Team 9
RHFM, Inc.: A Proximal Radioulnar Joint Implant for Surgical Intervention of Proximal Radioulnar Synostosis
RHFM, Inc.: A Proximal Radioulnar Joint Implant for Surgical Intervention of Proximal Radioulnar Synostosis
Team Members: Ryan Fuller, Evan Higgs, Brittany Metzler, Noberto Rodqiguez Marquez - SBHSE
Team Mentors: Dr. Timothy Schaub, MD - Phoenix Children’s Hospital
Dr. Sydney Schaefer - SBHSE
YouTube Link: View the video link below before joining the zoom meeting
Zoom Link: https://asu.zoom.us/j/99141251904
Abstract
Radioulnar synostosis is the fusion of the radius and ulna, radial head dislocation is the dislocation of the radial head from its annular ligament anchor, and Type III radial head fracture is a comminuted, displaced fracture involving the entire radial head, many cases of which minimize the range of motion of the forearm and hand of those with these conditions. Composed of titanium and ultra-high molecular weight polyethylene our device will offer pronation of the hand to 75 degrees, and supination to 85 degrees. Without this range of motion, patients would be unable to fully pronate and supinate their hands preventing them from being able to perform simple actions like receive change, or pick up utensils to eat. With roughly 350 cases of radioulnar synostosis, our primary development etiology, our market size is small but the potential impact that our device provides for patients is incalculable. Including the radial head dislocation and Type III radial head fracture cases increases our market size by about 22 times that of radioulnar synostosis. With a total development cost goal of roughly $690 per unit, and an ultra-conservative unit retail price of $1,000, our device is intended to become profitable. To substantiate our value proposition, our FDA regulated Class II proximal radioulnar abnormality and injury treating elbow implant is intended to improve the range of motion of the forearm by positioning said implant near the elbow. Our first phase of design achieved a dominant product concept by identifying the elbow as the primary driver for improving range of motion of the forearm and designing a device specifically for implantation into the elbow. To be marketable in compliance with FDA regulation, our device has demonstrated safety and efficacy by properly sizing the implant for the anatomy of the patient, selecting appropriate materials, reducing the likelihood of product failure, minimizing expense to the patient, and verifying and validating the above through modeling and physical testing. The team has utilized three dimensional modeling tools and physical prototyping techniques to draw, visualize, simulate, experiment, and analyze the design of our device throughout the process of its development. To ensure the safety and efficacy of our device, the product specifications on which our design team focused included the wear rate, longevity, durability, size, weight, stability, and ability to offer a full range of motion. Further development emphasized robust design, regulatory pathway identification and documentation, and business modeling during the continued development phase of this project. This project has been completed under the mentorship of Dr. Timothy Schaub from Phoenix Children’s Hospital, and Dr. Sydney Schaefer from ASU SBHSE.
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