Medical Devices Expert Witnesses: 22

Karl R. Leinsing, MSME, PE, President of ATech Designs, Inc., is a Professional Mechanical Engineer who specializes in Medical Device Product Development from concept to production. Mr. Leinsing has been granted over 34 patents (needle free IV valves, laparoscopic devices, needlescopic devices, suture lockers, catheters, mitral valve repair devices, knitting machines) and excels in solving the most complicated problems and design challenges. His company has a fully equipped medical lab with calibrated measurement and test equipment and all is fully documented with high quality reports with pictures and video to provide credible results and easy to understand compelling data.

The winner of five design awards, Mr. Leinsing is recognized as one of the top 100 medical device professionals in the nation by MD&DI. For dedication to his industry, he was made the 2014 Chairman of the Medical Device and Manufacturing Conference in Anaheim, CA. Mr. Leinsing has also been acknowledged for his work in a publication by Life Magazine. Mr. Leinsing offers litigation support services to the legal community. He has extensive experience with Patent and Product Liability cases including report writing, depositions, and testimony.

Areas of Expertise:

View Karl Leinsing's Consulting Profile.

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.

Kenneth "Kenny" Stein, MD
Board Certified Emergency Medicine & Internal Medicine 
Subspecialty Certified in NeuroCritical Care 

Kenneth "Kenny" Stein, MD, is Assistant Professor in the Department of Emergency Medicine, St. Louis University School of Medicine (a Level 1 Trauma Center). Dr. Stein has practiced Emergency Medicine for 29 years and Critical Care / Intensive Care Medicine for 27 years. For 20 years, Dr. Stein was an Emergency Physician at St. Anthony's Medical Center of St. Louis, one of the busiest emergency departments in the State of Missouri.

Dr. Stein has extensive experience in providing medical-legal expert services, having reviewed over 500 cases (both plaintiff and defense) and having given testimony over 200 times. Dr. Stein furnishes an unbiased opinion on medical malpractice/negligence cases. He also provides medical opinion concerning causation. Dr. Stein does not guarantee a favorable outcome but provides an honest assessment.

Dr. Stein has lectured nationally, and consults in the area of Pharmaceutical and Biomedical Product Development and Marketing.

Dr. Stein reviews cases (for both Plaintiff and Defense) of alleged Medical Malpractice / Negligence in areas including:

• Emergency Medicine        
• Critical Care Medicine / Intensive Care Medicine          
• Internal Medicine

Services provided include:

• Medical chart review and analysis   
• Providing opinion concerning the presence or absence of Negligence / Breach of the Standard of Care, Damages / Injury and Causation
• Survey of case for merit 
• Preparation of reports and / or affidavits        
• Preparation for opposing expert deposition and cross-examination        
• Medical literature search    
• Expert witness testimony at deposition and trial

Call 314-495-7009 for a complete CV, including presentations.

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.

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.

Timothy P. Harrigan, ScD, MBA, PE, is a Mechanics / Biomechanics and Modelling and Simulation Engineer with over 35 years of experience. He has spent 15 years in Orthopedic departments and the rest of his career in Biomedical Engineering. Dr. Harrigan has done accident reconstruction through analytical and computational models, and extensively used FEA, CFD and, Fluid-structure models.

Litigation Support - Dr. Harrigan has strong analytical skills and qualifications for both the biomechanical issues and the interacting mechanical and electrical environments. He works on both Design and Manufacturing Defects in Medical Devices, including total joint replacements, IV tubing, insulin pumps, IV fertilization, and heart valves. With 3 US Patents, and having passed the patent bar, Dr. Harrigan works effectively with IP professionals on expert reports Injury Biomechanics and Intellectual Property. 

Dr. Harrigan investigates injury and accident scenes to gather relevant data and develop quantitative models for impact injury, blast effects, vehicle collisions, industrial accidents, and premises injury. He develops situation models, accident scene models and device models, and evaluates the strengths and weaknesses of inferences from those working models. He's been Daubert/Robinson challenged but never excluded.

Selected Cases - August 2009 to Present:

• Investigated and testified on biomechanics in consumer product liability suit based on Chinese-made inflatable pool slide; won $20M verdict in Massachusetts. (Aleo v Toys-R-Us)
• Investigated and testified on biomechanics in consumer product liability suit based on Chinese-made inflatable pool slide; won $4M verdict in Missouri. (Grantham v Wal-mart)
• Investigated and testified on biomechanical factors in injury, including product, premises, and transportation litigation
• Provided expert testimony, developed finite element models, and made pressure measurements on bicycle seats in support of $3+M patent infringement claims in the U.S., Italy, and China
• Provided court testimony, deposition testimony, and reports in Patent infringement and validity actions including Inter-partes reviews. (IPR)

Certifications:

• Registered Professional Engineer, State of Texas #86769
• Registered Patent Agent, US Patent and Trademark Office, Registration #51,784

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.

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 

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. 

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.