Enhancing the Aesthetics & Data Sharing Capabilities for a FDA Cleared Class II Device

Overview

DBC Medical has developed an FDA cleared medical device which stimulates blood flow and provides therapeutic benefits to patients with diabetic foot ulcers. Despite the clinical efficacy of the device, clinicians worry that the current mode of data transfer is not secure. In addition, the current physical aesthetics of the device leave much to be desired.

Objectives

The team objectives for the semester were twofold. First, increasing the security of the device’s data transferring capabilities was investigated. Second, a series of recommendations regarding the aesthetics of the device based on customer needs was established.

Approach

-The first step was to identify customer needs. Clinicians and doctors were found to be concerned with securely transferring data, whereas patients didn’t want to be uncomfortable wearing the boot.
-Next, the team split into focus groups to generate concepts on how to accomplish both objectives. One group emphasized the needs of the clinicians, while the other focused on the patient’s needs.
-Upon establishing a framework to accomplish both objectives, a patent search was conducted to identify unique concepts and models to base the team’s ideas off.
-After a variety of concepts were created, the selection process began by using COMSOL and Solidworks simulations to model the aesthetics of the device. In addition, a circuit schematic and Android app were generated to increase the security of the device’s data sharing capabilities.
-Upon conclusion of the concept selection process, further numerical simulations and research was conducted to finalize the team’s aesthetic & data sharing recommendations for the device.

Outcomes

-The data sharing capabilities of the device will be safer as the transfer can occur over a secure app via Bluetooth.
-Switching from a Velcro lacing system to a reel knob lacing system will make the boot less bulky and will grant the patient more flexibility.
-Adjusting the placement of the compression support system from the front to the back will provide the patient with greater flexibility and comfort.
-Modifying the structure of the compression support system will enhance durability and flexibility, which will diminish adverse events and prolong the amount of time the boot can be used in treatment.