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.

Laura McLane co-leads McDermott’s white-collar and government investigations practice as well as the Firm’s False Claims Act (FCA) practice, and is a nationally renowned FCA litigator. For over 25 years, Laura has defended companies touching all aspects of the healthcare and life sciences industries in government investigations, qui tam litigation under the FCA, and related matters. Clients call Laura “an exquisite lawyer, very smart and incisive,” and a “fierce advocate for her clients” (Chambers USA). Laura was named Boston’s Lawyer of Year in Healthcare Litigation by Best Lawyers in America for 2025-2026.

Laura’s experience spans the spectrum of government oversight in healthcare and life sciences. Her clients include healthcare providers of all types as well as laboratories, pharmaceutical and device manufacturers, private equity investors, and an array of other entities that reach the healthcare space. Laura represents clients in FCA matters throughout the country, as well as in federal courts of appeals and the Supreme Court of the United States. She has extensively litigated the myriad issues that typically arise in FCA cases, including representing her client in the landmark Escobar case in the Supreme Court. Clients state that Laura is “fantastic, . . . efficient and able to pull in knowledgeable resources right to the issue” (Legal 500 US).  Her recent experience includes guiding multiple clients through government investigations and related matters arising from the novel issues presented by the Covid-19 pandemic, including issues relating to testing, vaccination and treatment. In addition to her healthcare experience, Laura defends clients facing FCA and other forms of government scrutiny in other industries, such as defense contracting and technology.

Beyond defending clients in investigations and litigation, Laura’s practice includes working closely with clients on FCA risk management and compliance assessments, and counseling buyers and sellers in transactions involving enforcement issues.

Monica A. Wallace focuses her practice on complex regulatory and transactional counseling to healthcare organizations, including health systems, hospitals, ambulatory surgery centers, physician groups, dental providers, behavioral health clients, integrated delivery systems, academic medical centers, DMEPOS and pharmaceutical manufacturers and suppliers, home health agencies, and venture capital and private equity firms and their health-related portfolio companies. Monica is a practice area leader for the Healthcare Regulatory & Compliance practice.

Monica concentrates her regulatory practice on healthcare fraud and abuse, Medicare and Medicaid enrollment, reimbursement and billing, legal assessments and audits, compliance programs, and other general regulatory matters including licensure, survey/certification and accreditation. Her transactional practice includes mergers, acquisitions and affiliations, divestitures, hospital/physician joint ventures and corporate reorganization.

Previously, Monica worked with hospital executive management at the University of Iowa Hospitals and Clinics on strategic academic medical center issues.