Prior to his retirement in December 2018, James Schneiter had been the founder, owner and president of America’s MedSource Inc., which designed, developed, licensed and marketed a variety of implantable vascular devices, laparoscopic devices and neurosurgical instruments. Schneiter has nearly five decades of experience in medical device design and production and is a recognized expert in the area of instructions for use (IFU) and independent laboratory IFU validation studies. Schneiter can be reached at [email protected].