Concept Elaboration
Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs.
Transforming Medical Device Development
Concept Creation – Collecting user needs and translating the needs into the right product
Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs.
Early concept confirmation allows the team to present the concept to customers for evaluation
Evaluating specific concepts leverages the CTQs and VOB to determine the best overall concept. Evaluation uses an iterative approach, with several teams, and a scoring process using a Pugh Matrix. For each iteration, the Pugh Matrix scores the alternative concepts. Scoring against the weighted set of criteria (CTQs and the VOB) established during previous steps …
User Needs can be transformed into Performance Parameters and through the QFD Process CTQs are identified. These CTQs will drive concept selection
Translating the Voice of the Customer (VOC) and Voice of the Business (VOB) into needs statements is critical to building the right product
Concept Development using QFDs and Super Concepts The process of concept development requires two integrated activities The identification of CTQs using the QFD. CTQs consist of those performance parameters that drive customer satisfaction. The QFD activity identifies the CTQs The evaluation and selection of concepts using the Super Concept process. Success iterations create and evaluate …
Feature Development and Performance Parameters Feature Deployment maps the VOC statements to a set of device features to be used as part of the QFD process. An effective mapping effort creates a minimum set of performance parameters, sufficient to allow the QFD to be effective. Developing the minimum set of performance parameters drives more …
Creating the Requirements – VOB (Voice of the Business) VOB (voice of the business) represents the commercial and other business considerations for the medical device. VOB development must be kept distinct from the activities associated with user needs in order to prevent the corruption of the true user needs. In developing these distinct needs, every …
Building VOC (Voice of the Customer) VOC (voice of the customer) is an expression of the effect that a customer would like to have on his life/environment for him to best perform his desired tasks. The process of developing VOC includes Gathering, understanding, targeting, and verifying the needs of non-business ‘actors’ directly affiliated with the …