Medical Equipment Expert Witnesses: 16

David N. Tran, MD, is a Doctor of Medicine who specializes in Diagnostic and Interventional Radiology. Dr. Tran attended Stanford University for medical school and completed additional training at UCSF for Radiology and Interventional Radiology. He currently practices at St Johns Health Center in Los Angeles, CA. 

Dr. Tran's clinical expertise is in Image Guided Cancer Therapies, including liver directed Y90 radioembolization and tumor ablations.  He also performs a wide spectrum of endovascular surgeries for vascular disease, fibroid disease, and benign prostate hypertrophy.

Litigation Support: Dr. Tran offers expert witness services to attorneys representing plaintiff and defendant. He performs independent medical examinations, second opinons, and litigation support. He is available for depositions and trial testimony as needed.

Areas of Expertise:

Computed Tomography Magnetic Resonance Imaging Fluoroscopy X-ray Ultrasound Nuclear Medicine

Arterial / Venous Angioplasty and Stenting Arterial / Venous Thrombolysis and Thrombectomy Fibroid, Prostate, Y90, and Trauma Embolization Tumor Ablation IVC Filter Placement and Retrieval Venous Sclerosis and Ablation

Gastrostomy and Jejunostomy Placement Renal, Ureteral, and Biliary Drainages Dialysis Access Central Venous Access Vertebral Augmentation Biopsy

Mr. John F. Schulte, is an accomplished Orthotic and Prosthetic practitioner with 40 plus years of experience consulting and treating Body and External powered upper and lower extremity prosthetics for all age groups.

Mr. Schulte has vast knowledge and experience in clinical practice prosthetic and orthotic component development, design, and manufacturing. A Clinician, Patient Care Consultant, and Senior Manager of 27 offices throughout 5 states, he is considered an expert in his field. Mr. Schulte continues to be asked to consult on Clinical ‘Best Practices’ by physicians, third party payors, peers, and patient users on the most appropriate component utilization and outcome measurements.

A published author, consultant, and Clinical Board Examiner, Mr. Schulte has treated and been involved with the treatment of persons of all ages with congenital birth defects, limb weakness and loss, and spinal cord injury.

Litigation Support - John Schulte's intimate knowledge in prosthetic and orthotic clinical practice and management, component prescription recommendation, and selection and utilization for all patient ages and levels of function make him an excellent expert witness resource. His services are available to attorneys representing plaintiff and defendant and include medical record review, second opinions, written reports, depositions, and trial testimony.

Areas of Expertise:

• Appropriate Prosthetic / Orthotic Component Selection Recommendation
• Utilization and Failures Due to Improper Manufacturing Processes
• Prescription Appropriateness
• Clinical Applications and Negligence Directly Related to Limb Weakness and Loss
• Spinal Cord Injury and Treatment
• Wrongful Death Investigation and Determination
• Limb Damage and Loss in Diabetics as Related to Footwear
• LifeCare Plan Consultation and Preparation as Related to Orthotics and Prosthetics

Education:

• New York University Medical School Orthotics and Prosthetics Certificate Program, Certification as Certified Prosthetist, 1973
• Northwestern University Medical School Orthotics and Prosthetics Certificate Program, Certification as Certified Orthotist, 1973

Christopher M. Daft, PhD, is an award winning, Oxford Educated Materials Scientist whose areas of expertise include medical imaging, electronics, semiconductors, medical devices, sensors, MEMS, signal processing, and image processing. A serial inventor who holds 23 United States Patents with several pending, Dr. Daft has diverse industry experience including multi-nationals such as GE, Medtronic, Fujifilm, Samsung, and Siemens as well as several start-ups. He is a well-published winner of grants from the National Institute of Health. Dr. Daft has been an Institute of Electrical and Electronic Engineers (IEEE ) Senior Member since 2004. He has three years of experience teaching electrical and computer engineering at the University of Illinois. Dr. Daft holds a BA and MA in Physics from Oxford University as well as Doctorate from Oxford in Materials Science.

