Paul Gadiock leverages his firsthand experience at the Food and Drug Administration (FDA) to provide life sciences, healthcare and other FDA-regulated companies with practical, strategic counsel at every phase of the product life cycle. Paul supports medical device, digital therapeutic, and biopharma companies, software as a medical device (SaMD) and clinical decision support (CDS) developers, and their investors on their FDA regulatory and due diligence needs, delivering premarket and postmarket regulatory guidance to maximize business outcomes.
From providing strategic regulatory approval direction at the product concept stage through post-marketing issues such as product marketing, labeling, advertising, and recalls and crisis matters, Paul has substantial experience helping his clients bring novel technologies and innovative products to market. His deep experience allows him to provide practical, business-minded due diligence support to buyers, sellers and investors in achieving their transaction goals.
As a member of the senior leadership team at the FDA’s Center for Devices and Radiological Health, Paul advised agency officials on issues related to the regulatory scope of the FDA’s policies, programs, regulations, and legislation to the medical device industry. He also collaborated with the Office of Inspector General (OIG) and Government Accountability Office (GAO) on analyses, investigations and oversight of major national programs.
In addition to his government experience, Paul provides a commercially minded approach rooted in real-world experience as a business development executive at a national diagnostic biotechnology company. In that role, he worked with an international team on market entry and regulatory compliance issues to effectively launch and promote products in new market. Prior to joining McDermott, Paul was a lawyer at several large national law firms.
