Steps 4.1 through 4.13
Key question to answer in Activity Stage 4: What prototype device/system must be designed, built and tested to demonstrate the utility of the draft Standard/Guideline in practice?
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Step 4.1
Establish working partnership with the governing body or regulatory agency for the Invention Phase. If no governing body exists, identify and approach the most relevant professional association to serve as the co-development partner. Ask the organization to answer the key question from Step 1.3:Why does envisioned solution to problem not yet exist?
The International (ISO) and National (ANSI, NGC) are the primary partners for Standards co-development in the field of Assistive Technology. The ISO published its accepted process: http://www.iso.org/iso/home/standards_development/resources-for-technical-work/support-for-developing-standards.htm.
The RESNA's Technical Standards Board is the partner within a professional society for the field of Assistive Technology: http://www.resna.org/assistive-technology-standards-board-atsb.
Step 4.2
Determine the combination of hardware and software that are necessary to create and test the envisioned Standard/Guideline. Then place the proposed engineering-based solution to the articulated problem within the structure of existing Industrial Standards or Practice Guidelines.
Projects should proactively address the mandate for International Harmonization of Standards across multiple agencies. The presence of existing standards may reveal opportunities to improve, refine or expand them. For a detailed explanation see: Deshpande, S & Nazemetz, JW (1999). Global Harmonization of Standards. http://www.okstate.edu/ind-engr/step/WEBFILES/Papers/Global_Harm_index.html
Step 4.3
Outline preliminary justification for project with structured path to delivering Standard/Guideline to relevant Governing/Regulatory bodies (from Step 1.4) and to Target Audience (from Step 1.5). The ISO's Preparatory Stage (20) convenes a group to initiate a Working Draft (WD) study.
Equivalent to ISO Preparatory Stage (20) http://www.iso.org/iso/home/standards_development/resources-for-technical-work/support-for-developing-standards.htm
Step 4.4
If necessary, implement Intellectual Property (IP) strategy in collaboration with the governing body which will own any copyright protection. Keep in mind the issue of International Harmonization of Standards.
The value of Standard harmonization is explained in: "Bhatia, J (2015) Harmonized International Standards & Conformance Facilitate Global Trade, Product Design and Development, 4/24/2014. https://www.ecnmag.com/blog/2014/04/harmonized-international-standards-conformance-facilitate-global-trade
Step 4.5
Assess regulatory, reimbursement and any related requirements for envisioned Standard/Guideline.
Generate understanding of design, validation, calibration or related requirements imposed by various governing Standards/Guidelines bodies/reimbursement agencies.
Step 4.6
Initiate key co-development practices with partners, if any are required to conduct downstream design, implementation, testing and verification.
Conduct repeatability and reproducability verification as necessary to ensure proposed test methods are accepted as valid and reliable. Answer question: Who will be using these Standards/Guidelines in practice?
Step 4.7
Assess project resource requirements (expertise, facilities, money and time) and availability of testing facilities and instrumentation.
Review project requirements in detail for staffing, funding, equipment and timeframes to design, conduct and analyze results from tests performed.
Step 4.8
Generate engineering implementation plan for tests conducted by Working Group.
Review requirements for any engineering analysis, design, fabrication/coding and testing. Consider generating a case-based simulation of how the Standard/Guideline would operate and influence products or practices to demonstrate utility to government body amd other stakeholders.
Step 4.9
Prepare proposal to secure necessary project funding from outside sources, if such additional funding is necessary. Identify potential fit within sponsor agency priorities by presenting summary to grant administrators.
Obtain required funding from extramural source (e.g., NIH/NSF; DOD/DOE; SBIR/STTR). Consider funding options from other Stakeholders such as interest groups or advocates.
Step 4.10
Once funding is secured, allocate adequate staff, facilities and finances to complete Working Group testing plan formulated in Step 4.8.
Budget adequate time, money and expertise, particularly from key experts and core staff to conduct tests of envisioned draft Standards/Guidelines.
Step 4.11
Gather, analyze and prioritize the targeted user's requirements for Standard/Guideline specified features and functions.
Conduct alpha focus groups to Industry standards.
Step 4.12
Identify Standard/Guideline specifications in light of final format and governing agency requirements.
PI and partners consider options for offering Standard/Guideline to target audience. Consider requirements for submission, review and approval by government body or regulatory agency where relevant.
Step 4.13
Update Work Group plan to complete Working Draft study and submit to governing body for comment and review (ISO 20.60).
Reconcile preliminary project justification with all other elements of the the project plan.
Decision Gate 4
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.