Defective Medical Device Expert Witnesses

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 qualified engineer obtained his BS in Civil and Structural Engineering and his MS in Management of Technology from Kennesaw State University and Southern Polytechnic State University. He is a certified Professional Engineer and is certified in OSHA requirements and engineering and surveying. He is a member of the National Society of Professional Engineers and the National Academy of Forensic Engineers. He has 8 Publications and is currently a Structural Design and Forensic Engineer at an engineering firm in the southeast. Some of his fields of expertise include forensic/failure and safety analysis, civil/structural design of public and private structures, and construction site accident investigations. A partial list of past subjects addressed include wood/concrete deck collapses, commercial/residential roof damage evaluations, excavation failures/incidents product liability, traffic accident reconstruction, mold source evaluation, construction cost estimating, hydrology/sewer studies, airport consulting, roadway design, geotechnical/subsurface investigations, construction materials failure analysis, structural analysis and design of various material components, scaffolding failures, water damage source evaluation, structural damage inspections, OSHA compliance evaluations, and concrete/asphalt pavement evaluation and design. Has an intimate knowledge of OSHA worksite regulations, and the various national building codes and standards for Industrial, Commercial and Residential structures.

This expert's professional career has spanned 50 years, while for the past 20 years he has specialized in guiding companies through the CE marking process for products prepared to enter the EU market and for companies in the US who want CE marking on their products for market flexibility and/or liability protection, many of which are medical devices and machinery. This expert conducts forensic legal analysis of companies' Quality Management Systems (ISO 9001), Environmental Management Systems (ISO 14001), and Quality System Regulations as stipulated by the FDA. He has hosted over 450 seminars and workshops and has published more than 300 articles and multiple books in the areas of Liability, EU Directives/CE Marking, Technical Standards, FDA Quality System Regulations, and ISO 90001 and 14001. He has developed and delivered on-site training programs on product liability exposure for medical device insurance companies, as well as for corporate counsel, defense counsel, and trial attorneys involved with medical devices and medical device manufacturers. As a Senior Consultant for both Excel Partnerships and SAI Global, he also developed and delivered on-site training programs on CE marking for the Medical Devices Directive and related Quality Management Systems. As Legal Expert/Expert Witness he has prepared legal materials for use in litigation involving Quality Systems and CE marked products as well as EU Administrative Reviews.

This expert has experience in Medical devices since 1992. Design experience since 1986. Areas of expertise include full life cycle product development of medical devices from conception through development including manufacturing, bench testing, verification, validation, packaging, labeling, clinical trials, regulatory approval, marketing, and sales training. Granted 28 patents (others pending), 7 awards, designs published by Life Magazine, was recognized as one of 100 notable people in the medical device industry by the Medical Device & Diagnostic Industry (MD&DI) publication in June 2008. This expert recently served as chairman of the Medical Device & Manufacturing Conference in 2014.

This highly qualified expert earned his BS and MS in biochemistry from Victoria University of Wellington and his PhD in microbiology from Lincoln University. After completing his education, he moved to the United States to pursue a career in medical device manufacturing. He held roles as a manager of microbiological services, pharmaceutical quality control, and market product stability at Lederle Laboratories. He then worked as a director of quality control the New York blood center, director of global quality assurance and microbiological development at Wyeth and director of pharmaceutical microbiology at Merck & Co research laboratories. Most recently, he has been a senior principal scientist at Merck & Co and is currently a microbiologist at an independent consulting firm. This expert has over 70 peer-reviewed publications in microbiological journals addressing factors of contamination in medical devices. He is also a member of the United States Microbiology and Sterility Assurance Committee.

This expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality solutions and training to both small and large companies, and entrepreneurs. This expert has been invited to speak nationally, and has authored 6 publications in FDA regulatory and quality matters.

This highly qualified expert has over 40 years of experience in medical device regulations. He received his BS in chemical engineering from Lowell Technological Institute and earned his MS in chemical engineering from the University of Iowa. He currently has 5 patents. Over the years, his work has included antimicrobial development and application, hydrophilic coating development and implementation, and over-the-counter and personal care product development. His former positions include research engineer for Eastman Kodak and GAF Corporation, project manager and laboratory supervisor for Biosearch Medical Products and Hydromer, and corporate manager of materials for Arrow International. Currently, this expert is the president of a medical device consulting company in Pennsylvania.

