11 Fda Medical Products Expert Witnesses Found

Plastic Surgery, Wound Care - Breast and Body Contouring, Aesthetic and Reconstructive Wound Management, Wound Care

...He has participated in several investigations for government regulators serving as a principle investigator for the FDA in multiple clinical studies regarding medical implant devices. Additionally, he has performed investigative work for private corporations gaining vast knowledge of the products and procedures used in many fields of medicine and surgery. Dr. Baker earned his Bachelor’s degree in pre-medicine in 1973 from Auburn University and received his Medical Degree in 1977 from the University of South Alabama College of Medicine in Mobile, AL. He completed his 5-year internship and residency in General and Vascular Surgery at Carraway Methodist Medical Center in Birmingham, AL in 1982. After 9 years of General Surgery practice, Dr. Baker completed a residency in Plastic & Reconstructive Surgery at the Mayo Clinic in Rochester, MN. He began his practice of Plastic and Reconstructive Surgery in Dothan, AL in July, 1993 retiring from the operating room in 2020. Dr....

Biomechanics, Medical Devices - Injury Causation Biomechanics & Personal Injury, Consumer & Medical Product Liability, Premises Liability, Slip, Trip & Falls, Accident Reconstruction, Animations and Illustrations, 3D Laser Scanning, Drone Aerial Mapping, Criminal and Shooting Reconstruction

...Bowley then completed a Post-Doctoral Fellowship at the Food and Drug Administration where she studied blood hemolysis via mechanical fragility of red blood cells in various medical devices. After completing her Post-Doctoral research, Dr. Bowley served as a lead medical device reviewer at the US Food & Drug Administration (FDA) in the Cardiovascular Division for over 3 years, including serving on the ASTM F04.30.06 Task Group as Co-Chair. Medical devices evaluated included: Drug-eluting stents, stents (cardiac and peripheral), and other Class III and Class II medical devices. Dr. Bowley returned to Federal Government Service in 2018 and worked at the Transportation Security Administration (TSA) as a Transportation Security Officer (TSO) (6 months), the US Patent and Trademark Office (USPTO) (1 year), and finally the US Consumer Product Safety Commission (CPSC) (2 years, 7 months)....

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 holding 27 U.S. Patents with 16 pending. - 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....

Biomechanics, Medical Devices - Injury Causation Biomechanics & Personal Injury, Consumer & Medical Product Liability, Premises Liability, Slip, Trip & Falls, Accident Reconstruction, Animations and Illustrations, 3D Laser Scanning, Drone Aerial Mapping, Criminal and Shooting Reconstruction

...Bowley then completed a Post-Doctoral Fellowship at the Food and Drug Administration where she studied blood hemolysis via mechanical fragility of red blood cells in various medical devices. After completing her Post-Doctoral research, Dr. Bowley served as a lead medical device reviewer at the US Food & Drug Administration (FDA) in the Cardiovascular Division for over 3 years, including serving on the ASTM F04.30.06 Task Group as Co-Chair. Medical devices evaluated included: Drug-eluting stents, stents (cardiac and peripheral), and other Class III and Class II medical devices. Dr. Bowley returned to Federal Government Service in 2018 and worked at the Transportation Security Administration (TSA) as a Transportation Security Officer (TSO) (6 months), the US Patent and Trademark Office (USPTO) (1 year), and finally the US Consumer Product Safety Commission (CPSC) (2 years, 7 months)....

Biomedical Engineering, Intellectual Property - Medical Devices, Failure Analysis, Products Liability, Mechanical Engineering, Biomechanics, Laboratories & Testing, MRI safety, FDA and Regulatory, Finite Element Analysis, Electromagnetic Compatibility, Magnetic Resonance Imaging, MRI, Patent Analysis

David Gross, PhD, PE, is the Director of MRI Safety Evaluations and Engineering Simulations at MED Institute. As a graduate research associate, he was awarded a Pre-Doctoral Fellowship from the American Heart Association (AHA) for his research focusing on improving the MRI safety of patients with implanted cardiovascular devices. He is a member of numerous societies, including the International Society for Magnetic Resonance in Medicine (ISMRM) where he received the Magna Cum Laude Merit Award at the 2016 ISMRM Annual Conference. Additionally, he was a member of the Ethics Subcommittee for the Biomedical Engineering Society. He graduated from Purdue University with a B.S. in Biomedical Engineering and M.S.E. in Interdisciplinary Engineering. He also holds M.S. and Ph.D. degrees in Biomedical Engineering from Ohio State University and is a licensed Professional Engineer.

Biomechanics, Medical Devices - Injury Causation Biomechanics & Personal Injury, Consumer & Medical Product Liability, Premises Liability, Slip, Trip & Falls, Accident Reconstruction, Animations and Illustrations, 3D Laser Scanning, Drone Aerial Mapping, Criminal and Shooting Reconstruction

...Bowley then completed a Post-Doctoral Fellowship at the Food and Drug Administration where she studied blood hemolysis via mechanical fragility of red blood cells in various medical devices. After completing her Post-Doctoral research, Dr. Bowley served as a lead medical device reviewer at the US Food & Drug Administration (FDA) in the Cardiovascular Division for over 3 years, including serving on the ASTM F04.30.06 Task Group as Co-Chair. Medical devices evaluated included: Drug-eluting stents, stents (cardiac and peripheral), and other Class III and Class II medical devices. Dr. Bowley returned to Federal Government Service in 2018 and worked at the Transportation Security Administration (TSA) as a Transportation Security Officer (TSO) (6 months), the US Patent and Trademark Office (USPTO) (1 year), and finally the US Consumer Product Safety Commission (CPSC) (2 years, 7 months)....

