Issue link: https://iconnect007.uberflip.com/i/1047182
NOVEMBER 2018 I SMT007 MAGAZINE 43 "Just recently, the FDA deter- mined that the 2C Tech technol- ogy can be categorized as a medi- cal device and not a drug," stated Astrid Berthe, VP of quality assur- ance and regulatory affairs for 2C Tech. Moreover, 2C Tech has been working with the FDA to use early feasibility studies as a pathway to approval. Early feasibility studies are a formalized FDA testing path- way intended to prove the concept of new tech- nology. When discussing how long it would take to go from classification to initial human testing, Berthe said, "Under this classifica- tion as a device rather than a drug, we could be conducting our first human early feasibil- ity study within 12 months. Under a drug clas- sification, it would have been much longer— years longer." Project Vive: No Approval Needed Not every product will need to follow the path to FDA approval. Some devices may be specifically designed for medical patients but are not medical in-and-of themselves. Mary Elizabeth McCulloch is the founder of Project Vive, a bootstrapped startup creating the affordable, portable, durable VozBox. Her customers and beta testers, for example, might have ALS, cerebral palsy, traumatic brain inju- ries, etc. These are people whose challenge isn't with thinking, but with communicating and being heard. "Our device does not need to be FDA approved; I didn't know that for the first few years," said McCulloch. "I thought that I was going to have to spend a lot of money and time. Then, I learned that a lot of medical devices don't need FDA approval." McCulloch's product is based on a souped- up, ruggedized tablet platform with a vari- ety of peripherals to allow users to control the device: buttons; vision tracking, joysticks, etc. McCulloch said, "A lot of times—particu- larly in the ALS community—the process is to apply to get a device. When the devices cost $10,000 to $16,000, it can be hard to be accepted; communication devices are only approved if they're medi- cally necessary. Sometimes insur- ance won't cover it at all. And if they do, approvals can take two to four months. For someone who has a degenerative disability, if they can't buy a $10,000 device out of pocket, then by the time they get their device, their abilities have already changed so much that some people can't even use that device. Medicare and Medicaid will cover devices like ours, but we would have to lock the device functionality. Medicare and Medicaid won't cover anything that's not a dedicated speech- generation device used exclusively for commu- nication. With ours, you can access the inter- net, App Store, and play games." To McCulloch, that's the whole point of her device. "We're going for a device people can buy out of pocket. Buy it now and start trying things early on," McCulloch stated. "Medical approv- als typically require an 80% speech impair- ment, as in 'unintelligible.' You can't even get an assistive device until you get to that point? Instead of making this fit into the insurance system, we're making a device that individu- als can buy on their own, which is more acces- sible for them." Because the VozBox is not physically changing anything about the user, the device does noth- ing medical to the user. "It's a communica- tion device, just like your cellphone," added McCulloch. "They're just using an alternate access method." VozBox would need a more thorough FDA approval, according to McCull- och, if "it would be in a medical context, such as a hospital or patient treatment setting with some type of medical intervention." Including FDA Approvals in the Design Phase In Libra's role as a contract manufacturer, Lynch and his team work closely with the original equipment manufacturers (OEMs) to verify the appropriate levels of reliability and testing required as a device moves up the clas- Jim Taylor