This expert has over 30 years of experience in medical device development, specifically cardiovascular devices. He earned his BS in chemical engineering from Arizona State University and is a member of the International Society for Endovascular Specialists. This expert has a high level of clinical expertise for surgical, vascular and endovascular devices and procedures and is well versed in implantable device failure investigation and evaluation. He previously served as the president of Arizona Heart Innovative Technologies, LLC and as the vice president of research and development for Direct Flow Medical. He is currently the CEO of a medical device company in California that develops products to improve the quality of life for those with spinal cord injuries and disease.

This highly qualified expert has over 15 years of experience specializing in the electro-mechanical systems in medical devices. Specifically, this expert specializes in oxygen concentrators, oxygen conserving devices, breathe detection, power circuit design, instrumentation, and sensing. He earned his BS in electrical engineering from Northwestern and his MBA from Kellogg Graduate School of Management and has his six sigma black belt certification. He has held several roles including VP of engineering at Joslyn Hi-Voltage, director of electrical engineering at Baxter Healthcare and director of device risk management at Hospira. This expert also served as the director of global respiratory engineering in the home medical equipment division of Invacare. Currently, this expert owns a consultancy focused on the medical device product development in TX.

This product design and liability expert has over 50 years of experience in mechanical engineering. He has devoted his entire career to the design, development, and commercialization of medical devices and similar consumer products, developing 5 patents along the way. He received his BS in mechanical engineering from California State Polytechnic College before obtaining his MBA from California State College. Formerly, he served as an engineer and department manager at California Injection Molding Co., a senior project engineer and the manufacturing engineer manager at McGaw Laboratories, the director of engineering at Hudson Oxygen Therapy Sales Co., and the president at Fallbrook Engineering Inc. Currently, he serves as the president of a consulting engineering services firm in Washington.

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 30 years of experience as an epidemiologist and nurse-midwife, with demonstrated experience in medical device safety including gynecologic surgical mesh, breast implants, hip replacement, cardiovascular and dermatologic devices, post-market surveillance, and pharmacoepidemiology. She received her BS in biology from the University of Illinois and a diploma in nursing from Evanston Hospital School of Nursing before earning her BS in nursing and her MS in perinatal nursing from the University of Illinois at Chicago. She then went on to earn a post-masters certificate in midwifery from the State University of New York at Stony Brook and her PhD in perinatal epidemiology from the University of Maryland at Baltimore. This expert is a certified nurse-midwife and a licensed registered nurse. She is active in her field as a member of several organizations, including the American Nurses Association, the American College of Nurse-Midwives, and the American Academy of Nursing. She is also highly involved in research, having authored several peer-reviewed journal articles and book chapters and spoken at multiple scientific conferences throughout her career. For her work, she has been the recipient of numerous honors and awards. With over 15 years in academia, this expert has formerly served as an assistant professor of child, women and family health at the University of Maryland, and adjunct assistant professor in prevention and community health and an adjunct clinical associate professor of clinical management and leadership at George Washington University, and, most recently, as an adjunct associate professor at the Uniformed Services University of the Health Sciences. Clinically, she has served as an maternal child health epidemiologist and a health sciences administrator for the United States Department of Health and Human Services and the CDC and has worked extensively with the FDA as an epidemiologist and branch chief for the FDA's Center for Devices and Radiological Health. Additionally, she served as the director of women's health, medical ethics and patient advocacy for the Office of the Assistant Secretary of Defense. Currently, this expert is the owner and CEO of an epidemiology consulting group based in Maryland.