Litigation Support - Dr. Daft provides litigation support in the areas of Intellectual Property and Medical Devices including Imaging, particularly Medical, Patents, Minimally Invasive Surgical Guidance, and more. His experience includes a variety of cases in the areas of wearable electronics, imaging systems, and surgical technology. Dr. Daft has extensive deposition and trial testimony experience.

Areas of Expertise:

Design Engineering Electrical Engineering Electromagnetic Engineering Microelectronics Medical Imaging Electronics Semiconductors

Medical Devices Sensors Software Engineering MEMS Signal Processing Image Processing Physics

View Dr. Christopher Daft's Consulting Profile.

Richard A. Lazar is the nation’s leading Automated External Defibrillator (AED) Program Compliance Expert. He and his company, Readiness Systems, design and document complete AED programs, remotely monitor AEDs, provide AED law and public policy resources and publish industry standards

An AED program consists of a design and supporting set of policies and practices that ready an organization for Sudden Cardiac Arrest (SCA) emergencies, suggest what actions should be taken if SCA is encountered and help manage the legal risks that come with owning AEDs. Industry standards and AED laws guide what to include in an AED program’s policies and practices.

Background Experience: For over 25 years, Mr. Lazar has designed and documented AED programs for AED programs nationwide. Examples include Microsoft, the Federal Aviation Administration, 24 Hour Fitness among many others. Earlier in his career, he practiced emergency medical services law, designed emergency medical services (EMS) systems, served as an EMS system administrator, and was an emergency medical technician. He also holds a law degree from Lewis & Clark School of Law and a Bachelor of Science degree in Public Affairs from the University of Oregon.

Mr. Lazar develops and publishes national AED Program Design Guidelines that describe industry standards for AED programs and the AED Law Center, the only comprehensive online information resource that helps AED owners learn about the AED laws for every state, understand the AED laws in plain English, and stay informed about pending AED legislation nationwide.

Litigation Support: As the leader in his industry, Mr. Lazar has provided both consulting and testifying expert services to lawyers in a variety of cases around the U.S. involving sudden cardiac arrest response in workplace and community (non-medical) settings. His deep understanding of AED programs has led him to testify before the U.S. Congress in support of the Cardiac Arrest Survival Act, the FDA on AED over-the-counter and reclassification issues, and numerous state legislatures on AED public policy issues and immunity laws.

View Readiness Systems' Consulting Profile.

Georgia J. Persky RN, MBA, PhD, CLNC, CNOR is a Columbia University trained nurse researcher with over 40 years of broad Clinical Nursing experience and 25 years of senior leadership in Hospitals, Nursing Homes and Home Health organizations. She also has 20 years of Surgical Nursing and Operating Room experience. Dr. Persky has expertise in the micro issues in nursing for adult patient care and the broad management, quality, and regulatory issues in hospitals. 

Background Experience - Dr. Persky served as Vice-President of Nursing and Patient Care Services for the past 25 years and most recently at New York Presbyterian Hospital/Columbia University Medical Center. For nine years, she was responsible for Patient Care Services, Risk and Quality Management and Patient Satisfaction for a 750-bed academic hospital. She directed a $200 million budget with 33 patient care units and Care Management, Respiratory Therapy, Social Work and Admitting Departments with 9 direct reports and 2,000 patient care employees.

Litigation Support - As a Certified Legal Nurse Consultant and Quality Reviewer, Dr. Persky has investigated hundreds of Malpractice and Injury cases as a quality reviewer and can assist in legal case review with chronologies, timelines, and evidence-based reports. She has testifying experience in malpractice and personal injury cases, as well as, with human resource and employee discrimination with an ability to attest to standards of care in clinical litigation. Dr. Persky's services are available to attorneys for the plaintiff and defense seeking an expert in nursing and patient care with a strong understanding of how heath care organizations work.

Areas of Expertise:

Nursing/Hospital Standards of Care Nursing Home and Skilled Nursing Surgical and Perioperative Nursing Quality and Risk Management Fall and Pressure Ulcer Prevention

Hospital Policy and Procedure Medication Safety Medical Device Safety Hospital Administration State, Federal, Joint Commission Regulatory Compliance

View Dr. Persky's Consulting Profile.

