Over 35 years experience - all aspects of medical devices; Broad range of products; 39 patents; PI, PL & IP; Landmark cases; Plaintiff/defense; Seasoned, successful, affable; Impeccable references.

None

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:

 

1993-2012    Consulting Engineer and Expert Witness (1995-2012)

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 (Mountain View, CA)                             
  • Laser micro-dissection disposable  elements and packaging designs.
• Better Care    (San Francisco, CA)                      
  • Male and female incontinence devices. 
• Cardeon, Inc.   (Huntington Beach, CA)                  
  • Specialty cardiac catheter.  
• Cardiometrics  (Mountain View, CA)                       
  • Diagnostic cardiac catheter  components.
• Decibel Instruments    (Hayward, CA)            
  • Disposable elements for innovative  hearing aid system.
• EconoMEDics Inc.          (Palo Alto, CA)    
  • Medical devices for emerging markets.
• Eunoe, Inc.           (Pleasanton, CA)                 
  • Implantable Alzheimer’s Disease  devices.
• Fallbrook Engineering        (Valley Center, CA)   
  • Various proprietary medical devices.            
• FemmeSource Health   (Pasadena, CA)          
  • Various gynecological diagnostic   devices.
• Fogarty Engineering        (Portola Valley, CA)  
  • Proprietary catheter devices.  
• Heartstream (Seattle, WA)                    
  • Multi-function defibrillator electrodes.  
• Hexcel   (Pleasanton, CA)                              
  • Proprietary materials-based device.  
• HiLife Therapeutics             
  • Lens enhancements for patient communications systems.
• Inviro Medical Devices   (So. San Francisco, CA)       
  • Innovative safety syringes  (Vancouver, BC)
• IPT, Inc.    (Palo Alto, CA)                           
  • Umbilical cord blood sampler/clamp. 
• Katecho, Inc.             (Des Moines, IA)           
  • Multi-function defibrillator electrodes and other proprietary devices.
• Keimar, Inc.  (Mountain View, CA)                       
  • Proprietary in vivo measurement of blood parameters.       
• KippGroup    (Ontario, CA)                           
  • Proprietary IV-related device.  
• Lucent Medical    (Bellevue, WA)           
  • Endoscopic tool containment systems.  
• Mallinckrodt / Nellcor     (Pleasanton, CA)     
  • Pulse oximetry sensors. 
• Mayfield Fund    (Menlo Park, CA)                
  • Medical technology evaluations.   
• McGaw, Inc.    (Irvine, CA)                         
  • Cannula-based needle-less injection sites for IV administration.
• Medasonics     (Fremont, CA)                       
  • Transcranial ultrasonic (Doppler) probe  mounting systems.
• Medisystems    (Seattle, WA)                    
  • Hemodialysis bloodline components. 
• Medtronic CardioRhythm  (San Jose, CA)
  • Cardiac ablation catheter systems.   
• Minimus Surgical   (Menlo Park, CA) (Founder)              
  • Proprietary obesity surgery devices.                      
• Natus Medical      (San Carlos, CA)                
  • Advanced ear couplers and electrodes  for newborn hearing screener.
• Nexan   (Cambridge, UK)                                  
  • Proprietary multi-function electrode  systems.
• Pneumation     (Evergreen, CO)                     
  • CPAP (Continuous Positive Airway Pressure)  system for sleep apnea.
• R&D Medical     (Lake Forest, CA)                     
  • Various high-volume disposables  including complex electrode systems.
• Rhaphis Medical     (Sunnyvale, CA)             
  • Semi-automatic surgical suturing device for the third world.
• Starion     (Palo Alto, CA)                              
  • Proprietary electrosurgery device.  
• Target Therapeutics         (Fremont, CA)   
  • Packaging and delivery system for  cranial catheter/coil occlusion device.
• Vigilo Networks     (Cupertino, CA)              
  • Remote sensing of physiological  parameters via disposable patch.         
• Woodside Biomedical    (Carlsbad, CA)      
  • Proprietary nerve stimulation electrode  designs (disposable and reusable)
• Woolsthorpe LLC    (Brentwood, TN)           
  • Proprietary pulse oximetry applications.  

 

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    Tangent Machine and Tool Corp., Farmingdale, NY

 

Summers     

• Tool Designer/Drafter and Machine Operator

 

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Product designs, inventions and patents (partial list):

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Consultant

Innovative percutaneous surgical devices and methods (Minimus)

• Inflatable anchors, obesity applications, organ wall implantation
• Patent No. 8,070,673 (December 6, 2011)

Innovative percutaneous surgical devices and methods (Minimus)

• Tissue modification, obesity applications, anchor systems
• Patent No. 7,931,580 (April 26, 2011)

Innovative percutaneous surgical devices and methods (Minimus)

• Device implantation, obesity applications, fastener systems
• Patent No. 7,255,675 (August 14, 2007)

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)

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)

Packaging and delivery system for catheter/coil occlusion device (Target)

• Injection molding, porous plastic, assembly techniques.
• Patent No. 5,669,931 (September 23, 1997)
• Canadian Patent No. 2173023C (August 28, 2001)

Multi-function defibrillation electrode systems (Heartstream)

• (Proprietary Information)

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.
• Japanese Patent No. 9122230A2 (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)

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Natus Medical

Neonatal breath sampling system

• Multi-lumen profile extrusion, activated carbon filters, OEM modifications.
• Patent No. 5,357,971 (October 25, 1994)
• Patent No. D 354,808 (January 24, 1995)
• Patent No. 5,404,885 (April 11, 1995)
• European Patent No. 0 648 088 B1 (August 16, 2001)
• European Patent No. 1 062 909 B1 (October 29, 2003)

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.

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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 Correction

Dual-path sample tube assembly for multi-function monitor

• Silicone rubber molding, solvent shrink sleeves, assembly techniques.

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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)
• European Patent No. 0 558 162 B1 (March 6, 1996)

Assorted injection sites, tubing clamps, chamber components and filters, etc.

• Ultrasonics, injection molding.

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Critikon

Complete (gravity, controller and pump) line of IV sets

• Clean room assembly, packaging, sterilization, off-shore sourcing.

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Menlo Care

• Adjustable catheter assemblies
• Extrusion, injection molding, materials.
• Patent No. 4,728,322 (March 1, 1988)
• Canadian Patent No. 1273540A1 (September 4, 1990)
• Patent No. 4,955,863 (September 11, 1990)
• European Patent No. 0 233 055 B1 (July 3, 1991)

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American Hospital Supply

Multi-volume air displacement pipette

• Seals, precision grinding, assembly techniques, injection molding.
• Patent No. 4,679,446 (July 14, 1987)

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Sole Proprietorship

The Liquid Bracelet fashion jewelry

• Consumer item, assembly techniques, fragrance, million pieces sold.

The Original Halley’s Comet Ball novelty toy

• Consumer item, assembly techniques, packaging, millions sold.

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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.
• Canadian Patent No. 1157722A1 (November 29, 1983)

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Magnetic Head Corporation

Method of manufacturing magnetic heads

• Casting, precision machining, assembly techniques.
• Patent No. 3,678,576 (July 25, 1972)

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Professional Affiliation:

• Society of Plastics Engineers (Senior Member)

 

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