FDA Approval Expert Witnesses in California

This highly qualified expert specializes in engineering and regulatory affairs for medical device commercialization. She earned a BS in mathematics from Oregon State University and a MS in Medical Device and Diagnostic Engineering from the University of Southern California. This expert currently owns and operates her own medical device company where she prepares and submits FDA regulatory services 510k applications.

This expert has been practicing anesthesiology at a 600 bed hospital in Southern California for nearly a quarter century. A graduate of UC Riverside, he attended medical school at Loyola Stritch School of Medicine in Illinois and thereafter completed residencies in General Surgery and Anesthesiology at Loma Linda University Medical Center. A diplomate of the American Board of Anesthesiology and an active member of the American Society of Regional Anesthesia and Pain Medicine, currently holds the post of Chief of Anesthesia at a major hospital in the Los Angeles area. He has additional experience in drug development of a safer abuse deterrent opioid currently going through the 505(b)2 FDA approval process and medical device development of a safer opioid pill dispenser currently going through the 510K class I FDA approval process.

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 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 10 years of experience in risk management and regulatory compliance in the financial services industry, with a focus on identifying compliance issues and implementing solutions to mitigate risk. In his work with the CFPB, he identified millions of dollars in remediation for consumers. Formerly, he worked in consumer protection roles with the Consumer Financial Protection Bureau and the California Department of Financial Institutions, as well as in compliance and risk management roles at San Diego County Credit Union and Union Bank. Currently, he is a compliance advisor with a national financial services group and is based in California.