MEDTECH EXPERT WITNESS TESTIMONY: TESTIFYING MEDICAL TECHNOLOGY CONSULTANT

MedTech expert witness testimony advisors weigh in on legal cases involving medical technologies, including medical devices, diagnostic tools, and healthcare equipment. Leaders’ expertise is critical in assessing the safety, efficacy, and compliance of healthcare technologies, providing insights that can significantly influence the outcome of legal disputes. We consider what MedTech expert witnesses are brought in to address.

1. Medical Device Safety and Efficacy
   SMEs get called upon to evaluate the safety and efficacy of medical devices. Advisors assess whether devices meet regulatory standards and whether they function as intended. For top MedTech expert witnesses, that includes evaluating the design, manufacturing processes, and testing protocols to determine whether a device’s failure caused injury or harm. Testimony helps determine whether a device met the necessary safety standards and if any defects or design flaws contributed to patient harm.

2. Regulatory Compliance
   Also a big task for a famous MedTech expert witness is to evaluate a medical technology’s compliance with regulatory requirements. Reviewers assess whether the device, software, or healthcare solution complies with laws and guidelines from regulatory bodies like the FDA or CE. Consultants examine whether the product went through the required approval processes, including clinical trials, quality control, and post-market surveillance, to ensure that it met all necessary safety and regulatory standards.

3. Product Liability and Malfunction Analysis
   In cases involving product liability, MedTech expert witnesses evaluate whether a malfunction or defect in a medical device led to patient injury or death. Consulting leaders analyze the circumstances of the device’s failure, the manufacturer’s response, and whether the product was used in accordance with the manufacturer’s instructions. KOL expertise helps determine whether the manufacturer was negligent in producing or marketing the device.

4. Clinical Trials and Testing Protocols
   MedTech expert witnesses are also involved in assessing the clinical trials and testing procedures used to evaluate the effectiveness of medical devices or technologies. Testifying advisors review the design of clinical studies, the methodology employed, and whether the results were accurately reported. Experts help determine if the technology underwent rigorous testing before being approved for market use, and whether the clinical trials adhered to industry standards.