Medical Equipment Expert Witnesses: 14

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

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.

Christopher M. Daft, PhD, is an award winning, Oxford Educated scientist whose areas of expertise include medical imaging, artificial intelligence, semiconductors, medical devices, sensors, MEMS, signal processing, and image processing. He holds 23 United States Patents with 20 applications pending, Dr. Daft has diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung, and Siemens as well as several start-ups. 

He has testified at trial 5 times and been deposed 14 times.

Dr. Daft has been an Institute of Electrical and Electronic Engineers (IEEE) Senior Member since 2004. He has three years of experience teaching electrical and computer engineering at the University of Illinois. 

Dr. Daft holds a BA and MA in Physics from Oxford University as well as Doctorate from Oxford in Materials Science.

Litigation Support - Dr. Daft provides litigation support in the areas of Intellectual Property and Medical Devices including Imaging, particularly Medical, Patents, and more. His experience includes a variety of cases in the areas of wearable electronics, imaging systems, and surgical technology. Dr. Daft has extensive deposition and trial testimony experience.

Areas of Expertise:

Design Engineering Electrical Engineering Electromagnetic Engineering Microelectronics Medical Imaging Electronics Semiconductors

Medical Devices Sensors Software Engineering MEMS Signal Processing Image Processing Physics

View Dr. Christopher Daft's Consulting Profile.

Consultants. Experts. Innovators.™

Operating from more than 110+ offices around the globe, we provide services to corporations, insurance companies, law firms, and government agencies.

Rimkus Life Sciences experts have a wealth of specialized expertise to help clients comprehend and improve how humans interact with their facilities, products, and systems.

Our experts offer significant professional experience related to studying and understanding human behavior and experience. Our experts have extensive knowledge involving but not limited to human health and medical devices, warnings and signage, perception and reaction, medicine and patient care, and health and sports activity.

The scientists, engineers, and researchers in Rimkus Life Sciences specialize in human based research to support product design and development, product validation, and development of instructions and warnings for use. Our experts work with clients across the globe in every major product sector. They understand how to leverage rigorous research and thoughtful analysis with creative problem solving to support the development of products.

Rimkus Global Services Overview

LIFE SCIENCE EXPERTISE

Biomedical Engineering

Human Factors

•   Product Safety •   Warnings and Safety Information •   Transportation Human Factors •   Occupational Safety •   Chemical Hazard Communication •   Railroad Grade Crossing and Trespassing Accidents

Medical Devices and Medical Error Accidents Involving Children Maritime Safety and Recreational Sports Premises Liability Industrial Ergonomics and Time and Motion Studies

Legal Nurse Consulting

Medical-Legal Nurse Review Medical Record Organization and Indexing

Testifying Expert Locator Services

Product Safety

Technical Consultations Product Safety Consultations Applied Research and Testing Usability Chemical Hazard Communication

Training Historical Research and Analysis Range of Projects Publications and Research

Sports Science Consulting

Product Validation Testing Applied Research and Data Collection Product Safety and Usability Research Program Management

Scientific Consultation Policy Development Regulatory Guidance Technical Communications Education Programs

Toxicology Food Safety

Toxicology Drug and Alcohol Impairment Consumer Product Toxicity

Food Safety Environmental and Workplace Toxicology Pharmaceuticals Toxicology

View our full suite of Life Sciences Expert Services.

GLOBAL OFFICES

Rimkus operates from 110+ offices worldwide, with headquarters in the following cities.

Australia Grosvenor Place, Level 31 225 George Street Sydney NSW 2000 Phone: +61 2 9290 1495 Email: APEnquiries@rimkus.com

Malaysia Menara Citibank Suite 20.04 Level 20, 165 Jalan Ampang 50450 Kuala Lumpur Phone: +60 3 9212 1204 Email: APEnquiries@rimkus.com

New Zealand Level 2, 1 Broadway Newmarket Auckland 1023 Phone: +64 9 5201929 Email: APEnquiries@rimkus.com

Singapore  138 Market Street Level 5, CapitaGreen 048946 Phone: +65 6016 6057 Email: APEnquiries@rimkus.com

United Kingdom 5th Floor 40 Lime Street London EC3M 7AW Phone: +44 12 5767 6107 Email: EurEnquiries@rimkus.com

United States 12140 Wickchester Ln Ste 300 Houston Texas Phone: +1 800 580 3228 Email: Expert@rimkus.com

View a full list of Rimkus Office Locations.

View Rimkus Quantum and Delay Expert Services Profile.
View Rimkus Forensic Expert Services Profile.

