2018
DOI: 10.1371/journal.pone.0195291 View full text |Buy / Rent full text
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Abstract: 3D printing is an emergent manufacturing technology recently being applied in the medical field for the development of custom bone prostheses and scaffolds. However, successful industry transformation to this new design and manufacturing approach requires technology integration, concurrent multi-disciplinary collaboration, and a robust quality management framework. This latter change enabler is the focus of this study. While a number of comprehensive quality frameworks have been developed in recent decades to … Show more

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“…Recently published work of the authors described the steps 5.1 to 5.3 of the QbD risks assessment procedure developed specifically for AM patient‐specific bone implants and scaffolds. This prior study resulted in a comprehensive design and fabrication process flow diagram, and a risk breakdown structure (RBS) containing 86 FMs that lead to quality nonconformances and 178 potential undesirable effects on product quality . The current study extends on this prior work, focusing on steps 5.4 to 5.7 of the QbD risk assessment procedure for the design and fabrication of AM patient‐specific bone implants and scaffolds (Figure ).…”
Section: Scopementioning
“…As a result, the team selected face‐to‐face interviews as the main data collection method for this research. These semistructured interviews were performed with experts on the previously identified list of risks in order to conduct a detailed risk assessment process …”
Section: Methodsmentioning
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