Human Factors for Medical Devices
Upcoming Hybrid Courses
Upcoming Virtual Courses
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.
Speakers
Tressa J. Daniels
Sr. Director, Global Human Factors and Usability Engineering, Teleflex
Tressa has shared her 24 years of experience in Human Factors Engineering in both regulated and non-regulated industries. Currently Tressa is the Sr. Director, Global Human Factors and Usability Engineering at Teleflex. She contributes to industry by teaching the AAMI Human Factors in Medical Device Design course, serving on the AAMI Human Factors Engineering Standards Committee as well as hosting regular webinars for both AAMI and outside the US organizations focused on medical device design and development. Tressa holds a Master’s in Human Factors Engineering and Applied Experimental Psychology and a Bachelor’s degree in psychology and is based in San Diego California.
Melissa Lemke
Senior Principal Human Factors Engineer at Kymanox
Melissa Lemke is a Senior Principal Human Factors Engineer at Kymanox with experience in applying human factors during the design and development of combination products and medical devices to generate first-time successful human factors regulatory submissions. Since 2003 she has worked with clients to develop new product user interfaces, update existing products, address post-market issues, and develop technical publications and training efforts related to human factors and the user
Edmond W. Israelski
Ed Israelski is a consultant and the 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 (Abbott Labs) 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, building and 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.