1. Solution to medical device problems: High cost and bad user experience

The Genesis Artificial Pancreas is based on the CoreMD. The CoreMD provides wireless communication and power infrastructure for replaceable wearable medical devices ("wedges"). In an artificial pancreas, these wedges sense interstitial glucose, alert the user that a certain threshold has been reached, and inject sub-cutaneously delivered drugs like insulin and glucagon (or amylin/symlin). The CoreMD, which is reusable, provides a Bluetooth 4.0 Low Energy link, a coin cell battery rechargeable via a micro USB connector and a few interface connectors, with control lines, to the wedges (replaced after a few days of use).

1.1 Lower Costs:
The wedges could be manufactured at a considerably lower cost, decreasing the final price to the patient, since they would not contain a CPU, communication hardware, nor batteries.

1.2 Improved User Experience:
The Bluetooth 4.0 LE link allows designers to create a small, light, wearable medical device and enables it to have friendly graphical user interface on a smartphone or PDA running Android, iOS, etc. This is an environment in which people feel comfortable and are even able to easily hide their medical condition, if they so desire.

This patent pending wearable "medical device hub" is unique and there's nothing this versatile and expandable in the medical device industry today.

2. Functionality, technology, materials, and design:

A simple demonstration App has been written to run on an Android smartphone or PDA. This application communicates with the CoreMD and relays the wedges' commands and data requests. The CoreMD can drive infusion mechanisms, read sensor data, etc. Information from the sensors and/or from drug infusion activity is then relayed back to the smartphone or PDA for the user to see its status, analyze it and/or take proper action. Its simple demonstration application is ready and can communicate with the CoreMD prototype. The current prototype system runs reliably while reading the input signal from a potentiometer (simulating a glucose sensor), automatically calculating an amount & which substance to deliver based on some parameters, and easily controlling output lines to LEDs (simulating glucagon and insulin pumping).

3. Advantages over existing products:

This device enables the replaceable wedges to be manufactured at a lower cost since they would not contain a CPU, communication HW, nor batteries. It's modular and expandable. Disposable insulin pumps are thrown out every 3 days and they contain the CPU, batteries, etc. The CoreMD makes it possible to keep the part that has the CPU, wireless HW and batteries, while throwing out only mechanical components. It allows for complete closed-loop systems to be integrated and connected to the same "hub" (the CoreMD), instead of having multiple independent devices with CPUs, wireless HW and batteries, as seen today when diabetes management medical devices try to integrate an insulin pump with a CGM (glucose monitor). The Bluetooth LE link makes it possible to use a smartphone to control the system, which also lowers system cost and provides the user with a friendly graphical interface.