• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    Optimize EP Launches CaRM Cardiac Device Data Management Platform

    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR

    Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

    Moon Surgical Expands Leadership Team
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Pharmaceutical Focus: A Look at Combination Products

    The Printed World: Additive Manufacturing in Medtech

    The Lost Year: 2020 Year in Review

    Extrusion Evolution

    Little Big Parts: Micromolding Under the Microscope
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Fixing Face Mask Form and Function

    The Heart of the Matter: Trends in Cardiology

    Virtually the Same? The Challenges of Online Conferences

    Digital Health Delivers During a Year for the Ages

    Advanced Technology for Staking and Swaging Medical Plastics
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Spectrum Plastics Group

    maxon

    Medicoil

    FUTEK Advanced Sensor Technology Inc.

    MW Life Sciences
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Meeting Critical Ventilator Product Requirements Amid Pandemic

    Impact of COVID-19 on the Medtech Supply Chain

    Finding the Upside to a Challenging Year

    Preparing Your Design Controls for FDA Approval

    A 'Trial and Error' Approach to Micromolded Parts
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    MW Life Sciences

    Qosina Corp.

    Medbio LLC

    maxon

    Element
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    MDIC Names Director of the National Evaluation System for Health Technology Coordinating Center

    New leader joins organization from the Patient-Centered Outcomes Research Institute.

    Related CONTENT
    • CMS Expedites Breakthrough Device Access; Industry Applauds
    • Medtech Matters: Talking Robotic Surgery with Zimmer Biomet
    • Vonco Products Receives ISO 13485:2016 Certification
    • BioSerenity Achieves FDA Clearance for Wearable Device System
    • Greenlight Guru and Nelson Labs Partner
    Business Wire04.19.17
    The Medical Device Innovation Consortium (MDIC) has announced Rachael L. Fleurence, Ph.D., has been selected to serve as the National Evaluation System for health Technology (NEST) Coordinating Center’s first executive director, effective April 24. She joins MDIC from the Patient-Centered Outcomes Research Institute (PCORI), where she has led PCORI’s initiative to build the National Patient-Centered Clinical Research Network, or PCORnet, for the past five years. PCORnet has been a transformational effort to engage patients and leverage electronic health data to improve the speed and efficiency of clinical research in the United-States.

    “We are thrilled to have Dr. Fleurence lead the Coordinating Center,” said MDIC Board Chairman Mike Minogue, president, CEO and chairman of Abiomed. “The first step in building a strong organization is hiring the right leadership. Rachael is an established leader with direct experience in building a national data network.”
     
    In September 2016, MDIC was awarded $3 million in seed funding by the U.S. Food and Drug Administration (FDA) to establish the NEST Coordinating Center. The goal of NEST is to more efficiently generate better evidence for medical device evaluation and regulatory decision-making. A national evaluation system would generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence, and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices. The initial phase of the project has been focused on hiring the executive director and establishing coordinating center governance.
     
    “I am thrilled to lead this exciting initiative between stakeholders across the medical technology ecosystem under the auspices of the MDIC. With its key objectives of ensuring safety, expediting patient access, and enabling innovation, I believe that NEST has the potential to truly transform the medical device ecosystem over the next few years,” said Fleurence.
     
    “Bringing on a leader with experience building patient-centered data networks is critical to the success of the Coordinating Center,” said Jeffrey Shuren, M.D., J.D. director of the FDA’s Center for Devices and Radiological Health. “We look forward to collaborating with Dr. Fleurence to build a sustainable Coordinating Center for NEST.”

    Fleurence's initial focus will be to establish the Coordinating Center governance structure and identifying demonstration projects that pilot methods for tracking medical device data and patient-reported outcomes through the use of real-world evidence.
     
    “We have greatly appreciated Rachael’s energetic leadership as she guided PCORnet to stability and achievement,” said Dr. Joe Selby, PCORI executive director. “We’ll miss her immensely, but NEST is a perfect next step and she’s the ideal choice to further the vision we share of harnessing clinical data and stakeholder input in service of the research needs of patients, clinicians, policymakers, and manufacturers.”
     
