HFES 2025 Recap: Insights from the Field Driving Human Factors Excellence

The Goddard Technologies Human Factors team attended HFES 2025 in Toronto, where we immersed ourselves in the Medical and Drug Delivery Devices track. This year’s sessions reflected the evolving demands on human factors professionals, particularly in the medical device industry, where usability, safety, and regulatory readiness must align.

By participating in targeted workshops and panels focused on regulatory shifts, evolving validation methods, and usability strategies, our team deepened its expertise in supporting clients through every stage of the product development lifecycle. For decision-makers evaluating potential partners in human factors engineering (HFE), our presence and participation at HFES 2025 reaffirm Goddard’s leadership in delivering human-centered, regulation-aligned solutions for complex devices.

Strategic Participation: Sessions That Moved the Needle

Our team attended a curated set of sessions focused on emerging trends and unresolved challenges in human factors engineering. 

These sessions were not only informative but also actionable. The insights gained will directly inform how Goddard Technologies supports safer, more effective device development and regulatory compliance for our clients.

Key Takeaways by Human Factors Activity

Design Processes

One major discussion centered on the integration of human factors validation with design validation. Development teams can streamline timelines without sacrificing safety or efficacy by conducting task-based simulated use testing as part of a single, unified evaluation.

Instructions for Use (IFU) Development

Best practices call for initiating risk documentation (such as URRA) before IFU development begins. This alignment ensures that documentation is relevant, user-focused, and traceable throughout the development process.

Formative Evaluations

• Expert Reviews benefit from empirical data inputs, enhancing the objectivity and impact of low-cost review activities.
• Contextual Inquiry emerged as a critical consideration, especially in low- and middle-income countries, where 40% of devices reportedly fail post-deployment due to contextual misalignment.
• Children’s Usability Testing was highlighted for participants aged six and up, emphasizing the need to create environments that support comprehension and trust.

Validation Testing

• Scope Adjustments: The FDA has shown flexibility around validation testing scope—both narrowing and broadening—when justified by study design and risk assessments.
• Participant Criteria: New methodologies, including Bayesian modeling, are challenging the legacy rule of 15 participants per group. These models help predict when 90% of use errors have likely been captured.
• Lay User Dyads: The FDA now considers patient-caregiver pairs as a unified user group, increasing the inclusivity and realism of validation studies.
• Training Considerations: While details were limited, discussions highlighted strategies for integrating training components in ways that do not bias outcomes.
• Moderator Techniques: Practical insights were shared to help moderators balance non-biasing guidance with meaningful probing—particularly when navigating ambiguous FDA expectations.

Knowledge Task Questions (KTQs)

New guidance from AAMI HE75 (2025) emphasizes context. If a participant answers a KTQ incorrectly without consulting labeling, this should be factored into root cause analysis rather than simply flagged as a usability failure.

Root Cause Analysis (RCA)

A consistent message: blame the interface, not the user. RCA should generally occur after all use scenarios and KTQs are complete unless delaying risks data degradation through memory decay or recency effects.

Use Error (UE) Classification

Experts at HFES 2025 disagreed on how strictly errors should be classified. While not all mistakes must be deemed formal UEs, every misstep should inform mitigation strategies. The emphasis remains on ensuring safe, intuitive user experiences.

OTC Device Selection

Traditional recruitment methods for over-the-counter devices were criticized for their burden. A proposed framework included:

• Leveraging census data to structure participant quotas
• Formative testing with both intended and unintended users
• Allowing self-correction during validation if justified
• Modifying HAQs and selection procedures to better reflect real-world use

Regulatory Activities

Although specifics were limited, sessions included recommendations for aligning validation protocols with global submission requirements, an area critical for clients planning multi-market launches.

AI in Human Factors

Multiple tools that integrate AI into human factors workflows were showcased. While promising, these tools must be adopted in accordance with Goddard Technologies’ internal guidelines and data policies.

Turning Knowledge into Action

For Goddard Technologies, HFES 2025 was not just a conference but an opportunity to validate our approach, sharpen our practices, and bring back refined strategies to benefit our clients. From design validation to OTC recruitment, our team integrates these learnings into active and future programs.

As the regulatory landscape evolves, it is more important than ever to work with partners who understand the nuances of human factors engineering and how to translate those insights into compliant, user-safe medical devices. Our attendance at HFES 2025 reinforces our commitment to leading in this space with precision, depth, and real-world expertise.

Let’s talk about how our human factors team can support your next development cycle.