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Ken Skodacek has been working with medical devices for over 25 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 internal and external grievances and disputes. He also represents the Center’s Innovation Team and is a founding member of the Center’s Payor Communications Task Force, which coordinates the FDA/CMS Parallel Review program and provides opportunities to improve patient access to innovative devices important to public health by engaging medical device manufacturers, payors, and healthcare technology assessment organizations earlier in the medical device development process, especially when planning to gather clinical evidence to support regulatory and coverage decisions.
Ken also serves an important role in the Center’s Clinical Trials Program, where he is responsible for leading the development and implementation of policies, programs, and procedures intended to improve the quality, efficiency, and consistency of the Investigational Device Exemption (IDE) submission and review process. He works directly with FDA review teams and sponsors to optimize interactions and communication during the review process, to expedite initiation of clinical trials that collect valuable clinical evidence and fulfill regulatory requirements, ultimately improving patient access to high-quality, safe, and effective medical devices of public health importance. He also coordinates numerous internal and external professional development opportunities for Center staff, sharing his experience and connections for the benefit of the organization. He also supports other important CDRH initiatives including the Early Feasibility Study (EFS) and Breakthrough Devices (previously known as the Expedited Access Pathway) programs as well as collaborative activities with organizations such as the Medical Device Innovation Consortium and the Clinical Trials Transformation Initiative. He served as the Project Manager for the Center’s total product lifecycle reorganization, supporting the planned formation of the Office of Clinical Evidence and Analysis.
He previously led the FDA’s Entrepreneurs-in-Residence team focused on streamlining the path to reimbursement for innovative medical devices, which led to the formation of the Center’s Payor Communications Task Force. He previously served as the Clinical Trials Lead in the Division of Bioresearch Monitoring and led the review of numerous pre-market submissions for cardiovascular medical devices, led review teams during public advisory committee meetings, and supported multiple other cross-Center collaborative initiatives including the Safety Signal Escalation and Critical to Quality programs.
Outside of FDA, he serves as a team coach and program facilitator for the IDEA Lab’s Ignite Accelerator, an internal innovation startup program for Health and Human Services staff that want to improve the way their agency works using methodological coaching and technical guidance within a fast-paced, entrepreneurial framework. He also supports the Office of Personnel Management’s Innovation Lab, which teaches human-centered design principles across the Federal Government and helps to develop and implement innovative solutions that address complex public challenges.
Prior to joining FDA/CDRH in 2008, he worked in the medical device industry, serving in numerous engineering and leadership roles including Manager of Clinical Engineering, Senior Manager of the Heart Failure Program, and Vice President of Field Clinical Engineering, with a focus on leading technical teams that served as the interface between engineering staff and physicians, managing numerous US, international, and pre-clinical studies, and preparing Investigational Device Exemption and Pre-Market Approval submissions to FDA.