Medical Applications of 3D Printing and Standardization Issues

Abstract

The three-dimensional (3D) printing itself is not a novel technology, it is more than 30 years old. Stereolithographic

(SLA) technology has been used as the first and popular technology for medical application

of 3D printing. Since 1991 Radiology and Plastic Surgery have published articles about SLA for

rapid prototyping anatomical 3D models. Medical applications of 3D printing have been popularizing

and stabilizing so far. Implantable medical devices such as metal or absorbable implants, surgical

guide systems, prosthesis and orthosis, and 3D anatomical models for normal or diseased anatomy

have been developing and expanding its markets so far. There are many obstacles, such as insurance,

authorization as a medical device, and lack of standards technology for further expansion of medical

applications. Many technical specifications and guidelines for authorization as medical device have

been published by regulatory bodies from many countries. Even though international standards for 3D

printing have been developing more and more, there have been few standards for medical application

of 3D printing. In this harsh environment academia, company, research institute, regulatory bodies, and

government have been doing good job for the development of 3D printing industry.