SBIR-STTR Award

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.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve diagnosis of pediatric otitis media (ear infection). Otitis media is the leading cause of unnecessary antibiotic use in children and the second most common pediatric physician appointment. It is estimated that more than 90% of children will suffer at least one case of otitis media before age 5. Despite its prevalence, there may be less than 60% diagnostic accuracy in primary care where the vast majority of cases are seen. Current clinical diagnostics have proven inadequate to address over-prescription of antibiotics and unnecessary specialist and surgical referrals. Otitis media is typically diagnosed using an otoscope to view the tympanic membrane (eardrum) and assess visual signs of an infection. Otoscope designs have changed little since the 1800?s. This SBIR Phase II project advances a novel device that integrates clinical standard otoscopy with a novel technique to non-invasively assess ear health using light in real time and with 98% accuracy. This new otoscope has the potential to create a new standard of care in diagnosis and management of otitis media, and stands to save billions in direct healthcare costs through more accurate diagnosis.This Small Business Innovation Research (SBIR) Phase II project will advance translation of a device providing clinicians with an objective, real-time indicator of ear health during standard otoscopy. At the push of a button, the LED driven measurement will provide an instantaneous, accurate indication of the presence or absence of middle ear effusion (MEE) ? the most sensitive and specific indicator of acute otitis media per established clinical guidelines. This project will meet the desired technical specifications of sufficiently sensitive visualization capabilities and reducing measurement time from 1.4 seconds to less than 300 milliseconds. This project will also: 1) Optimize manufacturability and assembly; 2) Develop a standard automated calibration system; and 3) Conduct standard electronic, photobiologic, and biocompatibility testing for safety and regulatory purposes.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.