Dr. Shoemaker spent 21 years as an active duty Army microbiologist helping develop medical products for the warfighter. Early on in his career he was assigned to a one year tour of duty at the FDA to learn what it takes to get the FDA “seal of approval” for medical devices. He gained significant experience developing in vitro diagnostic tests for the biothreat agents at the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID), and was instrumental in getting the first anthrax diagnostic test (Gamma Phage Assay) cleared by FDA for human use within the CDC Laboratory Response Network. During subsequent assignments he advised and assisted the DoD on hundreds of different FDA-regulated products, including diagnostic products for traumatic brain injury and circulatory shock in trauma patients, a novel device to treat balance and gait disorders, and numerous others. After retiring in 2013 he was recalled back to active duty for a year in 2020 to support the DoD COVID-19 Task Force by identifying problems and implementing solutions to support military clinical laboratories worldwide. The acme of his career was advising GEN James “Mad Dog” Mattis on the pitfalls of deploying the unapproved Theranos diagnostic device to Afghanistan. Since retiring from active duty he established ‘Shoemaker Regulatory Consulting, LLC’, and enjoys assisting medical device startup companies develop and execute regulatory strategies that will lead to potentially life-changing and life-saving products.