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
Assaults and Fights
Occupation or Workplace
Failed Medical Implants
Sports and Recreation, Occupational Overuse / Injury
Ernest P. Chiodo, M.D., J.D., M.P.H., M.S., C.I.H. is a physician, attorney, Certified Industrial Hygienist (C.I.H), and biomedical engineer. Dr. Chiodo is board certified in the specialties of Internal Medicine, Occupational and Environmental Medicine, and Public Health and General Preventive Medicine. Dr. Chiodo served as the Medical Director of the City of Detroit and was the chief physician in charge of measures designed to protect the public health of over one million persons. He has also been the lead expert witness in a number of high profile cases including serving as the lead expert witness in a mass toxic tort case for Gerry Spence.
Low speed motor vehicle collisions are a common occurrence. The use of cellular phones, text messaging, and e-mailing while driving has only increased the frequency of low speed motor vehicle collisions. A motor vehicle collision where there is only minor damage to the vehicles may result in personal injury claims for substantial sums.
In toxic tort litigation, a person is often claiming to have developed cancer or some other serious disease due to having been exposed to a particular substance. Determining if the exposure to the substance was the cause of the disease is often a central focus of the litigation.
It is a common error that an attorney retains the wrong type of expert to testify in a lawsuit. This error is particularly common when the expert is a medical specialist. It is widely believed that a medical doctor who specializes in a particular organ system is qualified to formulate opinions and testify as to all issues concerning that organ system.
Dr. Yadin B. David has over 35 years experience in Managing Medical Technologies from Pre-Purchasing Evaluation phase, to Installation, Training, Servicing and Incidents Investigation. His expertise includes wide variety of medical devices and accessories including infusion pump, laser, electrosurgery unit, monitors, X-ray, defibrillators, implants, monitors, warmers, surgical instruments and catheters. Dr. David is also an expert in Electromagnetic interferences (EMI) medical devices and in Telemedicine and TeleHealth systems. His experience includes review and analysis of patent infringements allegation and validity. Dr. David serves a Consultant for industry and institutions including the Food and Drug Administration (FDA), General Hospital and Personal Use Devices Panels, World health Organization (WHO)and medical devices manufacturers. His services include testing, adverse events investigation, engineering reports, equipment management program review and risk assessment. Dr. David has given many national and international presentations about medical technology management, telemedicine and medical devices regulations.He authored manuscripts, chapters and books.
In a remote village in Central America, an otherwise unmanaged child's infection can take a turn for worse if not for the long distance diagnosis capacity brought about by the recently installed telemedicine system between Zacapa, Guatemala, and Houston, Texas, where subspecialists in the field of Pediatric Dermatology viewed the wound and prescribed the critically needed treatment.
The dependence in medicine on technology to deliver services is continuously growing. The number of microprocessor-based diagnostic, therapeutic, and patient monitoring devices used in the clinical environment is ever-increasing.
Clinical Engineering focuses on managing the deployment of medical technology and integrating it appropriately with desired clinical practices. It provides a description of the wide range of responsibilities clinical engineers encounter, describes technology management and assessment in detail, and reviews the standards and regulatory agencies of interest.
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.
Imagine this scenario: Early stage company Smallco develops an exciting new technology, which it uses to create the prototype of its first product - Brakethroo! A large company in the same field, Bigco, becomes aware of Brakethroo, and realizes that if the product works as hoped, it could be a valuable addition to Bigco's product range. Bigco offers to buy the technology and product from the shareholders of Smallco. The merger and acquisition (M&A) agreement specifies an up-front payment, and one or more payments dependent on achievement of milestones. Bigco agrees to use "commercially reasonable efforts" to achieve the milestones. Smallco and Bigco sign the agreement, the shareholders of Smallco get an immediate payout and look forward to further milestone payments.