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This is the first of three episodes of \u201cInnovation and Protection: The Future of Medical Device Regulation,\u201d a podcast miniseries created to replace the 2020 Petrie-Flom Center Annual Conference in light of the COVID-19 pandemic. These episodes highlight a selection of papers that were written for the conference, which was organized in collaboration with the University of Copenhagen\u2019s Center for Advanced Studies in Biomedical Innovation Law (CeBIL) and the University of Arizona Health Law Program. All of the papers will be published in an edited volume. This first episode looks at big-picture issues with medical device regulation in the U.S. First, Petrie-Flom Center Faculty Director I. Glenn Cohen interviews Matthew Herder, Director of the Health Law Institute at the Schulich School of Law at Dalhousie University to discuss his paper, \u201cA 'DESI' Designed for Devices: Insights from the FDA's Drug Efficacy Study Implementation program initiated during the 1960s for the improved regulation of medical devices today.\u201d Then Petrie-Flom Center Executive Director Carmel Shachar talks with Efthimios Parasidis, Professor of Law and Public Health at Ohio State University about \u201cCompulsory Medical Device Registries: Legal and Ethical Issues.\u201d Last, Christopher Robertson discusses \u201cCrisis Equals Opportunity and Danger: The opioid epidemic, problem-solving courts, and the manufacture of a new medical device market,\u201d with author Ross Silverman, professor at Indiana University\u2019s School of Public Health.