Experts from Labcorp hosted a Coffee Talk session to provide MD&M West attendees with a primer on biocompatibility. Chris Parker, PhD, associate department dead of In Vivo Biocompatibility at Labcorp, went back to the basics to unpack the complexity of biocompatibility. Biocompatibility is an ever-changing topic and this talk review not just what biocompatibility is, but how to classify a device and select endpoints for analysis. He also explained the difference between horizontal and vertical standards and FDA guidance documents.
Diving into details, Parker explored the common differences between ISO 10993-1 and FDA expectations, and he discussed the ins and outs of sample preparation for testing. Finally, he explained which standards are most commonly used for the evaluation of each endpoint and introduced common biocompatibility methods.
Parker has worked closely with medical device manufacturers to develop their testing programs and support their regulatory product submissions. His areas of expertise include medical device biocompatibility and efficacy modeling. He has authored numerous journal publications and white papers and is a member of many AAMI BE and ISO TC/194 working groups for ISO 10993.