This session brings together a public health expert, a healthcare policy advisor, a medical device manufacturer, and a cardiologist to explore how emerging PFAS regulations are shaping patient care and medical technology innovation. Speakers will discuss the public health drivers behind tightening PFAS oversight, legislative approaches to defining and managing essential uses, and the clinical importance of fluoropolymers, materials with no water solubility or bioavailability that remain critical to the performance and reliability of lifesaving devices. Speakers will discuss the public health drivers behind tightening PFAS oversight, legislative approaches to defining and managing essential uses, and the clinical importance of fluoropolymers in life saving devices.
Attendees will gain a multidisciplinary understanding of how regulatory change intersects with medical necessity, and what is required to ensure both environmental protection and continued access to safe, effective medical devices.
Session Chairs:
- Teri Whitman, Medtronic
- Kimberly Chaffin, Medtronic
Speakers:
- "History of the Production, Chemistry and Environmental Impact of PFAS"
Matt Simcik, University of Minnesota - "The Regulation of Forever Chemicals: State and Federal Perspectives"
Michael Morton, Medical Alley Association - "Stability Characterization of Materials used in Medical Devices"
Kimberly Chaffin, Medtronic - "Clinical Perspective of the use of Fluoropolymers in Cardiac Leads & Catheters"
Pierce Vatterott, Cardiologist (retired) - Panel Discussion
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Presentation Details
Matt Simcik, PhD
Professor and Major Chair
Division of Environmental Health Sciences
University of Minnesota
"History of the Production, Chemistry and Environmental Impact of PFAS"
Bio: Dr. Simcik is a professor in the Division of Environmental Health Sciences at the University of Minnesota’s School of Public Health. He has spent over 30 years studying the fate and transport of organic contaminants in the environment. For the past 20+ years that has focused on per- and polyfluoroalkyl substances (PFAS). Recent work has involved remediation techniques and how these chemicals accumulate in foodwebs. Dr. Simcik earned his B.S. in Chemistry from Michigan State University, his M.S. in Civil Engineering from the University of Minnesota and his Ph.D. in Environmental Science from Rutgers University.
Michael Morton
Senior Policy Advisor
Medical Alley Association
"The Regulation of Forever Chemicals: State and Federal Perspectives"
Bio: Michael has forty years of experience in the medical device industry. He has worked for companies including Alcon Labs; CarboMedics; W.L. Gore and Associates; Sorin Group; and Medtronic.
He is currently an independent regulatory consultant, and senior policy advisor for Medical Alley. Michael has been recognized as a Fellow of the Regulatory Affairs Professional Society (RAPS) and has served on the RAPS Board of Directors. In 2021, he received the Founder’s Award, the highest level of recognition for the regulatory profession. Michael has been active in industry groups, including the Advanced Medical Technology Association (AdvaMed) where he chaired the AdvaMed PMA Working Group, and the Pediatric Devices Working Group, and was a member of the Heart Valve Task Force. Michael represented industry within Study Group 1 (Premarket) of the Global Harmonization Task Force. He has also served as the industry representative to the FDA Circulatory System Devices Advisory Panel.
Kimberly Chaffin, PE, PhD (Session Chair)
Vice President Enterprise Technologies
Bakken Fellow
Technical Fellow
Medtronic
"Stability Characterization of Materials used in Medical Devices"
Bio: Kim Chaffin, Ph.D., P.E., is a Medtronic Vice President, Bakken Fellow, and Technical Fellow whose contributions in material science have helped shape modern medical device innovation. She is a sought-after speaker and policy advisor with deep expertise in biostability and biocompatibility, supported by an extensive record of refereed publication. Passionate about advancing STEM, Dr. Chaffin serves on the Science Museum of Minnesota’s Board of Trustees and holds multiple academic advisory roles.
Pierce Vatterott, MD
Cardiologist (retired)
"Clinical Perspective of the use of Fluoropolymers in Cardiac Leads & Catheters"
Bio: After training and clinical practice at Mayo, Dr Vatterott was able to work with the extraction pioneer Dr Duncan Sellers at Geisinger Clinic. A year later in 1990 he moved to St Paul. There he practiced clinical cardiac electrophysiology and raised a family. Over 32 years built a clinical cardiac electrophysiology practice with a special interest in lead extraction and research.
Practicing in the rich Twin Cities medical industry environment, he has been able to be part of research and development at Medtronic, Boston Scientific, and Visible Heart Lab at the University of Minnesota. Research interests have been in the development of leadless pacers, new CIED leads, lead extraction imaging, new lead extraction tools and how bench testing can be used to optimize the safety and efficacy of lead extraction.
Dr. Vatterott is a Merck Scholar of the American College of Cardiology in Electrophysiology Research, a Fellow of the American College of Cardiology and a Diplomate of the Heart Rhythm Society. Dr Vatterott retired from clinical practice in 2022 but continues active in research on new device therapy, lead extraction and is an advocate for the importance and safety of PFAS in the practice of cardiac electrophysiology.
Teri Whitman, PhD (Session Chair)
Sr. Research Director
Cardiac Pacing Therapies
Medtronic
Bio: Teri Whitman, PhD is a Sr Research Director for Medtronic’s Cardiac Pacing Therapy business. She has more than 25 years of experience in the medical device industry and leads a research team focused on novel cardiac therapies and implant procedures for pacemakers and defibrillators. Whitman’s research interests include novel cardiac therapies, hemodynamics of arrhythmias, minimally invasive cardiac procedures, and design and delivery of pediatric devices.