SBIR Phase I: Handheld Device for Detection of Otitis Media

该SBIR第一阶段项目推进了一种新型医疗光谱设备，以促进中耳感染的准确诊断。 该设备使用定制的多LED微芯片和光电探测器来照亮中耳，并以熟悉的耳镜形式收集反射光。 分析反射光特征以确定是否存在中耳液-中耳感染的标志。 我们的重点是优化产品设计和算法，以确保数千台大规模生产的设备和数百万患者的黄金标准准确性。 该设备将是一种具有成本效益的手段，在最需要的初级保健中实现改进的耳部感染诊断。 大约90%的儿童在5岁之前至少经历过一次耳部感染，而疑似耳部感染的误诊是美国不必要的儿科抗生素使用的主要原因。 总的来说，耳部感染导致美国每年至少50亿美元的直接医疗保健费用，以及数十亿美元的父母生产力损失。 改善耳部感染诊断有可能消除数百万不必要的抗生素处方-这是减缓耐药微生物发展的关键一步。 解决这一挑战需要一种具有成本效益且始终准确的产品。该项目将实现第一个用于中耳积液的商用光学光谱产品，以及唯一能够准确评估非常蜡质耳朵的耳朵健康的已知方法。 虽然光谱学作为一种科学方法被广泛应用，但商业医疗产品相对较少。 高成本、笨重的光谱仪单元是限制针对初级保健和其他低利润医学专业的产品开发的主要限制，其中存在巨大的需求。 拟议的工作能够实现成本效益的制造和部署拟议的耳部感染设备，并将成为其他下一代基于LED的光谱医疗设备的平台。 研究人员将开发一种算法方案，以纠正大规模生产的LED和光电二极管组件的可变性，并设计和构建测试系统，以自动对每个完成的医疗器械组件进行纠正。 与基于光谱仪的系统相比，所得到的方法和系统将使得能够以低至100倍的单位成本部署医疗光谱系统。 由此产生的耳部感染设备将使临床医生更容易遵守美国儿科学会和美国家庭医生学会的指导方针，在初级保健中治疗耳部感染，在那里是最需要的。这个奖项反映了NSF的法定使命，并已被认为是值得的支持，通过评估使用基金会的知识价值和更广泛的影响审查标准。

This SBIR Phase I project advances a novel medical optical spectroscopy device to facilitate accurate diagnosis of middle ear infections. The device uses a custom multi-LED microchip and photodetectors to illuminate the middle ear and collect reflected light in a familiar otoscope form-factor. Reflected light signatures are analyzed to determine the presence or absence of middle ear fluid - a hallmark of middle ear infection. The focus is to optimize product design and algorithm to enable gold standard accuracy across thousands of mass manufactured devices and millions of patients. The device will be a cost effective means to achieving improved ear infection diagnosis in primary care where it is most needed. Roughly 90% of children experience at least one ear infection before age 5 and misdiagnosis of suspected ear infection is the leading cause of unnecessary pediatric antibiotic use in the US. Collectively, ear infection results in at least $5B direct healthcare costs annually in the US and billions more in lost parent productivity. Improving ear infection diagnosis has the potential to eliminate millions of unnecessary antibiotic prescriptions - a crucial step in mitigating development of resistant microorganisms. Addressing this challenge requires a product that is cost-effective and consistently accurate.This project will enable the first commercially available optical spectroscopy product for middle ear effusion and the only known method capable of accurately assessing ear health in very waxy ears. Although optical spectroscopy as a scientific method is widely practiced, comparatively few commercial medical products exist. High-cost, bulky spectrometer units are a primary limitation restricting development of products tailored to primary care and other low margin medical specialties where there is great need. The proposed work enables cost-effective manufacture and deployment of the proposed device for ear infection and will be a platform for other next-generation, LED-based optical spectroscopy medical devices. The investigators will develop an algorithmic scheme to correct variability in mass manufactured LED and photodiode components and design and construct test systems to automatically apply corrections to each completed medical device assembly. The resultant methods and systems will enable deployment of medical optical spectroscopy systems at up to 100X lower unit cost as compared to spectrometer based systems. The resultant device for ear infection will enable clinicians to more easily adhere to American Academy of Pediatrics and American Academy of Family Physicians guidelines for treating ear infections in primary care where there is greatest need.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.