“Madris worked with me and my team to make sure the IT needs were translated, communicated, and worked through to ensure smooth operations for the members of Kaiser Permanente. Madris always listened to the issues, clarified expectations and communicated with the technical experts to make sure the issues were addressed correctly the first time. She was always professional and yet fun at the same time!”
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
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You're managing a project with tight timelines. How do you maintain consistent quality assurance?
Address scope creep but re-evaluate your goals if something you didn’t expect is staring you in the face. Be honest about progress and roadblocks. Don’t wall off the client because you may find they will reprioritize in a way that makes sense to the project and its goals.
Activity
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I’ve heard similar stories from multiple nurses. The fact pattern sounds familiar to me. I’m interested in speaking with any nurse or healthcare…
I’ve heard similar stories from multiple nurses. The fact pattern sounds familiar to me. I’m interested in speaking with any nurse or healthcare…
Liked by Madris Kinard, MBA
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GOOD NEWS UPDATE re FDA participation in standards and policy writing: As Co-Chair of the AAMI US Working Group 04 (ISO14155 and ISO18969), I am…
GOOD NEWS UPDATE re FDA participation in standards and policy writing: As Co-Chair of the AAMI US Working Group 04 (ISO14155 and ISO18969), I am…
Liked by Madris Kinard, MBA
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The cuts at CDRH should be of concern to everyone. They affect FDA’s ability to get new devices to market and to review adverse events to identify…
The cuts at CDRH should be of concern to everyone. They affect FDA’s ability to get new devices to market and to review adverse events to identify…
Shared by Madris Kinard, MBA
Experience
Education
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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
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Project Management Professional (PMP) - PMI
Project Management Institute
Issued ExpiresCredential ID 1277496
Publications
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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. -
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.
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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 authorsSee publication
Courses
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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
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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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In this chaotic time for federal employees, what will change and what will stay the same at FDA’s device center? In a just-released podcast, Naveen…
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🎉🏈 It's time for Super Bowl LIX! 🌟 There are four former Penn Staters in this year's big game 💙🤍 Who do you think will take home the trophy?…
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