Devise a fluidic test methodology, laboratory fixturing, and test protocol to characterize fluidic performance of Transcend's implantable MIGS device sufficient to obtain FDA 510(k) clearance to market.
Based upon early experience gained at CooperVision, the Xinetix team devised a test protocol to characterize the flow performance an fluidic resistance of this micro implantable device. At the time there were no established test methods established for this type of device. A standard based upon existing generation glaucoma "shunt" devices was in draft form with the FDA. Xinetix determined that this test methodology was inappropriate for testing of Transcend's new generation of implantable stents. As a result Xinetix proposed a unique test approach which was accepted by the FDA and eventually found its way into the present day international standards for testing devices of this nature.
