Issue link: https://iconnect007.uberflip.com/i/1108006
APRIL 2019 I FLEX007 MAGAZINE 21 What went into defining this device? Well, one of the things about the medical field that's interesting is we have four different custom- ers: patients, doctors, clinics, and payers. To answer your question about the journey in terms of starting the design, we have to take all of those players into account when we start laying out our product requirements, which then feed into our design inputs. Clemente: I think you're on a nice track. Would it be safe to say that the onset of wearable elec- tronics helped you find a solution? Flannery: I'm going to take a little hubris at this point and say we are the onset of wearable electronics (laughs). We're one of the driv- ers in this field. There are other people on the market, for instance, such as iRhythm, who are out there looking for wearable devices to record EKGs and a number of other players in different spaces. We're driven by a need to solve a clinical problem. We're not a hammer looking for a nail or a technology-driven solution; tech- nology is our tool to solve a genuine clinical need. In a lot of ways, we're taking the best that technology has to offer and designing it for our own product requirements and needs. We're driving the revolution, not following on the wave. We like to think of ourselves as at the forefront. Matties: You knew it was going to be a wear- able early on and would have to be a flexible circuit at that point, right? Flannery: Yes. One of the reasons we liked working with Lenthor was we knew we were going to want to push the envelope on a few things to achieve the most efficient form fac- tor—the lightest, most flexible and reliable, and again, highest quality. There's also certain practicality to the wear- able space. You can see a convergence of tech- nical capabilities where the smartphone indus- try has driven low-power sensors and super- efficient telemetry and made things smaller, lighter, and cheaper. So, there's this technology pool to pull from as you're designing a device for your area. Wearable sensors are a nice path because unlike an implantable, they can be a non-sig- nificant risk (NSR) device. One of the things that drives a lot of our design decisions is, "How is this going to play in the FDA approval cycle?" If I can possibly get it into a wearable device, that's a much easier path to get to mar- ket than if I have to build an implantable that is of significant risk. The risks are a lot higher when you break the skin and enter the body. Another factor driving wearable innovation is the recognition that the regulatory environ- ment facilitates getting to market faster for an NSR device. We'll admit that we made a pivot early on from an implantable monitor- ing device for a peripheral bypass graft in part by recognizing this. It's very hard to raise the amount of capital it takes to get an implantable product into the market because of how long you have to support a company before you can ever get your first dollar of revenue. You're see- ing so much opportunity in the wearable space due to technical capability meeting regulatory opportunity; that confluence is creating all of the activity in the medical wearable space. Matties: When you started to design the cir- cuit, what was that process like? Flannery: There were a number of consid- erations in each of the core elements of our device. First, we used a Cypress PSoC device because they have a rich library and we can take advantage of their existing FCC certifica- tion. We're using a variation of low-energy BLE 4.2 telemetry so that we can stand on those Wearable sensors are a nice path because, unlike an implantable, they can be a non-significant risk (NSR) device.