When:
Wednesday, June 16 | 11:15 am - 12:00 pm
Where:
Tech Center
Level:
Intermediate
Advanced
Participant Type:
Product Development, Quality/Regulatory
Orthopedic devices comprising new biomaterials necessitate a complex regulatory and product development testing plan. The decision tree begins with the answers to three key questions. Is your new biomaterial considered a drug by the regulating authority? Is your biomaterial permanent or absorbable? Are one or more of the constituents of the biomaterial truly new for first-time use in an orthopedic device? This presentation outlines ways to develop an efficient, successful regulatory and development plan, including a definition of the regulatory path, data requirements, consensus standards for materials and testing, scientific literature and the time and money to execute. Dr. Poggie also provides case studies based on his decades of experience in working with new materials.
Learning Objectives