Expert Details
Medical Device Design and Manufacturing: Laboratory Devices, Surgical Instruments, and Disposables
ID: 717319
California, USA
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.
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 |
|---|---|---|---|
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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 |
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| Years | Employer | Title | Department |
| 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. |
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| Years | Employer | Title | Department |
| 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 |
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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