This Small Business Innovation Research (SBIR) Phase I project addresses the important unmet clinical need of enabling orthopaedic surgeons to collect bone graft from the patient?s pelvic bone in a minimally invasive manner without the patient morbidity and added surgical time intrinsic to the current standard bone graft harvesting methods. The research objectives of the proposed project are to ensure an acceptable level of safety and efficacy of the technology in a simulated use environment (technical feasibility) and to determine the feasibility of attaining the desired manufacturing cost point for this technology (commercial feasibility). These objectives will be completed by investigating various materials and manufacturing processes as well as conducting several key verification tests to develop the current proof of concept into a functional prototype. This project has strong intellectual merit because this transformative technological concept has the potential to disrupt the current methods that surgeons employ for harvesting bone graft by introducing a novel solution that improves patient outcomes, surgical time, and hospital costs.
The broader impact/commercial potential of this project can strongly influence the healthcare system. The technology of the proposed project has the potential to make a broader impact by decreasing the risk of performing the bone graft harvesting procedure compared to current methods and consequently increase the number of surgeons who choose to collect a patient?s own bone graft in lieu of using inferior bone graft alternatives/substitutes. Furthermore, whereas fewer new, inexperienced surgeons are currently being trained to utilize the patient?s own bone graft because of the risks of current harvesting methods, these surgeons may be encouraged to perform the harvesting procedure with the introduction of the proposed concept. The increase in use of the patient?s own bone will benefit patients because of the widely accepted clinical benefits of autogenous bone graft compared to synthetic or exogenous alternative solutions. The proposed technology may also have a significant commercial impact to hospitals because of potential decreases in operating room time and post-operative patient hospitalization time (compared to the standard harvesting procedure) as well as decreased per-procedure product costs (compared to substitute bone graft products).
Avitus Orthopaedics is addressing the important unmet clinical need of enabling orthopaedic surgeons to collect bone graft from the patient’s pelvic bone without the patient morbidity and added surgical time intrinsic to the current standard bone graft harvesting methods. To address this need, the company is developing an innovative surgical device for minimally invasive bone graft harvesting that has various applications in primary orthopaedic procedures (e.g., spinal fusion, extremity non-union, foot & ankle fusion, etc.). In line with the technical development of this technology, the research objectives of the Phase I SBIR Award were to ensure an acceptable level of safety and efficacy of the technology in a simulated use environment (technical feasibility) and to determine the feasibility of attaining the desired manufacturing cost point for this technology (commercial feasibility). Through the course of the project, multiple manufacturers and manufacturing processes were investigated in order to evaluate the feasibility of building the different components of our technology in a scalable and cost effective manner. We were able to explore parallel supply chains and compare the costs of each to determine which pathways would allow for a sustainable business model. Additionally, we were able to identify the requisite verification testing and design the protocol study for these tests. Furthermore, a thorough analysis of the possible sterilization processes used to sterilize the device for clinical use was conducted, and a protocol has been developed to conduct the sterilization. Upon building the pilot batch of products, these verification and sterilization tests will be carried out to ensure the technology’s expected performance in a simulated use environment. The project has strong intellectual merit because this transformative technological concept has the potential to disrupt the current methods that surgeons employ for harvesting bone graft by introducing a novel solution that improves patient outcomes, surgical time, and hospital costs. Furthermore, the broader impact/commercial potential of this project can strongly influence the healthcare system. The technology developed and refined through this project has the potential to make a broader impact by decreasing the risk of performing the bone graft harvesting procedure compared to current methods and consequently increase the number of surgeons who choose to collect a patient’s own bone graft in lieu of using inferior bone graft alternatives/substitutes. Furthermore, whereas fewer new, inexperienced surgeons are currently being trained to utilize the patient’s own bone graft because of the risks of current harvesting methods, these surgeons may be encouraged to perform the harvesting procedure with the introduction of the proposed concept. The increase in use of the patient’s own bone will benefit patients because of the widely accepted clinical benefits of autogenous bone graft compared to synthetic or exogenous alternative solutions. The technology may also have a significant commercial impact to hospitals because of potential decreases in operating room time and post-operative patient hospitalization time (compared to the standard harvesting procedure) as well as decreased per-procedure product costs (compared to substitute bone graft products). These clinical and commercial benefits are integral drivers of our mission to bring this innovative technology to market.
