The emphasis on safety is the only constant in medical device development. Design requirements, hardware architectures, development processes, and safety regulations all remain in a state of flux. To stay competitive, manufacturers must deliver safe devices on time and on budget, using a mix of legacy and next-generation tools and processes.
As more and more functionality is delivered via software, developers are struggling to integrate piecemeal legacy tools and development processes with new tools and technologies without jeopardizing safety certifications. For example, in many designs, some elements of the software have to remain fixed, providing verified safety-critical functions, while other parts can add new features, functions, and innovations while keeping the hardware fixed to maintain safety compliance. Today's embedded software technologies are fully capable of addressing these issues and cutting the cost and complexity of safe medical devices.