Expert Details

Expert in Medical Device Failure Analysis, Medical Device Product Liability, Patent Infringement Analysis, Patent Invalidity and Validity Analysis, Patent Claim Construction

Expert ID: 733758 Missouri, USA

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Expert has over 20 years in the medical device and electronics industries, with contributions exemplified in the numerous products that were developed under his leadership. These products today are improving the quality of healthcare, in hospitals, sub-acute and alternate care settings. Expert's industry experience includes positions as senior director, global R&D and Engineering for Nellcor Puritan Bennett, a Mallinckrodt/Tyco Company, which later became Covidien, and R&D team leader for Ethicon Endo-Surgery, a Johnson & Johnson (J&J) Company.

At Nellcor, he led the R&D group to bring to develop devices for diagnosis and treatment of respiratory disorders, including pulmonary function testing and oxygen generation devices for patients suffering from chronic obstructive pulmonary disease (COPD), asthma and sleep related disorders. This includes oxygen concentrators, oxygen conserving devices, high-pressure gas tank regulators, stationary and portable cryogenic oxygen systems and telemonitoring devices, Continuous Positive Airway pressure (CPAP) ventilators, Biphasic Positive Airway Pressure (BIPAP) ventilators, aerol devices to treatment of restrictive airway disorders such as asthma, spirometers and flow sensors for lung function testing. At J&J I led design and development of disposable instruments for laparoscopic and endoscopic for general, gynecologic and thoracic surgery, including surgical staplers, graspers, dissectors and biopsy forceps, surgical knives and blades and suction-irrigation devices. I have been awarded 19 utility patents for my inventions.

A registered professional engineer, Expert earned BS and MS degrees in industrial and mechanical engineering, from the University of Portland, a Ph.D. in Industrial and Mechanical Engineering from Northeastern University, a MBA from the Kellogg School of Management, Northwestern University, certificates in product development and European regulatory requirements for product safety and testing, respectively from Harvard Business School and TUV Rheinland NA. He served on the board of Ranken Jordan Pediatric Hospital in Saint Louis, and was an adjunct professor of engineering at Missouri University of Science and Technology. Expert is listed in Marquis Who’s Who in Science and Engineering, Who’s Who in the World, Who’s Who in America, and Outstanding Scientists of the 20th Century by International Biographical Center Cambridge, England.

He provides consulting and expert witness services in the areas of product liability (evaluation of design and manufacturing defects), product failure analysis; and patent litigation matters, including patent infringement (validity), non-infringement (patent invalidity), and patent claims interpretation and construction from the viewpoint of one skilled in the art.

Education

Year Degree Subject Institution
Year: 2002 Degree: MBA Subject: Business Administration Institution: Northwestern University
Year: 1994 Degree: PHD Subject: Industrial & Mechanical Engineering Institution: Northeastern University
Year: 1984 Degree: MS Subject: Mechanical Engineering Institution: University of Portland
Year: 1980 Degree: BS Subject: Industrial & Mechanical Engineering Institution: University of Portland

Work History

Years Employer Title Department Responsibilities
Years: 2001 to Present Employer: Undisclosed Title: President & CEO Department: Biomedical R&D Responsibilities: A biomedical research and development company, to develop innovative medical devices for anesthetic, surgical and respiratory care in non-traditional hospital settings. And to provide expert witness and consulting services to attorneys representing plaintiffs or defendants on medical device product liability and patent infringement cases.
Years: 1998 to 2001 Employer: Nellcor Puritan Bennett/Mallinckrodt Inc. Title: Senior Director Global R&D/Engineering Department: Respiratory Group R&D Responsibilities: Responsible for a global R&D organization comprising 150 scientists and engineers and a $20 million R&D budget, with product development sites in the United States, France and Canada. Developed diagnostic and therapeutic devices for a $400 million business unit within the Respiratory Group. Developed diagnostic spirometers, compressed gas and liquid oxygen systems, oxygen concentrators, and oxygen conserving devices for treatment of chronic obstructive pulmonary disease (COPD); CPAP and BPAP ventilators for treatment of sleep related disorders, breathing tubes and sleep masks .
Years: 1994 to 1998 Employer: Ethicon Endo-Surgery Inc./Johnson & Johnson Co. Title: Team Leader Research & Development Department: Endo-Mechanical Devices Group Responsibilities: Directed R&D group for a $200 million business unit focused on endoscopic surgery. Led parallel projects and cross-functional teams of design, manufacturing, reliability and quality engineers, marketing, finance, regulatory and clinical personnel, to develop, test, validate and bring to market a family of handheld devices for general, gynecologic and thoracic surgery, including surgical skin staplers, clip appliers, graspers, dissectors, trocars and biopsy forceps, in accordance with FDA/GMP guidelines.
Years: 1983 to 1994 Employer: Digital Equipment Corporation Title: Worldwide Strategy Manager Integrated Product Development Department: Engineering Systems Group Responsibilities: Led worldwide product development strategy for a $400 million business unit. Managed strategic joint ventures for the development of design and manufacturing automation technologies targeted at Digital’s VAX/VMS and ULTRIX platforms. Negotiated technology licensing agreements and strategic alliances, to close technology gaps, reduce cycle-time, and cost of goods sold.
Aligned global partners and development teams through a unifying process, called the simultaneous product development process; a unique approach to product development, which establishes operational guidelines for managing products throughout their life cycles.
Years: 1980 to 1983 Employer: Tektronix Title: Senior Industrial/Mechanical Engineer Department: Test & Measurement Systems Group Responsibilities: Responsible for mechanical design, simulation, testing and manufacturing process planning. Designed adjustable work dispensers and automated assembly systems. Led projects on numerical control and distributed intelligence.

International Experience

Years Country / Region Summary
Years: 1994 to 2001 Country / Region: Europe Summary: Led product development, sustaining engineering and regulatory activities across sites in the United States, France and Canada with a $25 million R&D budget.

Career Accomplishments

Associations / Societies
American Institute of Mechanical Engineers
Institute of Industrial Engineers
Saint Louis Kellogg Alumni Association
Member American Society of Mechanical Engineers
Senior Member Institute of Industrial Engineers
Licenses / Certifications
Registered Professional Engineer, Missouri, USA.
Professional Appointments
Adjunct Professor, Missouri University of Science & Technology (formerly University of Missouri Rolla)
Adjunct Professor, Saint Louis University
Adjunct Professor University of Maryland University College
Adjunct Professor University of Phoenix
Adjunct Professor. Fontbonne University
Awards / Recognition
The Marquis Who's Who in Science & Engineering
The Marquis Who's Who in the World
The Marquis Who's Who in America
Publications and Patents Summary
19 United States Medical Device Patents

Additional Experience

Expert Witness Experience
Expert has served as an expert witness on product liability and patent litigation cases for attorneys representing plaintiffs as well as defendants, drawing from decades of research and development and manufacturing of surgical and respiratory devices. His expertise is based on more than 20 years of practical experience experience in product design and manufacturing of medical devices, and a solid knowledge of standards governing same, including the United States FDA and European CE regulatory requirements and quality ISO quality standards.

Language Skills

Language Proficiency
English Ability to speak and write proficiently.

Fields of Expertise

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