Ms. Bain is a Partner in NDA Partners. Ms. Bain is a biomedical engineer with more than 25 years of regulatory affairs experience in the medical device industry. She has played an integral role in the development of a wide variety of medical devices, including orthopedic implants, tissue-based devices, and combination products. Her primary focus has been on steering new products through the FDA approval process, including the design and management of pre-clinical and clinical studies, and writing and overseeing FDA submissions. Prior to joining NDA Partners, she held executive officer positions at Cook Medical companies, and worked with the FDA as an industry representative on a number of task forces for developing FDA guidelines and policies.