Expert Details

Expert in Medical Device Design and Manufacturing: Laboratory Devices, Surgical Instruments, and Disposables

Expert ID: 717319 California, USA

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Expert has expertise in the design and development of laboratory devices, surgical instruments, and disposables for the biotechnology, pharmaceutical, medical device, electronic, cosmetic, and consumer product industries. Examples of products he has developed and/or patented are an I.V. disposable product line, an enteral product line, volumetric pumps and disposables, and a microaggregate transfusion filter. Expert has also been involved in the development of a probe cover and a probe cover dispenser for use on a "next generation" electronic hospital thermometer. Additionally, he has experience with biomaterials, thermoplastics, elastomers, and polyurethanes.

Expert has directed the efforts of engineers, physiologists, regulatory specialists, technicians, model makers, machinists, and tool builders for numerous medical products. These products have included I.V. pump and administration sets, blood processing and transfusion equipment, I.V. catheters, laser fiber optic catheters, elastomeric fluid dispensers, and hemofiltration devices. His consulting firm specializes in product development, CAD design and drafting, and manufacturing engineering. Expert is proficient in management, including supervising and designing training programs, planning business strategies, implementing use of equipment and services, and acting as liaison between corporate departments.



Expert may consult nationally and internationally, and is also local to the following cities: Los Angeles, California - San Diego, California - Long Beach, California - Santa Ana, California - Anaheim, California - Riverside, California - Glendale, California - Huntington Beach, California - San Bernardino, California - Chula Vista, California

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Education

Year Degree Subject Institution
Year: 1972 Degree: MS Subject: Mechanical Engineering Institution: University of Wisconsin, Madison
Year: 1971 Degree: BS Subject: Mechanical Engineering Institution: University of Wisconsin

Work History

Years Employer Title Department Responsibilities
Years: 1989 to Present Employer: Undisclosed Title: Vice President, Owner Department: Responsibilities: He is responsible for Business Development, Corporate Management, Project Management, Client Interface and general operation of the consulting firm.
Years: 1988 to 1989 Employer: Diatek Corp . Title: Manager, Manufacturing Engineering Department: Responsibilities: Managed support services for facilities and all manufacturing of electronic thermometers and related disposables, plus headed up disposable development for tympanic thermometer program.
Years: 1983 to 1988 Employer: IMED Corp . Title: Manager, Pilot Engineering/Disposable Design Department: Responsibilities: Ran pilot manufacturing of IV Pumps, new sterile disposables and custom sets.
Years: 1979 to 1983 Employer: Oak Industries Title: Director Telecomunications Department: Responsibilities: Cooridinated telecom function for HQ and sattelite facilities, developed Pay TV business units nationwide, training responsibility for installation and service
Years: 1974 to 1979 Employer: Fenwal Division, Baxter Trevenol Lab s Title: Engineer & Program Manager Department: Responsibilities: Blood filter design and development, blood cell separation systems for plasma generation.
Years: 1972 to 1974 Employer: USCI, Division of CR Bard Title: Biomedical Engineer Department: Responsibilities: He designed test equipment for vascular implants, plus developed new line of aortic implants

Career Accomplishments

Associations / Societies
AAMI, American Filtration Society, Scripps Research Institure, Society of Plastics Engineers
Professional Appointments
Past Board Member, Medical Plastics Division of SPE
Publications and Patents Summary
He has 10 US patents, numerous international patents, and has been an ivited speaker to technical innovation conferences and technical trade meetings

Additional Experience

Expert Witness Experience
He has provided expert services to courts and has been an expert witness in at least 6 cases. He has provided technical review, prepared reports for the clients and has testified in State Court
Vendor Selection
He has evaluated and selected well over 200 different vendors providing components, assemblies, oem manufacturing, processing services, testing, sterilization, etc., etc., etc.
Marketing Experience
He has designed and helped launch dozens and dozens of sterile single use disposables, implants, diagnostics, theraputics, electronic devices, electro-mechanical devices, computer controlled devices, and so on. His entire career has been in new product development
Other Relevant Experience
He is a Principal Investigator for an National Institute of Health SBIR Grant to develop a device to collect umbilical cord blood which is a rich source of stem cells

Fields of Expertise

medical device design, medical device manufacturing, plastic medical device, medical device, project management, medical polymer selection, thermoplastic material selection, high volume, low cost product assembly, high volume, low cost product design, biocompatibility testing, integrated product team, cannula, United States patent, autoclavable plastic material selection, medical filter, biomechanical engineering, investigational medical device exemption regulation, polymer selection for chemical compatibility, elastomer selection, dispensing device, 510(k) document, instrument design, therapeutic device, industrial design, electrosurgical instrumentation, disposable medical device, electronic system program management, manufacturability design review, management, new product development, computer-aided design, drug delivery, electronic medical device design, medical product packaging process, medical device reliability testing, medical device packaging design, filtration, adhesive selection, design for manufacture and assembly, electronic medical device, biomedical device, processing, bioimplantable material, sterilization, medical instrument, thermoplastic resin, thermometer, surgical instrument, rapid prototyping, polyurethane, polymer selection, medical pump, medical laser, irradiation sterilization, intravenous infusion, fluid mechanics, fluid flow measurement, fluid dynamics, endoscope, elastomer, biomedical diagnostic instrumentation, catheter, blood, biotechnology, biomedical engineering, biomedical device manufacturing, biocompatible polymer, biocompatible metal, biocompatible material, artificial artery

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