Medical system design in a dynamic, regulated, multi-product, multi-life cycle environment

In many medical applications, system design encompasses the development of capital equipment along with a variety of single-use items necessary to deliver therapy and treat medical conditions. Typically, the capital equipment has a long anticipated service life and must be designed to accommodate a wide-range of single-use products, both legacy as well as future products which will bring new features to market. As the life cycle expectation for capital equipment grows, this can lead to a growing misalignment between capital equipment capabilities and future single-use products that will need to be supported. In this decoupled product life cycle environment, medical regulatory concerns must also be considered as it is time-consuming and challenging to make changes to capital equipment after it is installed. System needs and architectural trade-offs are described regarding decoupled product life cycle medical system design. This includes the need for capital equipment to provide a long service life, and also to anticipate the needs of future technologies and capabilities which may not yet have been envisioned.