Medical Devices, Biotech, Failure Analysis, Mechanical Eng, Materials, Reliability, Expert Witness

T. Kim Parnell, PhD, PE is a Professional Mechanical Engineering consultant and is Principal & Founder of Parnell Engineering & Consulting (PEC). Dr. Parnell holds PhD and MSME degrees in Mechanical Engineering from Stanford University, a BES from Georgia Tech, and is a registered Professional Mechanical Engineer (PE) in the State of California.  He is an ASME Fellow, an IEEE Senior Member, and a Member of ASM and SAE.  Dr. Parnell is Past-Chair of the IEEE Santa Clara Valley Section (IEEE-SCV) (over 12,000 members) and Past-Chair/Board Member of the IEEE Consultants' Network of Silicon Valley (IEEE-CNSV). Dr.Parnell is an experienced Expert Witness, has provided testimony in both trial and deposition, and has authored numerous expert reports and IPR declarations.  He has worked extensively as an expert in medical devices, patents, product failure, product liability, and personal injury. Dr. Parnell has been retained in medical device litigation cases that are in the news and adjudicated in MDLs.  Products include IVC Filters (Inferior Vena Cava Filters), Pelvic Mesh, Transvaginal Mesh, Intragastric Abdominal Balloon Weight Loss Systems, Back Pain Reduction Systems, and others. Dr.Parnell brings both breadth and depth of experience to clients.  He has over 34 years of professional consulting experience, has taught both graduate and undergraduate University classes (Visiting Professor at Stanford University & Adjunct Professor at Santa Clara University), and has also worked in industry.  His industrial positions include sectors such as software, hardware, medical devices, and telecommunications equipment. He has extensive experience in areas including patents, medical devices, Nitinol shape memory alloy material, mechanical failure of products or equipment, and material failure by fracture or fatigue. Dr.Parnell frequently works with early-stage companies as both a technical consultant and a business advisor in sectors including medical devices and flash memory technology.

Areas of Expertise:

Patents and Intellectual Property Medical Devices; Medical Instrumentation Shape Memory Alloys; Nitinol Composite Materials Finite Element Analysis (FEA) & Simulation Cell Phones, Personal Electronic Devices Laptop Computers, Keyboards, Keypads Gas Leaks, Pipe Failure, Vapor Cloud Explosions

Solar Trackers; Solar Energy; Wind Energy;  Battery Technology; Electric Vehicles Shape Memory Materials; Nitinol Heavy Truck Crashworthiness Consumer Products Product Design Refinement Piping, Pressure Vessels Failure Analysis; Reliability

Selected Professional Memberships:

• Registered Professional Engineer (Mechanical), California
• ASME (American Society of Mechanical Engineers), Fellow
• SAE (Society of Automotive Engineers), Member
• IEEE (Institute of Electrical & Electronics Engineers), Senior Member
• ASM International, Member
• SMST (Shape Memory and Superelastic Technologies), Member

View Dr. Parnell's Consulting Profile.

Mari S. Truman, PE, has more than 37 years of experience in Orthopedic Product Design and Development. As Principal Engineer with her company, Orthobiomech, LLC, she acts as an R&D design and development consultant to the orthopaedic industry and an injury biomechanics and medical device forensic expert.

Ms. Truman's design experience includes implants and instrumentation systems used to repair fractured bones, torn ligaments and/or to reconstruct spine, knee, wrist, hip, ankle, elbow, thumb based cmc, and other finger and toe joints for many of the USA based orthopaedic conglomerates and a few Asian, Australian and European firms.

Having designed and developed implants and instruments used for both human joint reconstruction and skeletal trauma repair, Ms. Truman is named on 12 Orthopaedic Patents and frequently gives talks on implant design and injury biomechanics on topics such as: knee and thumb-based joint surfaces and kinematics, joint design, rapid prototyping, medical device design control, and injury biomechanics.

