On October 15, NESTcc hosted a virtual event to kick off the NEST Collaborative Community Unique Device Identifier (UDI) initiative.
Our inaugural NEST Collaborative Community event gathered leaders from across the medical device ecosystem, including FDA, industry, payers, and patients, to discuss emerging issues related to unique device identifiers (UDI).
The NEST Collaborative Community provides a forum for stakeholders to work proactively to improve the speed of innovation and enhance the safety and effectiveness of medical device and health technology.
UDI was selected as the initial Collaborative Community focus because of its broad relevance across the medical device ecosystem, the importance of policy decisions to multiple stakeholders, and the urgent need for cooperative engagement.
View the Recording
Agenda
Thursday, October 15, 2:00 to 3:15 p.m. ET
Panel Discussion Biographies
Moderator: Terrie Reed
Terrie Reed, MSc, Director of Partner Relationships, Symmetric Health Solutions
In her role as Director, Partner Relationships at Symmetric Health Solutions she continues to advance the original vision of the UDI system by working with Symmetric customers and partners to ensure timely and accurate access to standards-based device information by supply chain professionals, clinicians and researchers. From 2010 to 2014 Ms. Reed was FDA Associate Director of Informatics and from 2015-2019 was Senior Advisor for UDI adoption. At FDA she led the cross-disciplinary UDI team that established the initial UDI regulatory policy, designed and rolled out resources now used by software developers, supply chain professionals, clinicians, researchers, manufacturers and regulators as a means to transform the tracking of device-related patient procedure information. She also collaborated across stakeholder groups advocating for UDI to be included in health IT standards that support device scanning by both manufacturers and healthcare providers.
Panelist: Dennis Black
Dennis Black, UDI Program Director, Becton, Dickinson and Company
Dennis Black has over 30 years of experience in the medical device industry and has worked in a variety of roles and functions. He joined BD, a leading medical technology company, in 1998 and currently works within the Global Regulatory team as the UDI Program Director. Dennis is currently focused on implementing Unique Device Identification (UDI) regulations in the U.S. and globally. This responsibility includes ensuring that BD’s product identification strategy meets healthcare provider needs and internal supply chain requirements while complying with all applicable regulations. Dennis presently serves on the GS1 Healthcare Global Leadership Team; the GS1 US Executive Leadership Committee; and the Strategic MarketPlace Initiatives (SMI) Board of Directors, where he is also Treasurer. He also collaborates with various industry work groups within AdvaMed, MedTech Europe, Global Healthcare Exchange (GHX), and the Association for Healthcare Resource & Materials Management (AHRMM) to solve multiple healthcare challenges.
Panelist: Rich Kucera
Rich Kucera, CEO, Symmetric Health Solutions
Rich Kucera is CEO of Symmetric Health Solutions, which he co-founded in 2018. He previously served in management consulting roles at Accenture.
Rich earned a bachelor of science degree in business administration and physics from Carnegie Mellon University.
Panelist: Chris Muir
Chris Muir, MPA, Director, Standards Division, Office of the National Coordinator for Health Information Technology (ONC)
Chris joined the Office of the National Coordinator for Health Information Technology (ONC) in January 2007. He has worked in state and federal government for over 25 years. Currently, Chris works within ONC’s Office of Technology as the Standards Division Director. Prior to this position, Chris was the Director for the State Health Information Exchange Cooperative Agreement Program in which ONC awarded over $500 million in grants to enable health information exchange in each state. Previous to ONC, Chris was the Strategic Projects Manager for the State of Arizona, CIO’s Office. Chris led key information technology initiatives including Arizona’s health information technology program. Chris received an undergraduate degree in Political Science and a master’s in Public Administration from Arizona State University.
Panelist: Erin Quencer
Erin Quencer, MS, Regulatory Health Scientist, Office of Strategic Partnerships and Technology Innovation (OST), Division of Technology & Data Services, CDRH, FDA
Erin Quencer is a Regulatory Health Scientist at the FDA and has been a member of the FDA’s UDI team for over 8 years. Erin works with industry, FDA-accredited issuing agencies, and international regulators to address UDI regulatory and policy issues. Erin completed her bachelor’s degree in Biology at the University of Richmond, and her master’s degree in Regulatory Affairs at the George Washington University.
