Issue link: https://iconnect007.uberflip.com/i/1047182
44 SMT007 MAGAZINE I NOVEMBER 2018 sifications. Higher reliability perfor- mance is critical as the classes get higher, so design and manufac- turing requirements become more stringent as well. Lynch said, "At Libra, we're the contract manufac- turer with a little 'm'; the OEM is the manufacturer with the big 'M.' Between these two groups, success requires a lot of communication between the little m and the big M." The baseline guidelines for manu- facturing medical devices, according to Lynch, is 21 CFR part 820—Good Manufacturing Prac- tices for Medical Devices. "This guideline is required for all medical devices," said Lynch, "Everything Class II requires a higher level of reliability than Class I." Lynch added that this reliability often is achieved through design: choice of components, design for manufactur- ing (DFM) discipline, and design for testabil- ity (DFT). "Class III merely continues the trend toward even higher reliability. A Class III device cannot have a failure because it sustains life," Lynch continued. "Class III also requires clinical test- ing and a premarket approval." Understandably, testing requirements increase as a device moves up the classifica- tions. DFT becomes much more important, as does test coverage. Virtually every component on the bill of materials (BOM) requires scrutiny for performance, reliability, and availability. Lynch gave an example: "We were work- ing with a recent medical device that included an ethernet connector. Originally, the BOM called out a $1 connector. We found in test- ing that the original connector demonstrated a 2% connection failure rate when the cable was inserted at an angle. By changing to a $3 ethernet connector, we found that the tighter tolerances and different design eliminated the at-angle connection failures. That $3 connec- tor would be the proper level of reliability for a Class III device, but that $1 connector may be acceptable for a Class II device." Lynch continued, "The point is that each component should be subjected to close perfor- mance scrutiny." Advice from Both Entrepreneurs It is clear that a key to success- fully bringing a new medical tech- nology product to market depends on learning the boundaries around any required FDA approval and making it a part of the design and specification process. Taylor said, "You can never be too soon," with the question of when to bring the FDA into the discussion with the designers. How did McCulloch conduct her research? "I learned by going to trade shows and expos and talking with people who had devices simi- lar to mine," she explained. "That's the quick- est way. When we went to ATIA—the Assistive Technology International Association—they had products there that were similar to ours, and they said, 'You don't need to get this FDA approved.'" 2C Tech's seminal technical development, according to Taylor, came out of "an idea to pursue a better approach to electrical stim- ulation of the retina than the artificial retina (implantable chip), and better than other simi- lar prostheses under development. Research on that idea led to the identification of QDs as a possible concept." This sort of breakthrough R&D, coupled with implantation into the body, increases the amount of testing involved in ultimately approving the product. The FDA suggests following these process steps premarket: 1. Classify your device because it will help you plan your design for appropriate levels of reliability, manufacturability, and testability 2. Choose the correct premarket submission and know your path to market so you can fund your project appropriately 3. Prepare the appropriate information for your premarket submission to the FDA 4. Send your premarket submission to the FDA and interact with staff during the review 5. Complete the establishment registration and device listing Michael Lynch