The DOI matches its Crossref record; 1 of the 1 references it cites were found in a registry or an index.
Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices
Open accessAbstract
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.
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Citations
Cites
Evaluation of 3D Printing and Its Potential Impact on Biotechnology and the Chemical Sciences
Gross, B. C., Erkal, J. L., Lockwood, S. Y., Chen, C., & Spence, D. M. (2014) · Analytical Chemistry · doi:10.1021/ac403397r · Cited by 1,746
Cited by
Additive manufacturing (3D printing): A review of materials, methods, applications and challenges
Ngo, T. D., Kashani, A., Imbalzano, G., Nguyen, K. T. Q., & Hui, D. (2018) · Composites Part B: Engineering · doi:10.1016/j.compositesb.2018.02.012 · Cited by 8,431
Additively manufactured medical products – the FDA perspective
Di Prima, M., Coburn, J., Hwang, D., Kelly, J., Khairuzzaman, A., & Ricles, L. (2016) · 3D Printing in Medicine · doi:10.1186/s41205-016-0005-9 · Cited by 328
Design, printing, and engineering of regenerative biomaterials for personalized bone healthcare
Jia, Z., Xu, X., Zhu, D., & Zheng, Y. (2023) · Progress in Materials Science · doi:10.1016/j.pmatsci.2023.101072 · Cited by 176
Metadata
- Authors
- Morrison, R. J., Kashlan, K. N., Flanangan, C. L., Wright, J. K., Green, G. E., Hollister, S. J., & Weatherwax, K. J.
- Venue
- Clinical and Translational Science
- Publisher
- Wiley
- Published
- 2015-08-03
- Volume
- 8
- Issue
- 5
- Pages
- 594-600
- ISSN
- 1752-8054 (ISSN-L)
- 1752-8062
- OpenAlex
- W1955801659
- Cited by
- 290
- References
- 1
- FWCI
- 28.02
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Morrison, R. J., Kashlan, K. N., Flanangan, C. L., Wright, J. K., Green, G. E., Hollister, S. J., & Weatherwax, K. J. (2015). Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices. Clinical and Translational Science. https://doi.org/10.1111/cts.12315
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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