Statement of problemTransparent facial orthoses (TFOs) are commonly used for the treatment of craniomaxillofacial trauma and burns to prevent hypertrophic and keloid scarring. A TFO is typically customized to the patient’s facial contours and relies on a precise fit to ensure good rehabilitative performance. A smart method of TFO design and manufacture is needed which does not require an experienced prosthetist, allowing for rapidly produced, well-fitting TFOs. Whether the rapid application reduces the final level of patient scarring is unclear. PurposeThe purpose of this clinical study was to determine whether a scalable, automated design-through-manufacture pipeline for patient specific TFO fabrication would be successful. Material and methodsThe automated pipeline received a 3-dimensional (3D) facial scan captured from a depth sensitive mobile phone camera. The scan was cleaned, aligned, and fit to a template mesh, with a known connectivity. The resultant fitted scan was passed into an automated design pipeline, outputting a 3D printable model of a custom TFO. The TFOs were fabricated with 3D printing and were both physically and digitally evaluated to test the fidelity of a digital fit testing system. ResultsA total of 10 individuals were scanned with 5 different scanning technologies (STs). All scans were passed through an automated fitting pipeline and categorized into 2 groups. Each ST was digitally fitted to a ground truth scan. In this manner, a Euclidean distance map was built to the actual facial geometry for each scan. Heatmaps of 3D Euclidean distances were made for all participant faces. ConclusionsThe ability to automatically design and manufacture a custom fitted TFO using commercially available 3D scanning and 3D printing technology was successfully demonstrated. After considering equipment size and operational personnel requirements, vat polymerization (VP) technology was found to be the most promising route to TFO manufacture.