SBIR Phase II: Productization, Clinical Validation, and Quality & Regulatory Activities for In-Home Diabetic Foot Imaging Bathroom Scale System

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a novel at home scale to reduce severe diabetic foot ulcers in patients with diabetic neuropathy, often sufferring from lost or impaired sensation. Ulcers affect approximatey one-fourth of diabetic patients over their lifetime significantly impacting their mobility and life expectancy. Estimates for diabetic foot ulcer treatments are as high as $40B per year and up to one-third of all direct diabetic healthcare spending. Long term effects include amputation of one or more extremities; accounting for a majority of non-traumatic lower extremity amputations each year. The proposed solution provides a remote at home monitor providing daily visual inspections for early signs of foot ulcers significantly improving current qualitative and often variable- inspection methods representing the current standard of care for detection. This Small Business Innovation Research (SBIR) Phase II project will develop a novel in-home health monitoring product for diabetic foot complications within constraints required for commercialization. The proposal builds on the company’s proprietary imaging and algorithmic method and prototype developed during the Phase I project with three concurrent objectives: (i) Advance the design, engineering and manufacturing activities to ruggedize the product suitable for patient use; (ii) Complete a clinical study with a partner health system to demonstrate patient use adherence and provider usability with the images and data suitable for clinical adoption; and (iii) Perform quality assurance testing of the manufacturable product at scale. The activities aim to complete a product suitable for commercialization for use at home as intended at cost, scale and quality. 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.