• BACKGROUND:

40+ years' experience including in product design, product development, and manufacturing in consumer, medical, and industrial product markets. Product innovation part-time academic since 2009, public speaker since 1985. Certified New Product Development Professional (NPDP) since 2008 by the Product Development and Management Association. Member of: Society of Plastics Engineers, Society of Manufacturing Engineers, American Society for Quality. Expert witness services to Product Liability, Intellectual Property, and Commercial Dispute litigators.

• PRODUCT LIABILTY EXPERTISE:

Retained by both plaintiff and defense counsel. Specialize in personal injury cases involving product defects, manufacturing defects, product safety, engineering design, mechanical failures, material failures, product quality assurance, and foreseeable misuse. 

• CASE EXAMPLES:

• Retained in cases involving 3M, Honeywell, Clorox, Ace Hardware, and others. 
• 3M Combat Arms earplug case, retained by two plaintiff firms. More at, https://bit.ly/Forbes-on-3M Daubert ruling at, https://bit.ly/EPR-3MEP-Daubert (Page 98). Two depositions. (Plaintiff) 
• Furniture review of the state of competitive product safety, mechanisms, warnings. Counsel represented major insurance company. Settled after report. (Defense) 
• N95 mask commercial dispute, settled after report. (Plaintiff) 
• Consumer electronics patent infringement, settled after report. (Defense) 

• MORE INFO AT:

Expert witness services offered can be seen at, https://bit.ly/PDEWS Preferred contact: eric@pinnaclepi.com

Content above is a selection of work, current case history available upon request. Expert witness testimonials at, https://bit.ly/EPR-EWT

• EXPERT WITNESS PODCAST INTERVIEW

Mari S. Truman, PE, has more than 40 years of experience in Orthopedic Product Design and Development. As Principal Engineer with her company, Orthobiomech, LLC, she acts as an R&D design and development consultant to the orthopaedic industry and an injury biomechanics and medical device forensic expert. Ms. Truman's design experience includes implants and instrumentation systems used to repair fractured bones, torn ligaments and/or to reconstruct spine, knee, wrist, hip, ankle, elbow, thumb based cmc, and other finger and toe joints for many of the USA based orthopaedic conglomerates and a few Asian, Australian and European firms. Having designed and developed implants and instruments used for both human joint reconstruction and skeletal trauma repair, Ms. Truman is named on 12 Orthopaedic Patents and frequently gives talks on implant design and injury biomechanics on topics such as: knee and thumb-based joint surfaces and kinematics, joint design, rapid prototyping, medical device design control, and injury biomechanics. Litigation Support - Ms. Truman has been providing Forensic Impact and Injury Biomechanics and Orthopedic Biomechanics to the legal industry for over 15 years. She draws on her strong knowledge of FDA and ISO EN13485 compliant design control processes, failure modes and effects analysis, clinically relevant tissue loading, and design safety assurance, including device performance requirements and warnings, during her medical device litigation reviews. Ms. Truman has a strong knowledge of the production and quality assurance processes used in the manufacture, cleaning, and sterilization of medical devices and the effects of such processes on product performance. Analysis of Traumatic Injuries Related To:

Falls and Fall Recovery Vehicular Collisions Assaults and Fights Projectile Impacts Occupation or Workplace

Failed Medical Implants Assistive Devices Orthotics Consumer Products Sports and Recreation, Occupational Overuse / Injury

View OrthoBioMech LLC's Consulting Profile.

John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies.

Mr. Stevens has 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, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices. 

Litigation Support - An FDA expert and seasoned business professional, Mr. Stevens is uniquely qualified to opine on cases involving the FDA's regulation of medical devices. He has served as an expert witness for over 30 court cases involving the FDA regulation of medical device firms. His services include thorough reporting, depositions, and trial testimony. 

Areas of Expertise:

• Submissions (510(k), IDE, PMA, De Novo)
• Medical Device Quality Systems
• FDA Inspections

View Mr. Stevens' Consulting Profile.

Dr. Ronnie I. Mimran, a Board-Certified Neurosurgeon, and former Oakland Raiders NFL Team Neurosurgeon, specializes in Spinal Cord Injuries, Traumatic Brain Injury, and Complex Spinal Surgeries. He is the Medical Director of Neurosurgery and the Neuroscience Department Chair at Sutter Medical Center where he maintains an active clinical practice. 

Litigation Support - As an award-winning teacher, Dr. Mimran brings the capacity to effectively and succinctly communicate complex neurological concepts to his medical-legal practice. He provides Forensic Neurosurgery, Neurosurgery Malpractice / Standard of Care services to attorneys for plaintiff and defendant, including medical record review, thorough reporting, depositons, and trial testimony as needed.

