Kathryn is the Director of Sanford Vascular Innovations, which is a part of Sanford Health that works in advancing the state of vascular care through innovation, expertise and research to reduce the cost of care while improving outcomes and quality of life for patients. She has more than 10 years of experience in introducing medical devices to market. A regulatory master, her many areas of expertise include bringing a novel drug-device combination product from idea to first-in-man; developing and managing a quality system with design control, design transfer and change management; managing vendor/supplier qualifications, audits and aseptic packaging; and development of device evaluation strategies, filing and carrying out investigational new drugs (IND) or investigational device exemptions (IDE).