Steps 2.1 through 2.3

Key question to answer in Activity Stage 2: What is the breadth of potential applications for the intended project output outside the targeted field, and what must be known about them?

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Click on the toolbox images to view tools related to each step.

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supporting evidence

Step 2.1

Define intended project outcome of development effort in the context of either as a new/revised Industry Standard to ensure conformity, or as a new/revised Clinical Guideline to encourage compliance. In both cases, the Standard/Guideline is deemed necessary to address a technology-based advance in the state of the practice. Ensure standard/guideline is new by reviewing catalogues maintained by all relevant governing bodies. Important to search for relevant operational standards/guidelines within individual countries as not all are represented in such catalogues.  

Key questions: Is the intended scope of the Standard/Guideline local, regional, national, international, industry specific?  Are there legal or regulatory barriers at these various boundaries? Are there examples to leverage from other levels or sources?  Who are candidates for adoption or implementation?

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supporting evidence

Step 2.2

Gather input from governing body and key stakeholders to assess value (business, market and technical) regarding the envisioned Standard/Guideline. Conduct informal surveys of key stakeholder representatives — particularly the targeted intended beneficiary group. To the extent it is relevant to future deployment, consider intellectual property issues (copyright, patent), their utility and potential to facilitate or hinder overall objective.

toolbox
supporting evidence

Step 2.3

Conduct a preliminary SLOT analysis (strengths, limitations, opportunities, threats) in collaboration with key stakeholders, to identify potential barriers and facilitators to achieving delivered deliverable. All procedural aspects — from design of testing/demonstration to time and effort costs of submission/review/approval process — each harbor potential as barriers. For example, timeframes for governing body balloting while necessary are not predictable or controllable.

Key questions: Is the envisioned Standard/Guideline disruptive to current standard operating procedures or processes? Are there any advantages or costs for adoption/compliance by stakeholders? How can project be harmonized with related standards/guidlines and best practices both domestically and in other countries?

Decision Gate 2

Does the proposed solution and path to output/outcome seem feasible to implement and accomplish? The project leader must decide now if envisioned project output and path to eventual product outcomes are still considered innovative (i.e., novel, feasible, useful) in light of results from objective value valuability assessments and SLOT analysis. A decision to continue initiates Stage 3 Research which requires secondary research to identify all knowledge relevant to project, and as necessary primary research to generate new to the world knowledge not available through existing literature or expertise.