Medical Devices Expert Witnesses: 19

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:

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:

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.

Quality Forensic Engineering, LLC is a full-service forensic engineering firm, providing engineering support to clients in the areas of accident reconstruction, biomechanics, fire investigations, patent litigation analysis, premises liability, product liability, and tire failure analysis. We use the latest technology and industry proven techniques to provide thorough analysis and conclusions for the most difficult engineering questions. Our forensic engineers support clients throughout the U.S. Headquartered in Tallahassee, FL, we have locations in Jacksonville, FL; Melbourne, FL; Tampa, FL; Indianapolis, IN; New Orleans, LA; San Diego, CA; Charlotte, NC; Columbia, SC; and Tucson, AZ.

Dr. Brian Pfeifer, PhD, PE - Dr. Pfeifer is an Engineering Expert with over 25 years of experience investigating thousands of cases involving a variety of forensic engineering issues. He is a leading expert in accident reconstruction, roadside safety, maintenance of traffic, commercial vehicle accidents, pedestrian accidents, bicycle accidents, and the analysis of mechanical systems and product failures. Dr. Pfeifer has a strong background in the design, development, and implementation of roadside safety hardware including guardrails, bridge rails, and crash cushions. Over 33 patents have been filed worldwide on behalf of Dr. Pfeifer and associated colleagues who invented safer guardrail systems, vehicle storage systems, shipping container handling systems, and material handling and storage methods. He has also utilized his technical knowledge and understanding of patents to assist in a number of matters involving patent litigation.

Dr. Pfeifer has published numerous papers to various organizations, covering topics such as new guardrail systems, energy absorbing guardrail terminals, breakaway sign mechanisms, and material handling technology. He has shared his expertise with many organizations on topics including vehicle collisions, bicycle accidents, roadway construction zones, and accident reconstruction expert witness utilization. Dr. Pfeifer is a registered Professional Engineer in nine states and he continues to refine his skills and knowledge of accident reconstruction and roadside safety by staying current with new technology and best practices. Dr. Pfeifer has extensive experience with providing deposition and trial testimony as an Engineering Expert. See Full Bio & CV.

Expertise:

Dr. Ian M. Zeller, PhD, ACTAR, is an accomplished engineer with more than 10 years of experience in Biomechanics and Computational Dynamics fields. He has investigated hundreds of cases ranging from motor vehicle accidents, recreational incidents, medical device designs, as well as injuries from product liability all across the United States. 

Dr. Zeller has graduate level experience in computational dynamics and orthopedic biomechanics with a specific emphasis in dynamics, vibrations, joint contact mechanics, and muscle control during static and dynamic loading applications. Dr. Zeller’s past research includes clinical and computational analysis of the human body with respect to the design and implantation of orthopedic devices for the knee, hip, and spine. He has published in peer-reviewed journals and presented research at both technical and surgical conferences in North America, Europe, and Asia. Dr. Zeller also worked with surgeons across the United States in the design and assessment of knee replacement devices, including personalized and prototype devices to optimize for efficacy and safety. 

Dr. Zeller is also accredited as a traffic accident reconstructionist and continues to conduct research as well as maintain a current knowledge of developing trends and best practices in the biomechanics and engineering fields. Dr. Zeller has published to various organizations on topics ranging from knee replacement design, forward solution modeling, joint mechanics, personalized joint replacements, material structures and properties as well as biological modeling of disease distributions. He also has an extensive testifying history including depositions, trials, and arbitrations.

 See Full Bio & CV.

Expertise:

Michael R. Hill, PhD, PE, is a Biomechanical Engineer passionate about applying biomechanics techniques to solve diverse problems in forensics, medical research, engineering, biology, science, and mathematics. He is an expert in experimental, theoretical, and computational Tissue Biomechanics, with a focus on injury mechanisms, human tissue damage, and nonlinear soft tissue mechanics.

Dr. Hill’s core strengths are in orthopedic and cardiovascular biomechanics, vehicle accident reconstruction, injury consistency analysis, mechanical design, instrumentation, experimental analysis, numerical methods, simulation, statistics, and image processing. Dr. Hill has lectured in the field of biomechanics and numerical methods, and his research has been published in 16 academic articles and presented at 40 international and national scientific conferences.

See Full Bio & CV.

Expertise:

View Quality Forensic Engineering's Industrial Forensic Engineering Expert Witness Profile.

