Expert Details

Expert in Biomaterials, Biotechnology, Medical Devices, Polymer Chemistry, Biomedical Engineering, Materials Engineering, Healthcare (regulatory), Intellectual Property Strategy

Expert ID: 735392 Virginia, USA

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Expert has more than 20 years experience in biomaterials and medical devices, both in industry and as a university professor performing research. His research has a translational focus, so he has conducted numerous pivotal animal studies related to the fields of orthopaedics, trauma surgery, cardiovascular, and wound healing. Expert's research has resulted in three successful submissions to the FDA for clearance of a medical device and has worked on PMA approval of several class III medical devices.

Scientifically, Expert is trained and has extensive expertise in polymeric materials. Past projects and experience have included medical product development, failure analysis, translational animal model development, safety/efficacy testing, regulatory filings, grant writing (including small business grants such as SBIR and STTR), publishing, and expert witness work (e.g. case development, depositions, expert reports and deposition testimony).

He also has had extensive experience in small business development (i.e. biotech/medtech startup) and launched three companies based on his research. He has done extensive patent prosecution, both US and foreign, developed IP strategy for biotech/medtech startup companies, and advised on IP strategy development. Expert has also performed patentability and freedom to operate assessments, and been an analyst for biotech/medtech investment.

Developed case strategy, provided data and expert report, expert testimony for several medical and consumer product liability cases. Prepared third-party opinions for pending patent applications. Research consulting in the manufacturing and healthcare sectors. Advised on development and implementation of regulatory strategy. Advised small business startups in healthcare space.

Education

Year Degree Subject Institution
Year: 1998 Degree: PhD Subject: Materials Science Institution: University of Cincinnati

Work History

Years Employer Title Department Responsibilities
Years: 2012 to 2019 Employer: Virginia Tech Title: Associate Professor Department: Biomedical Engineering and Mechanics Responsibilities: Conduct research; teach classes; mentor students
Years: 2008 to 2012 Employer: KeraNetics Title: Chief Science Officer Department: NA Responsibilities: Develop and manage R&D program, manufacturing, and regulatory affairs
Years: 2004 to 2012 Employer: Wake Forest School of Medicine Title: Assistant Professor Department: Institute for Regenerative Medicine/Department of Surgery/Department of Orthopaedic Surgery Responsibilities: Conduct research; teach classes; mentor students
Years: 1998 to 2004 Employer: Southwest Research Institute Title: Senior Research Scientist Department: Materials Engineering Responsibilities: Conduct contract research for a variety of industry and government clients

Additional Experience

Expert Witness Experience
Expert has provided case development consulting as an expert witness, expert reports, and deposition testimony.

Language Skills

Language Proficiency
English Native speaker

Fields of Expertise

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