This Washington-based expert has over 20 years of experience in chemistry and medical device research, specializing in polymer synthesis, polymer characterization, analytical chemistry, medical device design and intellectual property management. He received his BES in chemistry and photographic sciences from St. Cloud State University before earning his PhD in polymer chemistry from the University of Southern California. He is active in his field as a member of the American Chemical Society, is a highly-published author on the topics of polymer chemistry and medical devices, and holds 65 patents that have enhanced the field of polymer chemistry. Previously, he has served as a polymer chemist and then a senior polymer chemist at Medtronic, an adjunct professor of polymer chemistry at the University of St. Thomas, and a senior scientist at DexCom Inc. He also formerly served as an associate professor and then a professor of chemistry, as well the assistant dean of the college of science and technology and the interim assistant vice president and dean of graduate studies at Bloomsburg University. Currently, he serves as the vice president of intellectual property at a technology research lab in WA.

This expert in material sciences and electrochemistry received his BA in bio-engineering from the University of Pittsburgh before studying medical device fabrication science and then obtaining his PhD in physics at the University of Melbourne. He has experience with medical devices such as neural stimulators, neural recorders, and chemical sensors. This expert has two approved patents and two pending patents relating to materials used for medical devices and has published 27 articles in his field. Formerly, he served as a Fulbright research fellow at the Center for Eye Research Australia, a medical devices scientist at the University of Melbourne, and an NIH postdoctoral research fellow at the University of Pennsylvania. Currently, this expert is a senior scientist at a medical device company in California. He is also a co-founder and the CTO of a medical device company that specializes in developing bio-stable materials for neuro-interface devices.

This expert has over 30 years of experience in the medical device industry, with broad expertise in cardiovascular and endovascular fields with a focus on percutaneous catheters, heart assist devices, brain and aortic aneurysm treatment, and vascular closure products. He earned his MS in mechanical engineering at Moscow State Technical University and worked as the lead engineer at the Scientific Institute for Transplantology and Artificial Organs before moving to the United States. He is a registered patent agent through the US Patent and Trademark Office and is a member of the Association of University Technology Managers, the International Society for Rotary Blood Pumps, and the American Society for Artificial Internal Organs. He formerly served as the scientific director and vice president of technology at Datascope Corp. before he served as the CTO of Cerus Endovascular. This expert is currently the principal of a patent consulting company, the founder of a medical technology development company, and the vice president of product development for a medical device start-up in New Jersey.

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 qualified expert has been involved in the field of medical technologies for over forty years and is experienced with matters concerning FDA compliance on which he has authored several articles and papers and given talks on FDA compliance worldwide. He is also the vice president of a private medical technologies firm, making him intimately qualified to comment on the case at hand.

This expert has 25-plus years of Automotive Safety Research and Development, Accident Reconstruction, Concept Vehicle Design and Manufacture as a Scientist Engineer, Project Manager, Senior Project Engineer, Systems Engineer, (Design, Development, Manufacturing and Test Engineer). Qualified as a Motor Vehicle Accident Reconstruction and Bio-Mechanical Engineering Expert in Los Angeles, Orange, Riverside, Ventura, Kern, Alameda and San Bernardino Counties, Alaska, Iowa, Tennessee, Florida, Ohio, Idaho, Utah, Nevada, Arizona, Massachusetts and Texas. He has thirty-five years of Motor Vehicle Accident Reconstruction, Automobile and Motorcycle Product Defect, Forensic and Occupant Biomechanical Injury Analysis, Automotive Safety, Vehicle Design, Development, Manufacturing, Test Engineering and Patent Infringement analysis. This expert has extensive experience and knowledge of product defects in the following areas: Automobile, Truck, Motorcycle, Jet Ski, ATV, Snow Mobile, Golf Cart, Big Rig Truck cases: Involving airbags, seatbelts, seats, fuel system fires, transmission part-to-reverse, unintended acceleration, brakes, tires, axle failures, roof crush, side impact, roll propensity, vehicle handling dynamics, suspension and chassis, design and manufacturing defects.

This expert has over 40 years of experience as a mechanical engineer. His research in tribology, machining of advanced materials, medical device design, dental materials, and high temperature coatings is widely recognized in the scientific and engineering communities. He has published over two hundred fifty papers and reports related to machining of ceramics, mechanisms and mechanics of interfaces, wear and friction, boundary lubrication, and biotribology; and has given more than three hundred lectures on these subjects. He has served as President and CEO for a heart pump developer, a subsidiary for a product company where he served as Vice President of Biotechnology.

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).