Design and quality control for translating 3D-printed scaffolds

3D printing has become widely utilized for regenerative medicine research due to its ability to fabricate patient-specific scaffolds with well-controlled porous architecture and the capability of printing cells in 3D configurations. These characteristics, combined with the unique capability of producing implants and scaffolds for small, specific patient populations not feasible with other manufacturing techniques, have generated significant interest in using 3D printing to transplant implants and scaffolds for clinical use. However, like any clinically translated device, 3D printed scaffolds are subject to design control and quality control requirements to achieve regulatory approval. 3D printing, with its ability to make patient-specific and custom scaffolds; however, brings a number of challenges for design and quality control. In this chapter, we present an example design and quality control for a laser-sintered 3D-printed, resorbable polycaprolactone splint to treat tracheobronchalmalacia (TBM). This splint has been used clinically to save three children with life threatening TBM. We specifically describe a design control for the PCL resorbable splint, detailing design requirements for surgical, mechanical, and biomaterial needs of the splint. Design control entails not only the design requirements for the device, but also the tests to verify that the final device meets the design inputs (design verification) and the preclinical and clinical tests to verify that the fabricated device meets the clinical requirements (design validation). Finally, since design verification and validation are dependent on the laser sintering fabrication process, we detail the parameters of the laser sintering process as well as the methods used to assess devices made using the laser sintering process.