Human Factors for Medical Devices

Upcoming Virtual Courses

Human Factors

Human Factors for Medical Devices (Mar25)

Mar 10 to Mar 14, 2025

Human Factors

Human Factors for Medical Devices (June25)

Jun 30 to Jul 2, 2025

Human Factors

Human Factors for Medical Devices (Sept25)

Sep 17 to Sep 19, 2025

Overview

This course will help you understand critical human factors processes to consider when designing a medical device, how they affect its safety, and which steps to take to mitigate risks. Hear directly from FDA representatives from CDRH and CDER about the expectations for device usability, how best to conduct human factors evaluation and testing, the pre-market review process, and how strong human factors processes should be a part of the design and development of medical devices.

Objectives

A foundation for applying human factors will be set with discussions on user models and task analysis; anatomy of use errors; and how task analysis forms the basis for planning human factors efforts. Course content will also include a review of human factors methodologies – contextual inquiry, heuristic evaluations, formative studies, and summative studies. Relevant human factors standards are discussed as well as human factors in the post-market arena. There are hands-on exercises as well as real-life case studies illustrating the application of human factors to medical devices. 

Who Should Attend?

This course is designed for quality and design engineers; research and development managers; risk managers; personnel from marketing, regulatory affairs, quality assurance, clinical/medical affairs, and customer service; and government regulators who are new to the application of human factors to medical devices. AAMI recommends this course for professionals who already have a basic understanding of the framework of quality management systems, particularly design control, risk management, and CAPA activities, but need more in-depth information about the concepts, science, processes, methodologies, and practical applications of human factors. It is recommended that human factors personnel who are new to the medical device industry have working knowledge of the Quality System regulation and design controls. 

Materials

The registration fee includes a copy of ANSI/AAMI/IEC 62366-1:2015, FDA guidance documents, industry studies and references, and an eNotebook of the presentations with easy note taking capability.

Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.

Faculty

MaryBeth Privitera

Dr. Mary Beth Privitera, M.Design, FIDSA, is internationally known as an expert in medical product design, specifically in the area of applied human factors.  She is a Professor at the University of Cincinnati’s Department of Biomedical Engineering and works collaboratively among the Colleges of Medicine, Engineering and Design. She is a consultant to the medical device industry with expertise in user interaction design and human factors. Additionally, she serves as faculty and co-chair of the Association for the Advancement of Medical Instrumentation’s Human Engineering Committee.   

 As a Professor at the University of Cincinnati’s Department of Biomedical Engineering, she is a Co-Founder of the Medical Device Innovation and Entrepreneurship Program.  Her previous academic appointments include industrial design and in the Department of Emergency Medicine.  

 She has worked on devices which are intended for use across the practice of medicine and in home health situations.  Her current research focuses on applied ergonomics and design interpretation.  She has conducted contextual inquiry studies throughout the hospital with results intended to inform the design of devices, including physiologic monitoring and clinical decision making, software-based tools including intraprocedural augmented reality.  In addition, she  currently has had research funding supported by the Gates Foundation and US FDA CDER Division.  She is a Fulbright Scholar in collaboration with the University of Nottingham. 

 She has authored several peer reviewed articles and a books titled “Contextual Inquiry for Medical Device Design,” promoting best practices for phase zero medical device development.  Her 2nd book, edited and written in collaboration with AAMI Human Factors faculty is titled “Applied Human Factors in Medical Device Design.” This book aims at bringing all references and best practices together in one resource compendium.

Merrick Kossack

Emergo by UL|Senior Research Director, Human Factors Research & Design

Hanniebey Wiyor

U.S. Food and Drug Administration (FDA)|Human factors Regulatory Officer

Ebony Whaley

U.S. Food and Drug Administration (FDA)|Safety Evaluator & Human Factors Specialist

Oluwamurewa "Murewa" Oguntimein

U.S. Food and Drug Administration (FDA)|Human Factors Team Lead