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Case Study

Fractyl - Revita

Changing the way Type II Diabetes is managed and treated.
OVERVIEW

Fractyl Inc. is a manufacturer of surgical devices and the firmware and software that control them. Fractyl is currently in the research and development phase of an experimental technique to facilitate the surgical treatment of patients presented with Type II Diabetes.

THE CHALLENGE

Type II Diabetes patients currently are required to use multiple needle sticks a day to check their blood glucose, use needles to inject insulin, and also adhere to strict dietary requirements. Globally, it is estimated that more than 3 million people die each year from consequences related to high blood sugar and the World Health Organization projects that diabetes will be the seventh-leading cause of death by 2030.

Fractyl’s experimental catheter is designed to be inserted into the patient’s GI tract so that a balloon device can be guided to the patient’s duodenum to treat the diseased tissue under the direction of a surgical team. Fractyl had developed a prototype of this device, the firmware system to control it, and a Windows-based application to connect the firmware command bus to a touch-screen user interface. For upcoming clinical trials, the prototype needed to be rapidly adapted to a surgical setting - on touch screens, in sterile operating rooms, operated by surgeons with latex gloves.

THE VISION

Fractyl’s device and procedure, powered by Microsoft software and BlueMetal’s custom application, could have significant impact on the treatment of Type 2 diabetes. Type 2 is the most common form of diabetes, accounting for at least 90 percent of all cases (more than 300 million people around the world).

This development would have an astronomical impact on both the patient experience and the cost of traditional diabetes care as it relates to patient care costs. The public health benefits could be massive: a treatment that is proven to be safe and effective that could help end a global epidemic. Quite simply, a procedure lasting less than an hour now has the potential to change lives around the world.

THE SOLUTION

Fractyl had already built out a firmware solution based on the Modbus communication protocol. So, when Fractyl was ready for this next stage of development, the company made it a priority to partner with someone who had certified, deep expertise with Microsoft. BlueMetal’s experience building customized modern applications on Windows-based platforms—along with our stature in the Microsoft Partner community—helped to win the engagement. Time and quality were critical because of the scheduled clinical trials in South America and Europe.

BlueMetal’s task was to build a new version for their clinical trials of the Revita Windows application based on the existing design—a production-quality Windows user application based on the Windows Presentation Foundation. The end result was a touch-screen interface that allows a surgical clinician to manage the whole procedure and control the device via the touch screen—without needing to have a Fractyl engineering technician on site.

By giving surgical teams the ability to manage this procedure on their own, Fractyl and BlueMetal have made it more likely that the solution will be implemented by health care providers around the world, thus potentially changing the lives of hundreds of millions of people.

IN THEIR OWN WORDS
“Amazingly positive feedback from our clinical investigators this week. It would not be an overstatement to say that they were blown away by the thoughtfulness, attention to detail, quality/quantity of information, and intuitiveness of the clinical software and UI. One physician said that we have set a new standard for him in terms of user experience with the console.”

Harith Rajagopalan, Fractyl CEO


“The simplicity of each screen, the logical sequence of steps with easy to read pictures (very important in a multilingual setting), and the formatting altogether gave an added credibility to the Revita program. Importantly, with the way I saw the physicians operating the screens, I can see how this will help accelerate a site’s complete procedural independence, which will help free up much needed resources to work on other projects.”

Darin Wilson, Fractyl International VP