| dc.description.abstract | Additive manufacturing (AM), also known as threedimensional (3D) printing, is a disruptive technology that is revolutionizing many industries. It is gaining considerable attention, particularly in the medical field as it renders the possibilities of building new devices or modifying existing devices to match a patient's anatomy and to produce anatomically exact models, supporting health professionals with diagnostics and surgery preparation. In addition, the freeform building capability of AM allows the designer to have a complete control over the internal architecture of the device, along with tailored mechanical properties, such as compression strength, stiffness, and many surface features. As the processes of AM become wellunderstood, there is more control over the consistency and quality of the printed parts, positioning this technology for medical applications. With more and more medically approved 3Dprinted devices entering the market, the purpose of this paper is to give an overview of the regulatory pathway to the Food and Drug Administration approval of a medical device, along with common AM processes used in the medical industry. To conclude, medical devices that are enabled by AM technology and associated companies will be highlighted. | |
