the Medical Device Innovation Consortium

National Evaluation System for health Technology Coordinating Center Adds Clinical Laboratory and Patient Engagement Expertise to Governing Committee

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星期四, 七月 15, 2021

The NESTcc Governing Committee comprises stakeholders from across the medical device ecosystem, incorporating industry, regulator, patient, clinician, health system and payor perspectives.

Key Points: 
  • The NESTcc Governing Committee comprises stakeholders from across the medical device ecosystem, incorporating industry, regulator, patient, clinician, health system and payor perspectives.
  • As the Governing Committees American Clinical Laboratories Association (ACLA) appointment, Dr. Salama brings valuable clinical expertise while representing leading laboratories in the advancement of life-saving testing services at the forefront of diagnostic innovation.
  • In addition, the NESTcc Governing Committee must include the patient voice with representatives from patient organizations.
  • In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc).

MDIC Selects Booz Allen Hamilton to Support its Medical Device Cybersecurity Benchmarking Initiative

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星期一, 五月 17, 2021

b'The Medical Device Innovation Consortium (MDIC) today announced a partnership with Booz Allen Hamilton to establish a benchmark of the medical device industry\xe2\x80\x99s cybersecurity maturity and create resources to measure maturity over time.

Key Points: 
  • b'The Medical Device Innovation Consortium (MDIC) today announced a partnership with Booz Allen Hamilton to establish a benchmark of the medical device industry\xe2\x80\x99s cybersecurity maturity and create resources to measure maturity over time.
  • The goal of the Medical Device Cybersecurity Benchmarking Initiative is to measure cybersecurity maturity and benchmark across the industry to drive common improvements that reduce overall cybersecurity risk.\n\xe2\x80\x9cBoth the technical solution and the programmatic structure proposed by the Booz Allen Hamilton team is well aligned with the cybersecurity vision of MDIC and its stakeholders.
  • Booz Allen is committed to maximizing patient safety and the healthcare sector\xe2\x80\x99s resiliency through innovations in technology and security,\xe2\x80\x9d said Kelly Rozumalski, who leads Booz Allen\xe2\x80\x99s secure connected health initiatives and health cybersecurity portfolio across the defense, federal and commercial markets.\n\xe2\x80\x9cAs part of the FDA\xe2\x80\x99s ongoing commitment to strengthening medical device cybersecurity, we are pleased to support MDIC\xe2\x80\x99s Medical Device Cybersecurity Benchmarking Initiative.
  • The JSP \xe2\x80\x93 an initiative co-led by FDA with the medical device industry and healthcare delivery organizations - articulates a total product lifecycle approach to medical device cybersecurity.

National Evaluation System for health Technology Coordinating Center Welcomes MedStar Health to NESTcc Research Network

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星期二, 四月 6, 2021

The National Evaluation System for health Technology Coordinating Center ( NESTcc ), an initiative of the Medical Device Innovation Consortium ( MDIC ), today announced MedStar Health as the newest network collaborator to join the NESTcc Research Network.

Key Points: 
  • The National Evaluation System for health Technology Coordinating Center ( NESTcc ), an initiative of the Medical Device Innovation Consortium ( MDIC ), today announced MedStar Health as the newest network collaborator to join the NESTcc Research Network.
  • MedStar Health is pleased to join as a NESTcc Network Collaborator, and we look forward to our exciting and important work together, said Neil J. Weissman, M.D., FACC, FASE, chief scientific officer for MedStar Health and president of MedStar Health Research Institute .
  • Leveraging access to electronic health records, claims, and other relevant data from 4.2 million unique patients across MedStar Healths 10 hospitals and 300 service centers, MedStar Health Research Institute is the executive research organization for MedStar Health, headquartered in Maryland.
  • MedStar Health Research Institute is the research arm of MedStar Health, the largest health care provider in Maryland and the Washington, D.C., region.

Medical Device Innovation Consortium Releases Playbook of Best Practices for Shifting Organizations to a Culture Of Quality

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星期二, 二月 16, 2021

The Medical Device Innovation Consortium (MDIC) has announced the release of its Leadership Engagement Playbook of best practices and tools to help leaders move their companies from a culture of compliance to a culture of quality.

Key Points: 
  • The Medical Device Innovation Consortium (MDIC) has announced the release of its Leadership Engagement Playbook of best practices and tools to help leaders move their companies from a culture of compliance to a culture of quality.
  • The Leadership Engagement Playbook describes 10 best practices for moving from a culture of compliance to a culture of quality and provides a framework for piloting best practices.
  • Leaders can use the playbook to invest in a culture of quality, share their performance improvements, and shift out of a culture of compliance.
  • The Case for Quality Collaborative Community (CfQcc) offers a unique opportunity for medical device stakeholders to work together to enhance device quality and patient safety.

National Evaluation System for health Technology Coordinating Center Welcomes Regenstrief Institute to NESTcc Research Network

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星期四, 一月 14, 2021

The National Evaluation System for health Technology Coordinating Center ( NESTcc ), an initiative of the Medical Device Innovation Consortium ( MDIC ), today announced the Regenstrief Institute as the newest Network Collaborator to join the NESTcc Research Network.

