Process

Phase I is an immersion, planning and conceptual exploratory phase. Start excels at solving complex mechanical, electromechanical and energy based design problems. Thorough familiarization with the product, it’s procedural and user requirements and an understanding of the competitive landscape creates the groundwork for targeted concept generation. Start prides itself on its creative process. After a strong foundation of understanding has been built, a tireless concept development effort begins. The process doesn’t just solve design problems, but creates options for achieving an elegant result. The key outcome of phase I are detailed concepts that show mechanical and functional viability in 1:1 scale, have an optimal user experience “designed in” and give consideration to ultimate manufacturability and cost. Phase II takes down selected concepts from Phase I and designs, engineers, fabricates and performance tests proof of concept prototypes. Phase II prototypes attempt to prove out the most critical or challenging aspects of a particular design concept. These critical aspects could be mechanical, electrical, human factors or any combination. Often multiple concepts will be brought through the feasibility process in parallel to compress the schedule and afford design options. The result of Phase II feasibility prototyping is confidence. Confidence that moving forward with a concept into formal design development in Phase III is warranted, appropriate and a good use of resources. Phase II feasibility prototype output may include: mechanical or electro-mechanical prototypes, usability study models, preliminary risk analysis, engineering analysis, preliminary usability studies and performance test reports.
  • Project immersion
  • Review of product requirements
  • Review of product specifications
  • Review of competitive product
  • Benchmarking competitive products
  • Project planning
  • Concept strategy
  • Brainstorming
  • Viewing procedural videos
  • Attending procedures
  • Concept generation
  • Breadboard modeling
  • Preliminary industrial design development
  • Preliminary engineering analysis
  • Risk management plan
  • Preliminary hazards analysis
  • Concept rating matrix
  • Concept down selection for Phase II
  • Conceptual refinement
  • Engineering CAD development
  • Engineering analysis
  • Tolerance analysis
  • Phase II industrial design development
  • Human factors development
  • Prototype specifications and drawings
  • Material research/selection
  • Performance testing (bench, invitro and invivo)
  • Formative usability study
  • Updated risk management plan and hazards
  • Preliminary cost analysis
  • Performance test report
In Phase III a committed design direction has been chosen, its user interface is elegant, the engineering has shown good performance test results and the product is ready move into production design development for market commercialization. In Phase III design development will continue with an emphasis on part design and assembly for manufacturing. Human engineering and industrial design will be refined. Manufacturing specifications will be developed and Phase III full featured prototypes will be fabricated and tested. Product specifications will be finalized and verification test protocols and procedures will be developed. Risk analysis in the form of a design failure mode and effect analysis will be performed for the final design. A thorough technical design review will cover every aspect of the design to be released for manufacture. The output of Phase III may include the following:

 

  • Product specification
  • IO/VV table
  • Risk analysis/ dFMEA
  • Industrial design development
  • Production drawings and specifications
  • Bill of materials
  • Tolerance analysis
  • Assembly instructions
  • Pre-production prototypes
  • Pre-design verification testing
  • Usability testing/report
  • Design verification protocols and procedures
  • Sterilization validation
  • Biocompatibility testing
  • Packaging strategy and plan
  • Shelf life strategy and plan
  • Instructions for use
  • Validation study
  • DHF and DMR transfer
In Phase IV a full DMR (device master record) is transferred to pilot manufacturing. The DMR contains all of the drawings, specifications, CAD models, assembly instructions, sterilization requirements and any other details required to build the product as intended. Start will work with manufacturing through pilot production to support a thorough understanding of the product to be built. Start often supports assembly line set up, assembly fixtures and assembly equipment. Finished packaged product will come back to start for verification testing and final customer validation.

 

  • Transfer of DMR to manufacturing
  • Assembly line set up and equipment support
  • Assembly fixture design
  • Packaging, shelf life and accelerated aging support
  • Verification testing
  • Verification report
  • Validation support
  • Finalization of IO/VV table