Engineering Requirements for Mechanical Circulatory Support Devices

The application of thorough engineering principles has been key to the successful design, development, and manufacturing of mechanical circulatory support (MCS) devices for the last five decades. The engineering involved is multidisciplinary and includes mechanical, chemical, electrical, and materials engineering as well as sub-specialties such as computer, biomedical, reliability, and software engineering. Because MCS devices vary in their intended patient population, duration of use, and operation, no one set of engineering requirements can be specified for MCS devices. As a result, engineering requirements are determined and implemented for each MCS device using the methods of risk analysis and risk management.