Key Points: 
  • The National Evaluation System for health Technology Coordinating Center ( NESTcc ), an initiative of the Medical Device Innovation Consortium ( MDIC ), today announced the Regenstrief Institute as the newest Network Collaborator to join the NESTcc Research Network.
  • Based in Indianapolis, Regenstrief Institute is a global leader dedicated to improving health and healthcare through innovations and research in biomedical informatics, health services and aging.
  • With the addition of Regenstrief Institute, the NESTcc Research Network is now comprised of 15 Network Collaborators with access to data from more than 150 million patients.
  • In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc).

National Evaluation System for health Technology Coordinating Center Expands Governing Committee into Digital Health

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星期四, 十二月 10, 2020

The NESTcc Governing Committee is comprised of stakeholders from across the medical device ecosystem committed to the success of NESTcc.

Key Points: 
  • The NESTcc Governing Committee is comprised of stakeholders from across the medical device ecosystem committed to the success of NESTcc.
  • As the medical device and real-world evidence (RWE) ecosystem evolves to leverage digital health technologies, the NESTcc Governing Committee has selected Drs.
  • Dr. Feygin has led digital health organizations throughout his career, including establishing global efforts in the areas of advanced analytics, digital health transformation, and unified health IT infrastructure to improve patient safety and outcomes.
  • In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc).

National Evaluation System for health Technology Coordinating Center Announces First International Research Network Collaborator

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星期一, 七月 20, 2020

The National Evaluation System for health Technology Coordinating Center ( NESTcc ), an initiative of the Medical Device Innovation Consortium ( MDIC ), today announced NorthWest EHealth ( NWEH ) and Discover-NOW , the Health Data Research Hub for Real World Evidence, as its newest Network Collaborator partnership and first international addition to its Research Network .

Key Points: 
  • The National Evaluation System for health Technology Coordinating Center ( NESTcc ), an initiative of the Medical Device Innovation Consortium ( MDIC ), today announced NorthWest EHealth ( NWEH ) and Discover-NOW , the Health Data Research Hub for Real World Evidence, as its newest Network Collaborator partnership and first international addition to its Research Network .
  • The NESTcc Research Network is comprised of internationally recognized institutions with expertise in many medical device areas and access to secure robust data.
  • Discover-NOW, the Health Data Research Hub for Real-World Evidence, is a unique partnership led by London, UK-based Imperial College Health Partners as one of seven Health Data Research UKs Hubs.
  • In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc).

National Evaluation System for health Technology Coordinating Center Announces Launch of NEST 1.0

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星期二, 六月 30, 2020

The National Evaluation System for health Technology Coordinating Center ( NESTcc ), an initiative of the Medical Device Innovation Consortium ( MDIC ), today announced that it has officially opened for the management of sponsor-funded research projects to advance the use of real-world data (RWD) in medical device evaluation.

Key Points: 
  • The National Evaluation System for health Technology Coordinating Center ( NESTcc ), an initiative of the Medical Device Innovation Consortium ( MDIC ), today announced that it has officially opened for the management of sponsor-funded research projects to advance the use of real-world data (RWD) in medical device evaluation.
  • In this new phase, NESTcc is catalyzing the use of RWE in the medical device ecosystem, said NESTcc senior vice president Sandra Siami, MPH.
  • In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc).
  • MDICs mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders.

National Evaluation System for health Technology Coordinating Center Announces Six New Governing Committee Members and New Executive Committee Leadership

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星期三, 六月 24, 2020

NESTcc is adding representatives from stakeholder groups, including industry, health systems, academic research organizations, and patient groups.

Key Points: 
  • NESTcc is adding representatives from stakeholder groups, including industry, health systems, academic research organizations, and patient groups.
  • In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc).
  • MDICs mission is to promote public health through science and technology and to enhance trust and confidence among stakeholders.
  • Its initiatives improve product safety and patient access to cutting-edge medical technology while reducing cost and time to market.

Medical Device Innovation Consortium Selects Sandra Siami to Lead National Evaluation System for health Technology Coordinating Center

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星期一, 六月 1, 2020

The Medical Device Innovation Consortium ( MDIC ) today announced that Flora Sandra Siami, MPH, has joined the organization as Senior Vice President for the National Evaluation System for health Technology Coordinating Center ( NESTcc ).

Key Points: 
  • The Medical Device Innovation Consortium ( MDIC ) today announced that Flora Sandra Siami, MPH, has joined the organization as Senior Vice President for the National Evaluation System for health Technology Coordinating Center ( NESTcc ).
  • Ms. Siami also oversaw the business units pharmacovigilance and medical device activities, quality system administration, and domestic and international regulatory affairs efforts in 31 countries.
  • In 2016, the U.S. Food and Drug Administration (FDA) awarded the Medical Device Innovation Consortium (MDIC) $3 million in seed funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc).
  • Founded in 2012, the Medical Device Innovation Consortium (MDIC) is the first public-private partnership created with the sole objective of advancing medical device regulatory science throughout the total product life cycle.