Medical Device Products Liability Defective Labeling Expert Witness

Over 30 years industry experience actively involved in the design, development, manufacture, and quality control of medical devices.  Responsible for the design and implementation of corporate policies and procedures to assure safe and efficacious medical products in compliance with FDA rules and regulations.

AREAS OF MEDICAL DEVICE EXPERIENCE

Anesthesiology, Cardiovascular, Dental, Gastroenterology-Urology, Surgery Devices, Hospital and Personal Use Devices, Neurological Devices, Ophthalmic, Orthopedic, and Physical Medicine.

COMPETENCIES

• Provide litigation support services for cases involving suspect medical devices
• Medical Device FDA Regulations/Manufacturer Liability Expert.
• Provide testimony for deposition and/or trial (over 20 years). Rendered expert opinion reports and testimony in approx. 600 cases throughout the U.S.
• Determine if a causal relationship exists between a suspect medical device and its manufacturer, distributor, physician and/or hospital.
• Provide consulting services to the medical device industry in areas of operational proficiency and FDA regulatory compliance(over 20 years).
• Experienced executive level responsibility for Regulatory Affairs, Quality Assurance, Product Development, Manufacturing Engineering, Production Control, Reliability Assurance, Labeling, Training, and Packaging of Medical Devices.

ACHIEVEMENTS

• Designed, developed, and established medical manufacturing facilities.
• Biomedical Product Designer (eight years).
• “Certified Manufacturing Engineer” (eight years).
• Responsible for the technical transfer of a state-of-art pacemaker manufacturing operation to an independent production facility in Puerto Rico.

EDUCATION

October 1993
Ph.D.
Union Graduate School, Cincinnati, Ohio
Medical Technology Studies

October 1990 to April 1991
Minneapolis, Minnesota
Doctoral Internship:FDA Consumer Affairs Division

July 1989
Master of Science Degree
Cardinal Stritch University, Minneapolis, Minnesota
Project Management

January 1988
Bachelor of Arts Degree
Metropolitan State University, St. Paul, Minnesota

University of Minnesota, Minneapolis, Minnesota
Program Management

PROFESSIONAL EXPERIENCE

August 2004 to Present
President/CEO, A PRIVATE COMPANY
Prior Lake, Minnesota

January 1986 to Present
Co-Founder and Vice President, A PRIVATE COMPANY
Prior Lake, Minnesota

1985 to Present
Consultant, Guideline (formerly Teltec, Inc.)
Minneapolis, Minnesota

1983 to 1986
Vice-President of Operations, Angiomedics
Minneapolis, Minnesota

1982 to 1983
Manager of Manufacturing Operations, Astro-Med, Inc.
Warwick, Rhode Island

1980 to 1981
Manager of Documentation/Manufacturing, Daig Corp.
Minneapolis, Minnesota

1971 to 1980
Director of Technical Services, Medtronic, Inc.
Fridley, Minnesota/Humacao, Puerto Rico

1970 to 1971
Sr. Designer, Dicomed Corp.
Eden Prairie, Minnesota

BOARD CERTIFICATIONS   

• Board Certified Forensic Examiner (B.C.F.E.)
• Board Certified in Forensic Medicine (B.C.F.M.)
• Certified Medical Investigator – Level Five (C.M.I.-5)
• Certified Forensic Consultant – (C.F.C.)

ASSOCIATIONS

• Regulatory Affairs Professional Society
• Public Citizen Health Research Group
• American Board of Forensic Examiners
• American Board of Forensic Medicine
• Forensic Expert Witness
• Society of Manufacturing Engineers
• American Society for Quality Control – Biomedical Division
• The American Academy of Experts in Traumatic Stress
• American Academy of Certified Consultants and Experts
• American Society of Law, Medicine & Ethics
• Human Factors and Ergonomics Society

PATENTS: Upon Request

ARTICLE: Upon Request