Donna-Bea Tillman, PhD, MPA, FRAPS

Dr.Tillman, PhD, is a Senior Consultant with Biologics Consulting Group, where she helps clients navigate the FDA regulatory pathways, regulatory requirements, short and long term regulatory strategies, and assists clients with FDA interactions to increase the availability of safe and effective medical devices and combination products. Dr. Tillman is a biomedical engineer with more than 20 years of medical device regulatory experience, including 17 years at the FDA. Dr. Tillman is a former director of the FDA CDRH Office of Device Evaluation, and has broad expertise in medical device regulatory affairs. At the FDA she led a team of 375 scientists and clinicians responsible for the premarket review of medical devices in the US, planned, implemented, and monitored programs to achieve center and agency strategic initiatives, and provided executive leadership for the development of a regulatory framework addressing health information systems. Prior to this position, Dr. Tillman served as Deputy Director for the Office of Device Evaluation, Deputy Division Director for the Division of Cardiovascular Devices, and Chief of the Branch of Pacing and Electrophysiology Devices at the FDA, where she developed programs for the implementation of the Medical Device Modernization and User Fee Act, managed the medical device regulatory review program, and provided scientific and regulatory oversight of the review work of DCD branches, particularly with regard to novel, complex, and problematic issues. Dr. Tillman is also recognized as a thought-leader in the area of medical device regulatory requirements for software, and spent 2 years as the Director of Regulations and Policy at Microsoft establishing a medical device regulatory and quality program, managing premarket submissions and product registrations in the US and internationally, and overseeing the post-market safety program. Dr. Tillman became a Fellow of the Regulatory Affairs Professional Society in 2012, one of 12 highly accomplished professionals working in the healthcare product regulatory field honored that year. Dr. Tillman received a BS in bioengineering from Tulane University, a MPA in public administration from American University, and a PhD in biomedical engineering from Johns Hopkins University.

  • Senior Consultant, Medical Devices, Biologics Consulting Group
  • Former Director of Regulations & Policy, HSG, Microsoft Corporation
  • Former Director, Office of Device Evaluation, US Food & Drug Administration