Objective:

Current quality control of the breast scaffolds is performed via mechanical testing, which may be destructive and visual inspection by the technician. The non-destructive gold standard is microCT imaging and analysis, however this method is very expensive, time-consuming and limited to a few scaffolds only. The objective of this project is the development of a new quality control device and method suitable to provide quality assurance of large 3D printed soft tissue scaffolds.

Alignment within M3D Innovation:

1. Application of multiscale imaging.
2. Overlap with other projects that require a quality control within their additive manufacturing process.

Approach:

1. Evaluation of quality control (QC) metric.
2. Definition of parameters and acceptable margins.
3. Market analysis of current non-destructive optical and acoustical systems that could be used to perform QC.
4. Development of an automated/semi-automated image analysis algorithm to perform QC.
5. Evaluation of QC parameter: time, cost, accuracy.
6. Development of Quality Assurance (QA) Protocol using novel QC system.
7. Implementation of novel QA system in current BellaSeno’s QMS.

Key Milestones:

1. Evaluation of the quality control metric for breast implants.
2. Development of a novel non-destructive QC method.
3. Implementation of the QC system.