Recipient Organization
EMPO HEALTH, INC.
881 SNEATH LANE
SAN BRUNO,CA 94066
Performing Department
(N/A)
Non Technical Summary
Diabetic foot ulcers (DFUs) affect 1 in 4 patients with diabetes over their lifetime, causing over 100,000 amputations per year in the U.S., and costing the healthcare system over $40 B per year. Rural Americans face numerous compounding health disparities compared with their urban counterparts with regards to diabetic foot conditions. Patients with DFUs in rural areas face a 50% increased risk of major amputation compared to patients in rural areas, primarily due to a lack of access to specialized healthcare to detect early signs of these ulcers. While digital health tools can close the gap, limited access to reliable internet connectivity and technology infrastructure hinders their adoption and ability to address rural health disparities. Empo Health is focused on developing a novel in-home imaging bathroom scale for remote monitoring of the feet that can function effectively in the low-network conditions of rural areas. Empo's device has the potential to detect early signs of DFUs and other diabetic foot complications, improving monitoring of healing progress, and impacting daily behaviors and self-care practices for diabetic individuals in rural communities. The purpose of this Phase I project is to improve the device's ability to perform under low-network conditions, and then validate those improvements in rural areas of high interest as suggested by Empo's rural health partners. If successful, the Phase I project will demonstrate the feasibility of use of Empo's product by rural health networks to help reduce diabetic foot amputations for Rural Americans.
Animal Health Component
15%
Research Effort Categories
Basic
(N/A)
Applied
15%
Developmental
85%
Goals / Objectives
Overall Goal: The purpose of this Phase I project is to improve the device's ability to perform under low-network conditions, and then validate those improvements in rural areas of high interest as suggested by Empo's rural health partners. If successful, the Phase I project will demonstrate the feasibility of use of Empo's product by rural health networks to help reduce diabetic foot amputations for Rural Americans.Technical Objective I: Improve the device's hardware tolerance to low-network conditions.The major cellular carriers offer as low as 67% 4G coverage of remote rural areas, which poses a major challenge to use of network-enabled remote health solutions. This objective will focus on making hardware improvements to Empo's device through optimization of cellular signal transmission pathways and antennae, in order to ensure the cellular capability of the device to pick up strong signals. Success Criteria: In a lab environment, Empo's device is able to pick up a signal as strongly as a smartphone, and, as a stretch goal, as a cellular modem. It must continue to tolerate use by a 200kg patients with a factor of safety of 2x.Technical Objective II: Improve the device's firmware tolerance to low-network conditions.The slowest rural areas in the US have mobile internet speeds around 2 Mbps, translating to 0.25 Megabytes/second. Therefore, it is essential that a remote patient monitoring solution used in rural areas can perform as expected under low-bandwidth conditions and withstand extended loss of coverage. This objective will involve development of the firmware code running on Empo's imaging bathroom scale to satisfy these requirements. The technical risk in this Objective is that, given that the weight-bearing images captured by Empo's device are novel, typical algorithms may not suffice and may need to be customized. Success criteria: Device can tolerate a one-week network downtime and transfer all images from a capture within 10 minutes.Technical Objective III: Test the device's ability in rural areas with a rural health partner.After improvements have been made in a lab setting, they need to be tested and validated in the field. During this objective, Empo will receive input and guidance from its rural health partners on locations in which to test the device, and then will perform those tests. Any learnings or challenges will be fed back into an iteration cycle of the Objectives above. Success criteria: Images captured over a week's time from all three locations are uploaded by the device by one day after the week's end.
Project Methods
Technical Objective I:Improve the device's hardware tolerance to low-network conditionsTask 1.1:Improve transmissivity of chassis -This task will be considered complete when it's clear that no more metal can be safely removed from the device.Task 1.2:Optimize antenna design and placement-Trying different antenna designs and placements will be a very iterative process involving simulation and then testing. This task will be considered complete when the detected signal strength in Empo's device is comparable (or better than) that of a standard smartphone.Technical Objective II:Improve the device's firmware tolerance to low-network conditions.Task 2.1: Maximize available storage on the device through reduction in OS image and improvement of eMMC partitioning -At least 8 GB should be able to be freed up for image storage, not just 300 MB, but reaching that point is a significant R&D task. Repartitioning of the eMMC needs to be explored, and the OS size needs to be reduced substantially by pruning out unnecessary drivers and services.Task 2.2:Compress the images and weight data - This will be complete after exploring both lossy compression, lossless compression, and downsamplingTask 2.3:Throw away unusable images with edge computing - This is an exploratory task to be complete after exploring methods of ignoring non-patient users, examining load-data time-series profiles in real-time, and discarding non-whole-foot captures.Technical Objective III:Field-test the device in rural areasTask 3.1: Test in semi-rural areas as identified by rural health partners-To test, the device will be left on-location for one week, with an Empo employee (NOT an external patient) using it two times per day. The device will continually collect connectivity information. To pass the test, the device must have transmitted images from every usage interaction by one day after the end of the collection week. If performance is not met, further iteration will be carried out with tasks from Objectives 1 and 2.Task 3.2:Test in rural areas as identified by rural health partners -The test plan at these locations will be the same as with the previous task. Note that Empo employees, rather than patients, will be used during this feasibility Phase I, as clinical human subjects testing is out of scope.