MEDICAL MANUFACTURING
advice from a physician, they turn a corner to become FDA- regulated medical devices, Robinson said.
One leader in that space is Glooko Inc. (Palo Alto, CA). Glooko was founded in 2011 by a mobile app developer, a technologist, and a then-Facebook senior executive. Its diabetes management platform, Glooko MeterSync, down- loads readings from more than 40 of the most popular blood glucose meters, insulin pumps and continuous glucose monitoring systems to Android and iOS mobile devices. Other companies are moving into that sector. Late last
year, the FDA granted 510(k) clearance for LabStyle Innova- tions Corp.’s Dario Blood Glucose Monitoring System. The system includes a device housing that includes a blood glucose meter, lancing device, test strips, lancets, control so- lutions and a mobile application. The mobile app allows the user to look at glucose test results using Apple’s iOS 6.1 or above smart mobile device technology. It helps manage the disease by recording the BG results and other user-entered information such as carbohydrates, activity, and insulin use.
Medical Device Market Speeds Up “There have been big changes in the speed of innova-
tion,” Williams said. “We are seeing more new products, new apps, new solutions that meet consumers where they are than we saw even a few years ago. It’s driven by an innovation cycle associated with technology. It doesn’t take long to develop a new piece of software that does some- thing novel.”
That innovation cycle is moving much faster than the
regulatory environment for traditional healthcare infrastructure is accustomed to, Williams said. The FDA has continued to tweak the process in an effort to keep up with changes while maintaining safety. Producing or launching an innovative product in the US has been challenging compared to releasing the same product in Europe because the FDA’s system of approval and clearance depends on predictive devices—comparing a new device to one that has already been cleared or approved by the agency, Schorre said.
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The FDA classifi es medical devices as Class I, II and III. Class I devices, such as dental fl oss, are deemed to be low risk. Class II devices, such as condoms, are higher risk than Class I and are subject to more controls to reasonably assure the device is safe and effective. Class III devices are the highest risk—“anything where failure of the device would injure or kill a patient or user,” Schorre said—and require the greatest regulatory controls. Active implantable devices, such as pacemakers, are Class III.
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AdvancedManufacturing.org | June 2016
Some Class I devices, nearly all Class II devices and a few Class III devices must be cleared by the FDA via a 510(k) process, also known as Pre-Market Notifi cation. Most Class III devices are subject to the far more stringent PreMarket Approval (PMA) re- quirements, which involve clinical trials. Launching an innovative product in the US market is sometimes challenging compared to releasing the same product in the European market. That’s because the FDA has a predicate-based regula- tory system, which relies on comparing
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