There is currently no medical device in the market targeted towards addressing small spinal disc reherniations, making our device concept novel. We have taken a major step towards our goal by using computational analysis and physical testing to demonstrate that our device concept is able to reduce protrusion length in the annulus without yielding. We hope that future work on our device concept is able to develop into a marketed product with the means of eliminating the burden of disc reherniation in patients.

We have considered many ethical, health, and safety issues for our the device, which the FDA provides guidelines for. Our device is classified as a Class II Medical Device and regulated under 21 CFR 888.3070 with product code MNI. The development process for spinal implants is long and requires plenty of testing and clinical trials. This includes mechanical and tensile testing, animal testing, and testing in humans before releasing the device into the market to ensure proper function without causing potential harm to patients. Being able to enable the use of this device after stringent testing and assessment is necessary for bringing it from prototype to usability by patients.

After completing our project, there were many unfinished steps to improve upon for our device. We identified several that students who take this project on in the future can focus on.  For example, sealing the space between the annulus and the plug to minimize disc leakage. Another important consideration was in replacing PCL with another material that can better handle physiological forces. We also thought of including drug-eluting properties to promote disc regeneration.  Other considerations all pertain to different modifications of the device component to optimize performance. Future students should select the considerations that they deem most important and feasible based on their team's skills, experience, and direction for the project.