    “I have had the privilege of observing Rachael’s leadership firsthand in her role on the MDIC Board of Directors,” said Bill Murray, president and CEO of MDIC. “With her hiring, we have taken a major step in ensuring the success of the Coordinating Center.”
     
    Founded in 2012, the Medical Device Innovation Consortium is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle. MDIC’s mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders. The Minneapolis, Minn.-based organization works in the pre-competitive space to facilitate development of methods, tools, and approaches that enhance understanding and improve evaluation of product safety, quality, and effectiveness. Its initiatives improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market.
    Related Searches
    • innovation
    • medical
    • fda
    • forward
    Suggested For You
    Perspectives on Post-Pandemic: Consider the IT Infrastructure Perspectives on Post-Pandemic: Consider the IT Infrastructure
    Perspectives on Post-Pandemic: Expect Supply Chain Security to Increase Perspectives on Post-Pandemic: Expect Supply Chain Security to Increase
    Medtech Matters: Medtronic Medtech Matters: Medtronic's Robotic Surgery Status
    Medtech Matters: Surgeons Scrubbing In Virtually Medtech Matters: Surgeons Scrubbing In Virtually
    CMS Expedites Breakthrough Device Access; Industry Applauds CMS Expedites Breakthrough Device Access; Industry Applauds
    Medtech Matters: Talking Robotic Surgery with Zimmer Biomet Medtech Matters: Talking Robotic Surgery with Zimmer Biomet
    Vonco Products Receives ISO 13485:2016 Certification Vonco Products Receives ISO 13485:2016 Certification
    BioSerenity Achieves FDA Clearance for Wearable Device System BioSerenity Achieves FDA Clearance for Wearable Device System
    Greenlight Guru and Nelson Labs Partner Greenlight Guru and Nelson Labs Partner
    Katena Products Welcomes New CEO Katena Products Welcomes New CEO
    Medtech Veteran Joins VivaLNK Board Medtech Veteran Joins VivaLNK Board
    New Company Formed to Develop Peripheral Venous Disease Treatments New Company Formed to Develop Peripheral Venous Disease Treatments
    New Global Headquarters for Freudenberg Medical New Global Headquarters for Freudenberg Medical
    4D Biomaterials Awarded Funding for 3D Tissue Scaffolds 4D Biomaterials Awarded Funding for 3D Tissue Scaffolds
    Medtronic’s Mike Coyle to Lead iRhythm Medtronic’s Mike Coyle to Lead iRhythm

    Related Breaking News

    • Optimize EP Launches CaRM Cardiac Device Data Management Platform

      Optimize EP Launches CaRM Cardiac Device Data Management Platform

      Digital tool automates workflow processes and enhances data algorithms to efficiently improve patient care.
      Accesswire 01.15.21

    • Cardiovascular
      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030

      The use of TAVR over open surgical techniques for replacing an aortic valve has exploded globally in recent years.
      GlobalData 01.15.21

    • FDA Clears Canon Medical

      FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR

      New software version for Vantage Orian 1.5T also offers a solution to help clinicians image and quantify fatty liver disease.
      Business Wire 01.15.21


    • Neurological
      Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

      Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

      Next-generation digital therapeutic is designed for the treatment of Alzheimer’s disease.
      Business Wire 01.14.21

    • Surgical
      Moon Surgical Expands Leadership Team

      Moon Surgical Expands Leadership Team

      Adds Jeffery Alvarez, David Noonan, and Nicolas Linard.
      Moon Surgical 01.14.21

    • Royal Philips Partners with Merck on Fertility Treatments

      Royal Philips Partners with Merck on Fertility Treatments

      Partnership supports improved access to care and better outcomes in fertility treatment.
      Royal Philips 01.14.21


    • FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor

      FDA Clears Fever-Detecting Vital Data Sensor in New Cardiac Monitor

      Product contains integrated sensor technologies designed to measure patient activity, heart rate, and body temperature.
      PR Newswire 01.14.21

    • Surge Period Expected for ERCP and PTC Devices Market

      Surge Period Expected for ERCP and PTC Devices Market

      But the boost will not offset revenue losses due to COVID-19.
      GlobalData 01.14.21

    • Beckman Coulter Launches High-Throughput COVID-19 Antigen Test in U.S.

