THE USABILITY OF MEDICAL DEVICES
Human Factors and the Usability of Medical Devices
Founded in the early part of the 21st Century, The Moon on a Stick is company specialising in the training of Human Factors practitioners for the global medical device industry. Through our courses we help everyone involved in the design, development, marketing and selling of medical devices to the Human Factors testing requirements of the Food and Drug Administration (FDA).
Since 2014 we have been running 3-day courses covering FDA compliant human factors approaches for achieving safe and effective use of medical devices, medical apps and drug-device combination products, including the essential and effective implementation of use-risk analyses, evaluation and design processes.
The course offers you the unique chance to learn directly from the designer of the initial and on-going Human Factors review process at the FDA , and one of the World’s leading consultants in HF in Medical Devices.
With the experience of over 1000 new device reviews at the FDA and 1000’s of industry applications under their belts, you will learn what the assessor is looking for and how to construct your approach and submission strategy to ensure success.
For someone practiced in HF, but new to medical devices, this was exactly the course and content I needed to understand my new industry
Why Choose These Human Factors Training Courses?
# Intensive discussion of FDA perspective, precedents & priorities to ensure successful HF submissions.
# What the FDA Guidance, “Applying Human Factors. Etc” says about the HF review process priorities and how this applies to your submission to the FDA.
# How to interpret and understand, and respond to FDA feedback on pre-submissions including “Type C” meetings, deficiencies and disagreements.
# HF Testing, test theory and test data, test processes, protocol development and considerations of test bias.
# Analysis of use-related risks, considerations of IEC-14971 and associated FDA review expectations.
# “How-to” identify critical user tasks, and develop a Use-related Risk Analysis (URRA) from scratch that will be acceptable upon review and prevent unpleasant surprises when your HF submission is reviewed. .
# Special considerations of review expectations of CDER draft guidance for industry: “Human Factors Studies & Related Clinical Study … etc” and “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug- Device Combination Product Submitted in an ANDA”
# Formative testing, theory and practice with a sample medical device with IFU.
# Group projects beginning with overall HF evaluation plan, identification of users, user groups, user tasks, task criticality, URRA, formative testing, simulated use-based HF/U (Summative) validation testing, data collection, analysis and evaluation of test data, and HF test report.
# How to avoid vagueness and incompleteness in your submission.
CONTACT US TO DISCUSS YOUR REQUIREMENTS