TGFR Consulting LLC
Transforming Medical Device Development
These represent earlier additions of the blog
After task analysis has identified the failure modes, the next step is the mapping of hazards to these failure modes, identifying the sequence of events, and identifying the hazardous situation(s). The following figure illustrates the overall flow.
Medical Device Task Analysis will form the basis of future risk and workflow development
Elaborating the concept integrates the results of the concept definition into a complete system definition, the design inputs.
Task and preliminary hazard analysis identify the risk controls that a concept must implement to provide adequate product safety. Inputs Key Activities Outputs Clinical UseThe clinical use of the device Clinical Use Error DataData on the use errors and rates associated with the data. Clinical Hazards and HarmsThe clinical hazards and harms associated with the therapy. …
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
Building the right product involves the translation of user and business needs into a product concept
This is the intro to the 2nd Edition of the book “The Cascade, Building a Medical Device”