Medical Devices Expert Witnesses: 23

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:

Mechanical Engineering Biomedical Engineering Medical Devices Product Development Clinical Diagnostics Blood Collection Blood  / Cell Separation Needles / Lancets Biospecimens Point of Care Testing Microfluidics

X-Ray Spectroscopy Cell Therapy Intellectual Property / Patent Infringement Microscopy Physics Biomedical Sensing Optics Imaging Mathematics Glucose Monitors Lasers

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:

Lumbar Disc Herniation Cervical Disc Herniation Spinal Stenosis Laminectomy Spinal Fusion Spinal Fracture Spinal Injuries

Kyphoplasty Vertebroplasty Artificial Disc Spinal Cord Injury Spinal Tumors Scoliosis Back pain

Mr. John F. Schulte, is an accomplished Orthotic and Prosthetic practitioner with 40 plus years of experience consulting and treating Body and External powered upper and lower extremity prosthetics for all age groups.

Mr. Schulte has vast knowledge and experience in clinical practice prosthetic and orthotic component development, design, and manufacturing. A Clinician, Patient Care Consultant, and Senior Manager of 27 offices throughout 5 states, he is considered an expert in his field. Mr. Schulte continues to be asked to consult on Clinical ‘Best Practices’ by physicians, third party payors, peers, and patient users on the most appropriate component utilization and outcome measurements.

A published author, consultant, and Clinical Board Examiner, Mr. Schulte has treated and been involved with the treatment of persons of all ages with congenital birth defects, limb weakness and loss, and spinal cord injury.

Litigation Support - John Schulte's intimate knowledge in prosthetic and orthotic clinical practice and management, component prescription recommendation, and selection and utilization for all patient ages and levels of function make him an excellent expert witness resource. His services are available to attorneys representing plaintiff and defendant and include medical record review, second opinions, written reports, depositions, and trial testimony.

Areas of Expertise:

• Appropriate Prosthetic / Orthotic Component Selection Recommendation
• Utilization and Failures Due to Improper Manufacturing Processes
• Prescription Appropriateness
• Clinical Applications and Negligence Directly Related to Limb Weakness and Loss
• Spinal Cord Injury and Treatment
• Wrongful Death Investigation and Determination
• Limb Damage and Loss in Diabetics as Related to Footwear
• LifeCare Plan Consultation and Preparation as Related to Orthotics and Prosthetics

Education:

• New York University Medical School Orthotics and Prosthetics Certificate Program, Certification as Certified Prosthetist, 1973
• Northwestern University Medical School Orthotics and Prosthetics Certificate Program, Certification as Certified Orthotist, 1973

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:

Orthopedic Surgery Spine Surgery Sports Medicine and Surgery Endoscopic Surgery Minimally Invasive Surgery Sports Injury Back Injury Neck Injury

Whiplash Sports Concussion Case Valuation Impairment Medical Devices Innovation Understanding EMR Vehicle Injury Evaluation

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:

Epidemiology Health Risk Assessment Environmental Medicine Toxicity Heavy Metals Glyphosate-based Herbicides Pesticides and Herbicides

Volatile Organic Compounds (ethylene oxide, benzene, PFOS/PFAS) Vaccines Medical Devices (hip and knee implants) Natural Health Products Nutritional Supplements Nutrition Patient Safety

Marilyn McCullum, BSN, RN, CEN, is a certified Emergency Nurse with peer-reviewed publications, speaking engagements, and testifying experience. She specializes in emergency nursing, general nursing care, medical documentation bias, and medical products as an end-user. She stays active in her clinical position and teaches her peers about documentation and triage.

Ms. McCullum's expert opinions are unbiased, neutral, and fact-based, following the national Standard of Care.

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.