Expert Details
Medical Device Product Development; Drug Delivery Systems; Biomedical/Mechanical Engineering; In Vitro Diagnostics
ID: 736685
California, USA
Since the mid-1990s, Expert has operated an independent technical and management consulting practice, providing program management and senior mechanical engineering services to medical device and in vitro diagnostic companies, alongside consulting affiliations with several additional engineering and product development firms. Expert brings particular depth in applying Quality System Regulations and ISO 13485/ISO 14971 standards throughout the product development lifecycle.
Expert is a named inventor on numerous issued patents spanning dialysis systems, biopsy tissue sampling devices, and fluidic technologies, and has contributed to an award-winning fluidics design for a clinical DNA diagnostic system. For more than two decades, Expert has also served as an expert witness in medical device product liability and patent infringement matters, drawing on extensive hands-on product design and engineering management experience. Expert holds a Bachelor of Science in Mechanical Engineering from San Diego State University and completed MBA coursework at the same institution.
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: |
Responsibilities:Provides technical and management consulting specializing in medical device and in-vitro diagnostic product development, along with expert witness services for medical device product liability and patent litigation, both independently and in conjunction with consulting associates, across a broad range of medical device technology areas. |
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| Years | Employer | Title | Department |
| Years: 1995 to 2025 | Employer: Fallbrook Engineering Inc. | Title: Senior Consultant Associate / Program Manager | Department: |
Responsibilities:Provided on-demand consulting as Senior Program Manager and Senior Mechanical Engineer for medical device product development projects, including drug delivery devices, blood handling systems, surgical tools, and in-vitro diagnostic systems; also provided expert services in product liability and patent-related matters. |
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| Years | Employer | Title | Department |
| Years: 2014 to 2017 | Employer: BIT-Group USA | Title: Senior Consultant / Project Manager | Department: |
Responsibilities:Provided part-time consulting as Project Manager and/or Systems Engineer for in vitro diagnostic product development projects. |
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| Years | Employer | Title | Department |
| Years: 2010 to 2016 | Employer: Invetech USA | Title: Program Manager / Senior Mechanical Engineer | Department: |
Responsibilities:Provided consulting services as Program Manager and Senior Mechanical Engineer for medical device product development projects; advised on development of new clients and business in the North American medical device market. |
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| Years | Employer | Title | Department |
| Years: 1981 to 1995 | Employer: CareFusion Corp. (formerly IVAC Corp. / Alaris Medical Systems / Cardinal Health) | Title: Engineering Management - Principal Engineer | Department: Development Engineering |
Responsibilities:1991 – 1995, Technical Leader, Development Engineering: Led a cross-functional team facilitating product concept generation, design feasibility, and business planning for the company's largest product development program in its history; provided engineering management to 30+ personnel across electrical, mechanical, software, and disposables engineering; directed a $35M fluid delivery platform development effort with an estimated $300M market potential; led competitive technical benchmarking and clinical requirements-gathering efforts across 20+ U.S. and European cities; established design specifications, performance qualification plans, and development processes that became the basis for ISO 9000/9001 design control approval; managed outside engineering/testing consultants; coordinated a patent review process resulting in 50+ invention disclosures1984 – 1990, Department Manager, Mechanical Development Engineering: Managed mechanical engineering resources of up to 18 engineers with an annual budget exceeding $1.5M; led mechanical development and market introduction of six new drug delivery systems and more than a dozen disposable products; provided technical consulting on corporate technology evaluations; provided expert opinions on patent and product liability matters; managed the company machine shop and development test lab; directed selection and implementation of CAD/CAM systems and rapid prototyping capabilities 1981 – 1983, Department Manager, Instrument Sustaining Engineering: Managed mechanical engineering resources of 8 engineers with a $500K annual budget; responsible for transitioning instrument and disposable products from development to production; recruited, trained, and mentored engineering personnel; collaborated across engineering, quality, operations, and marketing functions |
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| Years | Employer | Title | Department |
| Years: 1978 to 1981 | Employer: Carbomedics Inc. | Title: Program Manager, Process Development Engineering | Department: |
Responsibilities:Redesigned processing methods and led a $1M project relocating a pyrolytic carbon coating facility; led development of a new mono-leaflet implantable heart valve; invented a rotary dry chemical delivery system for a fluidized bed coating process. |
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Additional Experience
| Expert Witness Experience |
|---|
| Expert has more than 20 years of expert witness experience in the areas of medical device product liability and patent infringement litigation, providing services both independently through a consulting practice and via affiliated consulting relationships. |
Career Accomplishments
| Licenses / Certifications |
|---|
| Ancillary training/coursework in: Design of Experiments (DOE), Design for Manufacturability (DFMA), Performance Excellence (PE), Total Quality Management (TQM), Quality Function Deployment (QFD), and additional quality management skills courses |
| Awards / Recognition |
|---|
| Award-winning product design recognition for a patented fluidics design used in a cassette-based clinical diagnostic system for DNA sample processing |
| Publications and Patents Summary |
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| 21 patents and patent applications listed across U.S., European, international (WO), Australian, and Canadian jurisdictions, representing several patent families covering: portable dialysis machines and disposable dialysis kits, biopsy tissue sample transport devices and containers, fluidic devices, engineered pumping segments, and pressure-sensing vessel systems. |
Fields of Expertise
intravenous drug delivery, Respiratory Care Devices, blood handling, auto-injector, inhaler, in vitro diagnostics, fluidics, hemodialysis equipment, insulin pump, Insulin Injector Pens, eCigarette litigation, medical device, Drug Delivery Systems, Dialysis Systems Design, Insulin Delivery Systems, Blood Handling Systems, ISO 13485 Compliance, ISO 14971 Risk Management, Medical Device Program Management, Fluidics Design Expert