Presentation
CANCELED - The Art of Observation
SessionPoster Session 1
DescriptionHuman factors/usability evaluations are a cornerstone of safe and effective medical device and combination product development, yet the role of the observer, also referred to as the notetaker in some organizations, remains undervalued and underdefined. In most study teams, training, guidance, and best practices focus almost exclusively on moderators, leaving observers relegated to the role of passive note takers. This imbalance overlooks a critical contributor to study quality. Poor or inconsistent observation can compromise data integrity, obscure use error patterns, and slow root cause analysis, often forcing teams to revisit hours of video to reconstruct events that should have been captured in real time.
The lack of emphasis on the observer role stems from several systemic causes: observers may be selected without sufficient human factors knowledge, deployed without context on product or study risks, and left without structured methods for capturing meaningful data. This results not only in inefficiencies and delays but also in the potential to miss insights that are vital for risk management, regulatory submissions, and ultimately patient safety.
This presentation reframes the observer as an essential member of the study team, whose contributions extend far beyond transcription. We will share a structured framework for preparing and empowering observers to contribute effectively, covering product familiarity, user characteristics, environmental considerations, study documentation, and use-related risk management concepts (e.g., URRA, residual risk evaluation, and benefit-risk analysis). Attendees will gain practical strategies for clarifying observer roles and responsibilities across all phases of a study, as well as actionable tips for efficient and accurate note-taking.
The novelty of this work lies in shifting the industry’s lens: while the moderator role has been studied, codified, and trained extensively, the observer’s role has not been systematically addressed in the human factors literature. This session fills that gap by offering a clear framework and practical guidance to elevate observer contributions.
Key takeaways will include:
• Why observers are critical to data validity and study efficiency.
• How trained observers can reduce reliance on video review and strengthen root cause analysis.
• Best practices for observer preparation, integration, and communication with the study team.
• Strategies to professionalize the observer role and align it with human factors principles.
By elevating and defining the role of the observer, human factors professionals can significantly improve study outcomes, regulatory readiness, and ultimately patient safety.
The lack of emphasis on the observer role stems from several systemic causes: observers may be selected without sufficient human factors knowledge, deployed without context on product or study risks, and left without structured methods for capturing meaningful data. This results not only in inefficiencies and delays but also in the potential to miss insights that are vital for risk management, regulatory submissions, and ultimately patient safety.
This presentation reframes the observer as an essential member of the study team, whose contributions extend far beyond transcription. We will share a structured framework for preparing and empowering observers to contribute effectively, covering product familiarity, user characteristics, environmental considerations, study documentation, and use-related risk management concepts (e.g., URRA, residual risk evaluation, and benefit-risk analysis). Attendees will gain practical strategies for clarifying observer roles and responsibilities across all phases of a study, as well as actionable tips for efficient and accurate note-taking.
The novelty of this work lies in shifting the industry’s lens: while the moderator role has been studied, codified, and trained extensively, the observer’s role has not been systematically addressed in the human factors literature. This session fills that gap by offering a clear framework and practical guidance to elevate observer contributions.
Key takeaways will include:
• Why observers are critical to data validity and study efficiency.
• How trained observers can reduce reliance on video review and strengthen root cause analysis.
• Best practices for observer preparation, integration, and communication with the study team.
• Strategies to professionalize the observer role and align it with human factors principles.
By elevating and defining the role of the observer, human factors professionals can significantly improve study outcomes, regulatory readiness, and ultimately patient safety.
Event Type
Poster Presentation
TimeMonday, March 234:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices