CHARLES E. CLEMENS
`1621 Hill Top Lane
` Encinitas, CA 92024
`Business Cell: (760) 613-2272
` Email: clemensco@aol.com
`Net: http://www.linkedin.com/in/clemensco
`
`SUMMARY
`
`Mr. Clemens is a seasoned Engineering professional with over 40 years Product Development
`experience in the HealthCare and Biomedical industries. He brings extensive design and systems level
`experience in Drug Delivery, Respiratory Care, Blood Handling, and In Vitro Diagnostic product &
`technology development, Program/Project Management, Risk Management & Analysis. Mr. Clemens
`utilizes excellent collaborative skills to achieve the most from people and technology. Importantly, he
`brings a great appreciation of effective application of Quality System Regulations, ISO13485:2016 /
`ISO 9001 standards to all his work. Mr. Clemens also has over 20 years Expert Witness experience in
`the areas of Medical Device Product Liability and Patent Infringement cases.
`
`PROFESSIONAL
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`Senior Consultant Associate / Program Manager – Fallbrook Engineering Inc. 1995 - 2018
`Provides consulting services in the capacity of Program Manager and Senior Mechanical Engineer for
`a wide variety of medical device product development projects including drug delivery devices, blood
`handling systems, surgical tools, and in-vitro diagnostic systems. Also provides Expert Services in the
`areas of product liability and patent related matters.
`
`Senior Consultant / Project Manager – BIT-Group USA, Irvine, CA 2014 - 2017
`Provides part-time consulting in the capacity of Project Manager and/or Systems Engineer for various
`In Vitro Diagnostic product development projects.
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`Invetech - USA, San Diego, CA (Part of Fortive Company - split off from Danaher) - Sept 2010 to
`April 2012 full time – Consultant 2012 - 2016
`Provides consulting services in the capacity of Program Manager and Senior Mechanical Engineer for
`various medical device product development projects. Additionally, Mr. Clemens advises Invetech in
`the development of new Clients and business in the Medical Device markets in North America.
`Invetech is an international product development company based in Australia specializing in Consumer
`and Industrial products, Life Science, In-Vitro Diagnostics, and Medical Devices.
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`CLEMENS CONSULTING COMPANY 1995 – Present
`Technical & Management Consultant specializing in Medical Device and In Vitro Diagnostic Product
`Development as well as Expert Witness services for Medical Device product liability and patent
`litigation.
`
`Principal Consultant / Project Manager
`Provides design and development consulting services both as an independent consultant and in
`conjunction with various consulting associates:
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`Products & Areas of Expertise:
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`IV Drug Delivery Systems
`IV Disposable Sets & Components
`Insulin Delivery Systems
`Drug Injector Pens
`Dialysis Systems & Disposables
`POC In Vitro Diagnostic Devices
`Liquid Drug Inhalers
`Pyrolitic Carbon Implants
`Thermal Droplet Generation
`Blood Pressure Monitoring Systems
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`Expert Witness – Medical Devices
`Pulmonary Breathing Circuits
`Digital Thermometry
`Prostrate Seeding Needles
`Liquid Biocompatible Adhesive Delivery
`Active “Smart” Implants
`Medical Support Appliances
`Liquid Drug Humidifiers
`Test Fixture Design
`Manufacturing Process Development
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1012, p. 1 of 5
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` Conceived and developed a unique drug
`evaporation system integrated with state-of-
`the-art Hudson humidifiers and Siemens
`ventilators
` Directed Engineering design efforts for an
`Insulin Pump start-up company - Bionica,
`Inc.
` Optimized a patented venting method for
`sterilized laryngeal mask products.
` Developed a unique drug compatible
`Pellathane coated heater wire for
`breathing circuits
` Qualified a unique pressure sensing sub-
`system by optimizing disposable / sensor
`interface
` Developed RF welding process for custom
`pneumatic orthotics
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`Some Specific Experiences:
`
` Program Director for new Blood Separation
`& Collection System product line
` Co-invented a peristaltic blood pumping
`and control system for portable dialysis.
` Designed and optimized an insert molded
`ultrasonic drug aerosol generation device
` Developed several conceptual clinical and
`disposable Inhaler devices
`
`Improved design of a wearable
`hemodialysis system and early development
`of clinical trial systems
` Developed Award winning and patented
`fluidics design for cassette based clinical
`diagnostic system for DNA sample
`processing – Osmetech plc and now
`GenMark Dx
`Investigated patented low flow precision
`technology (Thermal Time of Flight) for
`application to drug delivery and blood
`handling systems.
