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 Expert  108105

Expert in Biomedical Device Engineering

Available for your Consulting and Expert Witness Needs

South Africa
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
BIOMEDICAL PRODUCT DEVELOPMENT; MEDICAL DEVICE PRODUCT DEVELOPMENT; NEW PRODUCT DEVELOPMENT. Expert has dedicated his career to the research, design, development, engineering, and manufacturing of biomedical devices and instruments. Expert has directed medical device new product development projects and a product development department. As a consultant he has worked with numerous medical device companies on new products and their processes. He has gained extensive international consulting experience with Canadian, Swiss, and South African companies and has worked with emerging medical device companies from St. Petersburg, Russia. Expert is the principal inventor on numerous medical device patents and has written several published articles about the medical device industry.

BIOMEDICAL DEVICE DESIGN REVIEW; GOOD MANUFACTURING PRACTICE; MEDICAL DEVICE AUDITING; MEDICAL DEVICE DESIGN PROCESS. Expert understands the latest FDA Quality System Regulation and European Union MDD requirements for design controls including project planning, design input, design output, design reviews, design verification, design validation, design transfer, design changes and design history files, process validation, risk analysis, document and data control, and human factors engineering. He conducts seminars in medical device design controls; writes standard operating procedures and develops Quality Manuals for clients; and audits product development departments for compliance to ISO-9001, QSR, and MDD requirements. Expert has passed the Lead Auditor (Assessor) examination.

BIOMEDICAL ENGINEERING; MEDICAL DEVICE DESIGN. Expert is an expert in designing single patient use medical devices and their sterile packaging. He has been involved in the selection of medical or implant grade plastics and elastomers for injection molding, extrusion, machining, secondary operations, and assembly. He understands high volume production as well as assembly and packaging technologies. He works with 3-D CAD software in design layout.

BIOMEDICAL DEVICE; BIOMEDICAL INSTRUMENT; MEDICAL DEVICE; MEDICAL EQUIPMENT; SURGICAL INSTRUMENTATION. Expert is an expert in sterile fluid infusion devices, shielded needle products, cardiovascular catheters, surgical instrumentation, less invasive surgical devices, operating room equipment, wound closure devices, and critical care life support equipment. He has designed hemodialysis devices, IV catheters, forceps, graspers, endoscopic scissors, electrosurgical instruments, laser beam accessories, cannulas, trocars, insufflators, suction-irrigation probes, irrigation pumps, tissue filters, suction canisters, pneumatic-powered cutters, electrosurgical generators, endoscopic videocameras, video light sources, cryosurgical consoles, and internal organ staplers. He has also designed an electromechanical diagnostic instrument for breath analysis, a sleep apnea monitor-stimulator, and a disposable cartridge for DNA analysis.

TECHNOLOGY DEVELOPMENT; TECHNOLOGY EVALUATION. Expert does Dialog, Medline, and World Wide Web literature surveys and searches. He is familiar with technical concept assessment, product positioning and definition, competitive or alternative technology analysis, FDA and EU regulatory assessment, and development costs and timing estimates.

FORENSIC ENGINEERING; MEDICAL DEVICE LIABILITY; MEDICAL DEVICE SAFETY. Expert provides expert consulting and testimony to attorney clients regarding medical devices. He performs failure analysis, simulation and modeling, product testing and material analysis. He evaluates the technical aspects of patent claims and manufacturing processes. Analysis and opinions are by written report, deposition, and court appearance.


biomedical device


biomedical device design review


biomedical device manufacturing


biomedical engineering


biomedical instrumentation


biomedical product development


Current Good Manufacturing Practice


forensic engineering


Good Manufacturing Practice


medical device


medical device auditing


medical device design


medical device liability


medical device product development


medical device safety


medical equipment


new product development


technology development


technology evaluation


biomechanical engineering

Show Secondary and Basic Areas of Expertise

Often requested
with this expert:

Medical Device Design and Manufacturing: Laboratory...
Biomedical Engineering; Medical Devices
Biomedical Engineering, Manufacturing Engineering, R&D
Biomaterials and Product Development R&D for Orthopedic,...

Year   Degree   Subject   Institution  
1968   BS   Mechanical Engineering   University of Akron  

Work History:
Years   Employer   Title   Responsibilities

1989 to 2000


Expert Consulting Associates


Consulting Engineer


Specializes in biomedical engineering and medical technology with services in: technology scouting & portfolio development; RD&E; Design Controls; forensic consulting & expert consulting

1985 to 1989


Cabot Medical Corporation


Director of Engineering


Managed new product identification, design, development, manufacturing implementation, documentation, and sustaining engineering support of laparoscopic surgical and implant products.

1984 to 1985


Davis and Geck Division, American Cyanamid Corpora


Senior Engineer


1978 to 1984


Johnson & Johnson, Critikon Division


Manager of New Product Development


1975 to 1978


V. Mueller Division, American Hospital Supply Corp


Program Manager


1972 to 1975


Baxter Healthcare, Articial Organs Division


Senior Development Engineer


Career Accomplishments:

He belongs to the American Society of Mechanical Engineers, Association for the Advancement of Medical Instrumentation, and American Public Health Association.


He is a PE in Ohio and Pennsylvania.

Publications and Patents Summary

he has a total of 14 US and European patents on medical devices. He is the author or coauthor on 9 published articles.

Consulting Services:
Selected Consulting Examples:
  • Design control seminars to educate R&D staff about QSR/9001 requirements
  • Developing SOPs and quality manuals
  • Assisting in design reviews and FMEA reviews
  • Writing backup documentation and submitting 510(k)s
  • Internal auditing of R&D functions
Recent Client Requests:
  • Heat transfer modeling expert for consulting on heat transfer modeling of electromechanical medical device.
  • Expert in laparoscopic scissors for consulting on design of laparoscopic scissors.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Medical device engineering expert needed for consulting on Fox hollow catheters.
  • Dialysis expert testimony for consulting on dialysis machine failure.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
2001 to 2002   South Africa   Expert performed grant and contract development work for Stellenbosch University in Capetown.
1996 to 1996   South Africa   He conducted a design control seminar and audited a company for compliance to FDA QSR and ISO 9001 requirements.
1990 to 1991   Canada   He wrote SOPs and a quality manual for an in-vitro diagnostics manufacturer.

Additional Skills and Services:
Supplier and Vendor Location and Selection

Expert has experience locating vendors of medical device injection molding, medical grade plastic resins, medical and surgical device components and materials, optical components and endoscopy vendors, pneumatic components, medical materials safety testing labs, and metallurgists.


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