Learn tips from BARDA and the FDA for funding opportunities and smoother approval process for health devices.

"DRIVe-ing Innovation and Commercialization in Medical Diagnostics"

Speaker: Šeila Selimović, Ph.D., Branch Chief– Frontiers Branch, BARDA– Division of Research, Innovation, and Ventures, U.S. Department of Health and Human Services (HHS)

Bio: Šeila Selimović, PhD, serves as a Branch Chief in the Biomedical Advanced Research and Development Authority (BARDA) at the US Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR). Her work at BARDA focuses on de-risking enabling technologies on their path to commercialization, in areas ranging from digital health and wearables to biosensors and point-of-care diagnostics, to tissue engineering and life support technologies.

Prior to BARDA, Šeila was a Program Director at the NIH’s National Institute of Biomedical Imaging and Bioengineering and an AAAS Science and Technology Policy Fellow at the US Department of State. She completed her PhD in Condensed Matter Physics at Brandeis University and a postdoctoral fellowship at Harvard Medical School / Brigham & Women’s Hospital. Dr. Selimović has authored over 60 research articles and editorials and edited two scientific books.
 

“Advancing Medical Device and Digital Health Innovation”

Speaker: Jessica Paulsen, Associate Director for Digital Health, Office of Product Evaluation and Quality, U.S. Food and Drug Administration (FDA)

Bio: Jessica Paulsen is the Associate Director for Digital Health in the Office of Product Evaluation and Quality (OPEQ) in the Center for Devices and Radiological Health (CDRH) at the FDA. She provides executive leadership and strategic oversight of OPEQ’s digital health review practices and policy implementation. She also leads the Center’s Digital Health Focal Point Program which aims to promote communication, collaboration, and consistency in digital health product reviews across CDRH.  She previously served as the Director for the Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices in CDRH. She earned her B.E. in Biomedical Engineering and Engineering Management from Vanderbilt University.