Osseus Fusion Systems’ 3D printed titanium spinal implants won FDA clearance earlier this year, joining more than 100 devices and one drug currently on the market manufactured on 3D printers.
FDA Commissioner Scott Gottlieb has called 3D printing a transformative technology that could disrupt medical practice, and the agency is scrambling to keep abreast of new regulatory challenges.
Known as additive manufacturing, the process involves production of three-dimensional objects using a digital file. The printer layers successive images or files on top of one another until a solid 3D object is formed. The process allows designers to create 3D models of a patient’s anatomy for use in diagnosis or surgical planning. The technology is also being used to customize orthopaedic implants and accessories, prosthetics, hearing aids, dental implants and wearables, such as flexible sensors. In the future, doctors may be able to bioprint skin cells to help heal burn wounds and print out replacement organs.