SBIR Phase I: Preventing surgical wound infections in high-risk abdominal surgery

该小型企业创新研究（SBIR）第一阶段项目旨在对一种新技术进行技术可行性研究和临床前测试，该技术旨在预防最常见，最病态和最昂贵的医院获得性感染之一：手术伤口感染。 该技术是一种创新的手术工具，可为伤口提供全面的防污染策略，对外科医生来说也是用户友好的。 该设备有可能成为外科护理质量的变革性创新，特别是在350万接受高风险腹部胃肠道（GI）手术的患者中，其中伤口感染是最常见的。 第一阶段项目提出了三个主要目标。 首先，设备的设计和工程？的关键抗感染机制将最终确定使用定量计算机建模和台式测试，然后与外科医生用户在人体尸体上进行定性验证。 其次，将在适当的设计控制下构建初始批次的灭菌原型。 第三，这些原型将在大型动物手术模型中进行安全性和技术有效性测试。 如果这些目标得以实现，第二阶段的活动将包括完成生产工艺，启动人体临床试验，并申请FDA监管许可。该项目的更广泛影响/商业潜力与医疗保健的重大转变相一致，以提高患者护理质量。 仅在美国，手术伤口感染的费用就超过15亿美元，额外住院天数超过60万天，这是高风险腹部手术患者的主要医疗负担。 此外，供应商和医院今天面临着对其伤口感染率的更严格审查，医疗保健改革的全面变化激励了这些关键利益相关者投资于预防性解决方案。然而，目前的解决方案已被证明是不够的，并且手术器械领域的大型现有战略公司在市场上没有引人注目的产品。 所提出的技术具有竞争优势，因为它在相对开放的竞争环境中运行，并且其独特的作用机制提供了全面的伤口保护策略。 因此，从医疗质量和商业化的角度来看，这项技术有可能对伤口感染产生重大的全球影响。 这项技术的最初市场是结直肠手术;在300美元的高度竞争价格点，这转化为5亿美元的初始目标市场。 其他腹部手术的充分扩张机会将潜在市场总额提高到10亿美元。

This Small Business Innovation Research (SBIR) Phase I project seeks to conduct technical feasibility research and pre-clinical testing of a novel technology designed to prevent one of the most frequent, morbid, and costly hospital-acquired infections: surgical wound infection. The technology is an innovative surgical tool that provides a comprehensive anti-contamination strategy for the wound that is also user-friendly for the surgeon. This device has the potential to be a transformative innovation in the quality of surgical care, particularly in the 3.5 million patients undergoing high-risk abdominal-gastrointestinal (GI) surgery in whom wound infections are the most common. This Phase I project proposes three main objectives. First, the design and engineering of the device?s critical anti-infective mechanism will be finalized using quantitative computer modeling and benchtop testing, and then validated qualitatively with surgeon-users in a human cadaver. Second, an initial batch of sterilized prototypes will be built under appropriate design controls. Third, these prototypes will be tested for safety and technical efficacy in a large animal surgical model. If these objectives are met, Phase II activities will include finalization of manufacturing processes, initiation of clinical trials in human subjects, and application for FDA regulatory clearance.The broader impact/commercial potential of this project aligns with a major shift in healthcare to improve the quality of patient care. At a cost of over $1.5B and 600,000 extra hospital days in the US alone, surgical wound infection in high-risk abdominal surgery patients is a major healthcare burden. In addition, providers and hospitals face greater scrutiny on their wound infection rates today, and the sweeping changes in healthcare reform have incentivized these critical stakeholders to invest in preventative solutions. However, current solutions have been shown to be insufficient, and the large existing strategic companies in the surgical device space have no compelling products on the market. The proposed technology enjoys a competitive advantage in that it operates in a relatively open competitive landscape, and its unique mechanism of action provides a comprehensive wound protection strategy. Thus, this technology has the potential to make a significant worldwide impact on wound infection, both from a healthcare quality and commercialization standpoint. The initial market for this technology is in colorectal surgery; at a highly-competitive $300 price point, this translates to an initial target market of $500 million. Ample expansion opportunities to other abdominal operations raise the total potential market to $1 billion.