TGFR Consulting LLC Transforming Medical Device Development
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”
The FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices has triggered an increased interest in cybersecurity for medical devices . This guidance from the FDA details the key elements for protecting the medical device. These elements form a hierarchy as Asset – anything that has value to an individual or …
Test design needs to determine the right test level, minimize test overlap and ensure full coverage
Introduction Using agile software development for a medical device is quite possible, providing the process considers and adapts to some key constraints medical development imposes. These constraints include: Development needs defined set of Design Inputs. These input requirements represent an “engineering level of detail” for the system and are derived based upon the intended use, …