FDA Expert Witnesses

Intellectual Property, Medical Devices - Imaging, Patent, Ultrasound, Electronics, Transducer, ASIC, MEMS, FDA, Signal Processing, Neuro modulation, Regulatory, Integrated Circuit, Semiconductors, Biometric security, Ablation, Tomography, Parallel Computing, Surgical Guidance, Wearable Medical Device, Product Liability

Award winning, Oxford Educated scientist whose areas of expertise include medical imaging, electronics, semiconductors, medical devices, sensors, MEMS, signal processing and image processing. Dr Daft has deposition and trial testimony experience including district court, ITC and PTAB matters. Extensive Intellectual Property experience including patent development, analysis, licensing, and litigation. Serial inventor who holds 26 U.S. Patents. Diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung and Siemens as well as several start-ups. Well published. Winner of grants from National Institute of Health. Extensive international consulting experience. IEEE (Institute of Electrical and Electronic Engineers) Senior Member since 2004. Three years’ experience teaching electrical and computer engineering at the University of Illinois. Holds BA and MA in Physics from Oxford University as well as Doctorate from Oxford in Materials...

Medical Devices, Biomedical Engineering - FDA, Medical Devices, FDA Compliance, FDA law, FDA Inspections, FDA medical device regulation, FDA medical device labeling, FDA regulation of clinical trials, FDA approval of medical devices. Medical Device Recalls, Medical Device Complaints, FDA Inspections

A recognized expert on the FDA regulation of Medical Devices. Experience as an expert witness involving medical device firms and FDA requirements regarding approvals, recalls, complaint investigations, and labeling. Over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. Personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular device. Serve as an expert witness for cases involving FDA regulation compliance for medical devices. Regularly perform webinars regarding FDA and issues regarding clinical studies and medical devices. Finally, a ...

Pharmaceutical Regulation, Medical Devices - FDA, FDA expert FDA Compliance, FDA Regulations, FDA MAUDE , FDA Drug Safety, FDA Warnings, FDA Drug Warnings FDA Medical Device expert, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability

Dr. Sharlin’s experience: My key skill is identifying and developing facts supporting a legal strategy. (1) Drug reviewer at FDA. (2) Expert witness experience: Cases-37, Expert reports-16, Depositions-8, Testimony-1, Successful Daubert challenges-0. (3) Professional experience: Regulatory consultant (25 years), expert witness (10 years). (4) My cases have involved drug and medical device death and injury, patents, mergers, trade secrets, business interruption insurance, product labeling. (5) My skills: biological scientist, statistician, software developer, data integrity specialist, technical writer, educator, and FDA regulatory expert. (6) Talented technical writer, my writing experience includes:  Expert reports, scientific publications, audit reports for FDA compliance, standard operating procedures, FDA submissions, responses to questions from FDA. (7) I write custom software for data mining of safety information from FDA’s adverse event databases:  I extract f...

Medical Devices, Pharmaceutical Regulation - FDA, FDA expert, FDA regulatory, FDA medical device, FDA medical product expert, FDA medical product regulation, FDA medical device regulation, FDA compliance, FDA medical product compliance, FDA medical device quality, FDA warning letter, FDA enforcement, FDA consent decree, FDA quality system

Steve Silverman is an FDA regulatory expert with more than a decade in FDA leadership roles, including as the Director of the Office of Compliance in the medical-device center. Steve focuses on areas including post-market regulation, regulatory compliance and enforcement, medical device quality, and building effective business-regulator relationships. Steve is the President of The Silverman Group, a consultancy that serves medical product companies on regulatory, strategy, and policy issues. Before this, Steve worked as Vice President, Technology and Regulatory Affairs, with AdvaMed, the leading medical-device trade association. Steve focused there on device quality and compliance, pre-market approval, advertising and promotion, and combination products. Steve brings to these roles global consulting experience with McKinsey & Co. and a range of FDA leadership positions. At FDA, Steve directed the Center for Devices Office of Compliance, where he led device-quality initiatives, enga...

Regenerative Medicine - cell therapy, gene therapy, stem cell therapy, immunotherapy, regulatory, FDA, due diligence, HCT/P, Good Manufacturing Practices (GMPs), Good Tissue Practices (GTPs), viral vectors, T cells, CAR-T cells, NK cells, stem cells, autologous cell therapy, allogeneic cell therapy

Dr. Burger has 30 years of experience developing cell therapy and gene therapy products for immunotherapy and regenerative medicine. Since 2002 he has been a full-time consultant on development, GMP manufacturing, regulatory, and strategic aspects of cell and gene therapy. He has served over 180 companies, from biotech startups to Big Pharma, in North America, Europe, Asia, and Australia, consulting on cell and gene therapies from preclinical development through Phase I/II/III, and commercialization. Dr. Burger has been an expert witness in cases involving cell and gene therapy intellectual property, commercialization, FDA regulatory affairs, and GMP compliance. He is frequently an invited speaker at international conferences and has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board and ISCT committees on gene therapy, regulatory affairs, commercialization, and product/process development. A graduate of the University of Pennsylvania Sc...