Litigation Support - Ms. Truman has been providing Forensic Impact and Injury Biomechanics and Orthopedic Biomechanics to the legal industry for over 15 years. She draws on her strong knowledge of FDA and ISO EN13485 compliant design control processes, failure modes and effects analysis, clinically relevant tissue loading, and design safety assurance, including device performance requirements and warnings, during her medical device litigation reviews. Ms. Truman has a strong knowledge of the production and quality assurance processes used in the manufacture, cleaning, and sterilization of medical devices and the effects of such processes on product performance.

Analysis of Traumatic Injuries Related To:

Falls and Fall Recovery Vehicular Collisions Assaults and Fights Projectile Impacts Occupation or Workplace

Failed Medical Implants Assistive Devices Orthotics Consumer Products Sports and Recreation, Occupational Overuse / Injury

View OrthoBioMech LLC's Consulting Profile.

John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies.

Mr. Stevens has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices. 

Litigation Support - An FDA expert and seasoned business professional, Mr. Stevens is uniquely qualified to opine on cases involving the FDA's regulation of medical devices. He has served as an expert witness for over 30 court cases involving the FDA regulation of medical device firms. His services include thorough reporting, depositions, and trial testimony. 

Areas of Expertise:

• Submissions (510(k), IDE, PMA, De Novo)
• Medical Device Quality Systems
• FDA Inspections

View Mr. Stevens' Consulting Profile.

Lloyd Marks, MD, MBA, FACC, is an MIT trained Electrical Engineer, Johns Hopkins trained Pediatric Cardiologist, and Inventor. Always active in both medicine and medical engineering, Dr. Marks has been granted 22 Medical Device Patents. He currently gives advice to academic institutions, investors, and corporations regarding the commercialization of medical technology.

Background Experience - Dr. Marks was in academic medicine for 15 years, as the Director of the Cardiac Cath Lab at St. Christopher's Hospital for Children and the Division Chief of Pediatric Cardiology at the Children's Hospital of New Jersey. He was then in private practice for 18 years. In 1997 he opened his clinical practice, specializing in Pediatric and Adult Congenital Heart Disease, where he provided clinical evaluation, electrocardiography, echocardiography, stress testing, Holter/event monitoring, diagnostic cardiac catheterization, and interventional cardiac catheterization.

After closing his clinical practice in 2015, Dr. Marks went to business school and obtained an MBA from the Haslam School of Business, University of Tennessee. While there, he wrote a business plan with financial projections for his startup company, MGI Medical, LLC, commercializing a non-invasive patient monitor for the detection of post-operative bleeding. Dr. Marks has successfully licensed 9 of his inventions to industry and assigned 8 to MGI.

Litigation Support - With his unique background in the field of medical device commercialization, Dr. Marks has been involved in protracted Patent Infringement litigation with a successful outcome. He is adept at explaining to a jury in lay terms complex medical technology and terminology, ranging from MRI readings to the difference between "clinical" and "statistical" significance. Dr. Marks' cases include all matters pertaining to:

• Pediatric Cardiology Medical Malpractice
• Medical Devices Standard of Care
• Intellectual Property Protection
• Invention Commercialization

Areas of Expertise:

Medical Devices / Medical Monitors Cardiology / Pediatric Cardiology  Medical Record Review Medical Technology IP, Patents, Licensing, Royalties

Medical Device Inventions Medical Device Due Diligence Medical Technology Business Plans Medical Technology Financial Projections

View Dr. Lloyd Marks' Consulting Profile.

mdi Consultants, Inc - Experts in FDA regulatory affairs, quality assurance and ISO 9000 certification. With 6 years in the FDA and 26 years consulting to the industry, mdi Consultants, Inc. has been an invited Speaker worldwide on FDA regulations and policies and has obtained FDA expert status as third party auditors.

OUR APPROACH

We utilize the following three part approach to providing high quality services to our clients:

Unsurpassed consultant experience – we identify and recruit only top quality consultants with deep industry knowledge to provide the most complete and insightful advice to our clients

Up-to-date systems and processes – we have highly defined systems (e.g. manuals, training programs, technical files) and processes (e.g. audit methodologies, 510(k) submission, validations) that are constantly refined and kept current across the ever changing regulatory environment

Involvement in regulation development – we stay ahead of policies by participating in the development of regulation (e.g. HACCP, Scientific Advisor to U.S. Congressmen)

Vipul Kella, MD, MBA FACEP is a board-certified Emergency Medicine Physician who has been practicing for 15 years. Dr. Kella is a Fellow, of the American College of Emergency Physician, and is licensed in Advanced Cardiac Life Support (ACLS) and Advanced Trauma Life Support (ATLS).

