SBIR Phase II: Development of a Minimally Invasive Device for Harvesting Autologous Bone Graft

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II 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). The proposed 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 explore various design enhancements to the minimum viable product and assess the impact of these changes on the value proposition; and to explore adjustments to the minimum viable product and assess their fit for use in additional surgical procedures not accessible by the minimum viable product. These objectives will be completed by investigating various new product features and manufacturing processes as well as testing these concepts in various pre-clinical settings. 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.