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58 PCB007 MAGAZINE I NOVEMBER 2018 For designers moving into the medical or assistive technologies space, McCulloch advised, "There are a lot of policies, and they're al- ways changing. I would encourage anyone to start reaching out ear- ly. There are people in the medi- cal-legal space that know this leg- islation like the back of their hand. They can tell you why you would want FDA approval or why you wouldn't. Sometimes, it's a little bit of a toss-up on which way to go. How is your device classified? How are you going to label it? If Project Vive were targeting the hospital market, FDA approval would be a good idea, but we're not targeting hospitals. We're target- ing the daily quality of life for someone just trying to go about their day." However, 2C Tech's in-depth R&D approach elicits a different response. "The world of med- ical devices is drastically different today than it was only 10–15 years ago. Controlled clinical trials and proof of both safety and efficacy are now routinely required even for non-invasive diagnostics, and implantable devices take that to a whole different level of intensi- ty, scrutiny, and complexity," stat- ed Taylor. "If anything, we're in the thera- peutic device section more than a medical device," said McCulloch. "But that is the essence of an assis- tive medical device, isn't it?" Taylor's comments contrasted McCulloch's on this topic: "If the innovation is ground- breaking, as is the case with 2C Tech, then the pioneering work is critical, challenging, and potentially very time-consuming." If you're developing a medical device, find out early in the process whether or not your product requires FDA approval. As always, communication is king, and this is especially true in the medical segment. PCB007 Mary Elizabeth McCulloch At SMTA International 2018, Tom Forsythe, execu- tive vice president of KYZEN Corporation, busts myths around "how clean is clean?" He discusses the increas- ing cleaning challenges as devices become denser and form factors become even smaller, and how these trends are driving the need for cleaning and causing a gap in cleaning knowledge. Forsythe also speaks about their new products in data collection and monitoring software for cleaning equipment. KYZEN's Forsythe Discusses Gap in Cleaning Knowledge

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