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Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices
dc.contributor.authorMorrison, Robert J.en_US
dc.contributor.authorKashlan, Khaled N.en_US
dc.contributor.authorFlanangan, Colleen L.en_US
dc.contributor.authorWright, Jeanne K.en_US
dc.contributor.authorGreen, Glenn E.en_US
dc.contributor.authorHollister, Scott J.en_US
dc.contributor.authorWeatherwax, Kevin J.en_US
dc.date.accessioned2015-11-12T21:04:36Z
dc.date.available2016-12-01T14:33:05Zen
dc.date.issued2015-10en_US
dc.identifier.citationMorrison, Robert J.; Kashlan, Khaled N.; Flanangan, Colleen L.; Wright, Jeanne K.; Green, Glenn E.; Hollister, Scott J.; Weatherwax, Kevin J. (2015). "Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices." Clinical and Translational Science 8(5): 594-600.en_US
dc.identifier.issn1752-8054en_US
dc.identifier.issn1752-8062en_US
dc.identifier.urihttps://hdl.handle.net/2027.42/115990
dc.description.abstractThree‐dimensional (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 3D‐printed devices introduces new complexities when drafting a design control model for FDA consideration of market approval. The customizability and unique build processes of 3D‐printed 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 3D‐printed 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 3D‐printed bioresorbable implantable device.en_US
dc.publisherWiley Periodicals, Inc.en_US
dc.publisherETH Zurichen_US
dc.subject.othermethodologyen_US
dc.subject.otherFDAen_US
dc.subject.othersurgeryen_US
dc.subject.othertranslational researchen_US
dc.subject.othercomputersen_US
dc.subject.otherimagingen_US
dc.titleRegulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devicesen_US
dc.typeArticleen_US
dc.rights.robotsIndexNoFollowen_US
dc.subject.hlbsecondlevelPharmacy and Pharmacologyen_US
dc.subject.hlbtoplevelHealth Sciencesen_US
dc.description.peerreviewedPeer Revieweden_US
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/115990/1/cts12315.pdf
dc.identifier.doi10.1111/cts.12315en_US
dc.identifier.sourceClinical and Translational Scienceen_US
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dc.owningcollnameInterdisciplinary and Peer-Reviewed


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