Madris Kinard, MBA

Madris Kinard, MBA

York, Pennsylvania, United States
2K followers 500+ connections

About

Stepping into the forefront of healthcare IT, my leadership at Device Events has been…

Contributions

Activity

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Experience

  • Device Events Graphic

    Device Events

    York, Pennsylvania Area

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    Washington D.C. Metro Area

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    Silver Spring, MD

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    Rockville, Maryland

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    White Oak Federal Research Center

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    Baltimore, Maryland Area

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    Metro Washington D.C. Area

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    Washington D.C. Metro Area

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    Washington DC Bureau

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    York, Pennsylvania Area

Education

  • American University

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    Activities and Societies: PRSA member

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    Activities and Societies: National Honor Society Minor in Insurance

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    Activities and Societies: Golden Key National Honor Society

    Minor in Insurance, 1997

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Licenses & Certifications

Publications

  • Trends in Adverse Event Reporting for Inferior Vena Cava Filters and Estimated Insertion in the US, 2016 to 2020

    JAMA Internal Medicine

    From 2016 to 2020, there was a sustained increase in the annual number of AE reports to the FDA for IVCFs, and a sustained decrease in the estimated number of IVCF insertions in the US. The increased number of AE reports may reflect the increase in device fracture risk over time, if indwelling filters are not retrieved. It is unknown the extent to which the increased number of reports reflects improved reporting or an actual increase in the number of AEs. The estimates of annual IVCF insertions…

    From 2016 to 2020, there was a sustained increase in the annual number of AE reports to the FDA for IVCFs, and a sustained decrease in the estimated number of IVCF insertions in the US. The increased number of AE reports may reflect the increase in device fracture risk over time, if indwelling filters are not retrieved. It is unknown the extent to which the increased number of reports reflects improved reporting or an actual increase in the number of AEs. The estimates of annual IVCF insertions are limited by the lack of publicly available sales data and of non-Medicare claims data. Additionally, MAUDE data are subject to underreporting of AEs. Given the limited evidence of clinical benefit and the potential explanations for the trend data notwithstanding, the increasing number of US AE reports for IVCF warrants further study.

    Adverse event data was provided by Device Events.

    See publication
  • UDI Lineage: FDA Not Linking UDIs When a Device Changes Ownership

    Avalere Health

    Until FDA provides step-by-step instructions to device companies on how to manage Change of Ownership (presumably via guidance documents), the GUDID will likely remain an insufficient source for providing comprehensive device lineage, for post-market safety, research and surveillance.

    See publication
  • Unique Device Identifiers (UDIs) for Coronary Stent Post-market Surveillance and Research

    American Heart Journal

    A report from the FDA’s UDI demonstration project -- part of CDRH's medical device epidemiology network (MDEpiNet)

    Other authors
    See publication

Courses

  • Brand Strategy

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  • Database Marketing

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  • Insurance

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  • Knowledge Management

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  • Marketing Information Technology

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  • Risk Management

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Organizations

  • National Medical Device Registries Task Force

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    - Present
  • MDEpiNet S.M.A.R.T. Informatics Think Tank

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    - Present

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