Key question to answer in Activity Stage 4: What prototype device/system must be designed, built and tested to demonstrate the utility of the envisioned Instrument or Tool in practice?
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?
Conduct more detailed technical, business and market analyses based on the refined idea for the creation of the envisioned Instrument/Tool.
Layout proposed engineering-based solution to articulated problem through envisioned Instrument or Tool.
What combination of hardware and software are necessary to create and test an operational prototype of the envisioned Instrument/Tool?
Outline preliminary justification for project with structured path to delivering Instrument/Tool to relevant Stakeholders from Activity Step 1.5
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 Instrument/Tool.
Compile any design, validation, calibration or related requirements imposed by various regulatory/standards bodies/reimbursement agencies.
Initiate key co-development practices with partners, if any are required to complete design, construction and testing.
Identify and assess capabilities of any required external partners. Establish formal relationships with these external partners if transfer of ownership for production or deployment is planned.
Assess project resource requirements (expertise, facilities, money and time) and availability.
Review project requirements in detail for staffing, funding, equipment and timeframes. Identify potential distribution/promotion outlets for Instrument/Tool.
Generate engineering implementation plan.
Review requirements for engineering analysis, design, fabrication and testing.
Prepare proposal to secure necessary project funding from outside sources, if such additional funding is necessary. Identify potential fit within sponsor priorities.
Allocate adequate staff, facilities and finances to complete plan formulated in Step 4.8.
Gather, analyze and prioritize the targeted user's requirements for the Instrument/Tool's specified features or functions.
Identify Instrument/Tool specifications in light of construction options (pre-built or assembly kit assembly) and component costs.
Consider options for offering Instrument/Tool to external users. Generate preliminary Bill of Materials (BOM) for hardware, or registration fees for software, along with future effort to maintain, update and support, to assess full cost.
Update engineering development plan to complete project justification.
Reconcile preliminary project justification with all other elements of the the project plan.
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.