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46 SMT007 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 always changing. I would encour- age anyone to start reaching out early. There are people in the medi- cal-legal space that know this legis- lation 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 medi- cal 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 inten- sity, scrutiny, and complexity," stated 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. SMT007 Mary Elizabeth McCulloch Researchers at Northwestern University and Washing- ton University School of Medicine in St. Louis, Missouri, have developed the first example of a bioresorbable elec- tronic medicine: an implantable, biodegradable wireless device that speeds nerve regeneration and improves the healing of a damaged nerve. The collaborators—materials scientists and engi- neers at Northwestern and neurosurgeons at Washing- ton University—developed a device that delivers regu- lar pulses of electricity to damaged peripheral nerves in rats after a surgical repair process, accelerating the regrowth of nerves in their legs and enhancing the ulti- mate recovery of muscle strength and control. The size of a dime and the thickness of a sheet of paper, the wire- less device operates for about two weeks before naturally absorbing into the body. The scientists envision that such transient engineered technolo- gies one day could complement or replace pharmaceutical treatments for a variety of medical conditions in humans. This type of technology, which the researchers refer to as a "biore- sorbable electronic medicine," provides therapy and treatment over a clinically relevant period of time and directly at the site where it's needed, thereby reduc- ing side effects or risks associated with conventional, permanent implants. "These engineered systems provide active, therapeutic function in a programmable, dosed format and then natu- rally disappear into the body, without a trace," said North- western's John A. Rogers, a pioneer in bio-integrated technologies and a co-senior author of the study. "This approach to therapy allows one to think about options that go beyond drugs and chemistry." The research was published in the journal Nature Medicine. While the device has not been tested in humans, the findings offer promise as a future therapeutic option for nerve injury patients. (Source: Northwestern University) Researchers Develop Bioresorbable Electronic Medicine

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