Forensic engineers use the principles of engineering and physics to examine evidence in support of understanding the cause of an adverse event. In healthcare, when technology is involved, biomedical engineers with specific expertise in subject matters serve as forensic biomedical engineer. Subject matter areas that are important include such as regulatory compliance, medical device servicing, use of accessories, clinical environment conditions, human factors engineering, product design and manufacturing, and man-machine interface. Biomedical Engineering Consultants, LLC (BEC) brings the required expertise together on a case-by-case basis so that the derived conclusion is based on factual science.
With over one hundred successfully completed investigations, BEC, is uniquely qualified to investigate, collect and review information about products or medical technology-related process that failed or did not function as intended. In cases ranging from intellectual property disputes to product material manufacturing defect and to failure to warn – BEC expertise provided clear and evidence supported opinions that were critical for successful cases resolution.
When the need arise, special testing tools, such as scanning electron microscopy, simulation laboratory and specific safety analyzers are deployed in order to develop failure mode theory that is supported by test results. Once a mode of failure understood, BEC expertise contributes to the mitigation of the repetition of such a failure and to the improvement of the public safety.
This is unique environment were risk management is, at times, the resulting combination of medical product, use processes, user and maintainer compliance with instructions, and the condition of the facility. This is an integrated system consisting of various degree of contributing factors. Only biomedical engineering expertise, like that that is offered by Biomedical Engineering Consultants, LLC (BEC) and its associates, can methodologically and objectively explain the outcome.