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Intellectual Property Analysis Specialist, Expert Witness and Forensic Consultant.

30 years experience - all aspects of medical devices; Broad range of products; 31 patents; PI, PL & IP; Landmark cases; Plaintiff/defense; Seasoned, successful, affable; Impeccable references.

EXPERT ID: 8974

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Location:  US

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ADDITIONAL INFORMATION

 

Short Biography:

Education:
Villanova University, Villanova, PA: BS Mechanical Engineering, 1968
Summa Cum Laude
Newspaper Editor-in-Chief
1993 Alumni Professional Achievement Award


Harvard University, Cambridge, MA: Graduate School, 1968-1969
Engineering and Applied Physics
National Science Foundation Fellow


University of California, Berkeley, CA: Pre-Med Coursework, 1974-1975
Organic Chemistry and Biology

Experience:
1993-2004
Consulting Engineer and Expert Witness (1995-2004)
Independent consulting engineer specializing in medical products design and development with a focus on medium and high volume disposable devices and components. Expert witness information is available upon request. Engineering clients (in alphabetical order) have included:

Arcturus
Laser micro-dissection disposable elements and packaging designs.
Mountain View, CA

Better Care
Male and female incontinence devices.
San Francisco, CA

Cardeon, Inc.
Specialty cardiac catheter.
Huntington Beach, CA

Cardiometrics
Diagnostic cardiac catheter components.
Mountain View, CA

Decibel Instruments
Disposable elements for innovative hearing aid system.
Hayward, CA

Eunoe, Inc.
Implantable Alzheimers Disease devices.
Pleasanton, CA

Fallbrook Engineering
Various proprietary medical devices.
Valley Center, CA


FemmeSource Health
Various gynecological diagnostic devices.
Pasadena, CA

Fogarty Engineering
Proprietary catheter devices.
Portola Valley, CA

Heartstream
Multi-function defibrillator electrodes.
Seattle, WA

Hexcel
Proprietary materials-based device.
Pleasanton, CA

HiLife Therapeutics
Lens enhancements for patient communications systems.
So. San Francisco, CA

Inviro Medical Devices
Innovative safety syringes.
Vancouver, BC

IPT, Inc.
Umbilical cord blood sampler/clamp.
Palo Alto, CA

KippGroup
Proprietary IV-related device.
Ontario, CA

Lucent Medical
Endoscopic tool containment systems.
Bellevue, WA

Mallinckrodt / Nellcor
Pulse oximetry sensors.
Pleasanton, CA

Mayfield Fund
Medical technology evaluations.
Menlo Park, CA

McGaw, Inc.
Cannula-based needle-less injection sites for IV administration.
Irvine, CA

Medasonics
Transcranial ultrasonic probe (Doppler) mounting systems.
Fremont, CA

Medisystems
Hemodialysis bloodline components.
Seattle, WA

Medtronic CardioRhythm
Cardiac ablation catheter systems.
San Jose, CA

Natus Medical
Advanced ear couplers and electrodes for newborn hearing screener.
San Carlos, CA

Nexan
Proprietary multi-function electrode systems.
Cambridge, UK

Pneumation
CPAP (Continuous Positive Airway Pressure) system for sleep apnea.
Evergreen, CO

R&D Medical
Various high-volume disposables including complex electrode systems.
Irvine, CA

Starion
Proprietary electrosurgery device.
Palo Alto, CA

Target Therapeutics
Packaging and delivery system for cranial catheter/coil occlusion device.
Fremont, CA

Woodside Biomedical
Proprietary nerve stimulation electrode designs (disposable and reusable).
Carlsbad, CA

1989-1992
Natus Medical Inc., Foster City, CA
Vice President, Engineering and Manufacturing
Medical electronics and disposables for neonates. Start-up. Created and managed engineering, manufacturing, documentation, quality assurance, materials, clinical testing, customer and technical service. Established comprehensive vendor network. Thirty-five employees.

1987-1989
Nellcor Incorporated, Hayward, CA
Manager, Disposables Engineering
Pulse oximetry and capnography.
Design, management of small staff, clinical research, marketing aids, national sales meeting presenter.

1986-1992
Medisystems Corporation, San Francisco, CA
Consultant
Hemodialysis blood tubing sets and related components.
Individual contributor.

1986-1987
Critikon, Inc., San Jose, CA
Senior Mechanical Engineer
Intravenous delivery systems and sets.
Coordination of San Jose, Tampa and Japan Medical Supply.

1985-1986
Raychem Corp. / Menlo Care Inc., Menlo Park, CA
Consultant
Intravenous catheters and systems.
Individual contributor.

1984-1985
American Hospital Supply Corp., Emeryville, CA
Senior Project Engineer
Liquid handling systems, especially pipettors.
Individual contributor, liaison during transfer to American Dade.

1982-1983
Liquid Bracelet Company, Berkeley, CA
Sole Proprietor
Liquid-filled (IV tubing) fashion jewelry ($250,000 in sales).
Design, manufacturing, marketing, sales and public relations.

1975-1982
Cutter Laboratories, Berkeley, CA
Product Development Engineer
Intravenous delivery systems and components.
Individual contributor, liaison to other plants.

1969-1973
Magnetic Head Corporation, Hauppauge, NY
Design Engineering Supervisor
Magnetic tape heads for computer peripherals.
Created department, documentation and MRB systems.

1965-1967 Summers
Tangent Machine and Tool Corp., Farmingdale, NY
Tool Designer/Drafter and Machine Operator



Product designs, inventions and patents (partial list):


Consultant
Innovative safety syringes and accessories (Inviro)
Injection molding, assembly techniques, differential resistances.
Patent No. 6,394,979 (May 28, 2002)
Patent No. 6,616,632 (September 9, 2003)
Other patents pending.


