Rebecca (Becky) Bader, PhD, is Director of Regulatory Services at Cambridge Polymer Group. Prior to returning in 2023 after initially working for Cambridge Polymer Group from 2017-2020, Becky was Biocompatibility Engineering Manager at ZOLL Medical Corporation where she ensured biocompatibility and material compliance with harmonized standards and global regulatory requirements. Becky has over 20 years of experience in polymeric materials, drug delivery, medical device, and analytical chemistry. She is currently advancing analytical techniques for materials characterization at Cambridge Polymer Group. Becky has a B.Sc. in Chemistry from Rochester Institute of Technology, an M.Sc. in Chemistry from Princeton University, and a Ph.D. in Materials Science from Oregon State University.
Polymers have been used in medical devices since the early 20th century. Their unique combination of manufacturability, strength-to-weight ratio, cost, and biocompatibility drives their use in products ranging from permanent implants to surgical tools and robotics, but these strengths come with inherent risks. This panel will explore the complexities of material selection, regulatory clearance, and long-term performance. We will specifically address challenges in biocompatibility, sterilization, aging, and environmental impact, teaching attendees how to identify hidden material risks and avoid costly assumptions early in the design process.