity to reduce bias and improve interpretation. Hiring practices that favor inclusive expertise—such as designers who specialize in accessible interfaces, sociologists, and community liaisons—enhance study quality. Training programs must address cultural humility, implicit bias, and inclusive communication techniques. Regular reflexivity sessions encourage investigators to examine how their backgrounds influence task framing, observation, and interpretation. Governance structures should include patient advocates in decision-making about protocol amendments, publication priorities, and dissemination plans. Demonstrating responsiveness to participant concerns reinforces ethical integrity and broadens the study’s potential impact.
Long-term impact hinges on sustainable, equitable design processes.
Analysis plans should predefine subgroup analyses that explore performance across device types, settings, and user characteristics. Mixed-methods approaches illuminate not only what users do but why they do it, providing richer explanations for observed difficulties or successes. Reports should present actionable design recommendations aligned with observed constraints, such as alternative grips, control placements, or audio cues for low-vision users. Visualization of findings must be accessible, with readable figures and plain-language summaries. By translating results into concrete design decisions, researchers bridge the gap between usability science and real-world product development.
Dissemination must reach diverse audiences beyond the academic sphere. Plain-language briefs, community forums, and translated materials ensure that patient populations, clinicians, regulators, and manufacturers can apply the findings. Open data practices—within privacy constraints—facilitate secondary analyses by other researchers and practitioners. Collaboration with manufacturers during the iteration phase accelerates improvements and shortens the feedback loop. Finally, post-market surveillance should incorporate inclusive usability indicators to track device performance in ongoing real-world use, enabling iterative refinement that expands safe adoption.
Embedding inclusive usability into the regulatory pathway requires early dialogue with oversight bodies. Clear documentation of participant diversity, study limitations, and context-specific interpretations supports regulator confidence that products address broad needs. Standardized reporting templates that include demographic and environmental variables improve comparability across devices and jurisdictions. In parallel, organizations should adopt inclusive budgeting, ensuring resources for iterative testing, translation, and accessibility accommodations are not treated as optional add-ons. Demonstrating measurable equity gains—such as increased adoption among underserved groups—helps justify the investment and motivates continued stakeholder engagement.
Finally, institutions must institutionalize accountability for inclusive practice. Policies should require ongoing training, mentorship programs, and periodic audits of participant representation. Leadership accountability, with metrics tied to user diversity outcomes, reinforces a culture that values lived experience as essential knowledge. Cross-disciplinary collaboration—engineering, human factors, ethics, and social science—ensures that devices meet real-world demands while remaining safe and effective. When usability research is truly inclusive, devices become more usable, more trusted, and more life-enhancing for everyone who relies on medical technology in daily life.
