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10 - Biomaterials and Multifunctional Biocompatible Ultrananocrystalline Diamond (UNCD™) Technologies Transfer Pathway

From the Laboratory to the Market for Medical Devices and Prostheses

Published online by Cambridge University Press:  08 July 2022

By
Orlando Auciello
Edited by
Orlando Auciello
Orlando Auciello
Affiliation:
University of Texas, Dallas
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Summary

This chapter focus on a description of pathways undertaken to transfer the UNCD film technology from the laboratory into the market, through Original Biomedical Implants (OBI-USA) and OBI-México, founded by O. Auciello and colleagues. Topics discussed in this chapter include: 1) Summary of regulatory pathways in different regions of the worldfor approval of medical devices and prostheses; 2) description of pathway to bring to the market a UNCD-coated microchip (artificial retina) implantable inside the eye to restore partial vision to blind people), 2) description of the process to bring to the market a new generation of long life superior performance UNCD-coated prostheses (artificial hips, knees, dental implants, and more); 3) description of pathway to bring into the market a novel retina reattachment process using combined UNCD-coated magnet outside the eye and injection of super-paramagnetic nanoparticles inside the eye, pushing the retina backon to the inner eye’ layer, when attracted by the magnetic field created by the external magnet.

Keywords

summaryregulatory pathwayapprovalnewUNCDcoatingmedical devicesprostheses
Type
Chapter
Information
Ultrananocrystalline Diamond Coatings for Next-Generation High-Tech and Medical Devices , pp. 263 - 276
Publisher: Cambridge University Press
Print publication year: 2022

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References

Woo, R., Jenkins, D. D., and Greco, R. S., “Biomaterials, and historical overview and current directions,” in Nanotechnology in Nanoscale Technology in Biological Systems, Greco, R., Ed. Boca Raton, FL: Taylor and Francis, 2005.Google Scholar
Williams, D. F., “On the nature of biomaterials,” Biomaterials, vol. 30, p. 5897, 2009.Google Scholar
FDA. Homepage. www.fda.gov.Google Scholar
Constantz, B., “Crossing the chasm: adoption of new medical device nanotechnology,” in Nanoscale Technology in Biological Systems, Greco, R., Ed. Boca Raton, FL: CRC Press, 2005.Google Scholar
Rice, T. W., “The historical, ethical and legal background of human subjects’ research,” Respir Care, vol. 53 (10), p. 1325, 2008.Google ScholarPubMed
World Medical Association, Helsinki Declaration. www.wma.net.Google Scholar
European Commission Enterprise and Industry. Homepage. http://ec.europa.eu/atoz_en.htm.Google Scholar
Ministry of Health Labor and Welfare, Japan. Homepage. www.mhlw.go.jp/english.Google Scholar
Pharmaceutical and Medical Device Agency, Japan. Homepage. www.pmda.go.jp/english/index.html.Google Scholar
Medicines and Health Care Products Regulatory Agency, UK. Homepage. www.mhra.gov.uk/index.htm.Google Scholar
Gurman, P., Rabinovitz-Harison, O., and Hunter, T. B., “Regulatory challenges in biomaterials: focus on medical devices,” in Biomaterials Science: A Clinical and Engineering Approach. Boca Raton, FL: CRC Press, 2012.Google Scholar
FDA. United States FDA Medical Devices Control and Regulation Handbook, 4th ed. Washington, DC: International Publisher Publications, 2010.Google Scholar
FDA, “Overview of device regulation.” www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/default.htm.Google Scholar
ISO. Homepage. www.iso.org.Google Scholar
Feldman, M. D., Petersen, A., Karliner, L., et al., “Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment,” J. Gen. Inter. Med., vol. 23 (suppl. 1), p. 57, 2008.CrossRefGoogle ScholarPubMed
Dhruva, S. S., Bero, L. A., and Redberg, R. F., “Strength of the evidence examined by the FDA in premarket approval of cardiovascular devices,” JAMA, vol. 302 (24), p. 2679, 2009.CrossRefGoogle ScholarPubMed
Brown, S. L., Bright, R. A., and Travis, D. R., “Medical device epidemiology and surveillance: patient safety is the bottom line,” Expert Rev. Med. Dev. vol. 1 (1), p. 1, 2004.CrossRefGoogle ScholarPubMed
Medical Device Regulations, “Global overview and guiding principles: World Health Organization Report,” 2003. www.who.int/whr/2003/en/whr03_en.pdf.Google Scholar
FDA, “Medical device exemptions 510(k) and GMP requirement.” www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=878#start.Google Scholar
FDA, www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=878#start.Google Scholar
Humayun, M., “Interim results from the international trial of Second Sight’s visual prosthesis,” Ophthalmology, vol. 119, p. 779, 2012.CrossRefGoogle ScholarPubMed
Second Sight. Homepage. www.secondsight.com.Google Scholar

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