Speakers

Hany Demian is a master level reviewer in the Restorative Devices Branch in the Division of Surgical, Orthopedic and Restorative Devices (DSORD). Mr. Demian has been with the FDA for 16 years. During his career, he has reviewed different types of orthopedic implants from total joint replacements to spinal devices to bone cements and bone void fillers. He applies material science, engineering, clinical principles, appropriate laws and regulations to the review of marketing applications for investigational device exemptions (IDEs), pre-market approval (PMA) and 510K clearance medical device. Currently, he reviews calcium based bone void fillers, demineralized bone matrix human tissues used as bone void fillers, PMMA bone cements using in total joint replacement and vertebroplasty and kyphoplasty procedures, and temporary bone cement spacers containing antibiotics. In addition, Mr. Demian is the FDA liaison to US and international standards organizations as the Center Liaison for Polymeric Materials and STG member for Orthopedics. At ASTM, he is currently on the Editorial Review Committee for publication for ASTM International. Mr. Demian serves as mentor for new reviewers and provides internal training and represents the agency at national and international meetings.

Mr. Demian has a Master of Science, Bioengineering from Clemson University and a Bachelor of Science, Biological Sciences as from Clemson and the author of several publications on orthopedic materials and bone cement.