Provides Opinion & Testimony In:
Biomechanical Engineer, Accident Reconstruction, Injury Causation, Biomechanics, Product Liability, Mechanical Engineering, Biomedical Engineering, Automobile Accidents, Motorcycle Accidents, Bicycle Accidents, Pedestrian Accidents, Railroad Accidents, Marine, Aviation, Personal Injury, Premises Liability, Medical Devices, Patent Infringement, Regulatory Affairs, Highway Design, Forensic Science, FDA, Aeronautics, Traffic Accident Reconstruction, Marine, Slip trip falls, falls down staiways,
Expert Witness No. 779
Ph.D. Biomedical Engineering, University of Virginia
Dissertation Research Topic: Age-related Differences in Physical Activity Level and Bone Density in Humans.
Student Fellowship Award: Mazess Student Fellowship from the National Osteoporosis Foundation Awarded for Dissertation research
M.S. Mechanical Engineering, Stanford University
Area of Concentration: Thermosciences
Independent Study Project: Development and calibration of a device to measure transpired epidermal water loss (TEWL) from premature infants related to understanding Sudden Infant Death Syndrome (SIDS).
B.S. Mechanical Engineering, University of Connecticut
Group leader for senior project: Developed a self-contained vehicle to traverse through a column of Styrofoam packing peanuts (competed against 20 student groups).
Areas of Expertise
Mechanical and Biomedical Engineering
Forensic Expert Witness
Auto, Motorcycle, Bicycle, Pedestrian,
Railroad, Marine, and Aviation
Injury Causation Biomechanics & Personal
Product & Premises Liability
Medical Devices/Regulatory Affairs
Criminal & Shooting Reconstruction
Training & Mentoring
November 2008 – Present
An engineering consulting firm specializing in: mechanical and biomedical engineering, accident reconstruction, injury causation biomechanics, product liability, engineering analysis/R&D, medical devices, patent infringement, and regulatory affairs.
Forensic Expert Witness Association (FEWA) 2009 – present
Regulatory Affairs Professionals (RAPS) 2009 – present
American Academy of Forensic Sciences (AAFS) 2008 – present
National Academy of Forensic Engineers (NAFE) 2008 -present
Society of Automotive Engineers (SAE) 2006 -present
American Society for Testing and Materials (ASTM) Member and Primary FDA Liaison to ASTM F04.30.06 Interventional Cardiology Task Group and Task Group Co-Chair 2005 -2006, Member 2004 – present
American Society of Biomechanics (ASB) 1997 -present
Biomedical Engineering Society (BMES) 1993 -present
American Society of Mechanical Engineers (ASME) 1984 -present
Biologics Consulting Group, Inc.
Senior Consultant, Medical Devices
April 2008 -April 2009
Strategizing, preparation and critical review of all types of medical device regulatory document filings to the FDA including pre-IDE, IDE, 510(k) and PMA submissions. Product development and research for drug/device and biologic/device combination products. Product development and research for engineering testing and requirements for medical devices. Preparations for FDA meetings. Representing clients in interactions with the FDA. Creation, implementation, and review of client-specific regulatory strategies. Planning, writing, review of responses to agency questions. Development of client training classes to help clients better understand the regulatory process as related to medical device submissions.
Boster, Kobayashi, and Associates
Associate of Boster, Kobayashi & Associates
August 2006 -December 2008
A consulting firm specializing in the technical aspects of accident reconstruction and highway design. Typical assignments involve application of the laws of physics and principles of biomedical engineering in accident reconstruction, premises/product liability and injury causation.
Santa Clara University
Santa Clara, California
Part-time Faculty -2008
Winter and Spring Quarters, 2009 Fall
Mechanical Engineering Department
Developed and taught two new courses, Comparative Biomechanics I: Fluids and Comparative Biomechanics II: Solids and Structures. These courses were focused on the application of engineering principles to the physical world. Also developed and taught a new class called Forensic Engineering. This course focused on all aspects involved in working as an Expert Witness.
Food and Drug Administration (FDA), Center for Devices and Radiological Health
November 2002 -July 2006
Interventional Cardiology Devices Branch, Division of Cardiovascular Devices
Served as lead medical device reviewer within the Interventional Cardiology Devices Branch in the Office of Device Evaluation (ODE) for cardiovascular medical devices. Reviews predominantly involved pre-IDEs, IDEs, and to a lesser extent 510k and PMA submissions from the medical device industry. The vast majority of responsibilities involved engineering reviews of drug eluting stents and standards development activities for both the Interventional Cardiology Devices and the Peripheral Vascular Devices Branches. Served as Primary FDA Liaison to ASTM F04.30.06 Interventional Cardiology Task Group and as Task Group Co-Chair during 2005 -2006.
