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Cardiopulmonary Bypass Medical Device Engineer Medical Expert Witness



Expert Witness No.1341

Litigation – Quality Systems – Regulatory Compliance



1953 – 1955   Loveland High School, Loveland, Colorado

1955 – 1957   Canon City High School, Canon City, Colorado

1957 – 1961   Colorado State University, Fort Collins, Colorado
                         - B.S. Degree, Mechanical Engineering

1962 – 1966   University of Houston, Houston, Texas
- M.S. Degree, Mechanical Engineering
- Part time (night) student
- Thesis Title: Filtering Characteristics of a Long Steel Bar with Discontinuities in Cross Sectional Area
- Thesis Advisor, Douglas Muster, Ph.D., Department Chairman

1966 – 1969    University of Houston, Houston, Texas
- Ph.D. Degree, Mechanical Engineering
- Dissertation Title: A Blood Pump for Closed Chest Left Ventricular Bypass.
- Dissertation Advisors: Charles Dalton, Ph.D., Univ. Houston   Leslie A. Geddes, Ph.D., Baylor Medical*
 •    A large portion of course work and all research were done in the Physiology Department of Baylor College of Medicine, Houston, Texas.

1973 – 1974   Harvard Medical School at The Peter Bent Brigham Hospital
- Post Doctoral Studies in Biomedical Engineering, Pulmonary and  Intensive Care Medicine, Department of Surgery.
- Advisor: Philip A. Drinker, Ph.D.

Academic Honors:

     Pi Tau Sigma, Mechanical Engineering Honorary, C.S.U.
     Omicron Delta Kappa, Scholastic and Service Honorary, C.S.U.
     Sigma  Xi, Research Oriented Honorary, Univ. Houston

Fellowships and Teaching Experience:

     Texaco Fellow in Mechanical Engineering, Univ. Houston, 1966 – 1969.
     Student Asst., “Classical Physiology and Modern Instrumentation”, Baylor, 1967.
     Laboratory Assistant, Physiology Laboratory, Baylor, 1966 – 1969.

Professional Affiliations:

•    National Society of Professional Engineers (NSPE)
•    American Society of Mechanical Engineers (ASME)
•    Regulatory Affairs Professional Society (RAPS)
•    American Society of Extracorporeal Technology (AmSECT)
•    National Academy of Forensic Engineers (NAFE), Senior Member and Board Certified Diplomate in Forensic Engineering by NAFE, a CESB Member Board
•    Registered Professional Engineer in Colorado (Reg. No. 10025)

Past Affiliations:

•    Certified Clinical Engineer by AAMI
•    American Academy of Cardiovascular Perfusion (AACP)
•    AdvaMed (Formerly Health Industry Manufacturers Association, HIMA)
•    American Society for Quality (ASQ), Senior Member
•    Association for the Advancement of Medical Instrumentation (AAMI)

Professional Experience:

1961 – 1966    Texaco, Inc., Research and Technical Division, Bellaire, Texas
* Position: Mechanical Engineer
* Job Description: Mechanical design of miniature mechanisms, acoustic wave propagation, oil well drilling research, electromechanical and nuclear well logging research, hydraulic  power design.


1966 – 1969   Texaco, Inc., On educational leave.


1969 – 1973   Monaghan Company, Littleton, Colorado
* Positions: Product Development Engineer; Manager, Product Development
* Job Description: Design and development of products used in diagnosis and treatment of lung disease; respirators, humidifiers, pulmonary function analyzers, and intensive care ventilators.


1973 – 1974   Harvard Medical School (see above for details)


1974 – 1977   Monaghan Company (Became Hospal Medical Corporation)
* Positions: Staff Scientist; Product Manager
* Job Description: Acted as consultant to engineering and marketing departments in several phases of product planning and development.  Participated in advanced product research projects.


1977 – 1983   COBE Laboratories, Inc., Lakewood, Colorado
* Positions: Clinical Monitor (Cardiovascular Division); Manager, Clinical Affairs (Cardiovascular Division);
* Job Description: Responsible for clinical evaluation of new cardiovascular surgery products. In charge of quality engineering and clinical evaluation for cardiovascular products.

1983 - 1986    COBE Laboratories, Inc., Lakewood, Colorado
* Position: Manager, Advanced Projects (Hemodialysis Division)
* Job Description: Manager of a group responsible for technological  outreach in dialysis research and development.               


1986 – 1990   COBE Laboratories, Inc., Lakewood, Colorado
* Position: Director, Quality Assurance, Cardiovascular Division
* Job Description: Responsible for all quality assurance and regulatory activities for one of two corporate divisions dealing with extracorporeal life support, physiologic pressure monitoring, and surgical blood salvage. Included quality control, quality engineering, corporate biological and chemistry laboratories, product liability, and regulatory activities. Also responsible for environmental health and safety issues for the corporation.


1990 – 1999   COBE Cardiovascular, Inc. Arvada, Colorado (New Corporation, Division of       Gambro, Inc.)  
* Position: Director, Quality and Regulatory Affairs
* Job Description: Responsible for all quality and regulatory activities in the fields of extracorporeal life support, physiologic pressure monitoring, surgical blood salvage and related products. Responsibilities included domestic and international regulatory and standards compliance and submissions activities (FDA, ISO 9001 and CE Marking), quality assurance, quality engineering, clinical monitoring, receiving quality, product release, corporate blood testing laboratory, material toxicity testing, microbiology, OSHA, EPA, and product liability.


1999 – 2001   Gambro Renal Products, Inc. Lakewood, Colorado
* Position: Director, Quality and Regulatory Compliance
* Job Description: Responsible for quality and regulatory compliance for a manufacturer of hemodialysis equipment. Responsibilities included regulatory and standards compliance for FDA, ISO 9001 and CE Marking, quality engineering, receiving quality, and complaint management.                     


2001 – Present    J. Dennis Bruner, Ph.D., P.E., Inc.
* Position: Owner and Principal Consultant
* Job Description: Consultant in quality systems, regulatory compliance, and litigation involving medical devices. Expert witness in issues involving a wide variety of medical devices, specializing in cardiothoracic surgery, dialysis, respiratory care, and labels/labeling. Work has included investigation, report writing, counseling, and expert testimony in a wide variety of medical device malfunction and related cases. Worked as an expert in over 50 cases in state and federal courts and provided expert testimony in deposition, arbitration, and at trial. Cases involved products liability, intellectual property, contract disputes, tortious interference, and criminal actions. Work has included plaintiff and defendant clients in approximately a 50/50 ratio.

* Products involved in cases: pediatric and adult blood oxygenators; cardiopulmonary bypass circuit components; heart lung machine pumps; ECMO circuit components; dialysis machines; dialysis circuit components; access devices for hemodialysis; electrical pulse generators for pain relief; insulin infusion pumps; implantable pumps used for pain relief; video fluoroscopy systems; autologous blood salvage equipment; angioplasty catheters, balloons, and guidewires; replacement heart valves; laboratory diagnostic equipment; lung ventilators; prostate cryoablation systems; spinal implants; laparoscopy trocars; vena cava blood filters; TURP resectoscopes; automated external defibrillators and disposable electrodes;  indwelling central venous catheters; endovascular stent grafts for aortic aneurysms; intravascular stents and delivery catheters; orthopedic implants; laser based cellulite removal systems; and evacuated containers used for therapeutic phlebotomy.


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   Available Upon Request

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