National Evaluation System for health Technology Coordinating Center (NESTcc) Selects Inaugural Governing Committee | Business Wire

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, and

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:

• Naomi Aronson, PhD – Executive Director of Clinical Evaluation,

  Innovation, and Policy at the Blue Cross Blue Shield Association

• Kathleen Blake, MD, MPH – Vice President of Healthcare Quality

  at the American Medical Association (AMA)

• Marc Boutin, JD – CEO of the National Health Council (NHC)

• Mark Deem – Managing Partner at The Foundry, LLC, Venture

  Partner at Lightstone Ventures, and Medical Device Manufacturers

  Association (MDMA) nominee

• Bill Hanlon, PhD – Chief Development Officer and Head of Global

  Regulatory Affairs at LabCorp/Covance, and American Clinical

  Laboratory Association (ACLA) nominee

• Adrian Hernandez, MD, MHS – Professor of Medicine at Duke

  School of Medicine, Director of research, quality, and outcomes at

  Duke Heart, and Director of Health Services and Outcomes Research at

  the Duke Clinical Research Institute (DCRI)

• 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)

• Harlan M. Krumholz, MD, SM – Harold H. Hines, Jr. Professor of

  Medicine and Epidemiology & Public Health at Yale University, and

  Director of the Yale New Haven Hospital Center for Outcomes Research

  and Evaluation (CORE)

• Elizabeth McGlynn, PhD – Vice President of Kaiser Permanente

  Research, and Executive Director of the Kaiser Permanente Center for

  Effectiveness & Safety Research

• 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

• Vance Moore – President of Business Integration at Mercy

• William Murray – President and CEO of the Medical Device

  Innovation Consortium (MDIC)

• Jeffrey Shuren, MD, JD – Director of FDA’s Center for Devices

  and Radiological Health (CDRH)

• Sharon Terry – President and CEO of Genetic Alliance

• Diane Wurzburger, JD – Regulatory Affairs Executive at GE

  Healthcare, and 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, and 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, and 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, and 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 is

“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 are continuously

learning about the safety and effectiveness of medical devices after

they are approved and integrated into practice. The alignment of

government, industry, patient groups, and academia is truly remarkable –

and the commitment to transparency, accountability, and progress is

laudable – with the pieces in place, the time is now to make things

happen and show what is 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, or

payers, and 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, 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. For more information, visit www.mdic.org.