Design Control for Clinical Translation of 3D Printed Modular Scaffolds

Annals of Biomedical Engineering

Volumn 43, Issue 3, 2015, Pages 774-786

  Hollister, Scott J ^a   Flanagan, Colleen L ^a   Zopf, David A ^b   Morrison, Robert J ^b   Nasser, Hassan ^b   Patel, Janki J ^a   Ebramzadeh, Edward ^c,d   Sangiorgio, Sophia N ^c,d   Wheeler, Matthew B ^e   Green, Glenn E ^b  

^a UNIVERSITY OF MICHIGAN   (United States)

^b UNIVERSITY OF MICHIGAN MEDICAL SCHOOL   (United States)

^c J Vernon Luck   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e UNIVERSITY OF ILLINOIS AT URBANA CHAMPAIGN   (United States)

Author keywords

Additive manufacturing; Image based design; Regulatory; Spine fusion; Tissue engineering; Tracheobronchial malacia; Translation

Indexed keywords

3D PRINTERS; DESIGN; EDUCATION; MATERIALS TESTING; SCAFFOLDS (BIOLOGY); TISSUE; TRANSLATION (LANGUAGES);

ADDITIVE MANUFACTURING; IMAGE-BASED DESIGNS; REGULATORY; SPINE FUSION; TRACHEOBRONCHIAL MALACIA;

TISSUE ENGINEERING;

BRONCHUS; CERVICAL SPINE; COMPUTER AIDED DESIGN; DEVICES; HUMAN; SPLINT; THREE DIMENSIONAL PRINTING; TISSUE ENGINEERING; TISSUE SCAFFOLD; TRACHEA;

BRONCHI; CERVICAL VERTEBRAE; COMPUTER-AIDED DESIGN; HUMANS; PRINTING, THREE-DIMENSIONAL; SPLINTS; TISSUE ENGINEERING; TISSUE SCAFFOLDS; TRACHEA;

EID: 84939999814     PISSN: 00906964     EISSN: 15739686     Source Type: Journal    
DOI: 10.1007/s10439-015-1270-2     Document Type: Article

References (36)

