Medical Devices

With more than 100 attorneys, our IP Practice is one of the most active and highly regarded in the U.S. In this legal discipline, very few firms offer as wide a spectrum as that of our life sciences and technology experience. Technologies Covered by Our Practice

• Mechanical & Systems Engineering – products and devices designed to carry out specific functions, manufacturing, or process steps (e.g., medical devices, heat transfer, fluid control, and industrial process equipment)
• Life Sciences & Biotechnology – genetically engineered and DNA-based technology; implantable devices; diagnostics, vaccines, probes, vectors, and cell lines; and related discoveries for application in compositions, treatments, and therapeutics
• Electrical Engineering & Electronics― computer hardware, peripherals, and software; artificial intelligence; and digital devices

Our Health Care & Life Sciences Industry Group stands ready to meet our clients wherever they may be in the product development life cycle—research, commercialization, or distribution—to provide advice and practical solutions to clients, whatever the complexity of the need. We routinely draw from our extensive business and regulatory knowledge to help sector participants navigate the complete product life cycle, including:

• clinical research and development programs, including HIPAA privacy and consent;
• sales and marketing compliance, including employee training on fraud and abuse and Code of Ethics;
• marketing application strategies for drugs, biologics, and medical devices and U.S. state licensing requirements;
• government Price Reporting obligations for Medicare, Medicaid, the Department of Veterans Affairs, and 340B;
• the negotiation of customer and distributor supply agreements for both pharmaceutical manufacturers and medical device companies, including government purchasers under the Federal Supply Schedule (FSS);
• design and execution of Patient Access programs (e.g., kickstart, patient assistance and co-pay assistance programs for pharmaceutical manufacturers, limited pharmacy distribution networks, and hub service vendors); and
• international trade compliance, including country of origin.

We have extensive experience advising clients on risk management concerns involving mergers and acquisitions, public policy, IP protection, and an array of regulatory compliance matters relating to product marketing, foreign bribery, and import/export controls.

With former DOJ attorneys and in-house attorneys embedded in our Health Care & Life Sciences Industry Group, our attorneys have extensive experience in matters involving state and federal government law enforcement and investigations, including federal False Claims Act (FCA) defense, internal investigations, fraud and abuse compliance training, congressional investigations, and health care litigation.