2 research outputs found
Regulatory Considerations in the Design and Manufacturing of Implantable 3DāPrinted Medical Devices
Threeādimensional (3D) printing, or additive manufacturing, technology has rapidly penetrated the medical device industry over the past several years, and innovative groups have harnessed it to create devices with unique composition, structure, and customizability. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. The customizability of 3Dāprinted devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3Dāprinted medical devices pose unique challenges in meeting regulatory standards related to the manufacturing quality assurance. Consistent material powder properties and optimal printing parameters such as build orientation and laser power must be addressed and communicated to the FDA to ensure a quality build. Postprinting considerations unique to 3Dāprinted devices, such as cleaning, finishing and sterilization are also discussed. In this manuscript we illustrate how such regulatory hurdles can be navigated by discussing our experience with our group's 3Dāprinted bioresorbable implantable device.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/115990/1/cts12315.pd
Coāculture of adiposeāderived stem cells and chondrocytes on threeādimensionally printed bioscaffolds for craniofacial cartilage engineering
Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/145213/1/lary27200.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/145213/2/lary27200_am.pd