Several months ago I posted about product development project phases. I’ve managed several medical device product development projects. While the products and challenges have been unique to each, the basic steps and deliverables are very similar. With this post, I’d like to offer a high-level solution to defining project phases:
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It’s my belief that all phases should be address for all medical device projects.Â
- Phase 1: Build the Business Case – Due diligence to define user needs, intended use, market position, and intellectual property.
- Phase 2: Planning – Define product development project activities, tasks, milestones, and resource needs.
- Phase 3: Design & Development – Establish product design and manufacturing processes.
- Phase 4: Verification & Validation – Demonstrate the device is safe, effective, and meets user needs.
- Phase 5: Market Release – Regulatory clearance, transfer to manufacturing, and product launch.
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