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to take, and itemize your costs. A white board and sticky notes—one for each step—come in handy. “You don’t want to get hit with an unexpected electrical safety test that can cost $100,000,” he warned. Moore’s Step No. 3 is to file a submission with the FDA and answer any objections brought up by its reviewers. The clock on the government’s 90-day timeframe stops ticking while the applicant works on his answers. The Emergo Group Inc., global consultants for medical devices, got scientific about how long it takes the FDA to complete the 510(k) process and has done periodic analyses. “On average, it takes five months for the FDA to review and clear a medical device 510(k) application,” wrote Scott Schorre, vice president of global marketing for Emergo in his 2014 analysis of 24,000 applications cleared from 2006 through 2013. “About two-thirds of all 510(k) submissions are cleared within six months.” Moore offers a warning: “The FDA loves to get you wrapped


in pre-submission meetings, and there’s no timer on those,” he said. “Pre-submission meetings are not required. If you feel you have enough data to file a submission, then go ahead.” Lawrence offers tips on what goes into that submission. “The agency wants to see that in the history of designing and trying to get your device on the market that you’ve gone through a rigorous design process,” he said. “You have to prove you have internal controls so designs are vetted and peer-reviewed, tested and validated.” Keep track of all changes to the device’s design, he said. “At the end of the day your design history file will show the evaluation of the designs from the beginning to the end,” said Lawrence. “It’s not something foreign to the way engi- neering is typically done.” It’s always better to do your homework before submit- ting, even going so far as to talk with the people who will be reviewing your device. You can even go one step further and hire an FDA-autho-


rized third-party reviewer who can expedite the process, said Emergo’s Schorre, but the FDA still has final say-so. “Do the math to see if it makes sense for your situation,”


he said.


What to do if the FDA rejects your submission? “You can challenge those determinations by the FDA and companies have tried to do that,” said Lawrence. “You can appeal up their chain of command, and as a last resort argue [in court] that the FDA made an arbitrary and capricious decision. “[But] courts are typically very deferential to the scientific expertise of federal agencies.”


Photo courtesy Oxford Performance Medical


OPM’s patient- specific cranial


device became the first FDA-cleared, 3D-manufactured polymer implant.


Helping Bones Mend


Like DeFelice, Jake Evill also has an idea for bone prob- lems. But his device would support, rather than replace, bone that’s been damaged. It’s Cortex, an exoskeleton made of re- cyclable plastic that would replace plaster or fiberglass casts. Cortex looks like a custom-fitted plastic web that fits over an arm or leg: the device is more solid and less “webby” at the site of the break to provide extra support. It opens like a book, and snaps closed for one-time patient use. Once the break is healed, Cortex can be tossed in the recycling bin. To make Cortex, a patient would be X-rayed and 3D scanned. Then computer-aided design would calculate the device’s pattern for support in the area of the bone break, and an algorithm would be used to 3D-print the device. Evill was an industrial design student in New Zealand when he created Cortex. The James Dyson Foundation, established by the creator of the Dyson vacuum cleaner, thought so highly of Evill’s idea that it named him runner-up in its 2013 design engineering competition. Attorney Lawrence said of Evill’s device: “That being out- side the body it’s more akin to an arm sling or an orthopedic brace. I have a hard time believing it wouldn’t be similar to a predicate device.”


61 — Medical Manufacturing 2015


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