Donna-Bea Tillman, PhD, MPA

Donna-Bea Tillman, PhD, MPA

Group Leader, Medical Devices

Dr. Tillman came to Biologics Consulting in 2012 with over 17 years of medical device experience with the Food and Drug Administration (FDA), Center for Devices and Radiological Health.

Donna-Bea began her career at the FDA in 1994 as a reviewer in the Ob/Gyn devices branch, and entered management as the Branch Chief for Pacing and Electrophysiology Devices. She went on to become the Deputy Division Director for Cardiovascular Devices, and then served as director of the Office of Device Evaluation from 2004-2010. Although Donna-Bea has experience with many different types of medical devices, her area of special expertise is regulation of medical device software. During her early years at FDA, she performed numerous software reviews, and was a key member of the teams that wrote most of the FDA guidance document on software review. In 2000, she took over leadership of the FDA Software Policy Working Group, and over the next ten years, emerged as the FDA expert in the regulation of medical device software.

In 2010 Dr. Tillman joined Microsoft’s Health Solutions Group as the Director of Regulations and Policy, where she was responsible for obtaining the appropriate global premarket registrations and managing Microsoft’s post-market safety programs. Over the nearly two years that she was at Microsoft, her team established a medical device quality system and obtained ISO 13485 certification.

Donna-Bea received her BSE in Engineering from Tulane University, her PhD in Biomedical Engineering from the Johns Hopkins University, and her Master’s in Public Administration from the American University.

As a Senior Consultant for Medical Devices at Biologics Consulting, Donna-Bea utilizes her broad technical and regulatory expertise to assist clients in the following areas:

  • Advising clients on the regulatory requirements that may apply to software used in a medical environment
  • Short and long term regulatory strategy for medical device technologies and combination products
  • Assisting clients with strategy and development of preclinical testing and other product development issues
  • Assisting clients in preparing for FDA meetings and FDA Advisory Panel meetings
  • Preparing and assisting in the preparation of RFDs, Pre-IDEs, IDEs, 510(k)s and PMAs
  • Providing clients with a comprehensive "FDA style" review of submissions

Education

MPA, American University, Washington, DC (2005)

PhD, Biomedical Engineering, Johns Hopkins University, Baltimore, MD (1991)

BSE, Engineering and Biology, Tulane University, New Orleans, LA (1985)