03 - "FDA Responses to Simulation Data used in Recent 510(k) Submissions in Orthopedics"
Topic of the webinar:
FDA Responses to Simulation Data used in Recent 510(k) Submissions in Orthopedics
Panelists:
- Dr. Dana Coombs is a Senior Principal Engineer at Johnson & Johnson. Dana Coombs has over 25 years of experience with design, computer aided engineering, testing, simulation and structural analysis, biomechanics, and computational biomechanics. Dana Coombs also has over 25 years experience in the CAD/CAM/CAE and medical device industry. He has a B.S., M.S., and Ph.D. in mechanical engineering. His Ph.D research focused on spine computational biomechanics, probabilistics and optimization.
- Payman Afshari, PhD – Payman is a Sr. Principal Engineer at DePuy Synthes Spine with focus in computational modeling and Simulation. He is an active member of several external and internal insilico focused standard development and advocacy groups. He has been an advocate for increased role of modeling and simulation in digital evidence generation.
- Jeff Bischoff received his PhD in Mechanical Engineering from the University of Michigan. Following a post-doc at University of Auckland and several years as Assistant Professor at the University of South Carolina, he has been with Zimmer Biomet since 2006, with a strong focus on computational biomechanics. He is currently Director, Biomechanics Research, leading a team of biomechanicians in support of a variety of R&D efforts.
