Medical Equipment Expert Witnesses: 16

Shishir V. Shah, DO, is an award-winning Wound Care Physician in active clinical practice. Dr. Shah has 20 years of wound care clinical, safety, and leadership experience in acute care, skilled nursing, rehabilitation, and home health settings. A Certified Wound Specialist (CWS) with additional Board Certifications in Hyperbaric Medicine and Family Practice.

Dr. Shah is a National Key opinion leader, CMO for 9 outpatient wound clinics, and experienced as a Medical Director at several level 1 Hospital Programs. Dr. Shah is on faculty at Midwestern University Medical School where he trains students on skin and soft tissue procedures. He has significant private equity, medical device, startup, and consulting experience (with biomedical, consumer products, and device-related wounds.) He earned his undergraduate degree in Aeronautical Engineering from Rensselaer Polytechnic Institute.

Litigation Support - Dr. Shah serves as a Hyperbaric Medicine / Wound Care Causation expert witness, with deposition and trial experience. His nationwide services are available to defense attorneys, device companies, physicians hospitals, skilled nursing facilities, and for consumer product liability. Dr. Shah is timely, professional, articulate, and accessible.

Areas of Expertise:

Hyperbaric Medicine Hyperbaric Oxygen Supervision Wound Care Pressure Ulcers Diabetic Foot Ulcers Venous Ulcers

Infections Medical Devices Soft Tissue Injuries Surgical Wounds Traumatic Wounds Burns

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.

Dr. Andreas Plackis is an award-winning, triple board-certified Anesthesiologist and Cardiac Anesthesiologist. He is Vanderbilt residency and cardiothoracic anesthesiology fellowship trained, and in full-time clinical practice with hands-on patient care and supervision of CRNAs and SRNAs.

Dr. Plackis provides care for the highest acuity patients practicing at the only heart transplant center in Arkansas. One of a select few Arkansas anesthesiologists providing TEE imaging guidance for structural heart interventions.

Litigation Support - Dr. Plackis will assist either plaintiff or defense attorneys in establishing standard of care compliance and identifying breaches in anesthesiology medical malpractice cases. His services include written reports, deposition testimony, and trial testimony as needed. He is highly responsive to phone calls and emails. Two-week or less turnaround time for initial case opinion.

Areas of Expertise:

Airway Management Cardiac Anesthesia Thoracic Anesthesia Structural Heart Interventions TEE Invasive Monitoring Vascular Anesthesia

Ambulatory Surgery Orthopedics Ultrasound-guided Peripheral Nerve Blocks ENT Non-OR Anesthesia (Radiology/GI/Cath Lab) Epidural and Spinal Anesthesia Anesthesiology Standard of Care

Dr. Plackis is an experienced and articulate public speaker and presenter with multiple publications and local/national presentations. He has exemplary knowledge base as achieved a Top 1-3 percentile ranking nationally compared to peers in nearly all ABA licensing and training examinations. Diplomat of the ABA and NBE.

ERIC P. ROSE, NPDP, MBA, Product Design and Manufacturing Expert Witness for Consumer, Medical, and Industrial products.

 Product Liability, Commercial Dispute, Patent Infringement  services provided to plaintiff and defense attorneys.

BACKGROUND: 35+ years' experience in product design, product development, product testing, and manufacturing. Product innovation part-time academic since 2009. Certified New Product Development Professional (NPDP) since 2008. Member of: PDMA, SPE, ASQ. Public Speaker since 1985.

BS Product Design, ASU College of Engineering. MBA, Pepperdine University, Named inventor on numerous patents issued and pending worldwide, https://bit.ly/2UyCa4N  

Deposed as a product design expert witness 4 times since Spring 2020 including twice in the 3M military earplug MDL. Daubert ruling at, https://bit.ly/EPR-3MEP-Daubert (Page 98). 

