A Clinical Risk Assessment of a 3D-Printed Patient-Specific Scaffold by Failure Modes and Effects Analysis

This study aims to carry out a risk assessment to identify and rectify potential clinical risks of a 3D-printed patient-specific scaffold for large-volume alveolar bone regeneration. A survey was used to assess clinicians' perceptions regarding the use of scaffolds in the treatment of alveolar defects and conduct a clinical risk assessment of the developed scaffold using the Failure Modes and Effects Analysis (FMEA) framework. The response rate was 69.4% with a total of 41 responses received. Two particular failure modes were identified as a high priority through the clinical risk assessment conducted. The highest mean Risk Priority Number was obtained by "failure of healing due to patient risk factors" (45.7 ± 27.7), followed by "insufficient soft tissue area" (37.8 ± 24.1). Despite the rapid developments, finding a scaffold that is both biodegradable and tailored to the patient's specific defect in cases of large-volume bone regeneration is still challenging for clinicians. Our results indicate a positive perception of clinicians towards this novel scaffold. The FMEA clinical risk assessment has revealed two failure modes that should be prioritized for risk mitigation (safe clinical translation). These findings are important for the safe transition to in-human trials and subsequent clinical use.