Goddard’s Human Factors Team Presents at the International Symposium on Human Factors and Ergonomics in Health Care

The Goddard Human Factors and UX (HFUX) team presented alongside experts in the human factors and healthcare field at the International Symposium on Human Factors and Ergonomics in Health Care, held in New York, NY.

Human factors practitioners, regulatory experts, engineers, researchers, and business leaders from across the industry came together to discuss best practices and innovative methods in healthcare human factors.

As part of our commitment to elevating industry standards and driving meaningful innovation, the Goddard HFUX team contributed three posters grounded in our recent industry experience. Click each title to download our posters and scan the QR codes to participate in interactive activities!

Determining Minimal Environmental Fidelity for Simulated Use Studies

Authors: Katherine Hayna, Nia Michael-Peterson

This poster presents a practical framework for determining the minimal environmental fidelity needed for simulated-use human factors studies. It emphasizes balancing realism with feasibility to elicit authentic user behaviors while maintaining experimental control and resource efficiency. The framework includes clearly defining critical tasks and environmental factors that impact device-user interactions, designing the study environment to appropriate levels of fidelity aligned with study goals, and iterating through stakeholder feedback and pilot testing. This approach supports safe, effective device design and regulatory rigor.

Scan the QR code to see a 360 immersive view of how we minimally simulated a Sterile Processing Department!

Navigating Post-Market Human Factors in High Stakes Medical Device Decisions

Authors: Elizabeth Roe, Stephanie DeMarco Bartlett, Ash Shenoi

Post-market human factors engineering is the implementation of human factors processes in devices that have already been released to market. In this poster, we share our learnings from recent post-market human factors efforts in the form of three case studies. These case studies highlight key considerations for human factors efforts across the post-market timeline, from shortly after release to after safety-critical issues have emerged in the field, providing actionable insights for complex post-market development decisions.

Scan the QR code to share your thoughts about post-market human factors and learn from the experiences of others!

HFE In-Practice: Bridging Cross-functional Collaboration for Greater Success

Authors: Kristina Chepak, Mikayla Tinus, Riya Kesari

In medical device development, misalignment between human factors and other disciplines due to communication failures or ambiguous design change criteria creates expensive redesigns, regulatory risk, and delayed time-to-market. At Goddard, we have implemented two key tools to address this: The Human Factors Assessment and the Three Hats Framework. The Human Factors Assessment is a structured documentation tool, aligned with IEC 62366-1 & FDA Guidance, that uses decision logic to determine whether design changes require HF Validation or if existing evidence justifies none. The Three Hats Framework guides human factors engineers to adapt their communication approach across project phases to match the product lifecycle phase, stakeholder needs, and maximize influence. By leveraging an adaptive communication style and a tactical assessment tool, the Goddard team can foster earlier cross-functional alignment, reduce submission risk, and accelerate the delivery of safe and effective products.

Scan the QR code to take a short quiz and find out what human factors hat you wear!