IP Requirement: Owens and Minor IP

Experience Requirement:

– Mechanical Design

– Rapid Prototyping

​Fit testing is a standardized protocol used to evaluate the seal and fit of tight-fitting medical N95 respirators before they are used in healthcare facilities. The Occupational Safety and Health Administration (OSHA) mandates that users pass a fit test to ensure the respirator provides adequate protection against airborne hazards. Since the effectiveness of a respirator is directly tied to its fit, it must accommodate a wide range of facial shapes and sizes. However, users often struggle to find the correct size, and subtle changes in fit over time can compromise safety without the user’s awareness. As respiratory protection becomes increasingly critical in healthcare settings, there is a growing need for innovative solutions that improve the accuracy, efficiency, and accessibility of fit testing protocols.

Qualitative fit testing is a commonly used method that relies on the user’s ability—or inability—to detect a test agent through taste, smell, or involuntary cough. While several qualitative fit test kits are commercially available and meet OSHA/NIOSH standards, their general design is antiquated. These kits tend to be bulky, contribute to inefficient waste disposal, and are time-consuming and costly to administer, especially in high-volume environments like hospitals. Additionally, the subjective nature of the test depends entirely on the user’s sensory response, thus introduces variability and potential bias, which can affect the consistency of results and raises concerns about the true effectiveness of different respirators. Identifying opportunities to improve both physical design and encourage objectivity in result interpretation presents a valuable path toward enhancing speed, usability, and confidence in fit testing protocols.

The goal of this project is to design an updated fit test kit that addresses the limitations of current systems. This new design should feature a more modern/compact form factor, refine key aspects of the testing process, and could potentially incorporate a visual mechanism to validate user responses – reducing reliance on subjective feedback. These improvements will aid in increasing the reliability of fit testing outcomes, improve compliance with safety standards, and reduce exposure risks. Ultimately, this innovation could lead to safer workplaces, more efficient onboarding in healthcare settings, and more objective assessments of respirator performance that build confidence for both users and suppliers.