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Medical Device and Diagnostic Companies

Medical and Diagnostic Devices

Companies planning to develop and commercialize medical devices or diagnostics face a challenging financing, regulatory and reimbursement environment. Saul Ewing attorneys are experienced in helping medical device and diagnostic companies navigate these challenges. 
Many members of our team had careers before law school working as scientists, engineers, bankers and entrepreneurs. We bring a practical, business-oriented approach to advising our clients with respect to protecting and enforcing their intellectual property; developing, manufacturing and commercializing their products; contracting with clinical research organizations or university collaborators; or supporting financings, M&A and other business transactions. 

Our life sciences team includes patent attorneys and patent agents who have diverse scientific and engineering backgrounds that they draw upon to help clients in the due diligence, freedom-to-operate/clearance and patent protection contexts. Many have degrees in mechanical, electrical and chemical engineering, computer science, biotechnology, analytical chemistry, genetics and molecular biology. When intellectual property disputes escalate, our patent litigators are ready to step in to negotiate or, where necessary, litigate the matter to conclusion. 

Our broader team includes health care attorneys who counsel on federally-required disclosure of payments to physicians and teaching hospitals by device companies under the Sunshine Act, as well as white collar and government enforcement attorneys who provide representation in matters ranging from off-label marketing and whistleblower/qui tam complaints under the False Claims Act to exclusion and debarment actions involving allegations of fraud, waste and abuse in federal health care programs. Our attorneys have also litigated – and settled – product liability cases and other types of claims involving life sciences industry products.

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Gregory S. Bernabeo