Medical Devices Expert Witnesses: 21

Gary D. Fletcher, PhD,  is the Founder and Principal Consultant at RnDDx Solutions LLC, a consulting firm founded in 2015, focused on Industrial Mechanical Engineering and Biomedical Engineering and Research and Product Development.  In his 30 years of experience, he has been co-inventor on 23 patents for devices and methods in blood collection and processing.

Litigation Support - Dr. Fletcher has subject matter expertise in Medical Device Mechanical Engineering and subject matter expertise in Medical Devices for blood and specimen collection and sample processing for in vitro diagnostics, point of care diagnostics, and therapeutics, including glucose monitoring. He serves as an expert witness in patent infringement cases involving medical device and diagnostic biomedical engineering, blood collection, separation, fluidic preparation, glucose monitoring, and cell therapy preparation devices.

Dr. Fletcher offers patent litigation services to law firms and lawyers supporting medical device and diagnostic industry clients, who need physical science and mechanical and biomedical engineering expertise for District Court, PTAB, and ITC patent cases. As an industry consultant, his ideal clients are R&D, product development, and innovation leaders in startup, emerging, and established medical device and diagnostic companies, who face product development and competitive challenges.

Areas of Expertise:

Dr. Fletcher is an entrepreneurial executive with expanding R&D roles in business, technology, and new product development leadership and execution, building and guiding teams in both Fortune 500 and startup companies. With a PhD in physics from Yale, he has a proven record of leadership in creating innovative new businesses and products in healthcare, medical devices, diagnostics, life, materials, and optical sciences.

Tobias A. Mattei, MD, is a academic Neurosurgeon specialized in Complex Spine / Deformity Surgery. Dr. Mattei is currently practices as an Assistant Professor of the Division of Neurosurgery of St. Louis University. He has been an active member of the North American Spine Society, American Association of Neurological Surgeons, Congress of Neurological Surgeons, World Federation of Neurosurgical Societies, as well as many other international societies. 

Dr. Mattei is a member of the editorial board of The Spine Journal and Deputy Editor of the North American Spine Society Journal, the new open access initiative of the North American Spine Society. He is an active reviewer of several other neurosurgical journals including World Neurosurgery, Clinical Neurology & Neurosurgery, Journal of Clinical Neuroscience, Osteoarthritis & Cartilage, Journal of Engineering in Medicine: Part H, British Journal of Neurosurgery and Neurological Sciences.

As a researcher, Dr. Mattei has published more than 130 original research articles, having been cited more than 1400 times. He holds an unrestricted medical license in the states of Ohio, Missouri, New York, and Maine, and has never been submitted to any sanction or disciplinary action by any medical boards.

Litigation Support: Dr. Mattei provides expert witness services in the field of Spinal Injuries, Spine Surgery, Spinal Care, and Neurosurgery. He has provided expert review services for several scientific funding agencies in the U.S. (including the NIH Panel for Clinical Neurophysiology, Devices, Neuroprosthetics, and Biosensors) as well as abroad (including the Innovation and Technology Commission/ Hong Kong SAR Government and The Brain Tumor Charity - New Ideas Award/UK). 

Dr. Mattei's  litigation support services are available to attorneys for plaintiff and defense and include review of hospital records, medical reports, imaging results, operative reports, patient's evolution, depositions, and trial testimony.

Areas of Expertise:

Shawn A. Hayden MD, PhD, MBA, President and CEO of ONTO Orthopedics, has over 25 years of experience as an Orthopedic Spine, Trauma and Sports Medicine Surgeon in the Dallas Fort Worth area. Dr. Hayden’s focus has always been in providing high-tech, high-quality care to his patients. For this reason, he is constantly training on some of the latest diagnostic and operative technologies. 

Litigation Support - Dr. Hayden assists medical doctors, scientists, lawyers and law firms with civil matters, malpractice cases, business guidance, and idea generation. His services include medical record review, thorough reporting of causation, depositions, and trial testimony as needed.

Areas of Expertise:

Dr. Hayden graduated from Harvard College. He received his medical degree from the University of Massachusetts Medical School and his orthopedic training at the Harvard Combined Orthopedics Residency Program. Dr. Hayden is also fellowship trained in orthopedic trauma and spine surgery at The Massachusetts General Hospital and The Beth Israel Deaconess Medical Center. Diplomate of the American Board of Orthopedic Surgery and a Fellow in the American Academy of Orthopedic Surgeons. Dr. Hayden is board certified in Orthopedic Surgery. 

Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist with over 43 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials.

As a consultant in his own pharmaceutical development advisory firm for over 29 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls (CMC), to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products.  Technical and regulatory compliance due diligence services are furnished to institutional investors.  

Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.    

Litigation Support - Mr. Anderson has been deposed, testified in Federal Court, and functioned as a Subject Matter Expert Witness  and consultant to litigation in over 20 cases in the Pharmaceutical, Biologic, and Device Life Sciences space, focused in areas of Antitrust, Patent, and Product Liability.

View Timothy Anderson's Business Consulting Profile.

Joel Gagnier, PhD, is an experienced clinical Epidemiologist with over 25 years of experience in the assessment of general and specific causation in cases of Exposures to Chemicals and Medical Interventions, and the Risks of Disease or Adverse Events. He is a tenured professor with over 20 million dollars in funding and over 210 peer-reviewed publications.

Dr. Gagnier has methodologic expertise in human subject epidemiologic research (and more generally epidemiology), clinical research, systematic reviews and meta-analyses, as well as basic science research, statistics and biostatistics  

Litigation Support - Dr. Gagnier is an expert at finding the relevant literature, assessing the quality of the evidence, extracting the data, performing meta-analyses, finding the magnitude of the association, doing a causation assessment (Bradford hill analysis) and coming to final conclusions. He has been an expert on 15 separate cases, been deposed 10 times, and testified 4 times.

Areas of Expertise:

Dr Karthik Reddy Pammi, MBBS, MS (Orthopaedics)
Fellowship-trained orthopaedic surgeon performing 750+ robotic / computer-assisted knee and hip replacements and 300+ ACL / PCL/ shoulder arthroscopies each year at Apollo Hospitals, Chennai.

Expertise: 

Robotic TKA Alignment Errors, Early Loosening, Revision Arthroplasty, Tunnel Misplacement, Arthroscopy Complications, Implant Product Lability. Reports in =14 days; Zoom depositions U S-time; fees review $450/hr, depo $500/hr.