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Human Factors Analyses for Medical Device Teams

Human factors analysis support for medical device teams evaluating workflows, use-related risks, known use problems, and product usability earlier in development.

Loring Human Factors provides human factors analyses that help teams better understand how a product will be used, where use-related risks may emerge, and what design decisions need closer attention.

Our work includes task analysis, workflow mapping, use-related risk analysis, and expert review. These analyses help teams define critical tasks, identify known use problems, and build stronger foundations for design, validation, and regulatory planning.

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How LHF Helps

Practical analysis support across workflows, risk, and product evaluation.

Task Analysis

Breaking down user tasks to understand sequence, logic, and critical interactions.

Workflow Mapping

Mapping how steps, transitions, and decisions unfold during product use.

 

Risk Analysis

Identifying use-related hazards and areas that may affect safe, effective use.

Expert Review

Evaluating products and materials based on known usability principles and use problems.

Gap Analysis

Reviewing what is in place and where additional work may be needed.

Known Use Problems Research

Looking at known use problems from similar or predicate products to inform decisions.

Core Analysis Areas

Analysis methods selected based on product type, use context, and development needs.

Task Analysis

Analysis focused on how users move through tasks, steps, and decisions during product use.

  • Behavioral task analysis

  • Cognitive task analysis

  • Hierarchical task analysis

  • Workflow mapping

Risk Analysis

Analysis used to identify use-related hazards, potential failures, and areas of elevated risk.

  • Use-related hazards and risk analysis (URRA)

  • Use failure mode and effects analysis (uFMEA)

  • Fault tree analysis

Product Review

Analysis that evaluates product usability, known problem areas, and opportunities for improvement.

  • Heuristic analysis

  • Expert review

  • Gap analysis

  • Known use problems research

Built Around Safer Product Use

Strong analysis work helps teams understand more than what happened in a study. It helps them understand why problems may occur, what patterns matter most, and where design decisions need closer attention.

LHF uses human factors analyses to help teams make more informed product decisions, reduce avoidable risk, and build a clearer path toward safer, more effective use.

HF Analysis
Human Factors Analysis
Need support with HF/UE regulatory strategy?
We help medical device teams navigate submission expectations, strengthen documentation, and build a clearer human factors path forward.
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