Industrial additive manufacturing (AM) company Essentium, Austin, Texas, is collaborating with Vorum, Vancouver, Canada, to introduce a line of biocompatible 3D printing materials to be used in O&P devices. The materials meet International Organization for Standardization 10993 and US Food and Drug Administration guidance for intact skin surface devices as verified by certified, independent lab testing.
A study co-commissioned by Essentium and Vorum verified that Essentium’s PCTG, PA-CF, TPU 74D, and PET-CF are non-contact sensitive, non-cytotoxic, and non-irritant, enabling O&P clinicians to use the 3D printing materials for O&P devices that require long-term skin contact.
Biocompatible materials help ensure comfort for O&P patients who need to wear devices that contact their skin for long periods, the companies said in the statement.
“Modern O&P devices are often designed with a more intimate fit than in the past, which means we need to consider how the patient’s skin might behave in direct contact with the final orthosis or prosthesis,” said Angela Saunders, Vorum CEO. “We know the practitioners who work with our solutions need to be confident that they can provide the best possible result for their patients. Therefore, it’s imperative to have certified materials so that the 3D printed O&P devices work with the body, not against it.”
