Ken Skodacek has served as the Deputy Ombudsman for nearly 8 years with the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH). He provides a confidential, independent, and impartial resource for preventing conflicts and resolving scientific and regulatory disputes, both with and within CDRH. He also ensures fair and efficient processing of formal appeals consistent with statutory and regulatory requirements. He has served as the Co-Chair of the American Bar Association’s Ombuds Committee and Chair of the Ombuds Day Subcommittee. He is an active member of the Coalition of Federal Ombudsman, United States Ombudsman Association, and the American Bar Association’s Section of Dispute Resolution. He established and maintains the Ombuds Day webpage. Prior to his current role, he has led and supported multiple new initiatives within CDRH, with a focus on fulfilling strategic priorities for the organization in order to promote and protect the public health. He is also a founding member of the Center’s Payor Communications Task Force, which provided opportunities to improve patient access to innovative medical devices important to public health facilitating collaboration between manufacturers, payors, and healthcare technology assessment organizations. He has also led numerous training initiatives within the agency, including the Reviewer Certification Program and coursework on conflict resolution for new leaders. Outside of his work at FDA, he supported the Health and Human Services (HHS) Innovation, Design, Entrepreneurship, and Action (IDEA) Lab for multiple years, serving as a coach and co-facilitator for the HHS Ignite Accelerator, which trained and supported staff developing and testing ideas to address difficult challenges. Some of his work was captured in Design Thinking for the Greater Good: Innovation in the Social Sector. He has received formal training in professional coaching, human-centered design, and mediation. Before joining the federal sector, he worked for nearly 20 years as a biomedical and electrical engineer in the medical device industry. He held several leadership roles, focusing on the technical and clinical interface between companies, healthcare providers, and patients. His expertise spans the entire product lifecycle, from initial design concepts to successful product launches in both U.S. and international markets. Find and follow him on LinkedIn.