Dr. Jorge Perez, MD, is a Board-Certified Plastic Surgeon, practicing in Fort Lauderdale, Florida for over 30 years. A graduate and former faculty member of the Albert Einstein College of Medicine in New York City, he is selected regularly among Castle Connolly/U.S. News and World Report's listing of America’s Top Doctors.

Litigation Support - Dr. Perez is fluent in Spanish and has been retained as a consultant and medical expert for over 25 years. He has provided records review, examination and testimony in matters of adult and child plastic surgery, burns, scars, hand, skin and soft tissue injuries, for both plaintiff and defense. He assists attorneys in preparation for sentinel depositions and vigorous cross examination of opposing experts.

Areas of Expertise:

Dr. Perez is an author and has been featured as an expert in plastic surgery on worldwide media, including ABC, NBC, CBS, Univision, Telemundo and elsewhere. He has lectured and trained thousands of surgeons, in dozens of countries, in multiple languages, in the areas of facial rejuvenation, breast surgery, and body contouring.

He has served as a consultant to breast implant manufacturers Mentor/Johnson & Johnson and Allergan Medical, and has been an FDA principal investigator in breast, body contouring, liposuction and abdominoplasty. He was one of only 10 original investigators to develop Ultrasonic liposuction and was a participant in a national abdominoplasty study for Baxter bioscience. He was the keynote speaker on facial rejuvenation surgery at an international congress held in Brussels Belgium. Dr. Perez has served as plastic surgeon to a leading NYC Burn Center.

Dr. Perez recently gave a guest lecture entitled "How To Get The Most Out Of Your Retained Expert."

www.PerezPlasticSurgery.com. PerezPlasticSurgery@Gmail.com

CV available upon request.

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:

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.

Paul J. Michaels, MD, is a nationally renowned Anatomical and Clinical Pathologist with over 20 years of experience in his field. Dr. Michaels completed his medical residency and earned a Fellowship in Cytopathology from Massachusetts General Hospital / Harvard Medical School.

Litigation Support - Dr. Michaels offers expert witness services to attorneys representing plaintiff and defense. He has written over 100 general causation reports focusing on pathology and providing an extensive differential diagnosis in order to provide an opinion with a reasonable degree of medical certainty. Dr. Michaels has participated in numerous MDLs, been deposed over 60 times, and testified in court 6 times.

Areas of Expertise:

Background Experience - Dr. Michaels is currently a member of a 10-pathologist group that operates the largest and most comprehensive anatomic pathology services laboratory within Central and Coastal Oregon. He is one of two pathologists responsible for covering Bay Area Hospital, the largest hospital on the Oregon Coast, which serves as a regional referral center.

Dr. Michaels' roles at Bay Area Hospital include: Chairman of Pathology; Member of the Hospital Medical Executive Committee; Medical Director for Transfusion Medicine, Hematology, and Cytopathology; Member of the Cancer Committee; and Member of the Trauma Committee.

At Southern Coos Hospital and Medical Center, Dr. Michaels serves as Laboratory Medical Director where his Anatomic Pathology responsibilities include frozen sections, gross evaluation and sign-out of complex surgical specimens, review of numerous outpatient biopsies, GYN and NON-GYN cytology, presentation at tumor board conferences, and performing hospital autopsies. Clinical pathology responsibilities include peripheral blood smear and body fluid review, crystal identification, and evaluation of blood transfusion reactions.

Speaking Engagements and Presentations - Dr. Michaels has delivered seminars and presentations in Canada, Japan, and throughout the United States. Topics have included cytopathology, breast cancer, acute cellular rejection, and many more. 

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:

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. Mayer is an independent consultant and scholar that (for identification only) holds the position of Visiting Fellow in Human Flourishing,  Harvard University. He has been a full-time tenured professor with recent appoints in statistics, biostatistics, epidemiology, biomedical informatics, public health and medicine (psychiatry). He held various titles including, Professor (Part-time), Bloomberg School of Public Health and School of Medicine, Johns Hopkins University, Affiliated Professor, Mayo Clinic/ASU joint program in Biomedical Informatics, a member of the Research Staff at Mayo Clinic, and Professor at Arizona State University. 

