FDA Innovating Patient Access & Payer Task Force
- Mike BilligCo-Founder & CEO, Experien Group
- Danielle FauAdvisor for Technology and Innovation, CDRH
- Murray SheldonAssociate Director for Technology & Innovation, CDRH
Speaker bios
Mike Billig, Co-Founder & CEO, Experien Group
Mike co-founded Experien Group in 2003 with Darlene Crockett-Billig. His entire 40+ year professional career has been involved with regulatory affairs, quality systems, clinical research, and general management for medical device companies. Mike has secured regulatory approval for hundreds of medical device products across the U.S., Europe, Canada, Central and South America, and Asia. He is a recognized industry expert in the growing area of FDA De Novo submissions. Mike has led regulatory teams for a wide variety of technologies, including sterile disposable products, electronic instruments, robotics, combination products, mobile medical apps, and devices for regenerative medicine. Mike has particular expertise in interventional cardiology and cardiac surgery.
At Experien Group, Mike’s primary role for client companies is to provide strategic regulatory and clinical support, including virtual staff executive leadership. For several clients, Mike functions as the Acting Vice President of Regulatory, Quality and Clinical, representing the companies in Board of Directors meetings, sales meetings, industry symposia, investors meetings, regulatory agency interface, and more.
Danielle Fau, Advisor for Technology and Innovation, CDRH
Danielle Fau, M.S.E., is a Biomedical Engineer and on assignment to the Innovation Team the Office of Strategic Partnerships and Technology Innovation (OST), in the Center for Devices and Radiological Health (CDRH)/FDA. In this role, she works to address patient access barriers to medical devices. Prior to joining OST, Danielle was a Biomedical Engineer and Lead Reviewer of Gastroenterology and Endoscopy products in the Office of Product Evaluation and Quality (OPEQ). Before commencing her career in the federal government, Danielle worked for five years domestically and internationally in the Medical Device Industry, as a New Product Development Engineer and Whitaker International Fellow. She received her Masters and Bachelors of Science in Engineering, majoring in Materials Science and Engineering, from the University of Pennsylvania.
Murray Sheldon, Associate Director for Technology & Innovation, CDRH
Dr. Murray Sheldon, MD received his medical degree from the University of Michigan Medical School in 1975 and his cardiovascular fellowship at the Montefiore Hospital and Medical Center in New York. After practicing cardiac, thoracic and vascular surgery in Northern California for over 20 years, he entered the medical device industry, leading device development projects and providing expert consultative services to numerous start-up innovative medical device development firms. Dr. Sheldon joined the FDA in 2013 as the Associate Director for Technology and Innovation overseeing the Center’s initiative to proactively facilitate medical device innovation to address unmet public health needs and to align what is traditionally done at FDA with what is required to support the US medical device ecosystem. His primary focus is working with FDA staff, the medical device industry, the clinical community and other stakeholders on ways to facilitate bringing innovative medical devices to the patients in the US first in the world. Dr. Sheldon currently leads the Medical Device Payer Communication Task Force, identifying methods to streamline the path from FDA approval to reimbursement.










