# A low cost and effective foot orthotics fabrication framework

> **NIH NIH R44** · XYKEN, LLC · 2024 · $657,090

## Abstract

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.

## Key facts

- **NIH application ID:** 10866599
- **Project number:** 5R44AG069564-04
- **Recipient organization:** XYKEN, LLC
- **Principal Investigator:** Steven Yi
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $657,090
- **Award type:** 5
- **Project period:** 2021-06-01 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10866599

## Citation

> US National Institutes of Health, RePORTER application 10866599, A low cost and effective foot orthotics fabrication framework (5R44AG069564-04). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10866599. Licensed CC0.

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