Pharmaceutical Regulation, Infectious Diseases - Food and Drug Administration (FDA), drug/biologics safety/labeling/post-marketing surveillance, FDA drug/biologics regulations/procedures/applications (INDs/NDAs/BLAs), clinical trials, drug development, pharmacy compounding, HIV, MRSA, antibiotics, hepatitis, osteomyelitis, influenza, C. difficile

...Ross holds a medical degree from New York University School of Medicine, and an undergraduate degree in Molecular Biophysics and Biochemistry from Yale University. He completed his internal medicine residency training at NYU Medical Center, and infectious disease fellowship training at Yale University. Dr. Ross also holds a M.S. and Ph.D. in Biochemistry from NYU, and a Master’s Degree in Biomedical Informatics from Oregon Health and Sciences University. Dr. Ross spent 10 years with the FDA’s Center of Drug Evaluation and Review (CDER) as a medical officer, senior medical reviewer, medical team leader, and new drug review office management official. He has extremely broad experience with FDA regulatory submissions (INDs, NDAs, BLAs, post-marketing safety, labeling supplements) for both small molecules and biologics. He has extensive familiarity with FDA regulations, processes, and procedures, including drug/biologic labeling and compliance requirements. Dr....

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

Worked as an FDA regulatory expert witness in over 50 cases, deposed 16 times and testified 5 times. Based on experience training over 40,000 staff at FDA-regulated companies on technical and regulatory topics, skilled in explaining FDA related topics to juries. Broad and deep skills in drug, biologic and medical device development. Hands-on experience in the entire lifecycle of product development from initial regulatory strategy, clinical trial planning and execution, to submission preparation and review at FDA. Authority in the collection, statistical analysis, interpretation, and presentation of information to FDA. Expert in understanding FDA reviewer’s actions and reactions. Specialist in analyzing FDA compliance information to answer three questions: 1) What did the company know and when did they know it? 2) What should the company have known and when should they have known it? 3) What should the company have done and when should they have done it?...

Medical Devices, Mechanical Engineering - intravenous, IV, needle-free, heart valves, mitral valve, cardiovascular, FEA, nitinol, pumps, heart valve repair, sutures, stents, hernia, staplers, fasteners, plastics, polymers, textile, injector, syringes, catheters, CPAP, pen injector, e-cigarettes, engineering

Award winning nationally recognized medical device product development engineer. Experience in cardiovascular (AAA stents, mitral valve repair, heart remodeling, vascular assist devices), intravenous IV disposables & pumps, syringes, auto injectors, pen injectors, catheters, surgical instruments, minimally invasive instruments, e-cigarettes, CPAP, nebuliizers, RF endometrial ablation, Novasure, medical textiles, knitting, weaving, percutaneous devices, endoluminal devices, hernia repair, implants, animal studies, laparoscopic staplers, laparoscopic devices, medical grade plastics, polymers, manufacturing, prototypes, clinical studies, testing, FDA, GMP, and inspection.

Pharmaceutical Regulation, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use

Ethical Full Lifecycle Labeling/Prescribing Information That Never Cuts Corners For Pharmaceutical Giants Merck, Shire, and J&J: Labeling strategy and leadership that brings product labeling and products to market supporting vaccines and treatments for infections, internal medicine, oncologic, and rare diseases. These include life-saving, ground breaking, and first-of-its-kind products. Bring decision makers across divisions to the table to negotiate resolution of labeling issues - leading to the creation, revision, and maintenance of clear and compliant product labels that educate health care professionals and patients in the US, EU, Japan, and Rest of World. Gain consensus and champion proactive consensus-building across Research, Statistics, Regulatory, Joint Ventures, Legal, and Marketing on labeling - laser-focused on the bottom line: “What do the doctor and patient need to know?”...

Medical Devices, Biomedical Engineering - Medical Device Mfg./Design Defects, Surgical Instruments, Spinal Instrumentation, Medical Implants, Medical Device Patents, Pedicle Screws, Bone Screws, Spinal Cages, Knee Replacement, Patents Medical Devices, Hip Replacement, Spinal Rods

With 25+ years of design and development experience, Troy Drewry provides forensic engineering, litigation consulting and expert witness testimony regarding medical devices, including biomechanical devices and orthopedic implants and instrumentation, in cases involving FDA and regulatory processes, failure analysis, product liability, medical malpractice, and intellectual property, including trade secrets. He has hands-on experience in medical device companies, from startups to large corporations and knows their environments, constraints, issues, and concerns. He is ranked 17th out of the Top 100 Spinal Device Inventors (1971-2003). 62 US Issued Patents to date 27 US Patent Applications pending 17 Foreign Issued Patents to date 33 Foreign Patent Applications pending His company, Ragin Cajun Consulting LLC, is a product development consulting firm helping innovators and inventors take their ideas from concept to commercialization....