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Human Factors

We provide comprehensive human factors consulting and testing services for medical device, pharmaceutical, biotechnology, diagnostics, and digital health organizations.

We partner with companies developing new medical devices, drug delivery systems, diagnostics solutions, and digital health platforms. Our deep understanding of regulatory requirements and international standards for human factors combined with the principles of human-centered design enables us to help clients create products that meet user needs and safety and performance standards.

As one of the largest and most trusted partners in the healthcare industry, our dedicated human factors teams in the USA, UK and China provide bespoke services that meet your needs. We are excited to help you increase the pace and quality of product innovation and gain an edge on your competition.

End-to-End Human Factors Services

  • Human Factors Documentation
  • Formative Evaluations
  • Validation (Summative) Testing
  • Labeling & Instructional Design

Human Factors Documentation

We conduct a deep analysis of your product, intended use, and users to develop the human factors documentation needed to align with international standards and regulatory guidance.

Whether you need a gap analysis of your existing documentation or support with your entire usability engineering file, our team can help ensure your human factors documentation is compliant with international standards and regulatory guidance. We take an in-depth approach to assess and define your intended users, environment, use-related risk, and critical tasks to quickly rationalize the design of your usability studies. 

Services:

  • Usability Plan
  • Gap Analysis (in relation to international standards and regulatory guidance)
  • Use Specification
  • Identification of Known Use-Related Problems
  • Task Analysis
  • Hazard Analysis
  • Risk Analysis (URRA)

Formative Evaluations

Formative evaluations are critical to assessing safety and risk and identifying opportunities to improve usability through design.

We design and execute formative evaluations, leveraging research methodologies tailored to the product, stage of development, your learning objectives, and budget. We employ a range of methods, testing formats and degrees of analysis to help you identify usability issues and verify user needs. Our world-class design teams provide tangible solutions to mitigate risk and optimize all aspects of design including instructional materials and labeling. 

Services:

  • Protocol Design
  • IRB Management
  • Participant Recruitment & Scheduling
  • Test Facilities & Environment Simulation
  • Study Moderation
  • Data Analysis & Reporting
  • Actionable Design Recommendations

Formative Evaluation Methodologies:

  • Heuristic Evaluation
  • Expert Review
  • Cognitive Walkthrough
  • Comparative Analysis
  • Competitive Analysis
  • Usability Benchmark Testing
  • Cognitive & Perceptual Capability Analysis
  • Environmental Assessment
  • Anthropometric Assessment
  • User Preference & Acceptability
  • Non-Critical & Critical Task Evaluations
  • Pre-Validation (Summative) Testing

Validation/Summative Testing

Validation/summative testing allows us to gather evidence that demonstrates to international regulators that a product can be used safely and effectively by its intended users for its intended purpose.

We design and execute studies according to international standards and applicable regulatory guidance. Leveraging our team means you inherit our strong reputation with FDA, MHRA, EMA and other international regulators due to the quality of our testing procedures, study design, moderation, data analysis and reporting. 

We can also support residual risk analysis and develop the summary report (HFE/UE Report or Usability Engineering File (UEF)) for your regulatory submission. 

Services:

  • Protocol Design
  • IRB Management
  • Participant Recruitment & Scheduling
  • Test Facilities & Environment Simulation
  • Study Moderation
  • Data Analysis & Reporting
  • Residual Risk Analysis
  • Summary HFE/UE Report or Usability Engineering File (UEF)

Study Methodologies:

  • Validation/Summative Testing 
  • Supplemental Validation/Summative Testing 
  • Remediation Testing 
  • Comparative Use Studies 

Labeling & Instructional Design

We design high-quality labeling and instructional materials that effectively guide users and mitigate risk. 

An important aspect of your product’s risk mitigation strategy is its associated training, labeling and instructional materials. Our integrated team of human factors engineers and designers creates high fidelity instructions for use (IFU), quick reference guides (QRG), user manuals and design effective packaging and product labeling. 

Services:

  • Instructions for Use (IFU)
  • Quick Reference Guide (QRG)
  • User Manual
  • Packaging
  • On-Product Labeling
  • Training Program Development (Presentations, In-service checklists, digital aids, etc.) 

Looking for regulatory affairs and quality management services?

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Standards, Guidance, and Compliance with Regulatory Agencies

We follow international standards and are experts on the details and nuances of global HF regulatory requirements. 

International Standards & Regulatory Guidance

  • ANSI/AAMI/IEC 62366-1
  • ANSI/AAMI/IEC HE75
  • IEC 60601-1-6
  • IEC 60601-1-8
  • IEC 60601-1-11
  • IEC 82079-1
  • EN ISO 14971
  • FDA Guidance
  • EU MDR
  • EU IVDR
  • EU IVDD
  • China NMPA HF Draft Guidance

Agencies

  • FDA

  • EMA

  • MHRA

  • Notified Body (NB)

  • NMPA

  • PDMA

  • FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices, Feb 3rd, 2016.

  • FDA Guidance: Recommendations for Clinical Laboratory Improvement Amendments of 1988, Feb 26, 2020.