With the implementation of disc augmentation, not only does this allow surgeons to have an alternative to methods that restrict mobility or the use of steroids, but the use of hydrogel enclosed within a biomaterial opens paths to the use of stem cell/biological component delivery to promote tissue regeneration, which is a big field in the research industry.
As a permanent implant, a spinal herniated disc augmentation would qualify as a Class III medical device under FDA regulation. As such this device will require rigorous testing to determine its safety and effectiveness. In addition, this product will require premarket approval as well as premarket filling (510k). This device also falls under the classification of 888.3060 as an orthopedic intervertebral implant device. Addressing these regulations will be a vital stage in the development of this device for future aims.
For the next team(s) that take over this senior project, there are many different avenues that can be taken and improved upon. The team would be interested in looking further into deployment methods for the artificial IVD when it is placed into the place of herniation. Additionally, the next team(s) could look at using different materials to replace PTFE that optimizes the design. Finally, this project ended with two separate subprojects and designs that are up to future students to combine into one.