Issue link: https://iconnect007.uberflip.com/i/1108006
20 FLEX007 MAGAZINE I APRIL 2019 on dialysis; they go to dialysis treatment three times a week. Then, we're looking at conges- tive heart failure or heart failure at large, since 40% of dialysis patients are diagnosed with heart failure. These are two very big markets in need of innovation, especially in supporting the patients' lives outside of the clinic. Goldman: Today, we're here to talk about the topic for this issue, which is "From Design Through Final Product." Our thought was to follow a product through from the design—the very beginning—through all of your concerns and what happens to make that product a real- ity. Let's jump in at the design stage and talk about how everything worked out with Dave and Rich from Lenthor's perspective. I know the end was good, but what happened in between? David Moody: Tony, if you could give us a brief description of what determined the ultimate solution, that would be great. For example, it had to be a rigid-flex design from the stand- point of what you were trying to accomplish when you were all sitting around the table with a napkin trying to figure out what to do. Flannery: It's funny. We're all going to sit down and write our memoirs about this com- pany someday. GraftWorx has been around for about six and a half years, and we first cut our teeth on trying to bring a product to market on a monitoring system for peripheral arterial dis- ease. And there's a long, convoluted history that goes beyond the scope of this conversa- tion. What we ended up realizing was there was a tremendous opportunity to do this, and we'd get to market faster in the wearable space. It's no secret or surprise that there's a tremen- dous opportunity in medicine to generate data that can make a huge difference in a clinical outcome. As Amit was describing, we're trying to generate quality data that goes back to the clinic and has a positive impact on managing patients with a very difficult disease, end-stage renal disease. We wanted to design something that fits into a patient's lifestyle with very little impact on their lives. In terms of conveying what we're trying to do, this is something that sits on your skin, such as a small, smart bandage. We wanted it to move with you and be flexible, comfortable, light, and forgettable. But at the same time, it's a very sophisticated device. We have 11 dif- ferent sensor data streams acquired during a reading. There is encryption that goes on so that we're HIPAA-compliant in terms of how we store and transmit patient data. There is a tremendous optimization that went into power management so that our device lasts as long as it does on the skin, and this data is pulled into our cloud via a medical data relay (Figure 1). Figure 1: The GraftWorx end-to-end data path. Results from patient monitoring are transmitted via a semi-custom Bluetooth link to our B2H data bridge. Data is transmitted over a cellular IoT network to the Cloud where, after authentication, data is processed and alerts generated. Data and alerts are available to clinicians as part of their standard clinical workflow.