Kate Lee

Kate brings more than 25 years experience in medical device development and is responsible for the Regulatory, Quality and Human Factors functions at Bigfoot. Most recently Kate provided regulatory and quality consulting to companies in the cardiovascular and diabetes spaces. Prior to leaving consulting to join Bigfoot, Kate held a variety of leadership roles in regulatory, quality and product development, establishing a robust understanding of the regulated medical device space. At Hansen Medical, she served in roles with increasing responsibilities and was in charge of all regulatory activities, encompassing US and OUS submissions and post-market surveillance. Kate spent the first part of her career in R&D, developing and later leading teams in the development of innovative devices in the cardiovascular, vascular and gastroenterology specialties. Kate earned a Master’s degree in Smart Product Design from Stanford and a Bachelor’s degree in Mechanical Engineering from Harvard.