ARLINGTON, Va.–(BUSINESS WIRE)–The Medical Device Innovation Consortium (MDIC) Board of Directors has
established the inaugural Governing Committee for the National
Evaluation System for health Technology Coordinating Center (NESTcc).
The Governing Committee will recommend the strategic direction for NEST.
Its members represent NEST’s diverse stakeholders, including patients,
clinicians, medical device industry, regulators, health systems.
payers. The Committee’s first priority is to select NEST demonstration
projects that pilot the use of real-world evidence (RWE) to support
regulatory decision-making at different stages of the medical device
total product life cycle.
The inaugural NESTcc Governing Committee members are:
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Naomi Aronson, PhD – Executive Director of Clinical Evaluation,
Innovation. Policy at the Blue Cross Blue Shield Association
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Kathleen Blake, MD, MPH – Vice President of Healthcare Quality
at the American Medical Association (AMA)
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Marc Boutin, JD – CEO of the National Health Council (NHC)
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Mark Deem – Managing Partner at The Foundry, LLC, Venture
Partner at Lightstone Ventures. Medical Device Manufacturers
Association (MDMA) nominee
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Bill Hanlon, PhD – Chief Development Officer and Head of Global
Regulatory Affairs at LabCorp/Covance. American Clinical
Laboratory Association (ACLA) nominee
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Adrian Hernandez, MD, MHS – Professor of Medicine at Duke
School of Medicine, Director of research, quality. Outcomes at
Duke Heart. Director of Health Services and Outcomes Research at
the Duke Clinical Research Institute (DCRI)
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Tamara Syrek Jensen, JD – Director of Coverage and Analysis
Group at the Center for Clinical Standards and Quality at the Centers
for Medicare and Medicaid Services (CMS)
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Harlan M. Krumholz, MD, SM – Harold H. Hines, Jr. Professor of
Medicine and Epidemiology & Public Health at Yale University.
Director of the Yale New Haven Hospital Center for Outcomes Research
and Evaluation (CORE)
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Elizabeth McGlynn, PhD – Vice President of Kaiser Permanente
Research. Executive Director of the Kaiser Permanente Center for
Effectiveness & Safety Research
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Michelle McMurry-Heath, MD, PhD – WW Vice President Regulatory
and Clinical Affairs at Johnson & Johnson Medical Device Companies,
and Advanced Medical Technology Association (AdvaMed) nominee
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Vance Moore – President of Business Integration at Mercy
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William Murray – President and CEO of the Medical Device
Innovation Consortium (MDIC)
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Jeffrey Shuren, MD, JD – Director of FDA’s Center for Devices
and Radiological Health (CDRH)
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Sharon Terry – President and CEO of Genetic Alliance
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Diane Wurzburger, JD – Regulatory Affairs Executive at GE
Healthcare. Medical Imaging & Technology Alliance (MITA) nominee
NESTcc supports the operations of NEST, a national network designed to
efficiently generate better evidence for medical device evaluation and
regulatory decision-making. NEST will be a patient-focused,
strategically-driven, coordinated network of voluntary RWE partnerships.
Together, institutional data partners, methods partners. Patient
communities will coordinate efforts to generate higher quality data at
lower costs to inform and improve patient care.
Dr. McMurry-Heath, World Wide Vice President of Regulatory and Clinical
Affairs at Johnson & Johnson Medical Device Companies and AdvaMed
nominee to the NESTcc Governing Committee stated, “NEST represents a
groundbreaking opportunity to effectively and efficiently capture
medical device clinical experience in the real world. I’m delighted
and honored to be a part of the process.”
Governing Committee members were selected through an open call for
nominations published in December 2016, followed by a rigorous review
process that included a diverse set of reviewers from the medical device
industry, academia. Regulatory agencies.
Commenting on the Governing Committee selection process, NESTcc
Executive Director Rachael Fleurence, Ph.D. said, “Members were selected
based on their ability to represent broad stakeholder groups and provide
the leadership and vision required to realize the opportunities and
benefits NEST can deliver to the ecosystem.” Referencing NESTcc’s
commitment to transparency, she encouraged stakeholders to visit her
blog (mdic.org/cc/blog)
to learn more about the selection process.
Dr. Fleurence also highlighted the membership of National Health Council
CEO Marc Boutin and Genetic Alliance President and CEO Sharon Terry –
leaders of organizations that together represent more than 130 million
American patients. CDRH Director Jeffrey Shuren, M.D., J.D., said he's
“pleased to serve on the governing committee to help NEST achieve its
potential and to advance FDA’s mission for patients: first-in-the-world
access to innovative and safe medical devices.”
Echoing the sentiments of other Committee members, Dr. Harlan Krumholz
said that NEST has “the potential to ensure that we're continuously
learning about the safety and effectiveness of medical devices after
they're approved and integrated into practice. The alignment of
government, industry, patient groups. Academia is truly remarkable –
and the commitment to transparency, accountability. Progress is
laudable – with the pieces in place, the time is now to make things
happen and show what's possible in a public-private partnership focused
on the common good.”
About National Evaluation System for health Technology Coordinating
Center
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 Coordinating Center for the Medical Device
National Evaluation System for health Technology (NEST). The
Coordinating Center’s mission is to support the sustainable generation
and use of real world evidence throughout the medical device lifecycle,
using real world data that meets robust methodological standards and is
generated in the course of clinical care by patients, providers.
payers. For the purpose of enhancing regulatory and clinical
decision-making. For more information, visit www.nestcc.org.
About Medical Device Innovation Consortium
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. MDIC’s mission is to promote public health through science and
technology and to enhance trust and confidence among stakeholders. MDIC
works in the pre-competitive space to facilitate development of methods,
tools. Approaches that enhance understanding and improve evaluation
of product safety, quality. Effectiveness. Its initiatives improve
product safety and patient access to cutting-edge medical technology
while reducing cost and time to market. For more information, visit www.mdic.org.
Medical Device Innovation Consortium
Marina Damiano, PhD, +1
312-857-8382
[email protected]