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`CLEMENS CONSULTING COMPANY (con’t) 1995 – present
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`Clients and Associates (not inclusive):
`
`Alaris Medical Systems
`Becton Dickinson / Nanogen Inc JV
`Sparton Aubrey Group
`Osmetech Clinical Micro Systems
`Invetech USA / AUS
`Knobbe Martens Olsen & Bear
`Alliance Pharmaceuticals Corp
`Cohesion Inc.
`BIT-Group USA
`Fallbrook Engineering Inc
`Pozzi Wilson Atchison, LLP
`Aerogen Inc.
`Mission Medical Inc. / Terumo
`InJet Digital Aerosols
`White & Case, LLP
`Xcorporeal Inc..
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`CareFusion Inc., San Diego, CA (Formerly IVAC Corp. / Alaris Medical Systems / Cardinal Health) 1981-1995
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`Largest U.S. medical Drug Delivery Systems and Vital Signs devices manufacturer.
`
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`Technical Leader - Development Engineering
`(1991-1995)
` Worked in a cross-functional team environment with Marketing, Quality, and Manufacturing Team
`Leaders and facilitated the product concept generation, design feasibility, and business plan
`generation for the Signature Edition program. This was Alaris’s first “Heavy-weight” program team
`and was run as a company within a company.
`• Provided engineering management and supervision to all electrical, mechanical, software, and
`disposables engineering personnel (30+) for the inception, development, and introduction into
`production of IVAC’s largest product development program in its’ history (Signature Edition).
`
`• Directed the technology investigation, selection and development of the Signature Edition fluid
`delivery platform system, a $35M development effort with over $300M market potential over the
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1012, p. 2 of 5
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`CHARLES E. CLEMENS resume
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`following eight years. Participated in upper-management presentations and meetings developing
`the Signature Edition product positioning, feature selection, and final business plan.
` Traveled to 20+ major cities & 50+ Hospitals in the US and Europe to interface directly to Doctors,
`Clinicians, Nurses, as well as Regulatory Agencies to gather critical drug delivery knowledge to be
`used in a Quality Function Deployment effort. This effort resulted in the strategic focus of the
`entire product development program.
`Initiated & directed a competitive technical benchmarking effort of US & European drug delivery
`systems which provided the foundation for the marketing strategy as well as the fundamental
`measuring parameters for the design team.
` Responsible for both the instrumentation and plastic disposable interface, invention, detail design,
`and development as well as drug / system compatibility and functional conformance. Established
`Team Leaders in a consensus driven process to achieve business plan goals with respect to budget,
`timelines, and company goals. Additionally, all the design specifications, performance qualification
`plans and procedures, and process plans and procedures were achieved through the same process.
` Established the schedule, which all team members utilized for their planning. Helped define a new
`development and planning process, which was later used as a model for IVAC’s SOP’s. These
`SOP’s were the basis for successful ISO 9000/9001 design control approval. I was directly
`involved in the ISO implementation and qualification process.
` Provided technical direction in the review and selection of all out-sourced suppliers and industrial
`design companies. Helped train the technical team with new skills in the area of Quality Function
`Deployment (QFD), DFMA, Design of Experiments (DOE), and the Performance Excellence (PE)
`process. Utilized all new processes in the development of the Signature Edition program.
` Managed all engineering efforts provided by several outside consultants for the program such as
`IDEO Industrial design / mechanical development and engineering, Battelle Labs for elastomer
`development, noise and vibration analysis, and Failure Analysis Associates for plastic failure
`analysis.
` Coordinated a patent review process for the program with Fulwider, Patton, Lee & Utecht, a Los
`Angeles law firm. Supervised the creation of over 50 disclosures, many of which have been filed
`with the U.S. Patent Office and granted patent status.
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`Department Manager – Mechanical Development Engineering
`(1984-1990)
` Managed all mechanical engineering resources of up to eighteen Engineers with an annual budget
`of over $1.5M. Responsibilities included the mechanical development and market introduction of
`six new Drug Delivery systems and over a dozen new plastic disposable products.
` Provided technical consulting participation on corporate teams in the analysis of technology being
`considered for purchase by the company such as syringe pumps, fluid flow control devices, rotary
`peristaltic pumps, and specialized medical grade pressure transducers. In this capacity also
`provided Expert opinions for Patent and Product Liability issues facing the company.
