Project Scope

Out of Scope:

Stent & Delivery System

In Scope:

Valve

The scope of the project is limited by the resources of the design team. The most novel component of the device is the low pressure bi-directional passive valve. Stents are well understood and other available stents can be purchased for use in this device. Delivery systems are complicated and not overly novel. This combination of factors was used to define the scope as only the valve of the device.

The project scope was defined by first identifying the high-level breakdown of the device requirements & key components. The figure shown displays early ideas for each component while highlighting the final scope and direction of the project.