As Executive Vice President, Digital and Diagnostics Technologies, Zach leads AdvaMed’s three technology divisions: AdvaMedDx®, AdvaMed Digital Health Tech™, and AdvaMed Imaging. He continues to serve as Executive Director of AdvaMedDx®, where he leads strategy and operations for a multidisciplinary team representing more than 70 global in vitro diagnostic (IVD) manufacturers on complex policy, regulatory, and legal matters in the U.S. and internationally. Across the broader portfolio, he aligns strategy, policy, and advocacy among the divisions, oversees the executive directors of the Digital Health Tech and Imaging divisions, and advises AdvaMed leadership and the Board of Directors on the cross-cutting issues facing the industry.
Zach is a widely regarded expert on the legal and regulatory aspects of medical devices, artificial intelligence, and software as a medical device. Over a career spanning nearly two decades at the intersection of technology and healthcare regulation, he has helped shape forward-thinking policies that support the responsible adoption of digital and diagnostic technologies. Zach recently served as AdvaMed’s lead negotiator for the MDUFA VI user fee reauthorization with the U.S. Food and Drug Administration, and previously served as an industry negotiator in the MDUFA V process. He represents the Global Medical Technology Alliance on the World Health Organization’s (WHO) Global Diagnostics Coalition Steering Committee and is a member of the WHO Digital Health Technical Advisory Group’s Roster of Experts.
Zach previously served as AdvaMed’s Senior Vice President for Technology and Regulatory Affairs, leading the association’s work on digital health, software, cybersecurity, and postmarket policy. He led the creation of the medical technology industry’s Information Sharing and Analysis Organization (MedTech ISAO), and founded the AdvaMed Cybersecurity Summit. He also served as AdvaMed’s lead coordinator for its COVID-19 Action Team, guiding the medical technology industry through the unprecedented legal and regulatory challenges of the pandemic.
Before joining AdvaMed, Zach was Deputy Senior Counsel for Public Policy at Samsung Electronics, and previously was an attorney in the FDA and Healthcare practice at Morgan, Lewis & Bockius LLP. Zach earned his J.D. from The Catholic University of America, and received his B.A. in political science and criminal justice from Indiana University Bloomington.