Systems Engineering For Complex Portable Medical Device Development

As the demand for complex, portable medical devices continues to grow, reducing risk and increasing efficiency during the development of these products should be paramount. Taking a systems-engineering (SE) approach to development provides a holistic, organized, and deliberate method for identifying as well as reducing both patient and business risks early in the process. Furthermore, it facilitates efficient progression throughout the entire product development life cycle.

Systems Engineering Explained
The latest auto-injectors, pen injectors, inhalers, and insulin pumps on the market reflect the relentless industry-wide drive toward smarter, smaller, more-portable medical devices. To ensure reliability and repeatability, however, such complex devices demand a greater number of requirements, as well as more testing and validation during their development than do the larger, simpler devices of previous decades. In turn, they also carry with them greater technical and schedule risk.