Expertise in Medical Device Development and Injury Biomechanics, Product Liability, and Medical Device Cases
Trust Mari with your needs regarding product liability. She is an experienced expert witness.. She is an engineering consultant for medical device development, as well as an expert witness for injury biomechanics cases and product liability and medical device cases. With her vast knowledge and decades of experience, Mari is the preferred choice to meet your legal needs. Learn more about her consulting and expert witness services:
Design and Development of Orthopaedic Medical Devices
Mari is experienced in the product design and development of orthopaedic medical devices. She has designed and developed implants and instruments used for both human joint reconstruction and skeletal trauma reconstruction and repair. Mari 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. She 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.
Mari has a diverse design background that spans the complete product development cycle. She has been responsible for the safe design of medical devices from initial concept through hazard analysis, prototyping, testing, manufacturing, QA, and product release. She has engineered a wide variety of orthopaedic medical devices, such as trauma plates, screws, pins, wire, intramedullary nails, external fixation frames, spinal fusion devices, soft tissue anchors, tendon repair, and total joints (hip, knee, wrist, finger, toe, elbow, ankle, shoulder implants, and surgical instrumentation), and is thoroughly knowledgeable in safe design and safe manufacturing processes. She performed her work in compliance with ISO EN13485 and FDA guidelines as required in 21 CFR part 820.
Cases generally begin with a preliminary review of a patient's medical records and images to determine case facts and issues to potentially address. It is important that Mari conducts a review of the injured person's health history, daily physical activities and event medical records, including operative reports and imaging studies because as an expert, she needs a complete picture of the person to provide a complete analysis. This typically takes one to three hours to determine the health status of the person. Contact Mari for specific pricing.
- Was the product defective in a manner to cause a specific patient injury?
- Was the product robustly designed to allow safe installation by the surgeon?
- Were installation tools and instructions adequate and appropriately designed?
- Were the warnings, indications, and contraindications sufficient to assure proper installation and use?
- Was the product designed to withstand intra-operative installation forces?
- Was the medical device installed or used correctly (from a biomechanics viewpoint)?
- Was an adequate reviewing process employed prior to the product's release to the market?
- Was an adequate hazard analysis performed?
- Are issues of manufacturer's responsibility or quality control a factor in the device failure?
- What FDA or other government regulations are in place that pertains to the device failure?