Expert Details

Expert in Biomedical Device Engineering

Expert ID: 108105 South Africa

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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.


Design control seminars to educate R&D staff about QSR/9001 requirementsDeveloping SOPs and quality manualsAssisting in design reviews and FMEA reviewsWriting backup documentation and submitting 510(k)sInternal auditing of R&D functions

Education

Year Degree Subject Institution
Year: 1968 Degree: BS Subject: Mechanical Engineering Institution: University of Akron

Work History

Years Employer Title Department Responsibilities
Years: 1989 to 2000 Employer: McVay Consulting Associates Title: Consulting Engineer Department: Responsibilities: Specializes in biomedical engineering and medical technology with services in: technology scouting & portfolio development; RD&E; Design Controls; forensic consulting & expert consulting
Years: 1985 to 1989 Employer: Cabot Medical Corporation Title: Director of Engineering Department: Responsibilities: Managed new product identification, design, development, manufacturing implementation, documentation, and sustaining engineering support of laparoscopic surgical and implant products.
Years: 1984 to 1985 Employer: Davis and Geck Division, American Cyanamid Corpora Title: Senior Engineer Department: Responsibilities:
Years: 1978 to 1984 Employer: Johnson & Johnson, Critikon Division Title: Manager of New Product Development Department: Responsibilities:
Years: 1975 to 1978 Employer: V. Mueller Division, American Hospital Supply Corp Title: Program Manager Department: Responsibilities:
Years: 1972 to 1975 Employer: Baxter Healthcare, Articial Organs Division Title: Senior Development Engineer Department: Responsibilities:

International Experience

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

Career Accomplishments

Associations / Societies
He belongs to the American Society of Mechanical Engineers,
Association for the Advancement of Medical Instrumentation, and
American Public Health Association.
Licenses / Certifications
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.

Fields of Expertise

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, Current Good Manufacturing Practice auditing, breath, technology scouting, patient handling equipment, hemodialysis equipment, biomedical device engineering, needle safety, breath analysis, medical polymer molding, polymer biocompatibility, biocompatibility testing, electrosurgical product, disposable surgical product, surgical product, laser ablation, CE Marking, surgical equipment, medical ergonomics, medical device testing, instrument design, electrosurgical instrumentation, cystoscopy, endoscopy, foreign medical device regulation, biomedical coating material, laparoscopy, surgical implant device, electronic medical device design, medical device reliability testing, medical device process validation, medical device manufacturing quality control, medical device manufacturing, sleep apnea, Food and Drug Administration regulation, device code, biomedical instrument, surgical instrument, sleep disorder, plastic injection molding, FDA medical device regulation, laparoscope, implantable device, endoscope, electrosurgery, biomedical diagnostic instrumentation, catheter

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