Medical Devices Expert Witnesses: 25

Joanna Aiken is a Board-Certified Anesthesiologist practicing in the operating rooms and intensive care units at NYU Langone Health, ranked the #1 hospital in New York, and #3 nationally by the US World & News Report. Dr. Aiken functions clinically, and also serves as a Clinical Assistant Professor to the medical students, residents, and fellows affiliated with the New York University Grossman School of Medicine.

Dr. Aiken has participated and presented in both national, and international conferences on issues that include some of her interests: bioethics, surgical and critical care, and quality improvement.

Litigation Support - Dr. Aiken works to cultivate excellence through the art of clinical practice, physician education, and as an expert medical witness. Her services include medical record review, thorough reporting, depositions, and trial testimony as needed.

Areas of Expertise:

Anesthesiology Bioethics Ventricular Assist Devices Extracorporeal Membrane Oxygenation (ECMO) Patient Consent Guardianship Critical Care Critical Illness Pressors Inotropes

Intensive Care Unit Transfusion of Blood Product Perioperative Medicine Post-Operative Medicine Perioperative Medicine Post Anesthesia Recovery Operating Rooms Quality Assurance Patient Safety Medical Optimization

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:

Intravenous (IV) Systems & Disposables Hernia Repair Endometrial Ablation Laparoscopic Instruments Injection Ports Catheters Heart Valve Repair / Replacement Subcutaneous Ports

Bed Rails Cervical Screws Syringes, pen injectors, auto-injectors IV / Insulin Pumps Glucose Monitors Peritoneal Dialysis Pumps Abdominal Aortic Aneurysm (AAA) Repair Sleep Apnea Devices (CPAP)

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:

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.

Alexander R. Marmureanu, MD, is a prominent Thoracic and Cardiovascular Surgeon, with a special expertise in the field of minimally invasive surgery where he developed and pioneered several techniques and procedures. He maintains a busy and active cardiothoracic surgery practice performing over 400 surgical cases per year with outstanding results.

Litigation Support - Dr. Marmureanu provides expert witness case review for issues involving Cardiothoracic Medical Malpractice. His services are available to counsel representing both Plaintiff and Defense.

Education and Background Experience - Dr. Marmureanu completed his General Surgery Residency and a research fellowship at New York University Medical Center in New York City. He continued his surgical training at Mount Sinai Medical Center, also in New York City, where he was actively involved in the field of thoracic and cardiovascular surgery research. His cardiothoracic surgery fellowship was completed at UCLA, where he continued to practice as UCLA faculty/Clinical Instructor, and then joined Cedars Sinai Medical staff.

Achievements - Dr. Marmureanu is nationally and internationally recognized in the field of thoracic and cardiovascular surgery and has authored numerous research papers and clinical publications. He has built several very successful cardiothoracic surgery programs, and appeared as guest speaker on numerous TV and radio shows discussing the benefits of cutting edge surgical techniques as well as the advantages of minimally invasive surgery for the thoracic and cardiovascular patients. He is a member of multiple organizations Boards and committees, both nationally and internationally.

View Dr. Marmureanu's Consulting Profile.

Dr. David Schaafsma, PhD has over 25 years of experience in Optical Systems, Microscopy, Fluorescence & Spectroscopy, Optical Materials, Lasers, Optoelectronics, Sensors, and Data Acquisition. Dr. Schaafsma specializes in multi-disciplinary projects primarily for the medical device field, involving optics, electronics, software, and sensors. He has worked in diverse areas such as semiconductor manufacturing, telecommunications, and biotechnology. Dr. Schaafsma has been offering expert witness services for over 10 years. He has been retained as an expert in several areas of expertise, from angioplasty catheters to retinography cameras to optical microscopes of various stripes. Dr. Schaafsma is available for consulting, testing, analysis, inspection, reports (opinion), deposition, and trial testimony. 