Panelist: Mike Schiller
Mike Schiller, CMRP, Senior Director of Supply Chain, Association for Health Care Resource & Materials Management (AHRMM) of the American Hospital Association: Learning UDI Community
Michael Schiller, CMRP, is the Senior Director of Supply Chain for the American Hospital Association (AHA) and the Association for Health Care Resource & Materials Management (AHRMM), a professional membership group of the AHA. As the organization’s subject matter expert, he brings over 30 years of health care supply chain experience to this role. In this capacity, Schiller collaborates with industry leaders across the health care field on various supply chain, advocacy and regulatory initiatives. Working with AHA and AHRMM executive leaders, Schiller participates in the development and implementation of the association’s strategic direction and initiatives including the Cost, Quality, and Outcomes Movement, Clinically Integrated Supply Chain, Learning UDI Community and COVID-19 strategies including the AHRMM vendor-vetting program and the AHA Dynamic Ventilator Reserve. Schiller holds a graduate certificate in information systems management from the Keller Graduate School of Management, a Bachelor’s degree in business management from Northeastern Illinois University, is a Certified Materials & Resource Professional (CMRP), and a certified Lean Six Sigma Green Belt.
Discussant: Angie Botto-van Bemden
Angie Botto-van Bemden, PhD, President/CEO, Musculoskeletal Research International
Dr. Angie Botto-van Bemden is a patient advocate first and foremost. Angie is also the CEO/Founder of Musculoskeletal Research International and Clinical Research Experts, prompting patient access to better treatment options by focusing on what matters most- the voice of the patient! Angie has been integrating the patient voice in preventive, individualized, whole health care pathways directly with patients since her prior positions in the clinic, on the field and on research teams as Director of Research at the University of Miami, UHZ Sports Medicine Institute, as Adjunct Faculty at the Florida International University, College of Medicine, Department of Orthopaedics and has contributed as a patient advocate at the Arthritis Foundation, Leukemia and Lymphoma Society and Rare Diseases Networks. Her comprehensive understanding of clinical research = clinical care strategy, regulatory thinking and innovative guidances accelerates medical product development programs she leads. Angie currently works collectively with osteoarthritis stakeholders to ensure the voice of the patient is integrated in all programs and upcoming regulatory guidance.
Discussant: Hugo Campos
Hugo Campos, All of Us Research Program, California Precision Medicine Consortium
Hugo Campos has built a 20-year career fueled by a unique blend of creative and technical skills. The roles that he has played along the way include creative director, art director, visual designer, marketer, computer programmer, and presentation coach. Hugo is an advocate for patient autonomy, accountability, and access to health data. He was named a White House Champion of Change for Precision Medicine by President Barack Obama in 2015 for his data liberation advocacy. What particularly drives Hugo is a passion for participatory medicine, connected health, and patient empowerment through the use of technology. He believes that health care can—and must—be transformed into a truly patient-centric system. His own story includes being a hypertrophic cardiomyopathy patient with an implanted cardiac device and being a caregiver to parents with heart failure. He was invited to share his story, “Fighting for the Right to Open his Heart Data,” as a TEDx presenter at Harvard. He is a passionate advocate for the rights of patients to access their health data and become empowered participants in their own health care. His $30,000 implantable cardiac defibrillator continually collects information about his body, yet he has no access to this data; he wants to change that.
Discussant: Richard Embrey
Richard Embrey, MD, Medical Director, Blue Cross and Blue Shield of Alabama
Dr. Richard Embrey is a Medical Director for Blue Cross and Blue Shield of Alabama (BCBSAL). Dr. Embrey works with medical policy, health care analytics and public employee health plans. Rich received his medical degree from The Johns Hopkins University, completed surgical residency at the Massachusetts General Hospital and a fellowship in pediatric cardiothoracic surgery at the University of Alabama Birmingham. Dr. Embrey also received an MBA from the Fuqua School of Business at Duke University. Dr. Embrey spent more than twenty years in academic cardiothoracic surgery before joining BCBSAL.
