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  • Perspective
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Medical devices on chips

Nature Biomedical Engineering volume 1, Article number: 0045 (2017) Cite this article

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Abstract

The development of medical-device technology is constrained by the financial and ethical considerations of animal testing and clinical trials. Organ-on-a-chip systems are being developed to speed up drug development, yet there has been little recognition or support for the use of this technology in the development and testing of medical devices. In this Perspective, we introduce the concept of medical-device-on-a-chip (MDoC), highlight possible applications and discuss the potential of microfluidic high-throughput technologies for achieving significant time and cost savings over conventional testing. Rather than testing an entire macroscale device, a MDoC has the ability to recapitulate biological function in a physiome associated with medical-device use and to test interactions with device components. In the clinic, MDoCs could also incorporate individual human samples for personalized diagnostics. We also review research towards the integration of key elements of organ-on-a-chip technologies with medical-device testing.

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Figure 1: Development pathway and design considerations for medical devices.
Figure 2: Visualization of the throughput, expense, reproducibility and simulation capability of conventional testing, microplate testing and MDoC testing for the biofouling and cleaning of contact lenses.
Figure 3: Contact-lens-on-a-chip.
Figure 4: Microfabricated microfluidic flow-cell insert for studying bacterial interactions with medical-device hydrogel materials.
Figure 5: Microfluidic cell-culture models.
Figure 6: Human-gut-on-a-chip.

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Acknowledgements

Parts of this work were supported by the US Food and Drug Administration (FDA) Medical Countermeasures Initiative and the FDA Office of Women’s Health. This project was supported in part by an appointment to the ORISE Research Participation Program at the Center for Devices and Radiological Health (CDRH), FDA, administered by the Oak Ridge Institute for Science and Education through an interagency agreement between the US Department of Energy and the FDA/CDRH. The authors thank A. Hood and P. Goering at the FDA/CDRH/Office of Science and Engineering Laboratories/Division of Biology, Chemistry, and Materials Science for reviewing the manuscript and for discussions on medical-device biocompatibility and toxicology testing. The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services. The findings and conclusions in this Perspective have not been formally disseminated by the US Food and Drug Administration and should not be construed to represent any agency determination or policy.

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Authors and Affiliations

  1. Division of Biology, United States Food and Drug Administration, Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Chemistry and Materials Science, 10903 New Hampshire Avenue, Silver Spring, 20993, Maryland, USA

    Allan Guan, Yi Wang & K. Scott Phillips

  2. Department of Systems Design Engineering, University of Waterloo, Waterloo, Ontario N2L 3G1, Canada

    Parisa Hamilton & Maud Gorbet

  3. Department of Biomedical Engineering, The George Washington University, Science and Engineering Hall, 800 22nd Street NW, Washington DC, 20052, USA

    Zhenyu Li

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  1. Allan Guan
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A.G., P.H., Y.W., M.G., Z.L. and K.S.P. all worked on the writing and revision of this Perspective.

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Correspondence to K. Scott Phillips.

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Guan, A., Hamilton, P., Wang, Y. et al. Medical devices on chips. Nat Biomed Eng 1, 0045 (2017). https://doi.org/10.1038/s41551-017-0045

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