Prior to his retirement in 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 five decades of experience in medical device design and production, is a recognized expert in instructions for use (IFU) and independent laboratory IFU validation studies and is a co-founder of #IFUcan, an online community that examines and explores the world of manufacturer IFUs and provides thought-provoking content on past and current practices and procedures. Schneiter can be reached at [email protected].