Prior to his current position as a Physician and Partner in a multispecialty national acute care services company, Dr. Kella was Chief of a regional health system managing 100,000 patient visits in Frederick, Maryland. His responsibilities included developing quality initiatives, improving operations and efficiencies, patient experience, staffing, and recruiting.

Dr. Kella has delivered seminars and given presentations on healthcare administration, fraud and abuse, critical care, myocardial infarction, trauma, aortic dissection, sepsis and shock, and medical ethics

Litigation Support: Dr. Kella has served as a medical expert for 10 years. He has reviewed over 100 cases, and spent over 1,000 hours on case reviews and preparing reports.  He is dedicated to providing expertise to clients in a variety of areas, including medical malpractice, personal injury, forensics, disability, and others. 

Over the past ten years, Dr. Kella has been retained in the following areas: 

Emergency Medicine Critical Care Medical Negligence Forensics and Sexual Abuse Standard of Care

Nursing Home Liability Wrongful Death Independent Medical Examination Medical Device Liability Medical Fraud and Abuse

Areas of Expertise:

Critical Care Medicine                                                                      Emergency Medical Services Health Care Economics HIPAA Hospital & Medical Ethics Hospital Administration Medical Devices Medical Fraud

Medical Records Nursing Homes Wrongful Death Myocardial Infarction Trauma Aortic Dissection Sepsis Shock

View Dr. Vipul Kella's Consulting Profile.

Mary B. Gloeckner, RN, MS, APN, is a Medical-Surgical Clinical Nurse Specialist who specializes in Wound Care and Ostomy Nursing. She has been a nursing consultant at Trinity Medical Center in Rock Island, Illinois, a 500 Bed hospital, for over 36 years. Ms. Gloeckner started the Wound & Ostomy Clinic (WOC) program at Trinity when she began there in 1983. She served on 2 National Boards, the WOC Certification Board, and the Friends of Ostomates Worldwide. Ms. Gloeckner was also elected to sit on the International Board(ISTAP) on Skin Tears, which she still currently serves on. She was honored with receiving the 2011 Iowa Affiliate Wound, Ostomy and Continence Nurses Society's (WOCN) Nurse of the Year Award and the 2016 USA WOC Nurse of the Year Award. Ms. Gloeckner provides litigation support service to attorneys for Plaintiff and Defense. Her cases include issues related to Wound Care and Colon and Rectal Surgery. Ms. Gloeckner is available to review medical records for standard of care and causation. Areas of Expertise and Consultation:

Wound Care Decubitus Ulcers Colostomy Ileostomy Urostomy

Pressure Ulcers Venous ulcers Vascular ulcers Fistulas Diabetes

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.

Peter A. Crosby has over 35 years experience in the Medical Devices Industry. He has been the 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. In 2017, he retired as CEO from Mainstay Medical, after spending over 8 years as the founding CEO, doing several rounds of financing, taking the company public in Europe, and bringing Mainstay’s ReActiv8 to market in Europe. Although he continues to work with the company on a consulting basis, he has shifted his focus to helping other companies grow, as a board member, advisor, and in interim management.

With a university education in Biomedical Engineering, Mr. Crosby is the inventor on over 30 US patents and applications pending. He has managed the intellectual property portfolio of several companies. His clinical domain experience includes ophthalmology, otolaryngology, cardiology, cardiac surgery, orthopedics, pain management, anesthesia, and intensive care.

Litigation Support - Mr. Crosby has served as an expert witness in many cases including product liability, intellectual property (patent disputes), and commercial contracts disputes. He has testified in three cases in which the outcome hinged on interpretation of “commercially reasonable efforts.” Mr. Crosby's services are available to attorneys representing plaintiff and defendant.

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.

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.