The MedTech Conference: US Market Access Seminar

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.

Albert (Al) L. Sokol has nearly 50 years of experience representing a variety of large, medium and small life sciences and technology companies, often in multinational transactions. Types of work include venture capital and private equity investments, mergers and acquisitions, spin-offs, general corporate counseling, strategic alliances, executive compensation, licenses, collaborations, intellectual property matters, litigation, and other types of assistance.

After attending Yale University, Al lived abroad for four years, principally in Lusaka, Zambia, organizing, financing and operating a micro-credit company, primarily as an executive of the national Credit Union Association of Zambia.

While in law school, Al was an editor for the Boston University Law Review.