Medical Devices Expert Witnesses in Wisconsin

This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Currently, he is an Industry Consultant with a leading FDA consulting corporation.

This highly qualified expert earned his B.S. and M.S. in Mechanical Engineering and a Ph.D. in Biomedical Engineering from Marquette University. From 1977 until 2010, he held increasingly senior roles within Baxter Healthcare Corporation, most recently serving as the Technical Director of Applied Science & Technology. He was an Adjunct Professor at Northwestern University and spent four years at Exponent before becoming an independent consultant. The expert is a registered Professional Engineer in Illinois and has received 17 U.S. patents.

This highler qualified expert has two decades of experience in basic and applied reserach in the thermal sciences. He has published well over 100 scientific papers dealing with biological heat transfer, burn injuries, and medical devices, among others. He has consulted for many companies in the medical device field and has presented well over 100 technical presentations at conferences and meetings. He is a Full Professor at a major Minnesota University.

This highly qualified expert has more than 25 years of experience in FDA regulation of medical devices, encompassing nearly all FDA field positions. He earned his BA in biological sciences at California State University and completed MBA courses with Golden Gate University. This expert is certified in regulatory affairs and is an active member of the Regulatory Affairs Professionals Society, the American Society for Quality, and the FDA Alumni Association. Further, he has several publications and has presented both nationally and internationally on topics in his field. In his early career, this expert served as a consumer safety officer, consumer affairs officer, and representative for small businesses at the FDA. He then held several industry leadership roles, including manager of regulatory affairs at Unitek Corporation and vice president of regulatory affairs in clinical research and quality assurance at both Retroperfusion Systems Inc. and Baxter Healthcare Corporation. Additionally, this expert was a medical device specialist, a compliance officer, and the director of import operations at the FDA Los Angeles District as well as a supervisory investigator at the FDA Saint Louis Office. Currently, he is a private consultant for FDA regulated businesses in Illinois.

This highly-qualified expert has nearly 50 years of experience as a chemist. He received his BS in chemistry from the University of Illinois before earning his MS in organic chemistry from the University of Minnesota and his PhD in organic chemistry from Loyola University. Throughout his extensive career, he has gained experience in several facets of chemistry, including industrial chemicals, household chemicals, chemical exposure and accidents, product liability, premises liability, paint and coatings, labels and warning, aerosols and spray products, and patent infringement. He is active in his field as a member of several associations, including the National Paint and Coatings Association, the Federation of Societies of Coatings Technology, the American Society of Testing Materials, and the National Association of Corrosion Engineers. This expert began his career as a senior research scientist for the Continental Can Company before becoming the group leader for resin development at Rust-Oleum. While at Rust-Oleum, he also served as the manager for both coatings research and development and manufacturing technical support before holding the title of technical director. he has also served as an assistant professor of chemistry at Roosevelt University, an industrial research consultant for Northwestern University, the executive director of PRA Laboratories at Eastern Michigan University, and the vice president of R&D for Roman Adhesives. For over 20 years, this expert has served as a consultant for a private firm.

This expert has over 15 years of experience in the medical device industry as a quality engineer, quality systems and complaint investigator with emphasis on cardiovascular devices. A Certified Quality Engineer and Biomedical Auditor, his expertise includes managing quality systems, design and development of new product lines, product risk management and complaint investigations. He currently serves as Principal quality management systems and business Consultant for an independent consulting firm in both medical device and other industries. His understanding of medical device firm operations and intimate familiarity with medical device requirements in both the US and other geographies make him an ideal expert to provide advice in determining both legal and regulatory requirements for medical device firms as well as users (clinicians).