Integrating manufacturing considerations into design

Features which must be addressed at design level:

  • Ease of assembly
  • Ease of test
  • Modularity
  • Parts count
  • Manufacturing processes
  • Supplier considerations

Manufacturing personnel need to be present at design reviews early in development program. To the extent practical, design output needs to be appropriate for both design and manufacturing needs. Examples include:

  • By adding vendor test requirements to a component specification, document can be used for both design and mfg.
  • Most low level electronic and mechanical design drawings/specifications can be converted to documents appropriate for manufacturing DMR
  • Many elements of design verification protocols can be converted to manufacturing tests


Product vs. process considerations

  • Prior to product release, manufacturing process needs validation
  • Typical processes are assembly and test
  • Some elements of design verification can be used for process validation, but typically there are differences:
    • Design verification is targeted to a design specification
    • Process validation targets the repeatability and controls within the process
  • Design verification is used to release designs (drawings)
  • Process validation is used to release processes (assemblies, tests)


A checklist for manufacturing readiness includes:

  • Design control elements closed
  • Field/clinical testing closed
  • Regulatory approvals in place
  • Logistics for purchasing, product availability
  • Manufacturing process validated and released
  • Labels, manuals, other product materials released





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