Expert Details
Medical Device Development
ID: 736685
California, USA
40+ years Medical Device design & development (13 patents)
- Drug delivery devices, respiratory care devices, hemodialysis, and blood collection devices, in-vitro diagnostic instrument, and cartridge devices; 25+ years medical device product liability and patent infringement experience.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1979 | Degree: BSME | Subject: Mechanical Engineering | Institution: San Diego State University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 1995 to Present | Employer: Undisclosed | Title: Founder and Principal Consultant | Department: Consulting Engineering |
Responsibilities:25+ years of Technical & Management Consultant specializing in Medical Device and In Vitro Diagnostic Product Development as well as Expert Witness services for Medical Device product liability and patent litigation. Responsibilities include but not limited to Project management, team leadership, design reviews, and risk analysis, hands-on design, analysis, technology selection, requirements review and/or creation, prototyping, test and verification, documentation creation, and finally product liability and patent analysis litigation. |
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| Years | Employer | Title | Department |
| Years: 1995 to Present | Employer: Undisclosed | Title: Fallbrook Engineering Senior Consultant / Project Manager | Department: Engineering |
Responsibilities:Expert’s association with Fallbrook Engineering Inc. (FEI) goes back to the late 1980s when he managed Mechanical Engineering at IVAC Corporation and hired FEI to consult on various intravenous drug infusion pump design issues. Over time and ongoing association, Expert was eventually requested to assist on design projects that FEI was managing. In 1995, Expert left IVAC Corp. and started independently consulting full time and also began a sustained association with FEI that continues today spanning a period of more than 30 years in collaboration.Expert’s 40+ years of product development experience is centered in the Medical Device and Biomedical industries. He has worked directly on design or resource management to develop FDA approved medical products such as clinical IV pump systems, blood handling, and dialysis systems, drug pen injectors, drug inhalers, ambulatory insulin pumps, In Vitro Diagnostic fluidic systems and cassettes, numerous sterile plastic sterile single-use products, and even Pyrolytic Carbon heart valves, blood access ports, and dental implants. Expert’s management experience includes Senior Project Management at Fallbrook Engineering Inc., R&D Management and Technical Leadership at IVAC Corporation (now part of CareFusion, Inc), Program Director (via FEI) at Mission Medical (now part of Terumo Medical Corp), and Program Manager at CarboMedics Inc. Expert earned his BSME from San Diego State University as well as MBA course work. He completed management training with Eli Lilly and Company as well as numerous training courses in Design of Experiments (DOE), Design for Manufacturing and Assembly (DFMA), Hazards Analysis & Medical Device Safety, Quality Function Deployment (QFD), and Total Quality Management (TQM). Expert also organized and gained approval for the Design Control section of the FDA QSR & ISO 9000 Standards at two device companies. Expert’s FEI senior associate experience background includes 20+ years of medical device-centered Expert Witness work encompassing dozens of product liability and patent litigation cases, reports, depositions, and trial testimony. Expert is an inventor on sixteen patents and various other patent applications in the fields of Drug Delivery, in In-Vitro Diagnostic Systems, and Hemodialysis Systems. |
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| Years | Employer | Title | Department |
| Years: 1981 to 1995 | Employer: Ivac Corporation - now Carefusion Corp. a subsiderary of Becton Dickinson | Title: Engineering Management - Principal Engineer | Department: Engineering |
Responsibilities:Technical Leader:Worked in a cross-functional team environment with Marketing, Quality, and Manufacturing Team Leaders and facilitated the product concept generation, design feasibility, and business plan generation for the Signature Edition program. This was Alaris’s first “Heavy-weight” program team and was run as a company within a company. Engineering Department Manager: Managed all mechanical engineering resources of up to eighteen Engineers with an annual budget of over $1.5M. Responsibilities included the mechanical development and market introduction of six new Drug Delivery systems and over a dozen new plastic disposable products. • Provided technical consulting participation on corporate teams in the analysis of technology being considered for purchase by the company such as syringe pumps, fluid flow control devices, rotary peristaltic pumps, and specialized medical-grade pressure transducers. In this capacity also provided Expert opinions for Patent and Product Liability issues facing the company. • Trained in Eli Lilly management program and provided Technical Resources to Lilly instrument and disposable combination products during 1990 – 1995. • Managed the company machine shop with six Model Makers and Machining Specialists utilizing eight production mills and two CNC mills. Managed the Development Test Lab, which had four Senior Test Technicians and full laboratory equipment used for design verification testing. I managed the main test strategies and procedures for this test lab. • Directed the effort to select & implement new CAD systems for the mechanical engineering resources, (SDRC-Ideas then Solidworks). I hired resources to train and maintain the system, and integrated outside suppliers who interfaced their CAM systems. Directed efforts to establish an in-house CAD-CAM link between the design group and the PCB layout group and machine shop for rapid prototyping. I implemented extensive use of rapid prototyping on all projects such as computer modeling, solid modeling, stereolithography equipment selection and capital approval, and urethane cast molds. Engineering Department Manager - Instrument & Consumables Sustaining Engineering: Managed mechanical engineering resources of eight Mechanical Engineers with an annual budget of $500K. Responsibilities included all the mechanical engineering tasks in transitioning several new Instrument products and Disposables products from development to production while maintaining all existing production needs. • Position supervised the combined departments of Instrument Mechanical and Disposable Products sustaining engineering. Expert was responsible for recruiting, training, mentoring, and reviews of all mechanical engineering personnel. • Responsible for skillful interdepartmental collaboration between Engineering, Quality, Operations, and Marketing to resolve critical design issues impacting production, or field issues demanding immediate attention. |
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| Years | Employer | Title | Department |
| Years: 1978 to 1981 | Employer: Carbomedics Inc. | Title: Project Manager | Department: Engineering |
Responsibilities:Project Manager - Process EngineeringRe-designed processing methods, then planned and implemented a $1M project to move an existing Pyrolite® coating facility from San Diego, Ca. to Austin, Texas. I was responsible for the technical process/facility improvements, laboratory construction, and coating process validation in the new building. • Lead the development of a new mono-leaflet implantable heart valve • Invented and directed the proprietary design of an accurate rotary dry chemical delivery system to feed zirconium oxide granules to a fluidized bed coating process. |
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Career Accomplishments
| Licenses / Certifications |
|---|
| Certificates of achievement: Design of Experiments (DOE) Design for Manufacturability (DFMA) Performance Excellence (PE) Total Quality Management (TQM) Quality Function Deployment (QFD) |
| Publications and Patents Summary |
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| Patents: Portable Dialysis Machine x3 System and Method for conducting hemodialysis and hemofiltration Fluidic devises x2 Pressure Sensing Vessel Adapted to be Preloaded Against a Sensor x2 Engineered Pumping Segment x2 Disposable Apparatus and Kit for Conducting Dialysis x3 Tissue Sample Container and Methods Biopsy Tissue Sample Transport Device and Method of Using Thereof |
Additional Experience
| Expert Witness Experience |
|---|
| Expert has provided deposition/trial testimony as an Expert in 18 cases dating back to 1986. |
Language Skills
| Language | Proficiency |
|---|---|
| English | Good |