Presentation
Designing for Anatomical Diversity: Human Factors Evaluation of a Novel Nasal Drug Delivery Device
SessionPoster Session 2
DescriptionNasal drug delivery is sensitive to anatomical variability (e.g., nasal valve geometry, septal deviation, and nasal passage width). Many existing devices rely heavily on user technique (insertion depth, angle, actuation timing, and actuation force), leading to missed targets, inconsistent dosing, reduced adherence, unreliable task performance, and poor user experience – ultimately impacting treatment efficacy. When drug therapy requires precise dosing and targeted delivery to specific nasal regions to reach the brain, the device and user experience can determine treatment outcomes.
Rocket Science Health, in collaboration with Research Collective, conducted formative human factors usability research to evaluate three novel design controls intended to reduce inconsistencies in drug delivery due to user technique-dependence: 1) a dual-nostril introducer (nosepiece) that constrains insertion depth and alignment at the columella, 2) columella-based actuation to eliminate the need for a button press, and 3) compliant, inward-biased cannulas intended to extend beyond the nasal valve toward a consistent target region, referred to as the “vantage point”.
A two-stage human factors usability evaluation was conducted. The study had two primary aims: 1) to recruit users that were expected, based on published nasal anthropometry research, to fall near the lower and upper distribution tails of key nasal dimensions (i.e. adults with the smallest and largest noses) and to measure key anthropometric metrics; and 2) conduct a simulated-use usability study with participants representing these anatomical extremes to evaluate the fit, use, and comfort of the novel nasal drug delivery device technology.
Stage I: Anthropometric Screening Fifty adults (n=50) were purposely recruited across a broad range of ages, sexes, and self-reported race/ethnicity. Using distributions from published nasal anthropometry data, we oversampled participants expected to fall near the lower and upper tails of key nasal dimensions. Seventeen nasal measurements were taken per participant using calipers and standardized photogrammetry. This enabled the identification of participants at the anatomical extremes (both large and small) relative to device geometry and published data.
Stage II: Simulated Use Usability Study Thirty participants (n=30) representing anatomical extremes identified in Stage I were selected for hands-on device evaluation. After a brief orientation to the Instructions for Use (IFU), participants completed the full simulated workflow: device priming, insertion, cannula extension, and simulated actuation (no fluid delivered). Device fit, cannula extension and actuation, and task completion were assessed by direct observation, and any use-related issues (errors, close calls, difficulties) were recorded. Ease of use and comfort were collected via self-reported ratings.
Key Results:
● Fit and Function: All participants successfully inserted and positioned the device.
● Cannula Extension and Actuation: 100% of users extended both cannulas to the intended region for actuation (the vantage point).
● Task Completion: No workflow deviations, difficulties, or use-related errors were observed.
● Ease of Use: Average ease of use score was 4.8/5.
● Comfort: Average comfort score was 3.9/5, with most describing the device as comfortable or very comfortable.
● Subjective Feedback: Participants frequently reported the experience as significantly more comfortable than existing devices and nasal swabs.
These results reflect the impact of HF-driven, iterative design and formative testing. Features of the device technology include the introducer, stabilized by the columella and septum walls to constrain alignment and insertion depth. Columella based actuation mechanically couples full cannula extension with device actuation, reducing technique-dependence for that step and intended for repeatable dosing. The compliant cannulas adapt to individual anatomy while reaching deeper into the nasal cavity than typical delivery devices. Each design element was refined across several cycles of formative testing.
By intentionally recruiting participants most likely to experience fit or comfort issues identified in Stage I, the findings in Stage II demonstrate that devices can be designed to perform reliably—even in large and small adult anatomies—without sacrificing ease of use or comfort. The findings support continued development and clinical use of this nasal delivery system for therapies requiring targeted deposition and high user acceptance.
*** NOTE ***
This is one of two poster-session submissions by Rocket Science Health. Please consider placing both posters close together so our team can present effectively
Rocket Science Health, in collaboration with Research Collective, conducted formative human factors usability research to evaluate three novel design controls intended to reduce inconsistencies in drug delivery due to user technique-dependence: 1) a dual-nostril introducer (nosepiece) that constrains insertion depth and alignment at the columella, 2) columella-based actuation to eliminate the need for a button press, and 3) compliant, inward-biased cannulas intended to extend beyond the nasal valve toward a consistent target region, referred to as the “vantage point”.
A two-stage human factors usability evaluation was conducted. The study had two primary aims: 1) to recruit users that were expected, based on published nasal anthropometry research, to fall near the lower and upper distribution tails of key nasal dimensions (i.e. adults with the smallest and largest noses) and to measure key anthropometric metrics; and 2) conduct a simulated-use usability study with participants representing these anatomical extremes to evaluate the fit, use, and comfort of the novel nasal drug delivery device technology.
Stage I: Anthropometric Screening Fifty adults (n=50) were purposely recruited across a broad range of ages, sexes, and self-reported race/ethnicity. Using distributions from published nasal anthropometry data, we oversampled participants expected to fall near the lower and upper tails of key nasal dimensions. Seventeen nasal measurements were taken per participant using calipers and standardized photogrammetry. This enabled the identification of participants at the anatomical extremes (both large and small) relative to device geometry and published data.
Stage II: Simulated Use Usability Study Thirty participants (n=30) representing anatomical extremes identified in Stage I were selected for hands-on device evaluation. After a brief orientation to the Instructions for Use (IFU), participants completed the full simulated workflow: device priming, insertion, cannula extension, and simulated actuation (no fluid delivered). Device fit, cannula extension and actuation, and task completion were assessed by direct observation, and any use-related issues (errors, close calls, difficulties) were recorded. Ease of use and comfort were collected via self-reported ratings.
Key Results:
● Fit and Function: All participants successfully inserted and positioned the device.
● Cannula Extension and Actuation: 100% of users extended both cannulas to the intended region for actuation (the vantage point).
● Task Completion: No workflow deviations, difficulties, or use-related errors were observed.
● Ease of Use: Average ease of use score was 4.8/5.
● Comfort: Average comfort score was 3.9/5, with most describing the device as comfortable or very comfortable.
● Subjective Feedback: Participants frequently reported the experience as significantly more comfortable than existing devices and nasal swabs.
These results reflect the impact of HF-driven, iterative design and formative testing. Features of the device technology include the introducer, stabilized by the columella and septum walls to constrain alignment and insertion depth. Columella based actuation mechanically couples full cannula extension with device actuation, reducing technique-dependence for that step and intended for repeatable dosing. The compliant cannulas adapt to individual anatomy while reaching deeper into the nasal cavity than typical delivery devices. Each design element was refined across several cycles of formative testing.
By intentionally recruiting participants most likely to experience fit or comfort issues identified in Stage I, the findings in Stage II demonstrate that devices can be designed to perform reliably—even in large and small adult anatomies—without sacrificing ease of use or comfort. The findings support continued development and clinical use of this nasal delivery system for therapies requiring targeted deposition and high user acceptance.
*** NOTE ***
This is one of two poster-session submissions by Rocket Science Health. Please consider placing both posters close together so our team can present effectively
Event Type
Poster Presentation
TimeTuesday, March 244:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices