11:00 AM — 1:30 PM ET

Workshop I: Human Factors Validation of Combination Drug Products

Irene Chan, FDA CDER

This workshop provides a forum for an interactive dialog between the FDA/CDER human factors team and sponsors, consultants and other interested persons regarding human factors (HF) validation of combination drug products. Participants will have opportunities to ask questions to the presenters.

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Workshop II: Validating Usability in Electronic Health Records

Emily Patterson, The Ohio State University

Robert Stephens, Medtronic

​Attendees will develop the ability to understand how health information technology is designed and implemented to aid clinical work, as well as how to improve usefulness, usability, workflow, and compliance with intended use. The interactive session, with a heavy use of breakout rooms, uses active learning and case studies to teach how to design and evaluate electronic health records, clinical decision support, and electronic medication administration software.

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Workshop III: Applying HFE Principles to Produce Inherently Safe Medical Devices

Michael Wiklund and Alix Dorfman, Emergo by UL

​The purpose of this workshop is to give participants a strong and practical sense of how to design an inherently safe-to-use medical product. In the course of discussing over a dozen core principles for designing a safe medical device, the workshop leaders will cover such varied topics as making critical portions of labeling (e.g., component labels, warnings, user manual content) visually conspicuous and legible; protecting against inadvertent control actuations by various means; using automation to “stand watch” over critical conditions and signal when a problem is developing or occurring; and ensuring that physical forms, materials, and finishes encourage and/or facilitate safe use rather than create hazardous situations. Attendees will take-away from the workshop a working knowledge of design solutions that apply broadly to (1) products as diverse as epinephrine pen-injectors, heart-lung machines, and health-related mobile apps, and (2) products used in a variety of settings including the home, outdoors, physicians’ offices, laboratories, and hospitals.

1:30 PM — 2:30 PM ET

Break

2:30 PM — 5:00 PM ET

Workshop IV: Human Factors Validation of Medical Devices and Systems​

Rita Lin and Kimberly Kontson, FDA CDRH

​This workshop provides a forum for an interactive dialog between FDA/CDHR human factors team and sponsors, consultants and other interested persons regarding human factors (HF) validation of a variety of medical device and systems. Participants will have opportunities to ask questions to the presenters.

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Workshop V: A Crash Course on Cognitive Ergonomics Applied to Healthcare

Russell J. Branaghan, Research Collective, Arizona State University, and Northwestern University

L. Bryan Foster, Research Collective

Emily A. Hildebrand, Research Collective

​Despite researching, testing and designing cognitive tools for use by healthcare providers, patients and caregivers, many Healthcare Human Factors practitioners have never taken a university-level class in cognitive psychology or cognitive science. Moreover, while much of the material in those traditional classes is useful to Human Factors (HF) practitioners, some of it is not. This workshop provides a crash course on how the mind works, separating the HF wheat from the chaff. It addresses human cognitive capabilities and limitations, as well as their implications for design.

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Workshop VI: Simulation: Helping Smart People Learn from Dummies

Kimberly P. Stone, MD, University of Washington School of Medicine & Seattle Children’s Hospital

Ellen S. Deutsch, MD, MS, FASC, FAAP, University of Pennsylvania Perelman School of Medicine and Children’s Hospital of Philadelphia

Jennifer Arnold, MD, Johns Hopkins All Children’s Hospital

Jennifer Reid, MD, University of Washington School of Medicine & Seattle Children’s Hospital

Lennox Huang, MD, SickKids

David Kessler, MD, MSc, Columbia University Medial Center’

​Healthcare Simulationists have experience and insights that can be invaluable for Human Factors Experts seeking to learn about, and improve, healthcare delivery using simulation. Simulation is not new to HFE, but this workshop can expand your knowledge and diversify the tools at your disposal. Leaders in the field of healthcare simulation will address how to partner simulation with HFE, cultivate collaborators, obtain organizational buy-in, design projects and evaluate outcomes. The workshop will be structured as a series of mini-lectures followed by small group discussion applying principles and addressing challenges and strategies for success. Case examples from a variety of projects will be used to illustrate key points and the diversity of opportunities for simulation and HFE collaboration.

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