Updates from Washington: Navigating FDA and HHS Changes in a Shifting MedTech Landscape

Philip Desjardins, JD
Partner
Arnold & Porter

Philip Desjardins brings two decades of experience working with the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and serving in pivotal leadership roles in Johnson & Johnson’s MedTech businesses. His comprehensive insights into the intricacies of the FDA's operational framework and regulatory expectations and broad knowledge of the MedTech ecosystem position Phil as a leading authority on MedTech regulatory affairs and compliance. He has consistently delivered successful outcomes to a broad spectrum of clients, from emergent biotech startups to established global healthcare giants. As CDRH Associate Director for Policy, Phil was key in formulating the FDA’s current policies on medical devices and drug-device combinations, including legislation, regulations, and enforcement actions. He helped develop and implement CDRH policies in the MedTech space on clinical trials and audits.

Ralph Hall, JD
CEO
Hall Strategies, LLC

Mr. Hall is currently CEO of Hall Strategies, LLC and assists medical product companies and others with regulatory strategy and healthcare policy matters. He regularly works with multiple health care stakeholders, including FDA and Congress, to develop consensus solutions to complex health care challenges – all with the goal of improving patient care. Prior to starting this firm, for 10 years Ralph was a Principal with Leavitt Partners, an HMA company, a national healthcare policy and consulting firm assisting clients with regulatory strategy, health care policy and the transition to value-based care.  He is also a retired professor of practice at the University of Minnesota Law School and the Carlson School of Management where he focused his teaching, research and writing in the area of FDA regulation and health care policy. He has also served as a lecturer on FDA law at the University of Michigan Law School and as a Visting Professor at Indiana University School of Law - Indianapolis.

He is a frequent author and speaker on FDA regulatory issues and compliance matters and has testified a number of times before Congressional committees. He has authored or co-authored approximately 40 articles or book chapters.

Prior to his teaching and consulting career, Mr. Hall served in various capacities with Guidant Corporation including Senior Vice President and Deputy General Counsel—Litigation and Compliance and General Counsel of the Cardiac Rhythm Management group. During this time, he also served as Special Counsel to the Guidant Board of Directors Compliance Committee and as Counsel to the Guidant Chief Compliance Officer. Prior to joining Guidant, he spent 12 years with Eli Lilly, including serving as the head of Lilly’s worldwide environmental law group. Mr. Hall also spent several years in a large, national law firm. 

In addition, Mr. Hall served as CEO of a small medical technology research entity and is a co-inventor on 6 patents in the cardiac rhythm management field.

He received his B.A. magna cum laude with Honors in History from Indiana University and his J.D. cum laude from the University of Michigan where he was a Weymouth Kirland Scholar.