Fig 1.
QbD systematic product and process design development flow chart showing principal steps.
Fig 2.
Search strategy and selection of the studies.
Fig 3.
(a) Studies’ main objective, PU: Process understanding, PO: Prediction and optimization, RER: Reduction of experimental runs, DRM: development of robust manufacturing; (b) Percentage of reduction of experimental runs per paper; (c) QbD steps implemented in the reviewed studies.
Table 1.
The ideal eight quality dimensions of 3D printed bone implants.
Table 2.
Performance indicators of bone substitutes.
Table 3.
Summary of the ideal CQA of custom 3D printed bone implants and scaffolds.
Fig 4.
General process flow diagram of custom 3D printed bone prostheses and scaffolds.
Fig 5.
Detailed process flow diagram for the design and fabrication of custom 3D printed bone prostheses and scaffolds.
Table 4.
Example of FDA recommended initial ISO 10993 biocompatibility evaluation endpoints for medical devices in contact with bone tissue and blood.
Adapted from [200].
Table 5.
Linking CPP activities with CQA groups.
Table 6.
Linking CMA with CQA groups.
Fig 6.
Flow chart of selected quality risk assessment tools, and scope of present study.
Fig 7.
Ishikawa diagram, summary of causes of non-conformity to the quality of custom 3D printed bone implants.
Table 7.
RBS of the causes of quality non-conformity in custom 3D printed bone prostheses.