Areas of Expertise:

Traumatic Brain Injury / TBI Brain Surgery Brain Tumors Concussion Emergency Medical Services Independent Medical Examinations Medical Devices

Neurology Neurosurgery Personal Injury Spine Cord Injury Trauma Surgery / Trauma Medicine Thoracic Surgery Back Pain

Selected Background Experience

• Neurosurgeon Sutter West Bay Medical Group, San Francisco, CA December 2020 – present
• Chairman, Department of Neuroscience Sutter Eden Medical Center, Castro Valley, CA December 2021 – present
• Medical Director, Neurosurgery Sutter Eden Medical Center, Castro Valley, CA 2015 -- present
• Adjunct Clinical Professor UCSF Department of Neurosurgery 2006 – present
• Vice Chairman, Department of Neuroscience Sutter Eden Medical Center, Castro Valley, CA December 2019 – December 2021
• Neurosurgeon Pacific Brain and Spine, Danville, CA July 2005 – December 2020
• NFL Team Neurosurgeon Oakland Raiders, Alameda, CA 2009 – 2020

Dr. Mimran completed medical school at the University of Southern California. He subsequently completed a General Surgery Internship, Residency in Neurological Surgery, and Fellowship in Minimally Invasive Spine Surgery, at the University of Florida. During residency and fellowship, Dr. Mimran received the Charles Shank Award for Excellence in Neurosurgery, was a Delegate Fellow for the Council of Neurosurgical Societies, and was honored as the Outstanding Resident Educator in 2002. 

Between 2016-2018, Dr. Mimran completed an MBA at Cornell University. Dr. Mimran has published chapters and peer-reviewed articles in the Journal of Neurosurgery, Journal of Spinal Disorders and Techniques, Clinical Intervention Aging and the Journal of Stroke and Cerebrovascular Diseases. He has successfully patented two neurosurgical devices.

mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.

OUR APPROACH

We utilize the following three part approach to providing high quality services to our clients:

Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients

Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment

Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)

Victor L. Mandoff, BSc, MBBS, is a Board-Certified fully practicing Professor of Anesthesiology at a teaching hospital. With 17 years of experience in Anesthesiology and 10 years in Critical Care Medicine, his training keeps him current in the knowledge and practice of Evidence Based Medicine (EBM). Evidence Based Medicine is the integration of individual clinical expertise with the best available research evidence from systematic research and the patient's values and expectations.

UAMS Medical Center provides care to the highest acuity patients from the state and surrounding areas. It is the only level-one trauma center in Arkansas and the only one that does liver transplantations. Dr. Mandoff provides anesthesia for a variety of cases like liver transplants, kidney transplants, vascular surgery, thoracic, obstetric, neurosurgical, ENT, outpatient, GI, radiology, Cath Lab, Electroconvulsive therapy, etc. 

Litigation Support - Dr. Mandoff offers expert witness services to attorneys for plaintiff and defendant. Services include medical record review, thorough reporting, depositions, and trial testimony.

Areas of Expertise:

Acute Pain Management Regional Anesthesia Transplant Anesthesia NORA (Non-OR Anesthesia) Difficult Airways Critical Care Medicine ACLS

BLS Code Blue Emergencies Level 1 Trauma Management Narcotics Neuromuscular Blockers Simulator Training Moderate Sedation

Dr. Mandoff is the director of MOCA Simulation for Anesthesiologists, the Assistant Medical Director of the Simulation Center, and the Director of Liver Transplant Team and Transplant Anesthesia at the University of Arkansas for Medical Science. He is an award-winning educator who feels privileged to teach medical students, nurses, residents, SRNAs and junior faculty, and other faculty using simulation training. Dr. Mandoff has won many teaching awards, including “Golden Apple Award,” “Red Sash Award,” and  “Educational Excellence Award,” presented by residents, students, and the College of Medicine.

Dr. Mandoff is a Fellow of the American Society of Anesthesiologists (FASA). The FASA designation is the “highest acknowledgment that recognizes years of dedication to exceptional education, leadership, and commitment to the specialty” as per the American Society of Anesthesiologists website. He is also Critical Care Fellowship trained at the Cleveland Clinic Medical Foundation, Critical Care Board Certified, and practiced Critical Care Medicine from 2006 to about 2016.

An Oral Board Examiner for the American Board of Anesthesiology, Dr. Mandoff has been named in Arkansas Times Best Doctors in Arkansas list in both Anesthesiology and Critical Care Medicine.

Tom LeTourneau, LPO, CPO, FAAOP, has over 45 years of experience in the Design, Manufacture, and Fitting of Orthotic and Prosthetic Devices, including all Myoelectric applications and all Microprocessors.  He is a Certified Orthotist and Prosthetist by the American Board of Certification of Orthotist and Prosthetists and Fellow of the American Academy of Orthotist and Prosthetists.

