FocusRegulatory Science

Creating a Space for Innovative Device Development

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Science Translational Medicine  05 Dec 2012:
Vol. 4, Issue 163, pp. 163fs43
DOI: 10.1126/scitranslmed.3005269


  • Fig. 1.

    Modern family. MDIC will facilitate collaboration among federal agencies, industry, and nonprofit groups to spur innovation in regulatory science for the development of complex interdisciplinary devices. Shown are funding sources (blue boxes) for the various stages of medical device discovery and development (white boxes) [adapted from (7)]. Regulatory science is part of early-stage technology development (shown in center of the pathway as a tri-colored box). This crucial step is not funded by traditional sources and will be the focus of MDIC. Solid white arrows, source frequently funds this technological stage; segmented white arrows, source occasionally funds this technological stage. SBIR, small business innovation research grants.



  • Table 1.

    Device use. Number of procedures in the United States (2009). Source: U.S. Centers of Disease Control (

    Number of domestic inpatient procedures
    (N = 48 million per year)
    Insertion of coronary artery stent: 528,000
    Diagnostic ultrasound: 902,000
    CT scan: 497,000
    Arteriography and angiocardiography: 1.9 million
    Cardiac catheterization: 1.1 million
    Total hip replacement: 327,000
    Total knee replacement: 676,000

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