Regulatory Considerations in the Design and Manufacturing of Implantable 3D‐Printed Medical Devices

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.

[1]  Stefan Lohfeld,et al.  Selective laser sintering of hydroxyapatite/poly-epsilon-caprolactone scaffolds. , 2010, Acta biomaterialia.

[2]  Carol Rados.  Medical device and radiological health regulations come of age. , 2006, FDA consumer.

[3]  Shaun Eshraghi,et al.  Micromechanical finite-element modeling and experimental characterization of the compressive mechanical properties of polycaprolactone-hydroxyapatite composite scaffolds prepared by selective laser sintering for bone tissue engineering. , 2012, Acta biomaterialia.

[4]  U. Joos,et al.  Experimental and finite element study of a human mandible. , 2000, Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery.

[5]  Thomas Scheper,et al.  3D‐printed individual labware in biosciences by rapid prototyping: A proof of principle , 2015 .

[6]  S. Murgu,et al.  Tracheobronchomalacia and excessive dynamic airway collapse , 2006, Respirology.

[7]  Colleen L Flanagan,et al.  Bone tissue engineering using polycaprolactone scaffolds fabricated via selective laser sintering. , 2005, Biomaterials.

[8]  Neil Hopkinson,et al.  Effects of processing on microstructure and properties of SLS Nylon 12 , 2006 .

[9]  Marc E. Nelson,et al.  Bioresorbable airway splint created with a three-dimensional printer. , 2013, The New England journal of medicine.

[10]  Alok Sutradhar,et al.  Experimental validation of 3D printed patient-specific implants using digital image correlation and finite element analysis , 2014, Comput. Biol. Medicine.

[11]  Colleen L Flanagan,et al.  Treatment of severe porcine tracheomalacia with a 3-dimensionally printed, bioresorbable, external airway splint. , 2014, JAMA otolaryngology-- head & neck surgery.

[12]  P. McHugh,et al.  Dependence of mechanical properties of polyamide components on build parameters in the SLS process , 2007 .

[13]  Ho-Chan Kim,et al.  Fabrication direction optimization to minimize post-machining in layered manufacturing , 2007 .

[14]  V. Barron,et al.  Fabrication, mechanical and in vivo performance of polycaprolactone/tricalcium phosphate composite scaffolds. , 2012, Acta biomaterialia.

[15]  Tania S Douglas,et al.  Additive manufacturing: From implants to organs. , 2014, South African medical journal = Suid-Afrikaanse tydskrif vir geneeskunde.

[16]  Merve Erdal,et al.  Production of graded porous polyamide structures and polyamide-epoxy composites via selective laser sintering , 2014 .

[17]  Anne Marsden,et al.  International Organization for Standardization , 2014 .

[18]  Jim Banks,et al.  Adding Value in Additive Manufacturing : Researchers in the United Kingdom and Europe Look to 3D Printing for Customization , 2013, IEEE Pulse.

[19]  Gean V. Salmoria,et al.  Structure and mechanical properties of cellulose based scaffolds fabricated by selective laser sintering , 2009 .

[20]  Lianshan Lin,et al.  Validation of finite element models for strain analysis of implant-supported prostheses using digital image correlation. , 2013, Dental materials : official publication of the Academy of Dental Materials.

[21]  Experimental validation of 3 D printed patient-speci fi c implants using digital image correlation and fi nite element analysis , 2014 .

[22]  Bethany C Gross,et al.  Evaluation of 3D printing and its potential impact on biotechnology and the chemical sciences. , 2014, Analytical chemistry.

[23]  Suman Das,et al.  Selective laser sintering process optimization for layered manufacturing of CAPA® 6501 polycaprolactone bone tissue engineering scaffolds , 2006 .

[24]  Kevin Berisso,et al.  Three-Dimensional Printing Build Variables That Impact Cylindricity , 2010 .

[25]  Dietmar W Hutmacher,et al.  A comparison of micro CT with other techniques used in the characterization of scaffolds. , 2006, Biomaterials.

[26]  Scott J. Hollister,et al.  Mitigation of tracheobronchomalacia with 3D-printed personalized medical devices in pediatric patients , 2015, Science Translational Medicine.

[27]  G. Klein,et al.  3D printing and neurosurgery--ready for prime time? , 2013, World neurosurgery.

[28]  Daniel Roy Eyers,et al.  Assessment of non-uniform shrinkage in the laser sintering of polymer materials , 2013 .

[29]  M Bohner,et al.  Moisture based three-dimensional printing of calcium phosphate structures for scaffold engineering. , 2013, Acta biomaterialia.

[30]  James Butler.  Using selective laser sintering for manufacturing , 2011 .