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
