Overview
From bandages to pacemakers, medical devices have a single, primary purpose: to improve quality of life. Medical devices companies must be responsible for the safety and effectiveness of their products throughout the entire product development cycle. In the United States, the FDA recommends five stages for the device development process. These stages ensure the safety and efficacy of medical devices in the whole product development cycle, creating a need for rigorous pre-market trials and post-market surveillance activities to monitor the performance of medical devices. Many of these steps may overlap with each other as scientists invent, refine and test the devices.
Let’s explore the stage goals and the statistical techniques typically conducted within each stage through examples of different medical devices. You can use Minitab Statistical Software’s range of analytical and machine learning tools to understand each step of the product life cycle. If you don’t yet have Minitab Statistical Software, try it for free.
Stage 1: Device Discovery/Concept
Stage 2: Preclinical Research – Design and Prototype
Stage 3: Pathway to Approval - Testing and Validation
Stage 4: FDA Review and Deployment
Stage 5: Post- Market Safety – Monitoring, Maintenance, and Support
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