McDermott Will & Schulte, a global law firm

Michael (Mike) Ryan advises manufacturers, healthcare providers, and investors on the legal, regulatory, and reimbursement/market access issues that arise during the development and commercialization of medical devices, clinical laboratory testing services, biological products, and drugs. He helps clinical laboratories and life sciences companies maintain regulatory compliance and evaluate, develop, and implement strategies to optimize coding, coverage, and payment for novel technologies.

Additionally, Mike helps innovative companies identify and navigate applicable Food and Drug Administration (FDA) regulatory requirements for new technologies, particularly in vitro diagnostics and digital health products. He regularly advises clients on the FDA’s evolving requirements for laboratory developed tests (LDTs) and reviews promotional and marketing materials for FDA-regulated medical products.

Mike 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.

Richard B. Smith focuses his practice on representation of life sciences companies and related transactions. He has served as counsel to public, private and emerging life sciences companies, advising those companies on strategic business transactions such as licensing, joint ventures, and collaborations involving research, development, marketing, supply, clinical development and co-promotion of pharmaceutical, diagnostic and medical device products.

Richard also advises companies on other corporate issues common to life sciences companies, including corporate formation of new ventures, venture capital, private equity, venture philanthropy and other forms of financing, mergers and acquisitions, as well as university and institutional licensing and intellectual property strategies.