Steps 1.1 through 1.5
Key question to answer in Activity Stage 1: What governing body or stakeholder group controls the review, approval and advancement of this project's output? Do not assume that expertise in a field of practice translates into articulation of a problem/solution.
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Click on the toolbox images to view tools related to each step.
Step 1.1
Identify a problem faced by persons with disabilities that could potentially be addressed by a technology-based device. Collect all available information about an unmet need for standardization in some industry process or some guidance in clinician practice, by identifying and gathering input from the intended primary end user group (e.g., Persons with Disability/Family/Professional), along with all relevant information sources and potential secondary user groups (Researchers; Clinicians; Policy/Funders; Brokers; Manufacturers). This targeted unmet need should be articulated as a problem requiring a solution in the form of a new or an improved Industry Standard or Clinical Guideline.
Expert stakeholders help identify objective, measurable criteria as the basis for standard/guideline. They help set parameters such as known cut-off limits to be assigned as pass/fail. They also help identify unknown limits expressed as disclosure criteria pending necessary exploration and definition to identify their limits.
For Standards see:
NIST publication Standards Development in the United States
Also see ANSI publication: United States Standard Strategy
For Clinical Guidelines see:
Field MJ, Lohr KN (Eds). Guidelines for clinical practice: from development to use. Institute of Medicine, Washington, D.C: National Academy Press, 1992. and see Clinical Practice Guidelines.
Step 1.2
Identify the target professional group, governing body and/or regulatory agency relevant to the context of both Problem and Solution. These entities are important for both the problem validation and solution verification, and in most instances they are the final arbiters of the decision to adopt the project's output. Their cooperation and approval is viewed by sponsors as an important objective justification for continuing any Standard/Guideline project beyond the exploratory Research Phase, so it is critical to learn their evaluation criteria and evidence requirements early in the process. Key question: Was the idea for this Standard/Guideline truly derived from customer needs (or was it perhaps considered to be a natural evolution of research and development?)
At this early point the identification and communication with such government/regulatory bodies is treated as preliminary and provisional. Further refinement of project objective, performance parameters, and related R&D are necessary prior to presenting a fully formed draft for review by such bodies.
Key Standards governing bodies:
International Organization for Standardization (ISO)
American National Standards Institute (ANSI)
Key Guidelines governing bodies:
Step 1.3
Prepare a preliminary rough draft of a plausible solution (creation, revision, expansion) to the identified problem in an existing Standard or Guideline. Address two Key Questions: 1) How is the proposed solution superior to existing solutions — if they exist? 2) Why does the envisioned solution to the validated problem not yet exist?
This Step is equivalent to the ISO's Proposal Stage (10), where the investigator submits a proposal explaining the standard's value to society (e.g., education/certification, hazard/cost reduction, interoperability), for consideration by the governing body which determines if it is needed. Similarly RESNA has a standards development proposal that can be requested via email from: technicalstandards@resna.org.
See: Patel, S & J Henderson (2002). The role of Market-based and Committee-Based Standards. Harvard Business Review.
Step 1.4
Determine the contribution of this project with respect to the proposed deliverable(s). Will the project end with:
1) A Conceptual Discovery about the problem/solution suitable for publication/presentation (via NtK Discovery Phase)?
2) A Functional Prototype demonstrating proof of concept as an invention (via NtK Invention Phase);
3) A Commercial Product deployed in the marketplace via NtK Innovation Phase)?
Lead investigator may need to prepare a preliminary draft of the envisioned standard/guideline for presentation to external experts identified as potential collaborators. These experts may need to react to a clearly articulated scope of work, and shared objective, before they can commit to participation.
Step 1.5
Outline the path from planned project output (Conceptual Discovery; Prototype Invention; or Product Innovation) to the target market and beneficiary stakeholders. Address another set of key questions:
- How will target users find and assess the Product?
- What partners will be needed to complete downstream Stages/Gates?
Decision Gate 1
Does the proposed problem/solution set appear to be novel in state of practice; generally feasible to implement; will envisioned output be useful to target audience; and is there a clear path from project output to the beneficiary stakeholders?
The project leader has three options:
- Proceed directly to Stage 2;
- Reiterate Stage 1 if any of the critical elements are not fully validated; or
- Terminate the project due to inability to clearly articulate critical elements including: Problem, Solution, Target Audience, Project Path, or Intended Output.