Using JMP® to Improve Manufacturing Yield for Medical Devices Using Sequential Experimental Design
Chad Naegeli, Senior R&D Engineer, Incisive Surgical
The INSORB® |2030 subcuticular skin stapler approximates, closes, and fastens tissue using a penetrator to create an opening for u-shaped absorbable staples. The staples are placed below the skin and hold the incision during normal healing. The stapler competes against metal skin staplers and suture. A new production assembly machine was implemented that checks the functionality of every stapler for proper staple feeding by loading an extra staple and actuating a test-fire. The test-fire determines whether or not the stapler is rejected or accepted. Historically, the yield for this process is near 98.5%. The goal is to increase the yield beyond 99% using sequential experimentation.