Litigation Support - Mr. LeTourneau has over 20 years of experience  providing Orthotics and Prosthetics expert opinions to life care planning care management personnel and law firms for both plaintiff and defendant. Licensed Prosthetist and Orthotist by the state of Texas, he is available for record review, thorough reporting, depositions, and trial testimony as needed.

Areas of Expertise:

Orthotics and Prosthetics Design and Manufacture Orthotics and Prosthetic: Rehabilitation Fitting Care and Maintenance Activity Usage Coding and Pricing Artificial Limbs Upper Extremity Amputees Myoelectric Prosthetics Foot Prosthetics Spinal Orthosis

Amputees Braces - Leg, Knee, Hip Polio Bracing KAFO Stroke Drop Foot Foot / Toe Amputation Diabetics Diabetic Shoes Gait Deviation Worker's Compensation Medicare

Memberships, Certifications, & Highlights:

• Member of the Upper Extremity and Lower Extremity scientific society of the American Academy of Orthotists and Prosthetists
• Member of the American Association of Orthist and ProsthetistsCertification extensions in all myoelectric upper extremity Orthotics and Prosthetics, Micro-processor prosthetic Knee and feet applications, and X-finger applications
• Inventor / and or co-designer in Te-Evolution Above the Knee socket design, Stealth Ankle foot orthosis, " No more knee pain " Knee orthosis, acti-ankle
• CEO and Founder of a Multi-million dollar ( licensed and certified ) Orthotic and Prosthetic company
• Featured in articles and news organizations ( local and National )including CNN, NBC., CBS, the History Channel, and family circle magazine
• Awarded Freedom award for exceptional service for veterans ( only 35 companies nationwide receive an award )

Dr. Glenn Prestwich  is a National Academy of Inventors fellow with over 45 years of experience as a professor, entrepreneur, and biotech startup C-suite executive. Dr. Prestwich specializes in Biomedical Intellectual Property. He has been a prolific inventor since 1977, and an expert witness in IP law cases since 2007. He is an inventor on over 95 patents and patent applications, including 48 issued patents.

Litigation Support - Dr. Prestwich brings to all legal and technical cases a deep appreciation for how chemistry informs the invention and development of products that offer solutions to problems in the life sciences and medicine, ranging from disease detection and treatment to tissue healing and regeneration. He’s been involved in intellectual property litigation that concern medical devices, diagnostics, new pharmaceuticals, drug delivery, agrochemicals, and consumer products.

As an expert witness, Dr. Prestwich enjoys the challenges of dissecting the validity (or invalidity) of patents in litigation. He appreciates the subtleties of claim construction and works collaboratively with attorneys to identify successful arguments based on sound science and legal principles. He has drafted over 40 expert reports, declarations, and affidavits in support of his attorney clients.  He has been deposed 18 times and testified in Court four times.

Glenn D. Prestwich on Accessible and Experienced Expert Witnesses

Areas of Expertise:

Organic Synthesis Natural Products Chemistry Medicinal Chemistry Mechanistic Enzymology Agricultural Chemistry Chemical Biology Biochemistry

Intellectual Property Litigation Medical Devices Diagnostics New Pharmaceuticals Drug Delivery Agrochemicals / Pesticides Consumer Products

Publications - Dr. Prestwich is an organized, clear, and effective writer. He has co-authored  over 610 additional peer-reviewed articles in the scientific literature, and written over 50 single-author scientific publications, reviews and book chapters. His publications encompass areas such diverse topics as anti-cancer drugs, gels for wound repair, cell therapy, and regenerative medicine, insect and pest control agents, cholesterol-lowering agents, lipids and cell signaling tools, and anti-inflammatory agents.

Peter Crosby has over 45 years experience in the Medical Devices Industry. He has served as  CEO of six medical device companies (public and private) in four countries, and has been a member of the board (including chairman of the board) of over 10 companies. Mr. Crosby is an accomplished entrepreneur and company builder, and has brought many medical device products to the world market. He is an inventor on over 50 US patents and applications.

Education includes a Bachelor of Engineering (Electrical) and Master of Engineering Science (Biomedical Engineering).

Litigation Support - Mr. Crosby has served as an expert  in many cases including product liability, intellectual property (patent disputes including infringement, validity, IPR and ITC), alleged misappropriation of trade secrets, fiduciary duty of directors, and commercial contracts disputes (including commercially reasonable efforts"). 

Product Expertise:

Implantable Devices Cochlear Implants Cardiac Pacemakers Implantable Defibrillators Artificial Hearts and LVADs

Neurostimulation Devices In Vitro Diagnostics Medical Device Software Patient Monitoring Imaging / Ultrasound and X-Ray)

View Peter Crosby's Consulting Profile.

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.