9 - Additive manufacturing for biofabricated medical device applications

Abstract

Additive manufacturing (AM) for advanced medical device applications (biofabrication) encompasses a versatile, growing array of technologies for generating new 2D and 3D materials, synthesized layer-by-layer, for both living (e.g. cellularized scaffolds, tissues, organs, and organoids) and supporting devices (e.g. structural grafts or prosthetic devices). In traditional manufacturing (TM) methods of medical devices, feedstock material is removed from a bulk substance (e.g. titanium bar stock or allograft bone that is cut via a lathe or by computer numerical control [CNC] mill) to form the therapeutic implant materials or support devices. In contrast, AM deposits, fuses or otherwise builds layers of material anew to produce a therapeutic device. AM, particularly for biologics, typically builds materials in small quantities and at relatively slow speeds, such as by layering cells upon many layers of polymer to form a tissue analog. Biofabrication presents extraordinary opportunities for precision manufacturing of viable materials that otherwise are not readily manufacturable by TM methods. Current AM methods related to medical device manufacturing are reviewed in this chapter, including the state-of-the-art in biomaterial manufacturing methods and cellular printing, along with regulatory, quality and product development considerations related to producing AM products.