title: Regulatory Considerations in the Design and Manufacturing of Implantable 3D-Printed Medical Devices.
abstract: Three-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.
authors.affiliation: Department of Otolaryngology-Head & Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Morrison
authors.affiliation: Department of Otolaryngology-Head & Neck Surgery, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Khaled N
authors.initials: KN
authors.lastname: Kashlan
authors.affiliation: Department of Biomedical Engineering, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Colleen L
authors.initials: CL
authors.lastname: Flanangan
authors.affiliation: Michigan Institute for Clinical & Health Research, IND/IDE Investigator Assistance Program, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Jeanne K
authors.initials: JK
authors.lastname: Wright
authors.affiliation: Department of Otolaryngology-Head & Neck Surgery, Division of Pediatric Otolaryngology, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Glenn E
authors.initials: GE
authors.lastname: Green
authors.affiliation: Department of Biomedical Engineering, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Scott J
authors.initials: SJ
authors.lastname: Hollister
authors.affiliation: Michigan Institute for Clinical & Health Research, IND/IDE Investigator Assistance Program, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Weatherwax
mesh_terms: D020341:Absorbable Implants / Q000009:adverse effects / Q000592:standards; D001980:Bronchi / Q000473:pathology; D001995:Bronchography / Q000379:methods; D017076:Computer-Aided Design; D019981:Health Care Sector / Q000331:legislation & jurisprudence* / Q000592:standards; D006291:Health Policy; D006801:Humans; D062307:Medical Device Legislation / Q000592:standards; D061214:Patient Safety / Q000331:legislation & jurisprudence*; D017410:Practice Guidelines as Topic; D066330:Printing, Three-Dimensional / Q000331:legislation & jurisprudence* / Q000592:standards; D011474:Prosthesis Design / Q000592:standards; D011857:Radiographic Image Interpretation, Computer-Assisted; D018570:Risk Assessment; D014057:Tomography, X-Ray Computed; D014132:Trachea / Q000000981:diagnostic imaging; D055089:Tracheobronchomalacia / Q000000981:diagnostic imaging / Q000628:therapy*
keywords: FDA; computers; imaging; methodology; surgery; translational research