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Medical Endoscopic Surgical Devices Expert Witness

Provides Opinion & Testimony In:

Medical Device Product Development, Endoscopic Surgical Devices, Respiratory Devices, Drug Delivery, Manufacturing Process Design, Design Verification and Validation, FDA, CE Quality Systems Regulations, Regulatory Approval Process, Product Liability, Failure, Root Cause Analysis, Forensic Investigation, Patent Validation, Patent Infringement Analysis

Expert Witness No.391

Missouri

EXPERT 391

EXPERTISE SUMMARY

Consultant Specializing in Medical Device Product Development, Endoscopic Surgical Devices, Respiratory Devices, Drug Delivery Devices, Manufacturing Process Design, Design Verification and Validation, FDA and CE Quality Systems Regulations and Regulatory Approval Process, Product Liability, Failure and Root Cause Analysis, Forensic Investigation, Patent Validation and Valuation, and Patent Infringement Analysis.

EDUCATION

  • MBA Kellogg School of Management, Northwestern University, Evanston, IL, 2002
  • Ph.D. Industrial & Mechanical Engineering, Northeastern University, Boston, MA, 1994
  • MS Mechanical Engineering, University of Portland, Portland, OR, 1984
  • BS Industrial & Mechanical Engineering, University of Portland, Portland, OR, 1980

Certifications, Awards, Honors and Recognition

  • Registered Professional Engineer
  • Certificate New Product Development, Harvard Business School
  • Certificate European Medical Device Directives for Product Safety and Testing
  • Johnson & Johnson Achievement Award for Design Quality Assurance
  • Ethicon Endo-Surgery Innovation Award for Inventions and Invention Disclosures
  • UMR Faculty Recognition for contribution to Engineering Education Center
  • DEC 100 and DECathalon Awards for impact on revenue growth
  • Marquis Who’s who in Science & Engineering,
  • Marquis Who’s Who in The World
  • Marquis Who’s Who in America
  • 2000 Outstanding Scientists of the 20th Century, Int’l Biographical Center Cambridge, England.

AREAS OF EXPERTISE

  • Patent Infringement and Invalidity Analysis
  • Medical Device Product Liability
  • New product and process development
  • Design and development of respiratory devices
  • Diagnostic, monitoring, sedative and therapeutic drug delivery devices
  • Laparoscopic and endoscopic surgical devices
  • Medical device design verification and validation
  • Quality Systems Regulations – 21 CFR Part 820 QSR, ISO 9000 / ISO 9001 / ISO 13485
  • Regulatory approval process for Class I and Class II medical devices
  • Surgical staplers, skin stapling devices
  • Oxygen Concentrators
  • Oxygen Conserving Devices
  • Sleep Apnea – CPAP and BiPAP devices
  • Spirometry, Spirometers and Flow Sensors
  • Compressed Medical Gas Storage and Delivery Systems
  • Failure mode effect and criticality analysis
  • Incident Investigation, Failure and Root Cause Analysis
  • Forensic Engineering/Investigation Support
  • Quality Function Deployment
  • Conjoint Analysis
  • Project Management
  • Financial Engineering
  • Reliability Engineering
  • Statistical Quality Control
  • Concurrent Engineering
  • Design for manufacturing and assembly
  • Manufacturing process planning
  • Capacity Planning
  • Operations Management

PROFESSIONAL EXPERIENCE

  • 2001 – Present
  • President/CEO
  • Chief Executive Officer (CEO) and Chief Technical Officer (CTO) of Core Devices, a biomedical research and development company.
  • Founded company, to address unmet needs for technologies that enable surgical procedure in the field.
  • Established vision and direction, led funding efforts, appointed board members, recruited management team, developed business, strategic and operational plans, conducted market research, defined target markets and competitive strategies.
  • Led research and development activities, providing technical direction for new product and process development.
  • Developed R&D strategy that leverages academia for basic research, design firms and original equipment manufacturers for system and component level design, in order to reduce product development cycle time and cost.
  • Invented and secured 3 utility patents for an oxygen conserving device, a conformal oxygen system for persons with respiratory disability, and a backpack-able field anesthesia machine for surgical care on battlefields, disaster locations and rural hospital settings.
  • Validated market need through target customers, scientific presentations and independent research.
  • Awarded multiple grants by the National Institutes of Health (NIH) for proof of concept and prototype development of an ambulatory oxygen device and a portable anesthesia machine.
  • Served as an expert witness and consultant on patent litigation and product liability cases.

 

