Human Factors Consultancy for Medical Devices

Medical Device Human Factors Support

Medical devices are rarely used under perfect conditions. Users may be under time pressure, working in unfamiliar environments, dealing with physical limitations or relying on instructions they have only briefly reviewed.

Human factors engineering examines the relationship between the user, the device interface and the intended use environment. The purpose is to understand where interactions may lead to confusion, difficulty, close calls or use errors.

THAY Medical provides support across the human factors lifecycle, including:

• Human factors strategy

• User and use-environment research

• Use-related risk analysis

• Formative usability studies

• Human factors validation studies

• Comparative usability studies

• Instructions for use evaluations

• Participant recruitment

• Protocol and moderator-guide development

• Root-cause analysis

• Human factors reporting

• Regulatory submission support

We adapt the programme to the product, its development stage and the evidence already available.

Human Factors Strategy

A clear human factors strategy helps manufacturers identify what research is required, when it should take place and how each activity contributes to the wider development and regulatory programme.

We review the device, intended users, use environments, known risks, existing research and planned submission route. From there, we can help define an appropriate sequence of activities.

Starting early allows usability issues to be investigated while meaningful changes can still be made. It can also reduce the risk of discovering late in development that critical tasks, user groups or use scenarios have not been evaluated adequately.

Formative Human Factors Studies

Formative studies are used to investigate how users understand and interact with a developing product.

These studies may evaluate early concepts, prototypes, device interfaces, software workflows, packaging, training materials or instructions for use.

Rather than simply recording whether a task was completed, we investigate how the participant approached it, where uncertainty arose and what contributed to any difficulty.

The findings can help development teams refine the product before the design is finalised.

Human Factors Validation Studies

A human factors validation study evaluates whether the final device and associated materials can be used safely and effectively by representative intended users under realistic conditions.

The study should reflect the relevant user groups, critical tasks and use environments. It must also be conducted in a way that avoids coaching participants or introducing conditions that would not exist during real-world use.

THAY Medical can support validation-study planning, protocol development, participant recruitment, study execution, data analysis and reporting.

Participant Recruitment

The quality of a human factors study depends heavily on recruiting participants who genuinely represent the intended users.

We recruit patients, caregivers, healthcare professionals and specialist user groups according to project-specific criteria.

Our recruitment work can include:

• Reviewing recruitment feasibility

• Developing screening criteria

• Creating screening questionnaires

• Identifying recruitment channels

• Screening prospective participants

• Scheduling and confirmation

• Attendance management

• Replacement and backup planning

Recruitment assumptions should be tested early. A criterion that appears straightforward in a protocol may make the required sample much harder to reach in practice.

Study Delivery and Reporting

Successful study delivery requires more than a sound protocol. Participant scheduling, site setup, device accountability, moderator consistency, study materials and documentation all need to be controlled carefully.

We manage the practical aspects of the study alongside the research methodology.

Following the study, we analyse observed behaviours, use difficulties, close calls and use errors. Root-cause investigation is used to understand why an event occurred and whether it may relate to the device design, labelling, training, user expectations or use environment.

Results are then presented in a clear report for development, quality and regulatory teams.