The recent approval by the Food and Drug Administration (FDA) of the first drug produced by three-dimensional (3D) printing spurred many discussions regarding the use of this technology in the medical field. 3D printing is not new to medicine, as it has been used in medical research and practice for well over the past decade, but innovations in hardware, software, and materials have opened new avenues for its applications as an emerging technology that could alter existing models in healthcare.
3D printing was invented in the early 1980s and is a manufacturing method in which objects are created via fusion or depositing of materials into layers to create a 3D object.1 Typically, the 3D printer uses instructions in a computer-aided design (CAD) file to build the object layer by layer and moving along the x–y plane. It holds particular interest to medicine because as the software, hardware, and materials have evolved and improved, it has shown to be a less-expensive method for creating custom medical devices, models for surgical planning, and prosthetics. The first successful implantation of a 3D printed mandibular titanium prosthesis was performed by doctors at the University of Hasselt, Hasselt, Belgium in 20132 and last year the first successful implantation of a 3D vertebra was performed on a 12-year-old-boy at a Beijing hospital.3 3D printing is also being applied to less invasive procedures that require extremely customizable models – the FDA approved in August 2015 a new 3D printable material to be used as a denture base for optimal fit.4
Perhaps no FDA approval of a 3D technology in medicine has gathered as much attention as the recent approval of the first prescription medication created using a 3D printing platform. On August 3, 2015, Aprecia Pharmaceuticals received approval for Spritam (levetiracetam) tablets as adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in patients with epilepsy.5 While levetiracetam was already approved for seizure disorders, Spritam is produced using Aprecia’s proprietary printing platform called ZipDose that produces a porous formulation of the drug; this allows the drug to quickly dissolve with only a sip of water.6 Particularly with seizure disorders, the rapid release of a drug for patients with difficulty swallowing could improve treatment adherence. In a statement, Aprecia stated that 71% of patients in a survey reported having missed or skipped a dose of their seizure medication at some time and nearly half reported having a seizure after a missed dose at some time during treatment.6