Medical Device Expert Witness

Medical device expert witnesses evaluate device design, manufacturing processes, FDA regulatory compliance, clinical performance, and failure modes for implants, surgical instruments, diagnostic equipment, and wearable devices. They analyze complaint databases, adverse event reports, bench testing data, and clinical records to determine whether device failures resulted from design defects, manufacturing deviations, labeling inadequacies, or user error.

Cases commonly requiring medical device expertise include orthopedic implant failure and metallosis, cardiac device malfunction including pacemakers and defibrillators, surgical robot complications, infusion pump dosing errors, and hip and knee replacement recall litigation. These matters often involve mass tort coordination and require an expert who can address both the engineering failure analysis and the clinical impact on patients.

Subspecialty areas including orthopedic implant engineering, cardiac device technology, surgical robotics, in vitro diagnostics, and FDA regulatory affairs each involve different testing standards, premarket submission pathways, and post-market surveillance requirements. An expert with medical device industry experience in design, quality, or regulatory functions provides the technical depth that clinician-only testimony cannot replicate.