Barriers Implementing Patient-Specific 3D-Printed Bone Scaffolds in Australia: A Scoping Review.

Abstract

3D printing has emerged as an innovative technology over the last decade, with widespread uptake in several fields spanning science, technology and engineering; however, penetration into medical markets has been met with a variety of obstacles. At the 17^th Global Conference on Sustainable Manufacturing in 2018, medical technology stakeholders held a workshop to discuss the barriers that hinder the widespread adoption and diffusion of 3D printing technology in the Australian medical field. Patient-specific 3D-printed bone scaffolds were the central focus of this workshop, with five major barriers identified: material issues; manufacturing and postprocess approval; medical and professional endorsement and adoption; reimbursement; and staff training. To determine the progress made towards overcoming these barriers, we have reviewed the body of literature published from the 2018 conference until now. The most significant progress was observed in material issues with a significant increase in the number of materials and combination of materials that have been successfully printed and used in multiple animal trials and limited human cases. Manufacturing and postprocess approval issues that enable 3D-printed bone scaffold implantation have seen preliminary success with a handful of case trials documented with various levels of success, yet a distinct level of development is still required to satisfy this barrier before commercial production parameters and widespread adoption will be recognized. Medical and professional endorsement and adoption, reimbursement and staff training are yet to experience significant progression, with the possibility that the extent of these barriers will not be clearly understood until well after regulatory approval has been achieved.