FDA/CDRH Deputy Ombudsman
Ken Skodacek has been working with medical devices for nearly 30 years and is currently serving as the Deputy Ombudsman for FDA’s Center for Devices and Radiological Health (CDRH). In this role, Ken provides an independent, impartial, and confidential resource that informally investigates and resolves grievances and disputes, both internal and external. He is an active member of the Coalition of Federal Ombudsman and the American Bar Associations Ombuds Committee, and he serves as the Chair of the American Bar Association’s Section of Dispute Resolution Ombuds Day Subcommittee.
Within CDRH, he has served in various roles including the Clinical Trials Program, CDRH Innovation and the Payor Communications Task Force, Entrepreneurs in Residence program, the Office of Device Evaluation, and the Office of Compliance. Outside of FDA, he has served as lead coach and program facilitator for the Health and Human Services IDEA Lab’s Ignite Accelerator, an internal innovation startup program, and has supported the Office of Personnel Management’s Innovation Lab, which teaches human-centered design principles and helps to implement innovative solutions that address complex public challenges. Prior to joining FDA/CDRH in 2008, he worked for ~20 years in the medical device industry, serving in numerous engineering and leadership roles with a focus on leading technical teams that served as the interface between engineering staff and physicians; managing US and international clinical studies; pre-clinical studies; and preparing regulatory submissions to FDA.
Tuesday, September 15, 2020
9:35 AM – 10:05 AM EDT