      Beckman Coulter Launches High-Throughput COVID-19 Antigen Test in U.S.

      Test runs on company’s analyzers are capable of processing up to 200 samples per hour, enabling high throughput screening in 30 minutes.
      Beckman Coulter 01.14.21


    • Diagnostics
      Rapid Antigen Tests Manufacturer Acquires BIOLAB

      Rapid Antigen Tests Manufacturer Acquires BIOLAB

      Deal will create jobs and increase Innova's U.S. COVID-19 test kit manufacturing capability.
      Innova Medical Group Inc. 01.14.21

    • Neurological
      Medtronic Begins Adaptive Deep Brain Stimulation Trial for Parkinson

      Medtronic Begins Adaptive Deep Brain Stimulation Trial for Parkinson's

      First-of-its-kind study tests automated therapy that responds to brain signals in Parkinson's patients.
      PR Newswire 01.14.21

    • Diagnostics
      PerkinElmer

      PerkinElmer's SARS-CoV-2 RT-PCR Assay Earns EUA for Asymptomatic Testing

      Gold-standard testing of individuals without COVID-19 symptoms key to controlling the spread.
      Business Wire 01.14.21


    • Diagnostics
      High-Volume COVID Antigen Test Receives FDA EUA

      High-Volume COVID Antigen Test Receives FDA EUA

      Ortho’s Vitros can run up to 130 tests per hour and helps address testing backlogs, supply shortages, and delayed results.
      Ortho Clinical Diagnostics 01.13.21

    • CMS Expedites Breakthrough Device Access; Industry Applauds

      CMS Expedites Breakthrough Device Access; Industry Applauds

      New rule creates an accelerated Medicare coverage pathway for innovative products that the FDA deems ‘breakthrough.’
      MPO Staff 01.13.21

    • Patient Monitoring
      Valencell Launches Blood Pressure Monitoring Tech

      Valencell Launches Blood Pressure Monitoring Tech

      New technology can be built into a myriad of devices to provide accurate blood pressure readings.
      Valencell 01.13.21


    Trending
    • Cytotron Gains Breakthrough Status To Treat Breast, Liver, And Pancreatic Cancers
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Medtech Matters: Talking Robotic Surgery With Zimmer Biomet
    • 5 Ways Plastics Revolutionized The Healthcare Industry
    • Moon Surgical Expands Leadership Team
    Breaking News
    • Optimize EP Launches CaRM Cardiac Device Data Management Platform
    • U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    • FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    • Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation
    • Moon Surgical Expands Leadership Team
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Pharmaceutical Focus: A Look at Combination Products
    • The Printed World: Additive Manufacturing in Medtech
    • The Lost Year: 2020 Year in Review
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Brown Fat Associated with Reductions in Chronic Disease Risk
    NIH Study Identifies Antibacterial Properties in Taurine
    NSF Begins New Certification Program
    Coatings World

    Latest Breaking News From Coatings World

    Zeppelin Acquires MTI Mischtechnik
    Ezio Braggio Joins ChemQuest Europe
    IFS Coatings Announce Carbon Offset Program
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Optimize EP Launches CaRM Cardiac Device Data Management Platform
    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio
    Frontage Bolsters Clinical Services Capabilities
    Sanofi Unveils EUROAPI as Name of New European API Company
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Neenah to Host Packaging Webinar for Printers
    W.S. Badger is Named a ‘150 Top Impact Company’
    Mana Products, Meiyume and RPG Form The Vertical Beauty Alliance
    Happi

    Latest Breaking News From Happi

    A Surge in Interest for Supplements & Vitamins
    P&G, L'Oréal & Amorepacific Make News at CES
    Three Form Vertical Beauty Alliance
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Shemesh Adds U.S. Headquarters
    TZMO USA, Special Needs Group Form Partnership
    BAHP Announces 2021 Officers, Board of Directors
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.
    New Chief Clinical Officer on Board at IncludeHealth
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Toppan Announces 2050 Environmental Vision
    SOI Industry Consortium Joins SEMI as Strategic Association Partner

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login