Each of the design stages plays a crucial role in manufacturing a finished device. At NextPhase, we have the design engineering experience to develop your next-generation medical device. We can help you with cost, quality and performance improvements for current devices.
NextPhase can lead concept development or collaborate with your design team to provide a sounding board for design performance, manufacturing costs and processes.
- Participate in concept ideation
- Assist with parallel design paths and selection
- Prototype generation for proof of concept feedback and testing
Feasibility is a critical stage for our joint teams to develop value with design and manufacturing insights.
- Design for manufacturability and assembly, quality, cost, service (DFx)
- Human factors and use analysis
- Finalizing product requirements
- Assist with DFMEA mitigation or completion
- Define critical to function and critical to quality features of the design
- Packaging identification and design
- Identification of materials and suppliers
Design & Development is where we help you refine your product design to meet your customer and design inputs.
- Development and identification of manufacturing processes and equipment
- Engineering builds for early verification testing
- Test protocols and fixture development
- Create drawing packages and Bills of Materials
- Component and supplier qualifications
Design V&V is the stage where we help our customers make sure the product meets the intended use for the application.
- Design verification and validation builds for testing
- Human factors testing
- Master validation planning
We utilize the following key elements in conducting a proper design to manufacturing transfer:
- Process and equipment validation
- PFMEA development
- Documentation release
- Commercial launch