1. Arthur, W. B. The Nature of Technology: What it is and How it Evolves. New York: Free Press, 2009.
2. Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071408.htm. 2007.
3. Coelho, P. G., P. R. Fernandes, H. C. Rodrigues, J. B. Cardoso, and J. M. Guedes. Numerical modeling of bone tissue adaptation—a hierarchical approach for bone apparent density and trabecular structure. J. Biomech. 42:830–837, 2009.
4. Coelho, P. G., P. R. Fernandes, and H. C. Rodrigues. Multiscale modeling of bone tissue with surface and permeability control. J. Biomech. 44:321–329, 2011.
5. Crawford, D. C., T. M. DeBerardino, and R. J. Williams, 3rd. NeoCart, an autologous cartilage tissue implant, compared with microfracture for treatment of distal femoral cartilage lesions: an FDA phase-II prospective, randomized clinical trial after two years. J. Bone Joint Surg. Am. 94:979–989, 2012.
6. Design Control Guidance for Medical Device Manufacturers, http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070627.htm.
7. Dias, M. R., J. M. Guedes, C. L. Flanagan, S. J. Hollister, and P. R. Fernandes. Optimization of scaffold design for bone tissue engineering: a computational and experimental study. Med. Eng. Phys. 36:448–457, 2014.
8. Doyle, H., S. Lohfield, and P. McHugh. Predicting the elastic properties of selective laser sintered PCL/beta-TCP bone scaffold materials using computational modeling. Ann. Biomed. Eng. 42:661–677, 2014.
9. Eosoly, S., N. E. Vrana, S. Lohfeld, M. Hindie, and L. Looney. Interaction of cell culture with composition effects on the mechanical properties of polycaprolactone-hydroxyapatite scaffolds fabricated via selected laser sintering (SLS). Mater. Sci. Eng. C 32:2250–2257, 2012.
10. Eshraghi, S., and S. Das. Mechanical and microstructural properties of polycaprolactone scaffolds with one-dimensional, two-dimensional, and three-dimensional orthogonally oriented porous architectures produced by selective laser sintering. Acta Biomater. 6:2467–2476, 2010.
11. Eshraghi, S., and S. Das. 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. Acta Biomater. 8:3138–3143, 2012.
12. Harrison, R. H., J. P. St-Pierre, and M. M. Stevens. Tissue engineering and regenerative medicine: a year in review. Tissue Eng. Part B 20:1–16, 2014.
13. Hollister, S. J. Porous scaffold design for tissue engineering. Nat. Mater. 4:518–524, 2005.
14. Hollister, S. J., and W. L. Murphy. Scaffold translation: barriers between concept and clinic. Tissue Eng. Part B 17:459–474, 2011.
15. Hollister, S. J., R. A. Levy, T. M. Chu, J. W. Halloran, and S. E. Feinberg. An image-based approach for designing and manufacturing craniofacial scaffolds. Int. J. Oral Maxillofac. Surg. 29:67–71, 2000.
16. Hu, W. W., Y. Elkasabi, H. Y. Chen, Y. Zhang, J. Lahann, S. J. Hollister, and P. H. Krebsbach. The use of reactive polymer coatings to facilitate gene delivery from poly (epsilon-caprolactone) scaffolds. Biomaterials 30:5785–5792, 2009.
17. Jungebluth, P., E. Alici, S. Baiguera, K. Le Blanc, P. Blomberg, B. Bozoky, C. Crowley, O. Einarsson, K. H. Grinnemo, T. Gudbjartsson, S. Le Guyader, G. Henriksson, O. Hermanson, J. E. Juto, B. Leidner, T. Lilja, J. Liska, T. Luedde, V. Lundin, G. Moll, B. Nilsson, C. Roderburg, S. Stromblad, T. Sutlu, A. I. Teixeira, E. Watz, A. Seifalian, and P. Macchiarini. Tracheobronchial transplantation with a stem-cell-seeded bioartificial nanocomposite: a proof-of-concept study. Lancet 378:1997–2004, 2011.
18. Kandziora, F., G. Schollmeier, M. Scholz, J. Schaefer, A. Scholz, G. Schmidmaier, R. Schroder, H. Bail, G. Duda, T. Mittlmeier, and N. P. Hass. Influence of cage design on interbody fusion in a sheep cervical spine model. J. Neurosurg. 96:321–332, 2002.
19. Kang, H., C. Y. Lin, and S. J. Hollister. Topology optimization of three dimensional tissue engineering scaffold architectures for prescribed bulk modulus and diffusivity. Str. Multidiscipl. Optim. 42:633–644, 2010.
20. Kang, H., S. J. Hollister, F. La Marca, P. Park, and C. Y. Lin. Porous biodegradable lumbar interbody fusion cage design and fabrication using integrated global-local topology optimization with laser sintering. J. Biomech. Eng. 135:101013–101018, 2013.
21. Kinsel, D. Design control requirements for medical device development. World J. Pediatr. Congenit. Heart Surg. 3:77–81, 2012.
22. Lin, C. Y., N. Kikuchi, and S. J. Hollister. A novel method for biomaterial scaffold internal architecture design to match bone elastic properties with desired porosity. J. Biomech. 37:623–636, 2004.
23. Low, S. W., Y. J. Ng, T. T. Yeo, and N. Chou. Use of Osteoplug polycaprolactone implants as novel burr-hole covers. Singapore Med. J. 50:777–780, 2009.
24. May-Newman, K., and G. B. Cornwall. Teaching medical device design using design control. Expert Rev. Med. Devices 9:7–14, 2012.
25. Murgu, S., and H. Colt. Tracheobronchomalacia and excessive dynamic airway collapse. Clin. Chest Med. 34:527–555, 2013.
26. Partee, B., S. J. Hollister, and S. Das. Selective laser sintering process optimization for layered manufacturing of CAPA 6501 polycaprolactone bone tissue engineering scaffolds. ASME J. Manuf. Sci. Eng. 128:531–540, 2006.
27. Saito, E., D. Suarez-Gonzalez, R. R. Rao, J. P. Stegemann, W. L. Murphy, and S. J. Hollister. Use of micro-computed tomography to nondestructively characterize biomineral coatings on solid freeform fabricated poly (l-lactic acid) and poly (epsilon-caprolactone) scaffolds in vitro and in vivo. Tissue Eng. Part C 19:507–517, 2013.
28. Schantz, J. T., T. C. Lim, C. Ning, S. H. Teoh, K. C. Tan, S. C. Wang, and D. W. Hutmacher. Cranioplasty after trephination using a novel biodegradable burr hole cover: technical case report. Neurosurgery 58:ONS-E176, 2006; discussion ONS-E176.
29. Schwartz, S. D., J. P. Hubschman, G. Heilwell, V. Franco-Cardenas, C. K. Pan, R. M. Ostrick, E. Mickunas, R. Gay, I. Klimanskaya, and R. Lanza. Embryonic stem cell trials for macular degeneration: a preliminary report. Lancet 379:713–720, 2012.
30. Smith, M. H., C. L. Flanagan, J. M. Kemppainen, J. A. Sack, H. Chung, S. Das, S. J. Hollister, and S. E. Feinberg. Computed tomography-based tissue-engineered scaffolds in craniomaxillofacial surgery. Int. J. Med. Robot. 3:207–216, 2007.
31. Teixeira, M. B., and R. Bradley. Design Controls for the Medical Device Industry. New York: Marcel Dekker Inc, 2003.
32. Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072783.htm.
33. Williams, J. M., A. Adewunmi, R. M. Schek, C. L. Flanagan, P. H. Krebsbach, S. E. Feinberg, S. J. Hollister, and S. Das. Bone tissue engineering using polycaprolactone scaffolds fabricated via selective laser sintering. Biomaterials 26:4817–4827, 2005.
34. Yoo, D. J. Porous scaffold design using the distance field and triply periodic minimal surface models. Biomaterials 32:7741–7754, 2011.
35. Zopf, D. A., S. J. Hollister, M. E. Nelson, R. G. Ohye, and G. E. Green. Bioresorbable airway splint created with a three-dimensional printer. N. Engl. J. Med. 368:2043–2045, 2013.
36. Zopf, D. A., C. L. Flanagan, M. Wheeler, S. J. Hollister, and G. E. Green. Treatment of severe porcine tracheomalacia with a 3-dimensionally printed, bioresorbable, external airway splint. JAMA Otolaryngol. Head Neck Surg. 140:66–71, 2014.