Is it for you?

Learn how to apply user-centered design and UX throughout the design process to make medical technology safe, effective, usable, and satisfying for clinicians and patients. Improve the quality of healthcare and prevent injuries and deaths due to medical error.

The training is for everyone involved in improving the usability or user experience of medical device products and/or software. UX designers, product managers, software developers,  user acceptance testers, including those with no prior medical device experience. will benefit from learning this proven process.

What will you learn?

  • Intensive and comprehensive discussion of FDA pre-market perspective, precedents & priorities for every topic presented in the course.
  • How the FDA Guidance, “Applying Human Factors and Usability Engineering to Medical Devices” and IEC 62366-1 applies to your submission to the FDA.
  • HF Testing, test theory and test data, test processes, protocol development and summary reports.
  • Analysis of use-related risks and considerations of ISO 14971.
  • “How-to” identify critical user tasks and develop a Use-related Risk Analysis (URRA) from scratch that will be acceptable upon review.
  • In-class Formative testing, theory and practice using a sample medical device with IFU.
  • Group projects beginning with overall HF evaluation plan, identification of users, user groups, use environments, user tasks, task criticality, URRA, formative testing, simulated-use based HF/Usability (Summative) validation testing, data collection, analysis and evaluation of test data, and HF test report.
  • How to avoid vagueness and incompleteness in your submission

Course objectives

  • Define the role of human factors in the medical device design process
  • Understand appropriate human factors methodologies for the development of medical devices
  • Identify human factors standards relevant to medical device development
  • Review human factors documentation against the standards and process
  • Discuss human factors engineering requirements
  • Identify usability issues related to product design

Course curriculum

    1. How to use this course

    2. Before we begin...

    1. What is Human Factors Engineer / Usability Engineering

    2. FDA Human Factors Guidance

    3. FDA Common Review Concerns

    4. Applicable Standards, Regulations, and Guidance Documents

    1. IEC 62366-1 Process Summary

    2. Normal Use, Correct Use, Use Error, and Abnormal Use

    3. Usability Engineering and ISO 14971 Risk Management

    4. Use Specification, FDA

    5. Use Specification, Class Discussion

    6. Use Specification, IEC 62366-1 Summary

    7. Use Specification, IEC 62366-1 Terms

    8. Intended User Profile Example

    9. Operating Principle and Use Environment

    10. Use Environment Example

    11. Developing the Use Specification

    1. Preliminary Analyses and Evaluations

    2. Widely Used Usability Engineering Techniques

    3. Use FMEA and FTA

    4. Analysis and Evaluations Method Introduction

    5. Identify Problems Known to Exist

    6. Task Analysis

    7. Expert Review

    8. Heuristic Analysis

    9. Contextual Inquiry

    10. Interviews

    11. Formative Evaluations

    12. Risk - Class Discussion

    1. Use Scenarios

    2. ISO 14971 and Usability

    3. ISO 14971, Examples of Hazards and Sequence of Events

    4. Combining Task Analysis with Use Error Analysis

    5. PCA Framework

    6. Risk Control Approaches

    7. Elimination or Reduction of Use-related Hazards

    8. Use-related Hazards Class Discussion

    1. Types of Usability Evaluations

    2. Formative Evaluations

    3. Formative User Interface Evaluation Plan and Evaluation Protocol Example

    4. Cognitive Walkthrough and Analysis of Formative Results

    5. Summative Evaluations

    6. Summative User Interface Evaluation Plan and Evaluation Protocol Example

    7. Summative Evaluations, Sample Size and Re-Validations

    8. Summative Plan Class Discussion

About this course

  • $595.00
  • 63 lessons
  • 12 hours of video content
  • 9 editable templates
  • 90-day access to course

Human Factors and Usability Engineering in Medical Device Development