Navigating Trends and Best Practices For Cardiovascular Device Development

Agenda

·       NAMSA invites you to join us for this webinar, featuring a panel of recognized leaders in cardiovascular product development, as we discuss the latest industry trends and best practices related to cardiovascular Medtech development.
·       Attendees can expect to walk away with the following insights:
·       Considerations for developing novel technologies vs. iterating an existing technology
·       Managing new trends – Are they a distraction or a valuable tool?
·       Balancing planning, execution and flexibility in your product development plan
·       Surviving when disaster strikes – How to navigate a successful outcome
·       Time will be allotted for Q&A.
 
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Speakers

JACK RISDAHL

Principal Product Development Strategist

Dr. Jack Risdahl has over 27 years of experience in medical research and in vivo laboratory medicine. He has held numerous medical research leadership positions in both academia and industry. His current responsibilities include working with sponsors to design Preclinical studies for new medical products that meet regulatory requirements worldwide.

Prior to NAMSA, he co-founded the Integra Group Preclinical Services and acted as a managing partner. He has participated in numerous FDA meetings to discuss submission requirements, preclinical study design and interpretation of results. He has also been involved with several publications, including transplantation, inflammation, immunity, infectious diseases and medical devices. Dr. Risdahl holds two doctorate degrees in Veterinary Medicine (DVM, and Ph.D.)

CHRIS MULLIN, MS, RAC

Director, Product Development Strategist

Chris Mullin is currently the Director, Product Development Strategy at NAMSA where he oversees and manages client partnerships surrounding product development, regulatory, clinical, and market commercialization strategies. Chris began his career working on National Institute of Health (NIH)-funded academic clinical trials, and over the last 15 years, he has consulted for medical device organizations throughout the U.S. Asia, and Europe on various clinical trial programs. A highly sought-after industry expert, Chris has helped more than 100 global manufacturers optimize study design and research, providing proven strategies to address regulatory requirements for market approval and introduction. Chris has worked with multiple innovative technologies across a wide array of therapeutic areas, which has allowed him to provide valuable perspectives to clients on scientific and regulatory challenges – and suggested strategies for success – that impact the advancement of novel medical technology. Chris is a renowned leader in FDA Panel reviews and an extensive author; he has authored multiple peer-reviewed publications as well as a book chapter on clinical study design for translational research, has served as a lecturer for multiple universities, and serves as a journal editor. Chris holds a Master’s Degree in Biostatistics from the University of Minnesota.

DOROTHY ABEL, BSBME, AIMBE

Vice President, Regulatory Strategy

Prior to joining NAMSA through the acquisition of Syntactx, Dorothy Abel had a highly accomplished 30+ year career with the U.S. Food and Drug Administration (FDA) within the Center for Devices and Radiological Health (CDRH). At the FDA, Dorothy led the evaluation of vascular and endovascular surgery devices, and pioneered approaches for the evaluation of devices, including co-founding the Early Feasibility Study Program in collaboration with FDA colleagues, of professional surgical societies and international voluntary standards committees. Ms. Abel provides expert assistance in developing and communicating regulatory evaluation strategies and helps Clients achieve regulatory approvals and product adoption worldwide.

SARA VIDMAR

Vice President, Global Clinical Research Services

Sara Vidmar has over 30 years of medical device experience focusing on cardiovascular products and procedures. Before joining NAMSA, Sara held several roles leading the clinical and regulatory organizations for Structural Heart and Cardiac Rhythm Heart Failure Management. In many of her positions, she has been the corporate clinical leader addressing the need for real-world, longitudinal product performance and patient safety data. Sara’s other prior roles included responsibility for achieving FDA and global regulatory approvals for the drug-coated balloon therapy. Sara received her bachelor’s degree from University of Colorado, Boulder in Molecular, Cellular, Developmental Biology and her MBA from University of St. Thomas in Healthcare Management.

KENNETH OURIEL

Chief Medical Officer

Dr. Kenneth Ouriel is one of the country’s top vascular surgeons publishing more than 300 scientific articles and three texbooks. He is a frequent presenter at international conferences and brings over 30 years of experience in medical research. Dr. Ouriel began his undergraduate studies at the University of Rochester. After earning his bachelor’s in biology and psychology he studied medicine at the Pritzker School of Medicine at the University of Chicago. After graduating from Pritzker with honors in 1981, he became a general surgery resident at the University of Rochester, where he completed a vascular surgery fellowship and remained as a faculty member for 11 years. In 1998, he joined the Cleveland Clinic as its chief of vascular surgery and later became its chief of surgery overseeing 340 surgeons. In 2007, he led a Cleveland Clinic team in Abu Dhabi where they helped establish world-class care at the Sheik Khalifa Medical Center. In 2008, Ken served as senior vice president and chief of international operations at New York-Presbyterian Hospital while earning an MBA from Columbia University and the London Business School. In 2010, Ken founded Syntactx, a medical device development solution company which has now become part of NAMSA.