` Trained in Eli Lilly management program and provided Technical Resources to Lilly instrument
`and disposable combination products during 1990 – 1995.
` Managed the company machine shop with six Model Makers and Machining Specialists utilizing
`eight production mills and two CNC mills.
` Managed the Development Test Lab, which had four Senior Test Technicians and full laboratory
`equipment used for design verification testing. I managed the main test strategies and procedures
`for this test lab.
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1012, p. 3 of 5
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`CHARLES E. CLEMENS resume
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` Directed the effort to select & implement new CAD systems for the mechanical engineering
`resources, (SDRC-Ideas then Solidworks). I hired resources to train and maintain the system, and
`integrated outside suppliers who interfaced their CAM systems. Directed efforts to establish an in-
`house CAD-CAM link between the design group and the PCB layout group and machine shop for
`rapid prototyping. I implemented extensive use of rapid prototyping on all projects such as
`computer modeling, solid modeling, stereolithography equipment selection and capital approval,
`and urethane cast molds.
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`Department Manager – Instrument Sustaining Engineering
`(1981-1983)
` Managed mechanical engineering resources of eight Mechanical Engineers with an annual budget
`of $500K. Responsibilities included all the mechanical engineering tasks in transitioning several
`new Instrument products and Disposables products from development to production, while
`maintaining all existing production needs.
` Position supervised the combined departments of Instrument Mechanical and Disposable Products
`sustaining engineering. I was responsible for recruiting, training, mentoring, and reviews of all
`mechanical engineering personnel.
` Responsible for skillful interdepartmental collaboration between Engineering, Quality, Operations,
`and Marketing to resolve critical design issues impacting production, or field issues demanding
`immediate attention.
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` 1979 - 1981
`CARBOMEDICS INC., Austin, TX
`Manufacturer of proprietary Pyrolitic carbon coated bio-implants (e.g. heart valves)
`
`Program Manager - Process Development Engineering
` Planned and implemented a $1M project to move an existing Pyrolite® coating facility from San
`Diego, Ca. to Austin, Texas. I was responsible for the technical process / facility improvements,
`laboratory construction, and coating process validation in the new building.
` Lead the development of a new mono-leaflet implantable heart valve
`
`Invented and directed the proprietary design of an accurate rotary dry chemical delivery system to
`feed zirconium oxide granules to a fluidized bed coating process.
`EDUCATION
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`San Diego State University, San Diego, CA : Bachelor of Science - Mechanical Engineering, 1979
`
`San Diego State University, San Diego, CA : MBA Coursework, 1980 – 1982
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`Ancillary Coursework and Certifications:
`
`Design of Experiments (DOE)
`Design for Manufacturability (DFMA)
`Performance Excellence (PE)
`Total Quality Management (TQM)
`Quality Function Deployment (QFD)
`Numerous Quality Management Skills Courses
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1012, p. 4 of 5
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`CHARLES E. CLEMENS resume
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`PATENTS
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`US / European:
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`US 9,517,296 Portable Dialysis Machine
`US 8,597,505 Portable Dialysis Machine
`US 8,114,288 System and Method for conducting hemodialysis and hemofiltration
`US 7,863,035 Fluidic Devices
`US 5,563,347 Pressure Sensing Vessel Adapted to be Preloaded Against a Sensor
`EP 0 781 402 Pressure Sensing Vessel Adapted to be Preloaded Against a Sensor
`US 5,575,632 Engineered Pumping Segment
`EP 0 781 379 Engineered Pumping Segment
`US 8,771,511 Disposable Apparatus and Kit for Conducting Dialysis
`US 10,034,973 Disposable Apparatus and Kit for Conduction Dialysis
`US 10,092,905 Tissue Sample Container and Methods
`US 10,201,311 Biopsy Tissue Sample Transport Device and Method of Using Thereof
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`Canadian:
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`CA 2,199,406 Engineered Pumping Segment
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`Applications – US & International pending:
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`US20030224371
`US20060040311
`US20040042930
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`Integrated Cartridge for Sample Manipulation
`Integrated Cartridge for Sample Manipulation
`Reaction Chamber with Capillary Lock for Fluid Positioning and Retention
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`PFIZER, INC. v. SANOFI-AVENTIS DEUTSCHLAND GMBH
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`Ex. 1012, p. 5 of 5
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