Xyken, LLC SBIR Phase II Award, June 2022

Project Summary:We propose in this SBIR effort to develop a direct 3D mobile imaging based foot orthotics optimization system for clinicians to treat and prevent chronic conditions such as diabetic ulceration and malalignment. The proposed system leaps beyond the traditional orthotics production process, as it allows clinicians to directly and conveniently acquire patients' 3D foot structure from any needed postures (either weight bearing, non-bearing, or partial weight bearing), provides comprehensive details on patients' foot biomechanics, and optimizes orthotics design through finite element analysis. The proposed system also allows localized testing and refitting through a 3D printer, facilitating comfort orthotics design and thus improving the compliance issue faced today.The proposed solution will have the following impact and significance: facilitate effective prevention of the recurrence of diabetic foot ulcers; better foot orthotics customization experience; more comfort fit leading to better compliance; and lower treatment cost.Diabetic foot complications are common and costly problem. Approximately 30.3 million Americans, 9.4 percent of the U.S. population have diabetes, according to the American Academy of Orthotists and Prosthetists. In adults over age 60, about 1 in 4 have diabetes. With the aging population, this group is expected to grow at least 7% per year for the next 10 years. Custom foot orthotics are commonly used to treat and prevent the recurrence of foot diabetics. Undoubtedly, the development of a low cost and ubiquitous mobile platform based foot orthotics optimization and rapid prototyping method will have significant impact on the elderlies especially for the low and middle income sufferers.