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, clinical/biomedical engineers with specific expertise in subject matters serve as forensic engineering experts. Subject matter areas that are important include expertise in regulatory compliance (such as FDA regulations), medical device testing and servicing, use of accessories, specific clinical environments and systems, human factors engineering, product design and manufacturing, clinical workflow, 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 two hundred successfully completed investigations, BEC is uniquely qualified to investigate, collect and review information about product or medical technology-related processes that failed or did not function as intended. In cases ranging from intellectual property disputes to product manufacturing defects, maintenance compliance, and to failure to warn – BEC expertise provided clear and evidence-supported opinions that are critical for successful case resolution.
When the need arises, special testing tools, such as scanning electron microscopy, simulation laboratory testing, specific safety analyzers and other equipment used in medical device testing labs are deployed in order to develop a failure mode theory that is supported by test results. Once a mode of failure is understood, BEC expertise contributes to mitigation of the repetition of such a failure and to the improvement of public safety.
This is unique environment where the risk management state is, at times, the resulting combination of medical product, use processes, user and maintainer compliance with instructions, and condition of the facility. This is an integrated system consisting of various degrees of contributing factors. Only clinical/biomedical engineering expertise, like that offered by Biomedical Engineering Consultants, LLC (BEC) and its associates, can methodologically and objectively explain the outcome. The methodology has been developed by Dr. David at the largest medical center in the country and successfully deployed ever since.
BEC offers its forensic engineering, clinical engineering and biochemical engineering consulting services to clients from Houston, Pasadena, Pearland, League City and Cypress, Texas.