Material Selection is a hot topic in the medical industry. So, please attend the panel discussion moderated by our Engineering Program Director, Stacie Depner. We’re in a time period of very advanced materials development. Along with that comes increased risk. Related to this, the FDA has updated their guidance in 2016 to improve bio-compatibility evaluations. The guidance is intended to reduce adverse biological responses. Additionally, in the last couple weeks, FDA issued guidance called the Safety and Performance Based Pathways to further define expectations to mitigate risk. According to Principal Research Scientist, Jeffrey Ellis who combed through FDA data, 30-40% of product recalls are materials related. Risk is increased when pushing the limits of materials performance. Also, new materials hitting the market lack the historical understanding of factors that cause adverse events. Because of this, device developers need to be more aware of variation in processing than before.
The team on this panel has put together a list of material selection criteria for discussion. The panelists are excited to share this and similar material selection topics at MD&M on Wed. February 12th at 8:30 am in room 210C.