medical device design

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.

11122021 DESIGN STAGES BANNER
Concept

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

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

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 verification & validation

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
Design to manufacture transfer

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?

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