Human Factors for Medical Devices
Understand critical human factors processes to consider when designing a medical device, including how they affect its safety and which steps to take to mitigate risks
About the course
Medical device manufacturers with robust human factors processes are leading the market, delivering better clinical outcomes and better quality. Attend AAMI’s three-day Human Factors for Medical Devices training to understand critical human factors processes to consider when designing a medical device. 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 premarket review process, and how strong human factors processes should be a part of the design and development of medical devices.
What to expect
The course will set a foundation for applying human factors with discussion 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. Explore relevant human factors standards, as well as human factors in the postmarket arena. There will be hands-on exercises and 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.
The fee includes a copy of ANSI/AAMI/IEC 62366-1:2015 + A1:2020 (a value of $243), FDA guidance documents, industry studies and references, and an eNotebook of the presentations with easy note-taking capability.
Dates: March 8-10, 2021
Times: 8:00AM-5:00PM ET
Meet the Faculty:
Ed Israelski PhD, CHFP
Human Factors Consultant
Ed Israelski is a consultant and the recently retired director of Human Factors at AbbVie, a biopharmaceutical company. Ed’s consulting practice focuses on giving strategic advice to medical product clients to ensure compliance with US FDA and international standards to achieve regulatory approval. He joined AbbVie in 2001, where he led a cross-company team to imbed best-practice human factors engineering HFE design methods into all of AbbVie’s products, to ensure safety and usability. He did this through hands-on design and evaluation of key new products, managing a group of HF professionals; training and mentoring internal resources, writing corporate policy and guidelines and facilitating the use of outside professional HFE resources. For these efforts he was awarded a Lifetime Achievement Award from the AbbVie Volwiler Society. He is the co-convener for IEC and ISO Ergonomic and Usability Engineering groups in developing international Human Factors/Usability medical devices standards. Ed is also past co-chair of the AAMI Human Factors Engineering committee, which develops HF standards for medical devices. He is a certified human factors professional CHFP. He has authored fourteen book chapters and numerous articles in the area of human factors. Ed holds thirty patents. He is a fellow of the Human Factors and Ergonomics Society and a member of the National Academy of Sciences Board on Human-System Integration. He is on the editorial board for the journal Human Factors and serves as a regular reviewer for several other scientific journals. He has worked as a systems engineer, product manager, market researcher, industrial/organizational psychologist as well as a human factors engineer at various companies including Lucent Technologies - Bell Labs, formerly AT&T (28 years), Ameritech/SBC and Human Factors International, Ed is an adjunct instructor at Northwestern University and previously NJIT and Virginia Tech. He received a B.S. in electrical engineering from NJIT, an M.S. in operations research from Columbia University and a Ph.D. in industrial and engineering psychology from Stevens Institute of Technology.
Tressa J. Daniels
Tressa has worked in the field of Human Factors Engineering for 22 years. Her expertise is in user interaction design, ethnographic research and executing human factors analyses of consumer and medical products, including infusion pumps, oral medication dispensing systems, migraine machines and DNA Sequencers. Formerly, Tressa worked at becton Dickinson, Illumina, CareFusion, HP, Intel and Xerox and was a Human Factors instructor at Woodbury University in Burbank, CA and is also a member of AAMI Faculty in Human Factors in Medical Device Design. She is a member of the Human Factors and Ergonomics Society (HFES) as well as the Association for the Advancement of Medical Instrumentation (AAMI). She serves on AAMI’s Human Factors Engineering Standards Committee as well as hosts regular Webinars for AAMI. Tressa holds a Bachelors Degree in Psychology as well as a Masters in Human Factors Engineering and Applied Experimental Psychology.
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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 email@example.com.