Phase 1 - Concept & Feasibility
It begins with market research to identify unmet needs and potential solutions. The feasibility of the concept is assessed, considering technical, regulatory, and financial aspects. Initial concepts are developed to explore potential designs.
Phase 2 - Design & Development phase
Detailed CAD models and engineering drawings are created. Prototyping allows for early testing and iteration, while design for manufacturing ensures the product can be efficiently produced at scale.
Phase 3 - Verification & Validation
Rigorous testing ensures the product meets all specifications and regulatory requirements. Design verification involves bench tests and simulations, while validation confirms the product’s performance in real-world conditions. Regulatory submissions are prepared to seek necessary approvals.
Phase 4 - Manufacturing Transfer
It involves developing and validating manufacturing processes. This includes setting up production lines, securing supply chains, and conducting pilot production to ensure quality control.
Phase 5 - Commercialization phase
The product is launched into the market with a strategic approach to marketing, sales, and distribution. Post-market surveillance monitors product performance, gathers feedback, and manages any updates or recalls.
Phase 6 - Sustaining Engineering
It provides ongoing support, addressing product issues and implementing improvements. Compliance with evolving regulatory standards is maintained, and plans are made for the product's eventual phase-out.