We had the distinct pleasure to interview award winning designer Genesys Spine about their original and creative Stand Alone System design work. Genesys Spine is an award-winning industrial designer, that makes our world a better place with their original stand alone system works.
Genesys Spine ("GS") answered Design Interview ("DI") questions about their award-winning work AIS C Stand Alone System. Interview questions prepared by Frank Scott.
GS : a. The main principal behind the AIS-C Stand-Alone System is to provide surgeons and patients with a more efficient system for performing ACDF (anterior cervical discectomy fusion)procedures. A traditional ACDF procedure requires the implantation of both an interbody (to reestablish the disc height) and a cervical plate (to provide fixation to the surgical level to enable fusion to occur). This design combines the cervical interbody and the fixation device together - greatly simplifying the overall procedure. Instead of implanting two completely separate products in the patient, a single, integrated device system creates a more eloquent solution. b. At Genesys Spine we always strive to produce the most efficient and effective systems to help treat spinal pathologies. Surgeons appreciate the ease of use and we hope that leads to lower incident rates of complications for the patients. c. We were motivated to make this product after reviewing the limitations of other cervical stand-alone systems on the market. Every other cervical stand-alone system either utilized screws for fixation, required impaction to deploy, or could not be adequately revised. Each of these issues can have a significant effect on the surgical complication rate and the effectiveness of the procedure. Using screws for fixation requires a larger incision in the patient to accommodate the placement of screws at severe angles into the superior and inferior vertebrae. Separately, many other systems require impaction to deploy their method of fixation. The issue with impaction is that a device is being hammered directly toward the patient's spinal cord. Not only does the impaction place undue stress on the patient, there have been a number of incidents where the implants have dislodged toward and into the spinal cord. Last, the inability to properly revise (remove) many systems can lead to increased operating time or in severe cases; more invasive surgeries like a corpectomy. The Genesys Spine AIS-C Stand-Alone System eliminates all of these problems while providing all of the benefits of a stand-alone.
GS : Our focus was in providing a means for more effective ACDF procedures and better patient outcomes.
GS : First, we want to look at broadening the system offering through the use of new materials. Second, we want to look at applying this design into other products beyond the cervical spine.
GS : Genesys Spine has spent several years developing cervical stand-alone systems. The final product went through 9 months of prototyping, testing, and evolving the design.
GS : Due to the number of limitations and issues with other cervical stand-alone systems, Genesys Spine saw an opportunity to provide better patient care while simplifying the procedure for physicians. we did not feel that the evolution of two devices (cervical interbody and cervical plate) into one integrated system had to come with so many trade-offs for physicians and patients. The concept was fully developed internally by the Genesys Spine team using input from our design surgeons.
GS : The product is currently and will continue to be produced and sold by Genesys Spine. There are no plans to enter into partnerships or similar agreements at this time.
GS : Genesys Spine felt that the evolution of two devices (cervical interbody and cervical plate) into one integrated system did not have to come with so many trade-offs for physicians and patients. We saw the flaws in al the other devices on the market and felt compelled to develop something better.
GS : The concept was fully developed internally by the Genesys Spine team using input from our design surgeons.
GS : Neurosurgeons, orthopedic surgeons, and Doctors of Osteopathic Medicine.
GS : The Genesys Spine AIS-C Stand Alone System is a non-screw based, zero-profile, direct-anterior stand-alone interbody system for the cervical spine. The system utilizes quick, simple, non-impacting Anchor insertion which does not use an awl or drill. If the system needs to be revised, use of the removal instruments allows the locking mechanism to be defeated so the Anchor and interbody can be easily removed.
GS : AIS-C stands for Anchored Interbody System for the Cervical spine, hence the name AIS-C Stand-Alone System.
GS : Solidworks (3D CAD design software)and ANSYS (engineering simulation and 3D design software) were used to design, model, and analytically test different concepts. Physical prototypes for testing and evaluation were made using rapid prototyping including 3D printed devices. Physical prototypes were then tested and analyzed so the designs could be evolved. After many iterations, the AIS-C Stand-Alone system was born.
GS : There is an integrated locking mechanism that provides visual feedback to the surgeons that the system has been properly deployed and is locked into place. Regardless of the amount of data that can be provided to surgeons they always prefer a method to verify the system has been properly deployed. The AIS-C Stand-Alone System provides clear and immediate feedback upon deployment.
GS : We collaborated with a number of different design surgeons. Surgeons that had used other cervical stand-alone systems and were frustrated with the limitations and issues with those systems.
GS : Technology played an integral role in the design and development of this product. In a matter of a few days a concept could be designed, analytically tested, refined, prototyped, then physically tested. The use of SolidWorks, ANSYS, rapid prototyping, and 3D printing technology allowed the design to undergo numerous iterations of development and testing with each iteration producing a stronger, better, and safer design.
GS : Most of the research for this design centered on understanding what surgeons desired from a cervical stand-alone and what they disliked about the products they had seen and used. The design surgeon team was critical in Genesys Spine's understanding of precisely what the product should and should not do. These end use requirements were recorded and utilized throughout the evolution and testing of the AIS-C Stand-Alone System.
GS : The challenge was to give surgeons everything they asked for but without requiring any concessions. While there were many predicate stand-alone systems in the marketplace, they all had significant flaws and drawbacks. To develop such a substantial leap forward in the treatment of degenerative disc disease, Genesys Spine had to spend countless hours designing, developing, and testing concepts, only for potential flaws to be exposed by the design surgeons. Through cycle after cycle of this project, the design was refined countless times. Some of the specific challenges centered around utilization of a direct anterior approach. That requirement eliminated the use of screws as a form of fixation. Then, the design surgeons mandated that the system needed to be fully deployed without impaction. That further limited the options for integrated fixation. In addition, the instrumentation required to deploy the fixation components became more and more complicated. After all of that, the full system needed to be revisable - fully removable with simple tools. As each requirement was stacked on the prior, the solutions became more and more limited. Often times, a solution could be envisioned but would rely heavily on the surgeon to control. Those options would be discarded because we demanded that the system be simple to use, easy to maintain, and required little training.
GS : Genesys Spine takes tremendous pride in the AIS-C Stand-Alone system and wanted to be able to show it off to the international community. The A' Design Award and Competition provides a tremendous opportunity to do so.
GS : They say in life that you are proudest of the achievements that you work the hardest to achieve. At Genesys Spine, we set the bar extremely high on what we wanted to accomplish with this project. Because of this, the design process was extremely rigorous, difficult, and time consuming. In the end, we are proud that we didn't compromise and that we achieved our goal to produce a world-class system. We learned that all of the hours of work and dedication can pay off and to never settle.