Expert witness services at, https://bit.ly/PDEWS 

Expert witness testimonials at, https://bit.ly/EPR-EWT

AREAS OF EXPERTISE:

Product Development Product Design ISO 9001 Manufacturing  Design For Manufacturing (DFM) Plastic Product Design Personal Protective Equipment (PPE) Respiratory Protection N95 Masks

Hearing Protection / Earplugs Industrial Products Dental Devices Medical Devices Consumer Products Toys Durable Medical Equipment (DME) Furniture FMEA

View Pinnacle Product Innovation's Consulting Profile.

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.

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 )

Envista Forensics is a global leader in Forensic Engineering & Recovery Solutions. They provide Cause & Origin, Failure Analysis, Fire and Explosion Investigations, Accident Reconstruction, Damage Evaluations and Equipment Restoration Services following disasters of all kinds. Envista has offered Consulting Services to the insurance, legal and risk management industries, as well as businesses, public entities, and universities for over 25 years.

Their Experts travel globally from 30 offices located across the U.S., Canada, Mexico, the U.K., Australia and Singapore. Envista's experience counts when equipment, systems, structures, or data have been threatened by catastrophe or litigation. Their experts and advisors determine cause and responsibility, and identify the nature and extent of damage or loss and provide a full range of solutions to protect their assets.

Envista's technical professionals are trusted advisors and industry leaders. Their expertise is broad and deep, capable of withstanding all forms of scrutiny. Envista's services are available globally so that certainty is assured no matter where in the world it is needed. As the recovery from disasters has grown more complex, Envista has developed a comprehensive array of services to help their clients and has associates located around the globe to provide assurance no matter the type of loss or location of the disaster. Envista helps attorneys quickly get to meaningful answers on the many technical issues at the center of a dispute. Their engineers have decades of experience working with both defendants and plaintiffs.

They offer effective Expert Witness Testimony, with the ability to communicate effectively, build rapport with juries and judges, and maintain adherence to structured, methodical approaches in drawing conclusions are all extremely critical. Envista Forensics understands how critical the selection of an expert can be, and we understand what makes experts effective. Their court qualified experts have extensive experience providing expert testimony on a wide variety of engineering and technical matters.

Areas of Expertise:

Aviation & Aerospace Biomechanics Construction Defects Digital Forensics Electrical Injury & Electrocutions Causation Chemical Computer / Network Equipment Failure Construction Defect Disputes over Reparability of Damage Electrical Failure Equipment Restoration Fire & Explosion Analysis Equipment Restoration

Industrial / Manufacturing Equipment Materials Failure Mechanical Accidents Mechanical Failure Medical / Laboratory Equipment Product Failure / Liability Project Management Structural Failure Subrogation Utility & Energy Valuation of Structures or Equipment Vehicle Accident Investigation Workplace / Premises Accidents

View Envista's Consulting Profile.

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.

Duane M. Bryant MD, MS, is a seasoned Ophthalmologist certified by the American Board of Ophthalmology. Dr. Bryant has over 30 years of clinical and surgical experience with Cataracts, Glaucoma, Laser Surgery For Glaucoma, Laser Surgery for Diabetic Retinopathy, Laser Surgery for Central Vein Occlusion and Branch Retinal Vein Occlusion, and Intravitreal Avastin Injections.

Regularly participating in Continuing Medical Education courses, Dr. Bryant's expertise is cutting edge. In 2014 alone, he attended the Retinal Physician Symposium, the Kiawah Eye Meeting, the Diabetic Retinopathy and Vein Occlusion, and Current Concepts in Ophthalmology. 

Litigation Support - Dr. Bryant has been involved in expert witness, peer chart review, and IME work for over 10 years. His services are available to counsel representing both Plaintiff and Defense.

Consultative / Forensic Experience:

Cataract Surgery Glaucoma Laser Surgery Ocular Trauma

Diabetic Retinopathy (Medical and Laser Treatment) Vein Occlusion (Medical and Laser Treatment) Life Care Planning for cases of Visual Impairment See Case Descriptions

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.