Selected Areas of Expertise:

Medical Product Design / Development Optics – Geometric, Diffractive, Waveguide, Optical Technology, Optical Materials Networks, Data Links, Protocols Fiber Optics Lasers & Light Systems Embedded Computer Systems, Microcontrollers Infrared Materials, Technology, Products

Imaging & Microscopy (SEM & Optical), Spectroscopy Software & Programming, Embedded & High Level Languages Electronics, Embedded Design Sensors, Data Acquisition Semiconductor Metrology, Photovoltaics, Renewables Project Planning / Management ISO 9000, SPC Tooling / Process Development

View Dr. Schaafsma's Consulting Profile.

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:

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.

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:

Automation Dynamics and Control Systems Kinematics Machine Vision Manufacturing Mechatronics Photogrammetry Robotics

Segways Sensors Tire Mechanics Traction Control Wheel Slip Vibrations Warnings See Full List

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.

Clinical Experience Medical Surgical Nursing Shock / Trauma Intervention Procedural Services Preoperative, Intraoperative, and Postoperative Care Procedural Sedation Clinical Educator

Operational / Leadership Experience 2003 Iraqi War Veteran Multi-site Surgical Venues - UC Davis Medical Center, Kaiser Permanente Level 1 Trauma Academic Medical Center – UC Davis Medical Center Military – Naval Hospital Camp Pendleton, Operation Iraqi Freedom Fee for Service Ambulatory Surgery Services – ABSMC Surgery Center Clinic Management – Perioperative Medicine Clinic, Kaiser Permanente

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:

Surgical Standard of Care Medical / Surgical Units Operating Room Injuries Sterile Processing Adverse Quality / Safety Events Pre & Postoperative Complications Pain Procedures / Procedural Sedation Positioning Injuries Wrong Site Surgeries

National Nursing Standards Regulatory Guidelines Nursing Administration Medical Devices Patient Falls Medication Errors Failure to Rescue Team Communication Emergency Preparedness

Dr. Homayoon Kazerooni is a professor of Mechanical Engineering at the University of California, Berkeley, where he also serves as the director of the Berkeley Robotics and Human Engineering Laboratory. With more than 30 years of mechanical engineering experience and a doctorate degree from MIT, the results of this work on upper extremity augmentation led to Intelligent Assist Devices (IAD) that are currently marketed worldwide.

Litigation Support - Dr. Kazerooni has been deposed and testified in various Intellectual Property cases. His services include thorough examination and reporting, depositions, and trial testimony as needed.

Areas of Expertise:

Robotics Mechatronics Control Sciences Bioengineering

Exoskeletons Medical Devices Human Machine Systems Intelligent Assist Devices

Homayoon Kazerooni, Director, Berkeley Robotics and Human Engineering Lab addressing the EmTech Asia 2016 crowd on New Developments on Lower Extremity Exoskeleton Systems

Dr. Kazerooni is a professor, entrepreneur, and expert witness The Berkeley Robotics and Human Engineering Laboratory’s mission is to develop fundamental scientific and engineering principles on robotics, control sciences, exoskeletons, and bioengineering.  Dr. Kazerooni founded Ekso Bionics which became a public company in 2014. He's also the founder and current CEO of U. S. Bionics (DBA suitX) which brings advanced exoskeleton technologies to various markets.

Most of the developed technologies in this lab at Berkeley have found their ways to market.  Prior to his research work on lower extremity exoskeletons, Dr. Kazerooni led his team to successfully develop robotics systems that enhance human upper extremity strength.  The results of this work led to a new class of intelligent assist devices currently being used by workers worldwide for manipulating heavy objects in distribution centers and factories.  

Dr. Kazerooni holds a Doctorate in Mechanical Engineering from MIT and has published more than 200 articles, delivered over 130 plenary lectures in the U.S. and internationally, and holds over 200 pertinent patents and awards. He  has won numerous awards including Discover Magazine’s Innovation Award, the McKnight-Land Grant Professorship, and has been a recipient of the outstanding ASME Investigator Award. His research was recognized as the most innovative technology of the year in New York Times Magazine. 

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:

Regenerative Medicine Blood / Tissue Banking Cellular and Tissue Based Therapeutics Stem Cell Bioengineering Extracellular Matrix HSCs / MSCs Processing Cryopreservation

Longevity Cellular and Tissue Engineering Biotechnology Medical Devices Perinatal Tissues Transplantation Quality Control Regulatory and Potency Assays

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:

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 )

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.

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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)