Human Factors Engineering & Human Factors Regulatory Strategy

Kymanox® Human Factors, is one of the largest Human Factors teams in the industry.

At Kymanox®, we recognize that Human Factors Engineering (HFE) is more than just a regulatory exercise. Our comprehensive HFE services seamlessly integrate regulatory compliance with a deep commitment to enhancing user experiences and improving healthcare outcomes. From concept to post-market, we prioritize understanding user needs, behaviors, and environments to create solutions that empower users and minimize the risk of errors.

We are led by former FDA Human Factors leaders from both CDER and CDRH.

Deep Expertise

Capabilities Across the Product Development Lifecycle

Kymanox champions HFE/Usability Engineering (UE) principles throughout the development process to create innovative solutions.

Research
  • User Needs Translate to Product Requirements
  • Instructional Labeling Design
  • Prototype Concept/UI Design
  • Risk Management Planning
  • Human Factors Planning
  • Regulatory Strategy
  • Multimedia Labeling & Instructional Design
  • Prototype Concept
  • Risk Management Research
  • Risk Management Planning
  • Generative & Formative Methodologies
  • Regulatory Strategy
  • Recruitment Management
  • IRB Submission
  • Human Factors Studies
  • Regulatory Strategy
  • Risk Control Effectiveness
  • ISD Studies
  • HFE/UE Report
  • Regulatory Guidance
  • Lifecycle Management
  • Post Market Approval Studies
  • Change Management Impact Assets
  • Complete Human Factors Services

    The Kymanox® Human Factors Engineering (HFE) team ensures compliance with relevant regulations, standards, and guidance in usability engineering. Our approach follows established processes, such as IEC 62366 for usability engineering, ISO 13485 for Quality Management System alignment, ISO 14971 for risk management, and 21 CFR 820.30 for design controls.
    01

    Regulatory Strategy and Consulting

    Kymanox staff have extensive experience at the FDA, so we can provide guidance and support to conform to current industry practices, standards, and FDA regulations.
    02

    Human Factors Engineering and Consulting

    Our team leverages the extensive expertise within Kymanox to deliver an integrated approach for your product development strategies and programs including Quality, Regulatory, Engineering, and Validation.
    03

    Instructional Labeling and Training

    Kymanox uses evidence-based methods to analyze user skill and performance requirements and provide an array of services for Instructions for Use and product training.
    04

    Human Factors Study Execution

    HF Study Execution Including Formative Research, Formative and Validation Usability Studies, Actual Use Studies, Self-Selection Studies, Threshold Analyses, Comparative Use Studies, and Non-inferiority Studies, Human Usability Studies (diagnostics)

    Voice of the Customer

    "They understand my needs."
    DIRECTOR OF VALIDATION
    PHARMACEUTICAL COMPANY
    "The team at Kymanox are well-rounded and can help in a variety of areas. From the Human Factors standpoint, they are one of the only companies with direct agency knowledge - that’s invaluable."
    HUMAN FACTORS ENGINEER
    PHARMACEUTICAL COMPANY
    "It’s not very common to get that level of expertise from the other consulting companies."
    HEAD OF HUMAN FACTORS AND DEVICE STRATEGIC OPERATIONS
    GLOBAL BIOTECHNOLOGY COMPANY