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

Governing Committee reflects broad spectrum of medical device stakeholder perspectives

ARLINGTON, Va.–(BUSINESS WIRE)–The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), today announced the addition of six new members to its Governing Committee.

The NESTcc Governing Committee is comprised of stakeholders from across the medical device ecosystem committed to the success of NESTcc and, upon inception, was charged with inaugurating a Coordinating Center that is inclusive, patient-focused, and anchored in accountability and transparency. NESTcc is adding representatives from stakeholder groups, including industry, health systems, academic research organizations, and patient groups.

The new NESTcc Governing Committee members include:

• Michael Gibson, MS, MA, M.D., FRCP, FAHA, FSCAI, FACC, professor of medicine, Harvard Medical School, and CEO of the non-profit Baim Institute of Clinical Research
• Jennifer Kerr, MS, CCRA, RAC, president, Cook Research Incorporated (MDMA representative)
• David Maggs, M.D., vice president, medical affairs, Becton Dickinson Technologies and Innovation
• Danelle Miller, BS, MA, J.D., vice president of global regulatory policy and intelligence, Roche Diagnostics (AdvaMed representative)
• Diane Pickles, BA, program director, One Brave Idea, American Heart Association
• Art Sedrakyan, M.D., Ph.D., professor of population health sciences, Weill Cornell Medicine, and director, Institute for Health Technologies and Interventions and Medical Device Epidemiology Network’s Coordinating, Science, and Infrastructure Center

“Incorporating perspectives of key opinion leaders from diverse organizations has been a foundational element of NESTcc since its inception, and it will be critical to our success moving forward,” said Sandra Siami, MPH, senior vice president of NESTcc. “Each of our six new members brings strong leadership from across the health technology and medical device landscape, and their expertise will help us accelerate the use of high-quality, real-world evidence to support the availability of safe, effective, and innovative technologies for patients.”

In addition to the six new members, three existing NESTcc Governing Committee members have assumed leadership roles on the Executive Committee, each serving a two-year term in accordance with the terms of the NESTcc Charter:

• Chair: Adrian Hernandez, M.D., MHS, professor of medicine at Duke School of Medicine, vice dean and executive director, Duke Clinical Research Institute
• Vice Chair: Diane Wurzburger, J.D., executive of regulatory affairs, Developed Markets & Global Strategic Policy, GE Healthcare
• Treasurer: Kathleen Blake, M.D., MPH, vice president of health care quality, American Medical Association

“I am honored to have the opportunity to lead such a dynamic and talented Governing Committee for the next two years. As we move into the next phase of NEST, it will be crucially important to understand the needs of all stakeholders and advance opportunities for real-world evidence to solve key challenges facing health care today and in the future,” said Hernandez, who assumed the role of Governing Committee chair after serving a two-year term as vice chair.

About the 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) funding to establish the National Evaluation System for health Technology Coordinating Center (NESTcc). The Coordinating Center seeks to support the sustainable generation and use of timely, reliable, and cost-effective Real-World Evidence (RWE) throughout the medical device lifecycle, using high-quality Real-World Data (RWD) that meets robust methodological standards for the purpose of enhancing regulatory and clinical decision-making. For more information, visit http://www.nestcc.org.

About the 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 http://www.mdic.org.

Funding for NESTcc was made possible, in part, by the Food and Drug Administration through grant (3 U01 FD006292-03S1). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

Contacts

Sean McNabb

smcnabb@mdic.org
+1 202.688.1337