Build business case for commercial product & establish development plan based on established engineering methods.
Identify and approach key Co-Development partners as needed under signed Non-Disclosure Agreements. Have them verify answer to key question from Step 1.3: Why does envisioned solution to problem not yet exist?
Layout proposed engineering-based solution to problem.
Outline preliminary business case that is based on path to market outlined in Step 1.5.
Consider what combination of hardware and software is necessary to create envisioned product.
Implement intellectual property (IP) strategy in collaboration with patent attorney, technology transfer office, or relevant agents.
Assess regulatory, reimbursement and any related requirements for envisioned product.
Generate understanding of design, pricing and timing implications from requirements imposed by regulatory/standards bodies/reimbursement agencies.
Initiate key co-development practices with partners.
Establish formal relationships with these external partners.
Assess project resource requirements and availability.
Review project requirements in detail for staffing, funding, equipment and time frames.
Generate engineering implementation plan.
Review requirements for engineering analysis, design, fabrication and testing.
Prepare proposal to secure necessary project resources. Identify potential fit within sponsor priorities.
Allocate adequate staff, facilities and finances to complete plan formulated in Step 4.8.
Gather, analyze and prioritize target customer requirements.
Identify product features and specifications in light of production capabilities and component costs.
Consider feasibility of future scale up (mass production/delivery) of product, and estimate costs versus planned financing and target price points.
Generate preliminary bill of materials and estimated peripheral costs.
Assess required lead times for project components.
Complete business case using data gathered in prior steps and stages.
Reconcile preliminary business case with current understanding of constraints and requirements.
Should the development plan be implemented? Determine if all elements of the business case have been fully vetted and validated. If yes, continue on to Stage 5. If no, either terminate project or reiterate Stage 4.