SBIR Phase I: Handheld Device for Detection of Otitis Media

这个SBIR第一阶段项目提出了一种新的医疗光学光谱学设备，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明中耳，并在熟悉的耳镜外形中收集反射光。通过分析反射光信号来确定中耳液的存在或不存在--中耳感染的一个标志。重点是优化产品设计和算法，以实现数千台大规模制造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，可以在最需要它的初级保健中实现改进的耳朵感染诊断。大约90%的儿童在5岁之前至少经历过一次耳朵感染，在美国，疑似耳朵感染的误诊是不必要的儿科抗生素使用的主要原因。总体而言，耳朵感染每年导致美国至少50亿美元的直接医疗成本，以及数十亿美元的父母生产力损失。改进耳朵感染诊断有可能消除数百万张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。该项目将使第一个商业化的用于中耳渗出的光学光谱产品成为可能，也是唯一已知的能够准确评估非常蜡质耳朵的耳朵健康的方法。虽然光学光谱学作为一种科学方法得到了广泛的实践，但商品化的医疗产品相对较少。高成本、笨重的光谱仪单元是制约为初级保健和其他低利润率医疗专业量身定做的产品开发的主要限制因素，这些领域有很大的需求。拟议的工作使拟议的耳朵感染设备的制造和部署具有成本效益，并将成为其他下一代基于LED的光学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设备组装应用纠正。与基于光谱仪的系统相比，所产生的方法和系统将能够以高达100倍的单位成本部署医用光学光谱分析系统。合成的耳部感染设备将使临床医生能够更容易地遵守美国儿科学会和美国家庭医生学会在最有需要的初级保健中治疗耳部感染的指南。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.