Clinical Lab, Patient Engagement Experts Join NESTcc Governing Committee

The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), has added two new members to its Governing Committee: Mohamed Salama, M.D., professor of pathology at Mayo Clinic and chief medical officer for Mayo Clinic Laboratories; and Eleanor Perfetto, Ph.D., MS, executive vice president of strategic initiatives at the National Health Council.
 
The NESTcc Governing Committee comprises stakeholders from across the medical device ecosystem, incorporating industry, regulator, patient, clinician, health system and payor perspectives. Since its inception, the NESTcc Governing Committee has included nominees from the medical device trade associations, as industry representatives must comprise at least 25 percent of its membership. As the Governing Committee’s American Clinical Laboratories Association (ACLA) appointment, 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. Perfetto’s patient-focused research experience both informs and aligns with the commitment to patients NESTcc has outlined in its mission and vision.
 
“NESTcc is thrilled to welcome two leaders who share our dedication and passion for transforming the medical device ecosystem for the benefit of all stakeholders,” said Sandra Siami, MPH, senior vice president of NESTcc. “Mohamed Salama and Eleanor Perfetto bring extensive experience and unique perspectives to our Governing Committee and sharpen our focus on setting the standard for evidence generation and innovation in medical device research.”
 
With a clinical background in hematopathology, Salama has led research on the characterization and correlation of genetic/molecular aberrations and protein expression as well as morphometry using novel digital imaging and artificial intelligence tools. Prior to joining Mayo Clinic, Salama was a professor of pathology at the University of Utah, chief of hematopathology and vice president of the ARUP reference laboratories. He has authored more than 160 peer reviewed publications, books and book chapters.
 
Perfetto’s research and policy work primarily focus on patient engagement in health care, including comparative effectiveness, outcomes research, medical product development, value assessment and health care quality. Perfetto also holds a part-time faculty appointment at the University of Maryland School of Pharmacy, where she is professor of Pharmaceutical Health Service Research.
 
“As NESTcc continues to demonstrate the value of real-world evidence, we welcome the opportunity to add Governing Committee members who not only enhance our knowledge base, but also expand our impact,” said Adrian Hernandez, M.D., MHS, executive director at Duke Clinical Research Institute, vice dean of the Duke University School of Medicine and chair of the NESTcc Governing Committee. “The leadership of Drs. Salama and Perfetto will help us to ensure further success across NESTcc’s initiatives and strengthen our efforts to improve the lives of 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). The Coordinating Center is committed to transforming the way medical device technologies are tested, approved and monitored, combining real-world evidence with unparalleled expertise to accelerate patients’ access to safe and effective medical technology. 
 
Founded in 2012, the 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.