Senior Design
External Female Catheter Improvement
The core function of this project was to gain realistic experience in the Medical Product Development Process. This entry specifies my contributions and experience within a team effort,
to implement a customer-focused development process specific to the unique requirements surrounding the improvements of external female female catheters.
The existing device:
Bard Purewick Female External Catheter
Ethnography -
Discovering and Validating the Unmet Clinical Need
In this phase of the Medical Product Development Process my team and I generated ideas for potential unmet needs and worked together to utilize ethnography, in the field whenever possible, to validate the various ideas. Initially our team was very interested in ostomy care, but we eventually selected the improvement of Female External Cather Care. Particularly, we found support in our ethnographic data that the Bard Purewick was a significant product for improvement in urology care.
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The ethnography phase was completed with a class-wide solution idea generation activity. I was responsible for presenting our selected unmet clinical need several times to groups in our design course, and guiding discussion to generate solutions from my peers.
Presentation Materials:
The materials used for the idea generation presentations
Ideation -
Sketching Solutions and Confirming Simulation Capacity
Supported by the solution generation activity and the team's continued work with our contacts in urology we began the process of generating potential solutions. One such contact in urology, Tammy Clamann, a contact from SUNA (Society of Urologic Nurses and Associates) was originally contacted by me in my ethnographic efforts. Tammy became a valuable resource, originally pointing us in the direction of the Purewick.
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Based on input from Tammy in the team's ideation phase, I sketched an ultimately omitted design decision, an easy-open packaging for the catheter packaging.
Team Mobility Solutions (top),
Vaginal Anchor Solution Sketch (middle), Linearly Holed Tubing (bottom)
Prototypes -
Informal Verification of Design Decisions
The team decided to approach the improvement of the Purewick by addressing two core issues: mobility of the user and catheter leakage. Together we generated several different approaches to implement as improvement for mobility, and decided to attempt to decrease leakage with improvement of the wicking capacity.
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For mobility, I was tasked with prototyping an improved device shell with small stabilization anchor that would be minimally inserted into the vaginal canal. This insertion was ideated to anchor the device to prevent it from becoming dislodged during user movement. This idea was ultimately decided to not be implemented in further design due to the invasive nature of its function.
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To address wicking capacity, it was ideated that the tubing within the Purewick could have increased holes to absorb urine into the pressure output in more places. This would be an improvement over the singular absorbent hole at the bottom of the device, where leakage tends to occur. Fabricating the modified tubes was a group effort, and we each attempted to create different hole patterns to assess the effect on wicking capacity. The differences included different sized wholes with different spacing or patterns of spacing between them. I was responsible for creating a medium sized hole pattern that I made linear with intent of pointing toward the vulva, where the urine input will be flowing from.
Skills Lab -
Informal Testing
The team performed nearly all informal verification testing in the University of Pittsburgh's School of Nursing's Skills lab. The skills lab has several different pelvic simulation models that we assessed for different urine output collection testing with our modified device.
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My responsibilities in the skills lab included: testing setup, liquid volumetric collection data recording, liquid input preparation, visual documentation of testing setup, and overall testing assistance for other tasks performed by my teammates.
Testing Setup Image with Nurse Anne (top),
Pelvic Model Testing Setup (middle),
Liquid Volumetric Output Cannister (bottom)
Design Expo -
End of Semester Presentation
In preparation for the Design Expo, I assisted the team in verifying our poster was without errors. Sadly, I was unable to attend the Expo due to illness.
Gantt Chart -
Scheduling Development Efforts
The team ultimately utilized a Gantt chart to record and plan the process of our device's development. From ethnography to hazard and risk analyses for design specification requirements, the Gantt neatly shows the process as it developed through the Fall term semester.
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The Gantt also includes a record of assigned team members for each step in our process, and a preliminary outline of our Spring term schedule. I was ultimately responsible for generation of the Gannt. This required in depth reference to all efforts throughout the semester, deadline implementation and assignment of responsibility based on direction from team division of efforts.
Gantt Chart for the Fall and Spring Semesters
Fall Semester Summary
The improvement of female external catheters is a verified clinical and unmet need.
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The process of ideating solutions for this device has required help from peers, input from professionals, and a purposeful process for identifying appropriate solutions.
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Testing solutions is helped drastically by the resources of our university and requires teamwork and patience.
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The efforts of my design team have been extraordinary this semester and our efforts throughout this process have us well positioned to begin formal verification and validation testing near the start of the Spring semester.
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