A village in Haiti needs to provide umbilical cord clamps for pregnant mothers, but cannot afford a 10,000-unit minimum purchase order. An orthopedic surgeon, sick of long, arduous ACL repair procedures identifies the need for a complex tool to simplify and accelerate surgery. A Chinese man diagnosed with a rare sacral cancer needs a bespoke, durable implant to replace the tumorous bone matter once removed.
For scenarios like these, 3-D printing is the perfect method of manufacturing, and is quickly becoming a mainstream technique for producing medical devices, prosthetics, and drugs. The greatest opportunity for 3-D printing exists when the designer can “grow” a component to create complex surfaces and to match a patients’ anatomy. This digital revolution of physical healthcare products is driven by three trends: the building of clinical evidence for 3-D printing of medical devices, the introduction of new 3-D printing platforms using functional materials, and the FDA’s new framework for ensuring safety and quality.