Strict Liability and 3D Printed Medical Devices

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The 3D printing of medical devices is now a reality. The rapidly expanding field allows for incredible improvements in patient care, especially with regard to cost effectiveness, productivity, and a greater democratization and collaboration of design and manufacturing. 3D printing technologies have also expanded capabilities for mass customization of products. For example, using only photographs, custom fit hearing aids can now be designed in a matter of hours to mold perfectly to a patient's ear canals. This same type of customization is occurring regularly on artificial limbs, dental implants, and exterior spinal bracing used in patients with scoliosis or paralysis. A related field, 3D bioprinting, has already made it possible to cure previously untreatable conditions by allowing for the implantation of human tissue on diseased bladders, tracheas, and hearts. Given the incredible potential for these technologies, it is unsurprising that the market for 3D printed devices is expected to be worth $2.16 billion by 2020, with the bio printing market worth nearly $6 billion.