Design Process

STAGE 1: Business Case

  • Initial enquiry received, idea briefly outlined
  • Nondisclosure Agreement signed by both parties
  • Further details of idea proposed
  • Liability of idea assessed
  • GATE 1: Business Case Review  >  BUSINESS CASE APPROVED

STAGE 2: Concept Development

  • Literature & market analyses
  • Intellectual property & regulatory analyses
  • Development of concept based on client’s requirements
  • Budget & business case reviewed
  • GATE 2: Research Review  >  CONCEPT APPROVED

STAGE 3: Inputs & Plan

  • Design Input Requirements established
  • Initial risk assessment
  • Manufacturing input obtained
  • Design Input Requirements approved
  • GATE 3: Plan Review  >  INPUTS & PLAN APPROVED

STAGE 4: Design & Development

  • Design initiated to meet Design Input Requirements
  • Initial investigation & testing
  • Intellectual Property Protection obtained
  • Design of packaging/labels/Instructions for Use
  • Final prototypes made
  • Gate 4: Design Review  >  DESIGN APPROVED; DESIGN FREEZE

STAGE 5: Output, Verification & Validation

  • Full testing; outputs of design recorded
  • Design verification
  • Clinical review
  • Design validation
  • GATE 5: Output Review  >  OUTPUTS, V & V APPROVED

STAGE 6: Design Transfer

  • Supplier approval
  • Process Failure Mode Effects Analysis (PFMEA)
  • Manufacturing process established
  • Process validation
  • GATE 6: Transfer Review  >  PRODUCTION PROCESS APPROVED

STAGE 7: Regulatory

  • Technical File prepared
  • Declaration of Conformity raised
  • Review by appropriate regulatory authority
  • Design approved for sale by regulatory authority
  • GATE 7: Product Release  >  REGULATORY APPROVAL; RELEASED FOR SALE