Elaborating the Concept

Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs.

Elaborating the Concept SIPOC

Inputs	Key Activities	Outputs
Clinical Use Clear understanding of the overall therapy, workflow and risks associated with the seminal idea Risk Analysis and Essential Requirements The phase, function and mitigations developed as part of the risk analysis step. CTQs The key requirements identified as part of the concept selection process VOB – Business Requirements The Needs of the business Standards Regulatory as well as business standards consistent with the markets for the product Manufacturing Capability Characterization of capacity, measurement systems and process capability	Use Case Development A structured analysis of the clinical application to develop system modes of operations and interactions with other elements Architecture Elaboration Breaking the system down to into subsystems Requirements Elaboration Translation of the Performance Parameters, CTQs and concept into the system definition (use cases, requirements, architecture and interfaces) Final Concept Confirmation The final confirmation of the concept with the users	System Definition (Design Inputs) • System and Subsystem Requirements • Use Cases, Risk Control • Preliminary Architecture and Interfaces

The overall work flow is as shown in the following

Over the next several weeks we will discuss each of the activities, starting with the use case development