Medical Devices Expert Witnesses in Maryland

Biomedical Engineering, Intellectual Property - Medical devices, commercially reasonable efforts, patent, intellectual property, product liability, corporate governance, licensing, strategy, inter partes review, misappropriation of trade secrets, ITC, IPR, ITC, fiduciary duty, pacemaker, defibrillator, neurostimulator, biomedical engineering

Peter Crosby is a biomedical engineer with over 45 years experience in the medical device industry, and has served as CEO of six medical device companies, public and private, in 4 countries. He has served as a member of the Board of 13 companies, and is currently serving as a member of the Board of three companies. He has brought many medical devices from concept to market release, through R&D, clinical trials, regulatory approval (FDA and CE Mark) and market launch. He is an inventor of over 50 issued US patents and applications and foreign equivalents. He has served as an expert in multiple patent cases - infringement, ownership, validity, IPR and ITC. His clinical domain and specialty experience includes otolaryngology, cardiology, cardiac surgery, anesthesia, pain management, radiology and diagnostic imaging, in vitro diagnostic devices, orthopedic surgery devices, and oncology. His product experience includes cochlear implants, diagnostic ultrasound, mammography, implantable...

Woodstock, Maryland

Investigation, Medical Management - Acute Care, Ambulatory Surgery Centers, Dermatology, Internal Medicine, Medical Devices, Medical Management, Orthopedic Surgery, Pain Medicine Management, Physical Medicine & Rehab, Radiation Oncology, Radiology, Healthcare Compliance

Healthcare Consultant, Litigation Support, Certified Valuator, CPA [RN] Retired RN. ACS Advanced Coding Specialist -Board of Medical Specialty (BMSC) CPA Certified Public Accountant -State of Maryland CVA Certified Valuation Analyst - National Association of Certified Valuators and Analysts CRCE Certified Revenue Cycle Executive -American Association of Healthcare Administrative Management (AAHAM) CPC Certified Professional Coder -American Academy of Professional Coders (AAPC) CHBC Certified Healthcare Business Consultant -National Society of Certified Healthcare Business Consultants CPCO Certified Professional Compliance Officer

STEVENSVILLE, Maryland

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? Provide FDA related ...

Gambrills, Maryland

Medical Devices, Products Liability - ceramics, Dental Ceramics, Dental zirconia, hard materials, coatings, device failures, medical ceramics, zirconia, medical device standards, properties of materials, FDA, IP, Patents, Manufacturing and Processing

Gary Fischman is the principal and owner of Future Strategies Solutions LLC. He is a domain specialist in hard materials, specifically ceramics and hard coatings. He has done legal expert work in issues in medical and dental ceramics. Dr. Fischman has worked with discovery, written expert reports, been deposed and testified as an expert witness. Formerly, a tenured faculty member at the New York State College of Ceramics at Alfred University, Dr. Fischman worked in processing hard, strong materials that ranged from non-oxide semiconductors to oxide ceramics for biomedical applications. During the early years of biomedical applications of materials, Dr. Fischman was front and center developing classes, doing research specifically in hard material (non-oxides) as well as medical oxides (aluminas and zirconias). During that time, he teamed with a colleague and created a small business that made ceramics for biomedical applicationsn (Xylon Ceramic Materials). Dr. Fischman then tr...

Maryland

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

Dr. Bowley started her own engineering consulting firm in 2008 and has been a testifying expert since 2006. Corporate offices are located in Connecticut (HQ), Maryland, and Northern California. Additionally, Dr. Bowley teaches Engineering courses at local Universities. Susan M. Bowley, Ph.D. has been a practicing engineer since 1988. Dr. Bowley grew up in Ashford, CT and completed her B.S. in Mechanical Engineering at the University of Connecticut. She then started her professional engineering career at NASA Ames Research Center in Northern California where she worked in various capacities for over 13 years. While at NASA, Dr. Bowley earned her M.S. in Mechanical Engineering at Stanford University with a concentration in Thermosciences, including completion of an independent research study on Transpired Epidermal Water Loss in Premature Infants. After competitive selection for a NASA Full-time Graduate Study Fellowship, Dr. Bowley earned her Ph.D. in Biomedical Engineering at ...

Potomac, Maryland

Emergency Medicine, Hospital Administration - COVID, overdose, anaphylaxis, appendicitis, fraud, hospital administration, mental health, aortic dissection, sexual assault, myocardial infarction, fractures, negligence, sepsis, wound care, trauma, cardiac arrest, brain hemorrhage, stroke, medical devices, aneurysm

Background: Dr. Kella is a board-certified emergency medicine physician who practices in the Washington, D.C. area. In his twenty years of practice, he has worked both clinically and as a hospital executive in large hospital systems and has received awards for hospital safety and quality initiatives. He currently practices in the Washington, D.C. area and has been retained in high-profile civil and federal matters by firms across the country. Dr. Kella has both a clinical and executive background, with an MBA in hospital administration and 15 years of experience in hospital administrative and consulting roles. He is frequently retained for his expertise in corporate negligence and complex hospital administrative matters. He is also a chief medical officer and an experienced health tech expert, and he has been retained for his experience with medical devices and products. Board-certified in Emergency Medicine, and a highly experienced expert witness, having reviewed over 400 ...