Medical Devices Expert Witnesses: 24

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:

View Peter Crosby'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:

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.

Divya Chander, MD, PhD, is a board-certified Anesthesiologist with a Neuroscience PhD and extensive teaching experience. Dr. Chander trained at Harvard, UCSF, UCSD, and the Salk Institute. She is currently the Chair of Neuroscience and Faculty in Medicine at Singularity University. She is also a Visiting Scholar in the Stanford Department of Medicine, Biomedical Informatics, and was a member of the Stanford Anesthesiology Faculty for 8 years.

Litigation Support - Dr. Chander offers expert witness services to attorneys representing plaintiff and defense. Services include medical record review, thorough reporting, depositions, and trial testimony as needed.

Areas of Expertise:

Background Information - Dr. Chander's postdoctoral training Stanford (Deisseroth/de Lecea Labs) allowed her to use light-activated ion channels inserted in DNA (optogenetics) to study sleep and consciousness switches in brains. In the operating room, she applies EEG technology to understand what human brains and the underlying networks look like when they lose and regain consciousness. Dr. Chander also has a precision medicine initiative focused on understanding genetic variability in responses to anesthetic drugs and brain oscillations. Her goal is to understand neural mechanisms of consciousness, as well as the evolution of human consciousness secondary to human augmentation.

Dr. Chander is working on devices that read and write the brain (brain mapping, neuromodulation) and link to brain machine interfaces for diagnostic and therapeutic purposes.

Dr. Chander also works in the field of space life sciences. A finalist for astronaut selection and an alumnus of the International Space University, she has performed remote simulations of trauma rescues, anesthesia and surgery in Mars analogue settings with physicians in the US, France, and the Concordia base in Antarctica. She has also been involved with a consortium that elaborated a road-map for studying the effect of microgravity and radiation on the nervous system, cardiovascular system, cognition and sleep.

View Dr. Divya Chander's Consulting Profile.

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.

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:

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.

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 )

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. 

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:

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.

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.

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.

• 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

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, expert testimony, and conclusions for the most difficult engineering questions. Our forensic engineers are strategically located throughout the U.S. to support clients nationwide.

Dr. Brian Pfeifer, PhD, PE - Dr. Pfeifer is an Engineering Expert with over 27 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 30 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 Dr. Pfeifer's Full Bio & CV.

Expertise:

Dr. Ian M. Zeller, PhD, PE, ACTAR, is an accomplished engineer with more than 14 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 Dr. Zeller's Full Bio & CV.

Expertise:

Dr. Michael Hill, PhD, PE, has over 20 years of experience in the field of Biomechanics, including over 6 years of experience investigating, analyzing, and professing matters involving a variety of forensic engineering issues. 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. In his current role, Dr. Hill applies a biomedical perspective to a variety of cases, including vehicle and pedestrian collisions; biomechanical analysis and injury consistency; occupant and pedestrian kinematics; product and machinery failures; and slip, trip, and fall investigations.

Dr. Hill is a registered and licensed Professional Engineer in multiple States and holds a Doctor of Philosophy degree in Bioengineering with a focus on Biomechanics. He has investigated hundreds of cases involving motor vehicle accidents, slip, trip, and fall accidents, medical device failures, and industrial accidents across the United States. 

Dr. Hill has collaborated with cardiovascular and orthopedic surgeons, engineers, and scientists in the United States, Japan, and the United Kingdom on various medical research projects. He has lectured in the field of biomechanics and numerical methods, and his research has been presented at over 40 international and national scientific conferences and published in 17 academic articles with over 1,000 citations. Dr. Hill also has an extensive history of testifying in depositions and trials. See Dr. Hill's Full Bio & CV.

Expertise:

View Qforensics' "Tire Defect & Fire Origin and Cause" Forensic Engineering Expert Witness Profile.

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