Dr. Mayer continues to do research and mentor young physicians and medical students while doing a limited amount of consulting in epidemiology, biostatistics, statistics, observation studies and clinical trials. His consulting projects often focus on model development, execution and inferences. He is one of the few MD/PhD epidemiologists. He led a  group of 6000 physicians and epidemiologists that reviewed the science of COVID-19 

Rouzbeh R. Taghizadeh, PhD, is a Regenerative Medicine and Biomedical Engineering Expert offering more than 20 years of expertise as a Scientist, Innovator, and Entrepreneur in the development, processing, manufacturing of tissues, including bone marrow, umbilical cord (blood & tissue), amnion, chorion, placenta, adipose (fat), and other organs for clinical and non-clinical use, while considering the complex regulatory, trade secret, patent claims that arises from these areas.

Litigation Support - Dr. Taghizadeh provides subject matter expertise and expert witness testimony for scientific, technical, regulatory, trade secret and patent claims in the areas of:

Dr. Taghizadeh specializes in adult stem cells, primarily human hematopoietic and mesenchymal stem cells, the regenerative cells involved in successful bone marrow and umbilical cord blood transplantations, uniquely positions him to approach science and business with the same keen powers of insight that have consistently reaped success surmounting scientific and medical barriers in the field. 

He earned his Ph.D. in Stem Cell Bioengineering in 2006 from the Massachusetts Institute of Technology (MIT) and co-founded AuxoCell Laboratories, Inc. as Chief Scientific Officer in 2008 after completing his post-doctoral training from MIT and the Boston Biomedical Research Institute.

View Dr. Rouzbeh R. Taghizadeh's Consulting Profile.

Jason C. Goodwin, MS, MPH, RN, CNOR, is a highly skilled and decorated Veteran Nurse Corps Lieutenant, honorably discharged in 2006. As a Registered Nurse, Operating Room Manager, Director, and Administrator, he has extensive experience with regulatory mandates, expertise in national clinical standards, and ensuring best practices in procedural safety culture.

As a procedural department administrator and clinician, Mr. Goodwin has personally supervised the safe care in and around various procedures and operating room venues for 17 years, totaling approximately 300,000 individual patient encounters. An expert with quality and safety compliance regulation, he has successfully prepared teams for Joint Commission, AAAHC, Medicare, Inspector General, and State audits.  Mr. Goodwin has experience managing as many as 20 managers, 4 Lean/Six Sigma process-improvement personnel, 500 total employees, and $1.8 Billion in annual gross revenue.

Litigation Support - Mr. Goodwin provides expert witness services to attorneys representing plaintiff and defendant. He has been retained in approximately 30 cases. His services include medical record review, thorough reporting, depositions, and trial testimony as needed. 

Areas of Expertise:

Khalid Sorensen, PhD, is a highly accomplished technology leader in Automation, Mechatronics, Motion Control, Manufacturing, Machine Vision, and Human-Machine Interaction. He has over 20 years of experience developing and deploying world-class mechatronic, motion control, and automation solutions.

Dr. Sorensen has directed the development and implementation of 100s of complex, multi-disciplinary mechatronic systems for high-profile industry leaders including Toyota, Ford, Alcoa, Caterpillar, Boeing, NuScale, and many others, and high-profile facilities including Fukushima and Chernobyl.

Litigation Support - Dr. Sorensen has testified in numerous Product Liability and IP disputes – both at the Federal and District court levels, as well as the ITC, USPTO, and US Customs and Border Protection.

Areas of Expertise:

Career Highlights:

• Founded a technology company where he invented and was the Chief Architect of Expertoperator^TM, Safemove^TM, Automove^TM, and Cranevision^TM – technology known within the primary metals, automotive, and heavy-equipment sectors for enhancing crane safety, productivity, and ease-of-use; Developed state-of-the-art, on-line, time-optimal trajectory synthesis software for Cartesian machines - key drivers in the acquisition of his company 5 years after inception by a global leader in automation.
• Served as CTO at PaR Systems, a world-class supplier of large-scale robotic automation, control, advanced manufacturing, and nuclear-handling solutions.
• Founded Finity Engineering, which provides design, analysis, consulting, and litigation support services in the areas of robotics, automation, and mechatronics.
• Adjunct Associate Professor of Mechanical Engineering at Georgia Tech. Teaches various engineering topics including Dynamics, Controls, Vibrations, Mechatronics, the Design Process, Product Development, Engineering IP, Product Liability, and others.
• Invited talks at premiere institutions globally including MIT, Kumoh National Univ. of Tech, Korea Atomic Energy Research Inst., Hyung Hee Univ., Huazhong Univ. of Science & Tech.

View Finity Engineering's Business Consulting Profile.

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:

View Envista's Consulting Profile.