Quality Control of 3D Printed Resorbable Implants: The 3D Printed Airway Splint Example
3D printing combined with design using patient image data has enabled the development of patient-specific devices. This is especially true for smaller commercial entities and academic groups due to the lower barriers for 3D printing as a manufacturing method. Such patient-specific devices can significantly advance patient care but also face significant hurdles to ensure quality since (1) the devices are built in small lots for specific niche patient markets, (2) there is inherent variability in design parameters to match specific patient anatomy and function, and (3) nontraditional groups now have the capability to readily manufacture medical devices. Following the design control paradigm with specific attention to 3D printing idiosyncrasies is one path to address quality issues in patient-specific design. We present in this chapter an example of a design control approach for quality control of 3D patient-specific devices using a recently developed airway splint as a paradigmatic example for small lot 3D printed patient-specific devices.
Studies reported in the chapter on the airway splint were supported by the National Institutes of Health through NIH/NIHCD R21HD076370, NIH/NIHCD R01HD086201, and NIH T32DC005356. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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