Michael Ryan, JD

With deep experience in the life sciences industry, Mr. Michael W. Ryan advises manufacturers, healthcare providers, drug and technology developers, and investors on the legal, regulatory and reimbursement issues that arise during the development and commercialization of medical devices, clinical laboratory testing services, biological products and drugs. He guides life sciences companies and laboratories by evaluating and implementing strategies to optimize coding, coverage and payment for novel technologies. Mr. Ryan also helps innovative companies identify and navigate applicable FDA regulatory requirements for new technologies, particularly in vitro diagnostics and digital health products. In particular, he regularly advises clients on the FDA’s evolving requirements for laboratory developed tests (LDTs) and digital health products, such as clinical decision support (CDS) software. Mr. Ryan also counsels clinical laboratories on state and federal compliance issues, including those under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), state laboratory licensure laws, and billing and reimbursement rules. Mr. Ryan’s previous speaking engagements include the AdvaMed MedTech Conference, the Food and Drug Law Institute (FDLI) Annual Conference, the 2025 BIO International Conference and other industry events.