3D printing, also referred to as “additive manufacturing” or “rapid prototyping,” is the process of making three-dimensional objects from digital designs. Two of the most common types of printers are “disposition printers,” which deposit layers of materials until the 3D object is built, and “binding printers,” which build the object by binding, usually with adhesive or laser fusing, the underlying layers, to create a whole object at the end of the process.

Perhaps this seems pretty straightforward, but delving into the 3D printing of medical devices highlights the multiple aspects of this process, and underscores the potential challenges associated with the FDA’s current and future regulatory paradigm.

When it comes to printing medical devices, the first step involves developing a computer-aided design (“CAD”) file, or animation modeling software, which tells the printer what to make and how to make it.  After the finished design file is sent to the 3D printer, the user chooses a specific material.

3D-printed medical devices allow for a high degree of customization. Think of 3D-produced dental implants which fit perfectly the first time because they are manufactured for your mouth. Or a map of a highly delicate cardiovascular procedure sized precisely to your needs or, more importantly, those of your newborn. 
Continue Reading 3D Printing Series: 3D Printing of Medical Devices