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

小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力可能会对医疗保健系统产生重大影响。与目前的方法相比，拟议项目的技术有可能产生更广泛的影响，因为它降低了执行植骨采集程序的风险，从而增加了选择采集患者的外科医生数量-S自己的植骨，而不是使用劣质植骨替代品/替代品。此外，由于目前采集方法的风险，目前正在接受培训以利用患者S自己的骨移植的新的、缺乏经验的外科医生较少，但随着拟议概念的引入，这些外科医生可能会被鼓励执行采集程序。患者S自体骨使用量的增加将使患者受益，因为与合成或外源性替代方案相比，自体骨移植具有广泛接受的临床好处。拟议的技术还可能对医院产生重大的商业影响，因为可能会减少手术室时间和术后患者住院时间(与标准采集程序相比)，并降低每次手术的产品成本(与替代骨移植产品相比)。拟议的项目解决了骨科医生以微创方式从患者S骨盆收集骨移植的重要临床需求，而不会导致患者并发症，并增加了当前标准骨移植获取方法固有的手术时间。拟议项目的研究目标是探索对最低可行产品的各种设计改进，并评估这些变化对价值主张的影响；探索对最低可行产品的调整，并评估它们是否适合用于最低可行产品无法获得的额外外科手术。这些目标将通过调查各种新产品功能和制造工艺以及在各种临床前环境中测试这些概念来实现。这个项目具有很强的智力价值，因为这个变革性的技术概念有可能通过引入一种新的解决方案来改善患者结果、手术时间和医院成本，从而颠覆外科医生目前用于获取骨移植的方法。

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.