Why bioprinting in regenerative medicine should adopt a rational technology readiness assessment.

Paul D Dalton, Dietmar W Hutmacher, Cathal D O'Connell

Journal: Trends in biotechnology 2024;42(10):1218-1229

PMID: 38614839

Full Text on Elsevier Science View on PubMed

Abstract

Bioprinting is an annex of additive manufacturing, as defined by the American Society for Testing and Materials (ASTM) and International Organization for Standardization (ISO) standards, characterized by the automated deposition of living cells and biomaterials. The tissue engineering and regenerative medicine (TE&RM) community has eagerly adopted bioprinting, while review articles regularly herald its imminent translation to the clinic as functional tissues and organs. Here we argue that such proclamations are premature and counterproductive; they place emphasis on technological progress while typically ignoring the critical stage-gates that must be passed through to bring a technology to market. We suggest the technology readiness level (TRL) scale as a valuable metric for gauging the relative maturity of a bioprinting technology in relation to how it has passed a series of key milestones. We suggest guidelines for a bioprinting-oriented scale and use this to discuss the state-of-the-art of bioprinting in regenerative medicine (BRM) today. Finally, we make corresponding recommendations for improvements to BRM research that would support its progression to clinical translation.

Address: Discipline of Electrical & Biomedical Engineering, RMIT University, Melbourne, VIC, Australia; Department of Surgery, St Vincent's Hospital, University of Melbourne, Fitzroy, VIC, Australia; Aikenhead Centre for Medical Discovery (ACMD), St Vincent's Hospital Melbourne, Fitzroy, VIC, Australia.; Phil and Penny Knight Campus for Accelerating Scientific Impact, University of Oregon, Eugene, OR, USA.; Max Planck Queensland Centre on the Materials Science for Extracellular Matrices, Queensland University of Technology, Kelvin Grove, QLD, Australia; Centre for Behavioural Economics, Society & Technology (BEST), Queensland University of Technology (QUT), Kelvin Grove, QLD, Australia; ARC Training Centre for Multiscale 3D Imaging, Modelling and Manufacturing, Queensland University of Technology, Brisbane, QLD, Australia; Australian Research Council Training Centre for Cell and Tissue Engineering Technologies, Queensland University of Technology, Brisbane, QLD, Australia; Faculty of Engineering, School of Mechanical, Medical and Process Engineering, Queensland University of Technology, Brisbane, QLD, Australia. Electronic address: [email protected].

DOI: 10.1016/j.tibtech.2024.03.006

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MeSH Terms: Regenerative Medicine, Bioprinting, Humans, Tissue Engineering, Printing, Three-Dimensional, Technology Assessment, Biomedical