  • Nellcor Puritan Bennett – A Mallinckrodt Co., Saint Louis, MO
    1998 – 2001
    Sr. Director Global R&D
  • Led global R&D and engineering for the Alternate Care Segment; a $400 business unit within the Respiratory Group.
  • Managed product development, sustaining engineering and regulatory activities across sites in the United States, France and Canada with a $20 million R&D budget.
  • Built R&D from scratch to over 100 engineers and scientists, equipped with standardized design tools, laboratories and test engineering facilities.
  • Established a common product development process, to accelerate screening, adoption, development and commercialization of inventions.
  • Established development and career plans for managerial and individual contributors.
  • Unified cross-functional teams with a common product development process, performance metric and reward system.
  • Developed diagnostic and therapeutic devices for respiratory care, including chronic obstructive pulmonary disease (COPD) and sleep apnea disorder.
  • Brought to market more than a dozen new products, contributing over $200 million in revenue and average of 50% gross margin. This includes the Renaissance II spirometer for diagnosis of respiratory disorder, Puritan Bennett OxiClip (an oxygen conserving device), Aeris590 oxygen concentrator, HeLIOS (high efficiency liquid oxygen system), GK418, GK420 CPAP devices and sleep masks for treatment of sleep apnea,
  • KS330 and KS325 bi-level ventilator for respiratory support. These products are helping to advance patient care in acute, sub-acute and alternate care settings.
  • Prosecuted and was awarded 13 utility patents for novel oxygen delivery devices.
  • Established a global advisory board of thought leaders in medicine, to provide clinical guidance to R&D advances into emerging market areas.
  • Ethicon Endo-Surgery, Inc. A Johnson & Johnson, Co., Blue Ash, OH
    1994-1998
  • Team Leader, Research and Development, Endo-mechanical Devices
  • Led R&D for a $200 million business unit focused on endoscopic surgical devices.
  • Led parallel projects and cross-functional teams of design, manufacturing, reliability and quality engineers, marketing, regulatory and clinical personnel, to develop, test, validate and bring to market a family of handheld instruments for general, gynecologic and thoracic surgery, including skin staplers, graspers, dissectors, and scissors in accordance with FDA/GMP guidelines.
  • Translated customer needs into key product attributes and technical specifications using QFD and ConJoint techniques, resulting in positive customer ratings and 100% new product success rate. Introduced a platform strategy that emphasizes interchangeable parts, to consolidate suppliers, reduce material cost by $1.6 million and cycle time by 12 months.
  • Prosecuted and received three surgical skin stapler patents.
  • Relocated assembly from Peterboro, Canada to Juarez Mexico – reducing labor cost by $1.2MM
  • Earned Johnson & Johnson Achievement Award for design quality assurance on the Proximate-Plus-MD family of skin stapler projects.
  • Received Ethicon-Endo Surgery Innovation Award for contributions to patent estate

 

  • Digital Equipment Corporation, Marlboro, MA
    1983 – 1994
  • Worldwide Strategy Manager Product Development, Engineering Systems Group
  • Led worldwide product development strategy for a $400 million business unit.
  • Managed strategic joint ventures for engineering and manufacturing automation technologies targeted at Digital’s VAX/VMS and ULTRIX platforms.
  • Negotiated technology licensing and strategic agreements to close portfolio gaps, reduce product development cycle-time and cost of goods.
  • Established the simultaneous product development process; a unique approach to product development, which establishes operational guidelines for managing products throughout their life
    cycles.

 

  • Manager Aerospace Strategy and Data Integration Products, Engineering Systems Group
  • Responsible for worldwide Aerospace business strategy and development of industry specific design and manufacturing automation solutions.
  • Developed strategy to grow revenue from $500 million to $1.0 billion in five years.
  • Developed products for concurrent engineering and legacy CAD/CAM data integration based on IGES and Standard for The Exchange of Product Data (STEP) translators.
  • Harmonized strategy with CALS (Computer-Aided Acquisition and Logistics Support) – initiative for digital interchange of technical information among computer systems.
  • Represented DEC on the External Research Board investigating and proposing joint ventures.

 

  • Manager Manufacturing and Application Center for Technology
  • Managed a $20 million consulting practice targeted at Fortune 100 Aerospace and Defense Electronics manufactures.
  • Developed and delivered consulting modules on engineering and manufacturing process automation, concurrent engineering, product data management, Computer-Aided Design and Manufacturing
    (CAD/CAM), Computer-Aided Engineering (CAE), Deming, Juran, Ishikawa, Taguchi, Quality Function Deployment (QFD), Design-for-
  • Manufacturing (DFM), Total Quality Management (TQM) and
    operations management principles.
  • Managed delivery of multi-million dollars process re-engineering projects at Raytheon, Lockheed, GE, Grumman, Allied Signal, Sikorsky, Ford and General Motors.
  • Grew revenue by 50% to $30 million during a two year window.

 

  • Manager Mechanical Design Automation, Engineering Systems Group
  • Managed application engineering responsible for mechanical design automation tools, which were optimized to run on Digital’s computers, operating systems, and database management systems, including competitive migrations.

 

  • Strategic Alliance Mgr, Computer-Aided Software Engineering
  • Managed strategic alliances for computer-aided software engineering solutions
  • Developed strategic plans, performed portfolio gap analysis and negotiated joint ventures for a family of software design automation tools that fulfilled global customer needs.
  • Recruited and migrated Cadre and IDE’s SA/SD tools to Digital’s platforms

 

  • Tektronix, Test & Measurements Group, Beaverton, OR
  • 1980 – 1983
  • Industrial & Mechanical Design Engineer; Sr. Mechanical Design Engineer
  • Responsible for mechanical design, simulation, testing and manufacturing process planning. Designed adjustable work dispensers and automated assembly systems. Led project on numerical control and distributed intelligence.

ACADEMIC AND PROFESSIONAL AFFILIATIONS

  • Adjunct Professor Missouri University of Science & Technology
  • Adjunct Professor Saint Louis University
  • Adjunct Professor University of Maryland University College
  • Adjunct Professor Fontbonne University
  • Adjunct Professor Babson College
  • Adjunct Professor Framingham State College

PUBLICATIONS, Patents, Proceedings, Researchers and Inventors Citing My Work:
Available upon request or once retained

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