Our research and consultancy engagements take us to many different corners of industry. The design and engineering software that we focus on is the foundation of a host of products and processes, whether that is a design workshop, an industrial production line or a construction site. Common to these, and to many others, are fundamental methodologies such as life cycle management and systems engineering.
The evolution of Systems Engineering
Systems engineering as a discipline has evolved alongside the complexity of the systems being engineered. Originating – in a sense that we would recognise – at the beginning of the last century, the advent of the computer and more recently the development of embedded software to monitor and control devices has meant the need for formalised systems engineering has never been greater. When the industry involved is heavily regulated, as with the Medical Devices industry, there is a need for a holistic view across physical, mechanical, software and regulatory needs – through the entire lifecycle.
Applying a classic systems engineering approach provides a place for the information needed to take a concept from early stage models to completed tests.
Most importantly it guards against the creation of R&D silos that can too easily form when development teams are distributed.
We explored the application of systems engineering in the medical devices industry in a recent white paper sponsored by Dassault Systèmes. As well as managing interfaces between sub-systems and other technologies, the discipline of systems engineering delivers both product quality and patient safety by maintaining the links between requirements, verification tests and results.
Cost and time savings
Systems engineering saves cost and time by streamlining data communication and sharing across the extended, distributed team and across the many linked disciplines. Reducing time to market in this way is a huge driver for commercial success but in the medical devices field it also leads to improved patient outcomes – the goal of all stakeholders: device manufacturer, healthcare provider and regulator.
Medical device manufacturers are adopting the systems engineering approach to address increasing complexities, improve patient experience and deliver reliable products on time and to cost.
The white paper explores this subject in much more depth.