Speculum Handle for Trauma-Informed Care
This medical device design project was completed for the Bioengineering Senior Design capstone course at the University of Pittsburgh. My team's project is focused on improving gynecological health for survivors of sexual assault. Specifically, we designed an attachable handle for a speculum that allows patients to insert the speculum themselves. This solution intends on reducing the trigger that survivors of sexual assault might experience during pelvic exams and address a barrier in seeking care among this population.
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We are currently pursuing a provisional patent application for our device!
During Fall 2020, our main goal was to identify an unmet need and propose a device to address it. We contacted clinicians and reached out to patient populations to learn about unmet needs in areas ranging from orthopedics to mental health.
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I personally reached out to physicians at the the University of Pittsburgh Medical Center (UPMC) and set up informational interviews for our ethnography efforts.
After creating an unmet needs assessment matrix, we were able to narrow down our proposed field to women’s health, and refined our ethnographic efforts accordingly. By connecting with clinicians and patient populations in this women's health, we discovered a major concern was the lack of a trauma-friendly speculum to be used during a routine pelvic exam.
Survivors of sexual assault often experience great discomfort and can become triggered during pelvic exams, leading them to skip gynecological appointments and forego potentially life-saving exams.
While we initially considered redesigning the entire speculum, we realized this solution may not be widely adopted by clinicians as it requires increased costs to hospitals/clinicians.
Once we decided to pursue a design for an attachable speculum handle, we conducted an Initial Hazard Analysis and a Risk Analysis to identify important design considerations and rule out initial prototype options. We finally settled on the clinician-approved design below!
A foam core minimum viable prototype (MVP) of our handle design
Our initial CAD model, created in SolidWorks
Our final, 3D printed prototype
I created three use case scenarios, one for each customer archetype that we identified: a patient with a history of sexual trauma, a patient without a history of sexual trauma, and the clinical care provider, and described how each would accomplish their goal using our handle. I also helped to developed our User Needs document, which defined what each user needed to experience in our handle to achieve their goal. These two analyses were important to do in order to establish our design inputs.
Additionally,​ I organized our design inputs, verification and validation plans, risk matrix, and design outputs into an eQMS system called Greenlight Guru. I also helped develop our team's Verification Plan, plan based on our defined design inputs. With our final prototype design, I performed various verification tests, including fatigue and tensile testing, and generated the corresponding test reports.
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Our team showed that our handle is built according to our design requirements and functions properly. Based on user feedback, the modular handle meets both the clinician and patient needs – only minor design changes, like making a version of the proposed handle with a slightly longer grip for patient populations with lower motility, were requested by the target users.​
Our team presented our project at the Swanson School of Engineering Fall Design Expo, where we won the People's Choice Award, and also at the Spring Design Expo!
