Next Article in Journal
In Vivo Animal Study of a Highly Viscous N-butyl Cyanoacrylate Medical Adhesive for Intravenous Embolization
Next Article in Special Issue
The Potential of Stereolithography for 3D Printing of Synthetic Trabecular Bone Structures
Previous Article in Journal
The Simple Mix Design Method and Confined Behavior Analysis for Recycled Aggregate Concrete
Previous Article in Special Issue
Analysis and Optimization of Mechanical Properties of Laser-Sintered Cellulose/PLA Mixture
Article

Cartilage Tissue Engineering by Extrusion Bioprinting: Process Analysis, Risk Evaluation, and Mitigation Strategies

1
RegenHU Ltd., Z.I. du Vivier 22, 1690 Villaz-ST-Pierre, Switzerland
2
Rizzoli RIT-Research, Innovation & Technology Department, IRCCS Istituto Ortopedico Rizzoli, SSD RAMSES, Via di Barbiano 1/10, 40136 Bologna, Italy
*
Authors to whom correspondence should be addressed.
Academic Editor: Cecilia Persson
Materials 2021, 14(13), 3528; https://doi.org/10.3390/ma14133528
Received: 31 May 2021 / Revised: 16 June 2021 / Accepted: 21 June 2021 / Published: 24 June 2021
(This article belongs to the Special Issue Additive Manufacturing (AM) of Biomaterials)
Extrusion bioprinting is considered promising in cartilage tissue engineering since it allows the fabrication of complex, customized, and living constructs potentially suitable for clinical applications. However, clinical translation is often complicated by the variability and unknown/unsolved issues related to this technology. The aim of this study was to perform a risk analysis on a research process, consisting in the bioprinting of a stem cell-laden collagen bioink to fabricate constructs with cartilage-like properties. The method utilized was the Failure Mode and Effect Analysis/Failure Mode and Effect Criticality Analysis (FMEA/FMECA) which foresees a mapping of the process to proactively identify related risks and the mitigation actions. This proactive risk analysis allowed the identification of forty-seven possible failure modes, deriving from seventy-one potential causes. Twenty-four failure modes displayed a high-risk level according to the selected evaluation criteria and threshold (RPN > 100). The results highlighted that the main process risks are a relatively low fidelity of the fabricated structures, unsuitable parameters/material properties, the death of encapsulated cells due to the shear stress generated along the nozzle by mechanical extrusion, and possible biological contamination phenomena. The main mitigation actions involved personnel training and the implementation of dedicated procedures, system calibration, printing conditions check, and, most importantly, a thorough knowledge of selected biomaterial and cell properties that could be built either through the provided data/scientific literature or their preliminary assessment through dedicated experimental optimization phase. To conclude, highlighting issues in the early research phase and putting in place all the required actions to mitigate risks will make easier to develop a standardized process to be quickly translated to clinical use. View Full-Text
Keywords: FMEA/FMECA; bioprinting; cartilage regeneration; translational research FMEA/FMECA; bioprinting; cartilage regeneration; translational research
Show Figures

Graphical abstract

MDPI and ACS Style

Petretta, M.; Desando, G.; Grigolo, B.; Roseti, L. Cartilage Tissue Engineering by Extrusion Bioprinting: Process Analysis, Risk Evaluation, and Mitigation Strategies. Materials 2021, 14, 3528. https://doi.org/10.3390/ma14133528

AMA Style

Petretta M, Desando G, Grigolo B, Roseti L. Cartilage Tissue Engineering by Extrusion Bioprinting: Process Analysis, Risk Evaluation, and Mitigation Strategies. Materials. 2021; 14(13):3528. https://doi.org/10.3390/ma14133528

Chicago/Turabian Style

Petretta, Mauro, Giovanna Desando, Brunella Grigolo, and Livia Roseti. 2021. "Cartilage Tissue Engineering by Extrusion Bioprinting: Process Analysis, Risk Evaluation, and Mitigation Strategies" Materials 14, no. 13: 3528. https://doi.org/10.3390/ma14133528

Find Other Styles
Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Access Map by Country/Region

1
Back to TopTop