KATRINA GWINN

Katrina Gwinn specializes in providing high-level consulting services focused on medical device development, with deep subject matter expertise in neurology and regulatory pathways for health technologies. Her work centers on supporting federal initiatives like the Blueprint MedTech program, where she advises on clinical translation, regulatory strategy, and human-centered design for neurological devices. This includes navigating FDA submission frameworks, identifying unmet clinical needs in neurodegenerative and neurovascular conditions, and aligning device innovation with CMS reimbursement models and post-market surveillance requirements. Her approach integrates clinical neuroscience with federal procurement realities, ensuring that technical solutions meet both scientific rigor and regulatory compliance standards. She has demonstrated direct experience supporting the Department of Health and Human Services, particularly in advancing innovation pipelines under public health technology initiatives. Her engagement with HHS reflects a focused partnership in translating academic and startup-led neurotechnology into viable, scalable medical products that align with federal health priorities and patient safety frameworks. Her primary area of practice falls under NAICS 541990, encompassing specialized professional services that bridge clinical neuroscience, biomedical engineering, and federal regulatory policy. She positions herself as a niche consultant for agencies seeking expert guidance on neurotechnology development, where deep domain knowledge in neuroanatomy, neurophysiology, and neurodevice validation is critical to program success. As a Women-Owned Small Business and Woman-Owned Business certified entity based in Silver Spring, Maryland, Katrina Gwinn operates as a sole proprietorship with a lean, agile structure designed for responsive, high-impact advisory engagements. Her certifications enhance access to federal set-aside opportunities and signal alignment with government diversity and inclusion objectives, reinforcing her credibility in mission-critical health technology consulting roles.