`18 Prairie Clover, Littleton, CO 80127
`Phone 303-883-7584; Email: garyheath123@comcast.net
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`Bachelor of Science - Mechanical Engineering (MET), 1979
`University of Southern Colorado/CSU Pueblo, Pueblo, CO
`Masters in Business Administration, 1984
` University of Phoenix, Denver, CO
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`EDUCATION:
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`SKILLS:
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`Innovative engineering design and management, resulting in three issued patents
` Effective Medical Device Operations and R&D Management and Engineering Design in the areas of medical
`instruments, high volume, single use, sterile disposables, and sterile injectable solutions
` Worldwide Manufacturing Strategic Planning and Operations implementation
` Business acquisition strategies, negotiations and integrations
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`EXPERIENCE:
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` November 2009 TO PRESENT
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` EVERGREEN RESEARCH, INC.
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`Co-owner/Principal Engineer
` Co responsible for all aspects of Evergreen Research, Inc. ERI specializes in the Contract R&D, Contract
`Manufacturing and Contract RA/QA services to the Medical Device Industry. ERI has been in business for over 25
`years and is well recognized and regarded in the Medical Device Industry.
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`GARY HEATH & ASSOCIATES AUGUST 2007 TO OCTOBER 2009
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`President and Founder
` Technical and Operational consultant to the Medical Device Industry. Nearly 30 years of skill and expertise in
`the development, manufacturing and operational phases of medical devices, in particular, Medical Equipment,
`Single Use-Sterile Disposables, and Sterile-Injectable Solutions.
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`COBE/GAMBRO/TERUMO BCT, INC. - LAKEWOOD, CO
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`1988 – 2007
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`Director, Vice President, President and Chief Operating Officer
` Responsible for the Worldwide Operations of a $400M Medical Device Company, with over 2,000 employees.
` Responsible for Global Operations in three locations: Lakewood CO, USA; Gloucester, England, UK; and Larne,
`Northern Ireland, UK.
` Established the Gloucester, England Manufacturing Facility, as part of the Gambro BCT Strategic Operations
`Plan, to produce medical disposables for the Blood Banking Industry.
` Led the due diligence, negotiation and integration of the $12 Million Sterile, Medical Injectable Solutions
`acquisition of Ivex Pharmaceuticals, in Larne, Northern Ireland, UK.
` Managed multiple process redesigns that enabled Gambro BCT to maintain 65% average gross margins, over a
`19-year period.
` Responsible for Global Supply Chain Management and Global Logistics for over 19 years.
` Total responsibility for Global Manufacturing, Facilities, ITS, Quality, Regulatory, Terminal Sterilization
`(Gamma, ETO and Steam), Business Services (Model Shop, Printing Services, Laboratory Services,
`Environmental Health and Safety Services).
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`NxSTAGE Ex 2005-1
`Nipro v NxStage
`IPR2016-00744
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`GARY HEATH
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`COBE LABORATORIES, INC. - LAKEWOOD, CO
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`1983–1988
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`Senior Manufacturing and R&D Engineer, Engineering Manager and Manufacturing Manager
` Responsible for various design teams and manufacturing operations in equipment and disposables operations.
` Lead design engineer on a team that created unique designs in the dialysis and blood banking markets, enabling COBE
`to replace generic disposables with patent, protected proprietary products.
` Developed cost reduction and automation projects that lowered costs by over $20 Million and improved quality by
`over 60%.
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`TECHNICARE/J&J ULTRASOUND - LITTLETON, CO
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`1981 - 1983
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`Senior Project Engineer
` Responsible for the engineering support of the assembly of precision, hand held, medical ultrasound devices
` Co developed Technicare’s innovative mechanically beam steered, ultrasound probe.
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`ADR ULTRASOUND - TEMPE, AZ
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`1979 - 1981
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`Project Engineer
` Designed precision, hand held, medical ultrasound devices, which revolutionized the OB/GYN Ultrasound Market.
` Responsible for the manufacturing engineering support of these devices
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`PATENTS and AWARDS:
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`4,666,598 “Apparatus for use with fluid flow transfer device” granted 5/19/87
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`4,770,787 “Method of operating a fluid flow transfer device” granted 9/13/88
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`4,798,090 “Apparatus for use with fluid flow transfer device” granted 1/17/89
` Member of Who’s Who in The World, America, The West, and Finance and Industry
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`AFFILIATIONS:
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` Senior Member of Society of Manufacturing Engineers since 1979
` Senior Member of Society of Plastics Engineers since 1983
` Student of Demand Flow Technology
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`NxSTAGE Ex 2005-2
`Nipro v NxStage
`IPR2016-00744
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`GARY HEATH
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`HIGHLITES and ACHIEVEMENTS:
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`Born: November 5, 1954, Pueblo, Colorado
` Fourth generation Colorado Native
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`Graduated: 1973: Pueblo East High School with honors
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` 1979: University of Southern Colorado
` BS, Mechanical Engineer with honors
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` 1984: University of Phoenix
` Masters in Business Administration with honors
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` Senior Member of Society of Manufacturing Engineers since 1979
` Senior Member of Society of Plastics Engineers since 1983
` Co-designer of first mechanical beam steered, Real Time Ultrasound Medical Device for OB/GYN, at
`ADR Ultrasound, Phoenix, Arizona, 1979
` Hold multiple patents for Disposable Blood Tubing Sets used in the Kidney Dialysis Field. Over 45,000
`of these devices are produced each day for kidney dialysis use worldwide.
` Recognized in the industry as an expert in the field of medical device disposables design and
`manufacturing, materials selection, and sterilization methodologies.
` Member of Who’s Who in The West, In Finance and Industry, In America and In The World
` Appointed Director of Gambro BCT Global Operations in 1991
` Appointed Vice-President of Gambro BCT Global Operations in 1995
` Appointed President of Gambro BCT in 2000
` Appointed Chief Operating Officer of Gambro BCT in 2001
` Vice President of Global Operations for Gambro BCT until 2007
` Formerly responsible for all Gambro BCT Operations, with over 2000 employees globally and $400
`million in sales.
` Gambro BCT/Caridian BCT/Terumo BCT is the largest employer in Lakewood, Colorado and the fourth-
`largest manufacturing company in Colorado.
` Established the Gloucester, England Manufacturing Facility for Gambro in 1995, to produce medical
`disposables for the Blood Banking Industry.
` Purchased Ivex Pharmaceuticals in Larne, Northern Ireland, in May, 2004, on behalf of Gambro BCT.
` Co owner of Evergreen Research, Inc. since 2009.
` Serve on various Boards in the Medical Industry and consult in the areas of Manufacturing Practices and
`Medical Devices.
` Have traveled globally to Gambro Operations Facilities and Gambro Suppliers
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`NxSTAGE Ex 2005-3
`Nipro v NxStage
`IPR2016-00744