Chest-mounted, multi-function electrode systems (Nexan)
Rotary die cutting, hydrogels, adhesives, assembly techniques.
Patent No. D 425,203 (May 16, 2000)
Patent No. 6,385,473 (May 7, 2002)
Other patents pending.


Packaging and delivery system for catheter/coil occlusion device (Target)
Injection molding, porous plastic, assembly techniques.
Patent No. 5,669,931 (September 23, 1997)

Multi-function defibrillation electrode systems (Heartstream)
(Proprietary Information)
Patents applied for.

Advanced ear coupler and electrode designs (Natus)
Injection molding, die cutting, acoustic shaping, universal disposable.
Patent No. 5,826,582 (October 27, 1998)
Patent No. 5,913,309 (June 22, 1999)
Patent No. 6,386,314 (May 14, 2002)


Transcranial Doppler mounting systems (Medasonics)
Silicone rubber, nitrile PVC molding, disposable and re-usable.
Patent No. 5,390,675 (February 21, 1995)

Tubing clamps, needle guards and protectors, CAPD components, chambers, filters, tubing, injection sites, tamper-evident luer cap and injection site, connector systems, etc. for hemodialysis bloodlines (Medisystems)
Injection molding, blow molding, assembly techniques, stereo lithography.
Japan Patent No. JP9122230A2 (May 13, 1997)
Patent No. 5,772,624 (June 30, 1998)
Patent No. 6,165,149 (December 26, 2000)
Patent No. 6,620,119 (September 16, 2003)
Patent No. 6,666,839 (December 23, 2003)
Other patents pending.





Natus Medical
Neonatal breath sampling system
Multi-lumen profile extrusion, activated carbon filters, OEM modifications.
Patent No. 5,404,885 (April 11, 1995)
Patent No. 5,357,971 (October 25, 1994)
Patent No. D 354,808 (January 24, 1995)


Super Jelly Button* electrode and other electrode designs
Special purpose modifications to off-the-shelf products, hydrogels.

MiniMuffs* neonatal noise attenuators for NICU babies
Laminated foam, vacuum forming, acoustics, sequential vendor assembly.
Patent No. 5,243,709 (September 14, 1993)

ALGO-PAK* infant hearing screening supplies package
User-flexible, non-kit disposables pack, less packaging, more options.

DRI-PREP* prepping pads for electrode site preparation
Triple-laminated rotary die cutting, abrasives.

Ear Couplers* disposable ear phones for infant hearing screener
PVC foam, steel rule die cutting, hydrogel attachment technique.




Nellcor
Airway adapter family for multi-function (oximetry and capnography) monitor
Injection molding, filters (incl. hollow fiber), assembly techniques.
Patent No. 5,101,817 (April 7, 1992) with Certificate of Correction

Dual-path sample tube assembly for multi-function monitor
Silicone rubber molding, solvent shrink sleeves, assembly techniques.
Patent applied for.




Medisystems

Guarded winged needle assemblies
Multiple designs, injection molding, assembly techniques.
Patent No. 5,112,311 (May 12, 1992)
Patent No. 5,266,072 (November 30, 1993)
Patent No. 5,433,703 (July 18, 1995)
European Patent No. 0 436 646 B1 (August 31, 1994)


Assorted injection sites, tubing clamps, chamber components and filters, etc.
Ultrasonics, injection molding.
Patents to be applied for as required.




Critikon

Complete (gravity, controller and pump) line of IV sets
Clean room assembly, packaging, sterilization, off-shore sourcing.



Menlo Care
Adjustable catheter assembly #2
Extrusion, injection molding, materials.
Patent No. 4,955,863 (September 11, 1990)
European Patent No. 0 233 055 B1 (July 3, 1991)


Adjustable catheter assembly #1
Extrusion, injection molding.
Patent No. 4,728,322 (March 1, 1988)




American Hospital Supply
Multi-volume air displacement pipette
Seals, precision grinding, assembly techniques, injection molding.
Patent No. 4,679,446 (July 14, 1987)




Sole Proprietorship
The Liquid Bracelet* fashion jewelry
Consumer item, assembly techniques, fragrance, million pieces sold.

The Original Halleys Comet Ball* novelty toy
Consumer item, assembly techniques, pac packaging, millions sold. .




Cutter Laboratories

Injection site for fluids / UltraSite* #2
Ultrasonic welding, assembly techniques, automatic assembly.
Patent No. 4,416,661 (November 22, 1983)

Swage-molded injection site / UltraSite #1
Ultrasonic swaging, injection molding, universally adopted design.
Patent No. 4,294,249 (October 13,1981)

Injection device / injection bulb
Compression molding, sealing techniques, swabbing techniques.
Patent No. 4,252,117 (February 24, 1981)

Caged disc valve for volumetric chamber
Compression molding, injection molding, ultrasonic assembly.
Patent applied for.




Magnetic Head Corporation

Method of manufacturing magnetic heads
Casting, precision machining, assembly techniques.
Patent No. 3,678,576 (July 25, 1972)




Professional Affiliation:
Society of Plastics Engineers (Senior Member)


 

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Some of the Keywords entered by this Expert:

Suction Suction Seal Suction Blade
Endoscope Surgery Injury Surgery Cause
Tip Delivery Endoscope Cervical Injection
Breast Implant Vena Cava Clamp Plastic Blade
Fusion Cpap Pencil Set Connector
Cranial Laproscopy Guard Blood Pump
Electrosurgery Rod Vena Cava Pca Gynecology
Hydrogel Intellectual Property Controller Suction Protected Needle
Luer Activated Valve Injection Syringe Ip Warmer
Doppler Connector Alzheimer's Disease Needleless Components


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