Core Devices Inc.
John Izuchukwu
8342 Del Crest Drive Suite 403 Saint Louis, MO 63124
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About the Expert
Dr. Izuchukwu is an expert in product liability and patent infringement cases. His areas of expertise include endoscopic surgical staplers, skin staplers, ligation devices, clip appliers, linear and circular cutters, graspers, suturing devices, respiratory devices, respiratory masks, anesthesia machines, drug delivery devices, compressed gas containers, surgical staplers, pressure regulators, oxygen conservers, oxygen concentrators, cryogenic oxygen devices, compressed oxygen cylinders breathing circuits, endoscopic devices liquid oxygen systems, breathing tubes, sleep diagnosis and monitoring devices, sleep apnea products, sleep masks and sleep therapy devices, such as CPAP machines, CPAP devices, BPAP machines, BPAP devices and portable ventilators. During his industry career, he designed more than two dozen commercially successful medical devices, manufacturing process and quality control procedures, in compliance with FDA and CE Quality Systems Regulations. With 19 utility patents issued to him, Dr. Izuchukwu has successfully testified as an expert witness on product liability prosecution and defense cases, and has served as a consultant as well as expert on patent litigation cases. His forensic skills includes ability to pin-point causes of device and equipment failures, whether attributable to design or manufacturing defects, operator misuse or error.
Attorneys have found Dr. Izuchukwus unique educational, professional and life experience to be useful, when arguing their cases. In fact his expert testimony has led to several uncontested positive conclusions.
Areas of Expertise
- Failure Analysis
- Intellectual Property
- Medical Devices
- Patent Infringement
- Patents & Trademarks
- Products Liability
Expert's Profile
More Areas of Expertise
• 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 and CPAP devices
• Spirometry, Spirometers and Flow Sensors
• Compressed Medical Gas Storage and Delivery
• Failure mode effect and criticality analysis
• Incident Investigation and Root Cause Analysis
• Failure analysis
• Forensic Engineering
• Forensics Investigation Support
• Quality Function Deployment
• Conjoint Analysis
• Project Management
• Patent evaluation and valuation
• Financial Engineering
• Reliability Engineering
• Statistical Quality Control
• Concurrent Engineering
• Design for manufacturing and assembly
• Manufacturing process planning
• Capacity Planning
• Logistics planning
• Operations Management
Qualified as an expert witness in civil and criminal courts.
Dr. Izuchukwu has more than two decades of experience in designing biomedical devices. He understands the limitations and performance boundaries of medical devices, and is familiar with the health and safety standards regulating them. A multi-disciplined engineer with doctor of mechanical engineering degree, he specializes in medical devices and manufacturing processes, focusing on product liability and intellectual property cases. His expertise includes design failure analysis, failures involving mechanisms, components and materials of medical systems, reliability engineering and product reliability analysis.
As an expert witness, Dr. Izuchukwu represents both defendants and plaintiffs.
Visit Dr. Izuchukwu website for more information.
• 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 and CPAP devices
• Spirometry, Spirometers and Flow Sensors
• Compressed Medical Gas Storage and Delivery
• Failure mode effect and criticality analysis
• Incident Investigation and Root Cause Analysis
• Failure analysis
• Forensic Engineering
• Forensics Investigation Support
• Quality Function Deployment
• Conjoint Analysis
• Project Management
• Patent evaluation and valuation
• Financial Engineering
• Reliability Engineering
• Statistical Quality Control
• Concurrent Engineering
• Design for manufacturing and assembly
• Manufacturing process planning
• Capacity Planning
• Logistics planning
• Operations Management
Qualified as an expert witness in civil and criminal courts.
Dr. Izuchukwu has more than two decades of experience in designing biomedical devices. He understands the limitations and performance boundaries of medical devices, and is familiar with the health and safety standards regulating them. A multi-disciplined engineer with doctor of mechanical engineering degree, he specializes in medical devices and manufacturing processes, focusing on product liability and intellectual property cases. His expertise includes design failure analysis, failures involving mechanisms, components and materials of medical systems, reliability engineering and product reliability analysis.
As an expert witness, Dr. Izuchukwu represents both defendants and plaintiffs.
Visit Dr. Izuchukwu website for more information.
Personal Achievements
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
Licenses
- Registered Professional Engineer – Missouri
Special Training
- Certificate New Product Development, Harvard Business School, Certificate European Medical Device Directives for Product Safety and Testing, TUV Rheinland N.A.
Organizations
- Member American Society of Mechanical Engineers
- Senior Member Institute of Industrial Engineers
- 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
Honors
- 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 Scientists of the 20th Century, Int’l Biographical Center Cambridge, England.
Publications
- See attachment below
Percentage of time spent as expert
- 25%
Number of expert assignments / year
- 12
More Information
Listed in the Following States
Core Devices Inc. is listed with ExpertPages in the following jurisdictions: All US Regions and States, Canada (all Provinces).