AM to produce load-bearing prostheses: a viable technological perspective for now, in a near future, or never?

Additive Manufacturing technologies have opened new perspectives for the realization of tissue and organs substitutes. The main advantages come from the possibility of using the same technology to produce artificial or biological substitutes in a wide range of outer shapes and inner reticular architectures, which may pave the way to their use to produce personalized substitutes. Additive manufacturing technologies are based on layer-by-layer material fusion and deposition. As such, they have intrinsic limitations which may hinder the possibility to produce substitutes that meet the requirements for safe clinical use. As an example, discontinuities between layers may make the outer surface of a substitute significantly uneven, rough, and may even weaken the substitute mechanical properties in such an aggressive environment as the human body. Moreover, repeated thermal cycles (fusion and solidification) drastically limit the choice of materials which can be used. Finally, the outcome of the production technology is affected by many variables that it is not trivial to control to deliver the necessary quality and repeatability of the production process for medical applications. Indeed, the surface roughness of an implantable prosthesis or organ substitute is key to modulate cell adhesion and the susceptibility to chemical attack by body fluids. Structural strength is a mandatory requirement for load-bearing prostheses (e.g., orthopedic and dental prostheses). Materials for biomedical applications must not only be 3D printable, but also biocompatible and/or possibly have to promote cells growth and to prevent inflammatory reactions. The performance of artificial, bio artificial and tissue-engineered organs needs also to be certified and guaranteed, a rather difficult task to define for devices which may be unique, being tailored on the specific needs of the patient. In this paper, it will be discussed whether this technology is sufficiently mature to replace more traditional techniques or, alternatively, whether it should be limited to a restricted range of emergency applications until the existing relevant technological gaps are filled.