Manager Engineer

CURRICULUM VITAE

JAMES DENNIS BRUNER, Ph.D., P.E.

MEDICAL DEVICES

Litigation Quality Systems Regulatory Compliance

Contact Information:

Address: **** *. ******** ******, **********, Colorado 80111-4274

Phone/Fax: 303-***-****

E-mail: abqefx@r.postjobfree.com

Education:

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

1

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)

American Society for Quality (ASQ), Senior Member

Regulatory Affairs Professional Society (RAPS)

Association for the Advancement of Medical Instrumentation (AAMI)

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)

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)

2

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

3

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 malfunctions and related cases. Worked as an

expert in over 25 cases in state and federal courts and provided testimony

in deposition, arbitration, and at trial. Work has included plaintiff and

defendant clients.

Patents:

Holder of the following U.S. patents in the fields of oil well drilling and medical

devices:

3,719,239

4,266,550

4,185,638

4,016,885

Publications; Major:

Schuhmann, RE, Bruner, JD, Geddes, LA, Hoff, HE, Moore, AG, and Peters, JD,

Active Push-Pull Pump for Total Left Ventricular Bypass in the Closed Chest

Animal, Proc. 20th Annual SWIEECO Conference, 9B1-9B2, 1968.

Bruner, JD, and Muster, D, Filtering Characteristics of a Long Cylindrical Steel

Bar with Discontinuities in Cross Sectional Area, American Society of Mechanical

Engineers, Paper No. 66-PET-22, 1969.

Bruner, JD, Schuhmann, RE, Geddes, LA, and Hoff, HE, Design and Performance of

a Vacuum Reservoir Blood Pump, Journal of the Association for the Advancement of

Medical Instrumentation, C4(5), 182-188, 1970.

Gemer, M, Dunegan, LJ, Lehr, JL, Bruner, JD, Stetz, CW, Don, HF, Hayes, JA, and

Drinker, PA, Pulmonary Insufficiency Induced by Oleic Acid in the Sheep, The

Journal of Thoracic and Cardiovascular Surgery, 69, 793 799, 1975.

4

Bruner, JD, and Drinker, PA, The Physician, the Manufacturer, and Medical

Devices, Archives of Surgery, 110, 1511 1515, December 1975, and Medical Trial

Technique Quarterly, 307 319, Winter 1977.

Gemer, M, Drinker, PA, Lehr, JL, Bruner, JD, Don, HF, Hammer, HO, Whitin, EW,

and Melnick, JH, Acute Respiratory Insufficiency, Mechanisms of Improving

Oxygenation by Partial Cardiopulmonary Bypass, Surgical Forum, 27, 200 202,

1976.

Fisk, RL, Bates, P, Austin, J, and Bruner, JD, Evaluation of a Topical Myocardial

Cooling Device and Comparison of Modalities for Maintaining Myocardial

Hypothermia, The Journal of Extracorporeal Technology, 13(2), 194 197, 1976.

Publications; Posters and Abstracts:

Gemer, M, Dunegan, LJ, Lehr, JL, Bruner, JD, Stetz, CW, and Drinker, PA,

Experimental Model of Acute Pulmonary Insufficiency and its Use in Investigating

Extracorporeal Support, Federation Proceedings, 33, 353, 1974.

Gemer, M, Dunegan, LJ, Lehr, JL, Bruner, JD, Don, HF, Hammer, RO, Whitin, EW,

and Melnick, JH, Mechanisms of Improving Systemic Oxygenation in Partial

Cardiopulmonary Bypass, The American Society of Artificial Internal Organs,

Abstracts, 3,25,1974.

Gemer, M, Lehr, JL, Bruner, JD, Don, HF, Hammer, RO, Whitin, EW, Melnick, JH,

and Drinker, PA, Effect of Pulmonary Artery PO2 on Qs/Qt During Partial

Cardiopulmonary Bypass for Acute Respiratory Insufficiency, Federation

Proceedings, 34(3), March 1, 1975.

5

J. Dennis Bruner, Ph.D., P.E., Inc.

-

MEDICAL DEVICES

Litigation Quality Systems Regulatory Compliance

Fee Schedule

Medical Device Litigation

Effective 1 January 2008

Inspection, investigation, record review,

research, report writing and presentation,

counseling, conferencing, etc. $300.00 per hour

Testifying under oath (e.g. deposition, trial) $350.00 per hour

Travel time to and from destinations outside

Denver metro area $150.00 per hour

NOTES:

Personal car travel is billed at the current IRS business reimbursement rate

per mile.

Minimum out of town billing is 8 hours per trip.

All testimony under oath is subject to a 4 hour minimum billing

All fees are plus normal traveling and business expenses of airline, train, taxi,

personal car, parking, food, lodging, long distance phone calls, copying, etc..

Air travel within the continental U.S. and Canada will be coach. Travel

outside the continental U.S. and Canada will be business class. All travel

costs will be billed at actual costs.

Invoices will be sent monthly or as approximately 20 billable hours are

accrued. Invoices are payable net 30 days from date of invoice.

Accounts over 30 days past due will accrue interest at the rate of 2% per

month beginning two months from the original invoice date.

Advance payment, including estimated travel costs, is required for all

testimony appearances. Amount payable will be a minimum of 4 hours plus

any additional estimated appearance time, plus estimated travel time and

expenses. At least the minimum payment must be paid before testimony will

be given. Over payments will be refunded and underpayments will be billed

as soon as possible following appearance.

Advance payment (retainer) of $1000 is required for new clients. This

amount is non refundable if not fully used and will be subtracted from the

final billing or returned at the end of the engagement.

All fees are payable regardless of the outcome of the matter and are not

contingent in any way on the results of any investigation, the content of any

conclusions or opinions, or the outcome of the case.

6

Contact this candidate