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Turning your medical device innovation into reality
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.
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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
- Define critical to function and critical to quality features of the design
- Packaging identification and design
- Identification of materials and suppliers
- Perform product hazard analysis and early risk analysis
Design & Development is where we help you refine your product design to meet your customer and design inputs.
- Assist with DFMEA mitigation or completion
- 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.
NextPhase Medical Devices offers a comprehensive set of product design verification services in its product development life cycle including:
- Design Verification
- Functional and Performance Verification
- Environmental Testing
- Biocompatibility Verification
- Sterility Verification
- Electrical Safety and Electromagnetic Compliance per IEC 60601
- Packaging Transit Verification per ASTM or ISTA standards
- Software Validation
Design Validation activities mostly focus on Human Factors support that includes:
- User needs analysis & creation
- Formative & summative studies
- Use flow & task maps
- User research
- Interface design
- Usability testing
- Prototyping and simulations
- Usability studies
- Pre-clinical study engineering and product support
- Clinical study engineering and product support
We utilize the following key elements in conducting a proper design to manufacturing transfer:
- Process and equipment validation
- PFMEA development
- Documentation release
- Commercial launch
Want to learn more about the importance of having a design project in place?