Senior Design Project: IEORAD

IEORAD (Inner Ear Object Removal Assist Device) is a senior BIOE capstone project that aims to create a production equivalent medical device by applying knowledge about the medical device industry and the FDA regulatory process for medical devices.

Video Detailing Various Stages of IEORAD Completed:

This video illustrates the unmet clinical need that our medical device intends to address, hazards associated and accounted for by design changes, different stages of prototypes completed in the prototyping stage, and verification and validation efforts that were completed as part of the two semester senior design course.

IEORAD Prototype Evolution:

Prototyping began after determining design parameters and potential risks that the device could pose to the patient and sketching potential solutions. The low resolution prototypes were made from pipe cleaners and paper, and wires and popsicle sticks. The higher resolution prototypes were 3D printed using Fusion360 and then resin printers at Pitt Hillman's Open Lab. The final stage of the prototype is a Tough 2000 resin-based, one piece 3D model print dipped in liquid rubber.

Design Expo Poster:

This poster illustrates the unmet clinical need that our medical device intends to address, the results of the ethnography data obtained from clinicians, some of our design parameters, and a rough process of sketching and prototyping. A CAD model including the overhead attachment and the two forceps components are also included. This poster was presented at the University of Pittsburgh Swanson School of Engineering's Fall 2023 Design Expo.

Storyboard & Prototyping Photo Gallery:

This storyboard & photo gallery display the process that our team went through to develop and evaluate a medical device prototype.

Validation Testing Photo Gallery:

Images from validation testing at UPMC Children's Hospital are included below.

Personal Contributions

As part of this team, I personally established and organized the documentation for the project assignments which was later reorganized into a Design History File (DHF), contributed in project meetings with sketches of potential designs, initiated the prototyping stage with an initial prototype based on past sketching of potential solutions to ideate mechanism of attachment of prototype to otoscope, identified the regulatory pathway needed for FDA approval of the device, and established Fault Tree Analysis and Initial Hazard Analysis documents that later led to the development of a Product Design Specification document which illustrates in detail the properties of the components in the device based on design choices informed from risk management according to FDA guidelines on quality systems. Additionally, I was personally responsible for designing and executing a validation test protocol that assessed the ability of the otoscope prototype to attach to a standard otoscope and be removed in a manner that is simple and intuitive to the clinicians. The results from validation testing seemed to indicate that the current form of the device was not ideal for foreign body removal compared to the alligator forceps method, but they were still interested in the device and were excited to see potential redesigns in the future.