CERSI P.I.s and Collaborators: Lex Schultheis, MD, Ph.D., William Bentley, Ph.D., UMCP
FDA SMEs and Collaborators: Jorge Hernandez, M.S., James Coburn, M.S., CMDR USPHS, Matthew Diprima, Ph.D., Samanthi Wickamasekara, Ph.D., Berk Oktem, Ph.D., CDRH, Rahki, Ph.D., CDRH
Some medical devices not subject to premarket review by FDA are being fabricated by clinicians at the point-of-care using consumer grade 3D printers. However, any medical device in physical contact with a patient should be biocompatible to insure safety. No studies have been published that relate specific 3D manufacturing process parameters to standard industry measures of biocompatibility. Recognizing this, Dr. Lex Schultheis and his research team investigated whether a specific ABS feedstock that was expected to be biocompatible for permanent contact with skin and mucosal membranes would be altered by 3D printing, and thereby change biocompatibility in the final finished medical device.