ORISE Post Doctoral Fellow
June 2001 -November 2002
Hydrodynamics and Acoustics Branch, Division of Physical Sciences
Performed basic research to objectively study the amount of red blood cell damage (hemolysis) caused by medical devices in order to better predict hemolysis. One type of device studied was the class of roller pumps used in cardiopulmonary bypass surgery. Other studies involved determination of a reliable bench-top blood fragility tester. Laboratory studies will be continued into the future and be complemented with PIV flow visualization and Fluent FEM of several blood damage models.
George Washington University
2006 Spring Semester
Mechanical and Aerospace Engineering Department
Developed and taught a new course, Biomechanics I, focusing on human biomechanics.
Montgomery College (Community College)
2004 and 2005 Spring Semesters
Mathematics, Science, Physics and Engineering Division
Taught Physical Science 101, a laboratory based science course for non-science majors. Responsible for teaching and development of lectures, discussion and laboratory sessions.
National Aeronautics and Space Administration, Ames Research Center
Moffett Field, California
August 1994 -June 2001
Musculoskeletal Biomechanics Laboratory, Life Science Division
Biomedical engineering dissertation research in the Musculoskeletal Biomechanics Laboratory involving development of a Ground Reaction Force (GRF) sensor, direction of associated human research studies, and investigation of basic aspects of musculoskeletal remodeling. Laboratory Website Mistress/Developer. General: Heat transfer analysis and development of a finite element model using COSMOS/M for a Shuttle payload. Intercranial Pressure Research: Instituted an improved data acquisition method within one month. Initiated evaluation of response wave form (amplitude vs. time) in intercranial pressure. Conferred with regulatory consultant in order to document testing for future FDA approval.
Acting Assistant Division Chief
September 2000 -December 2000
Life Science Division
Administrative Activities: Represented the Life Science Division in meetings related to personnel, budget, projects, promotion and outreach. Prepared reports related to safety, ongoing projects (flight and ground based) and general information.
Full-time Graduate Study Fellowship
August 1993 – August 1994
Biomedical Engineering Department, University of Virginia
Completed all course work required for the Ph.D. degree in Biomedical Engineering. Surpassed school of engineering requirements by passing the Foreign Language Mastery Exam for Ph.D. candidates in French.
September 1992 – August 1993
Human Powered Centrifuge Project, Life Science Division
(Professional Development Program, Competitively Selected)
Led and managed the Human Powered Centrifuge Project. Wrote facility checkout, testing, and operation procedures. Scheduled workflow and established budgets for all phases of the project. Achieved a reduction in initial project cost estimate (estimated at over $100,000) by recognizing and instituting a simpler and more cost effective solution.
November 1988 – September 1992
Space Technology and Aeronautical Test and Simulation Divisions
Experience working in three different test facilities: Arc-Jet Facilities Complex, 3.5-Foot Hypersonic Wind Tunnel, 14-Foot Transonic Wind Tunnel.
Management/General: Coordinated and determined facility related equipment to support model testing. Inspected and documented facility in order to advocate future funding allocation and planning. Coordinated and monitored various facility projects ($100,000 – $950,000). Wrote facility reports associated with operational readiness and accident investigations. Managed and directed through shops various facility projects and upgrades ($5,000 – $10,000). Coordinated engineers from other organizations in investigating and solving facility problems as appropriate. Technical: Investigated, inspected and diagnosed facility shutdown problems and accidents. Determined tunnel critical electrical devices and analyzed facility operational logic sequence. Performed various structural and heat transfer calculations. Designed an insert/retract mechanism for an oxygen sensor. Calculated makeup water required for cooling tower operation. Selected various upgrades to facility equipment including pumps, thermocouples, and valves. Special Project: Directed and managed turning vane set inspection, evaluation, and repair project ($300,000) including scheduling and manpower.
University of Connecticut, Mechanical Engineering Department
Fluid Mechanics Laboratory, Storrs, Connecticut
June 1984 – July 1988
Assisted graduate student in fluids lab performing research on optimization of diffusers and turbine endwalls using the ice-formation method. Testing in water and wind tunnels. Applied Helium bubble and laser induced fluorescent dye flow visualization techniques. Worked independently to test and organize data on the new diffusers. Worked with various shop tools and techniques such as the drill press, and casting the ice-formations with hot beeswax, plaster and dental material.
Available upon request.
Specialized Training and Experience
Flight Training for Private Pilot Certificate
Currently logged over 30 hours of flight time toward the Private Pilot Certificate (VFR).