Standards/Guidelines

This version of the NtK Model is to guide the creation and deployment of Industry Standards or Clinical Guidelines as a project output (a defined solution to a defined problem), which are intended for collaborative effort between the Project Leader and the appropriate national or international governing body. The problem and solution set are defined in the context of an underlying need as defined by the target group which is intended to benefit from features/functions of project output. These targeted consumers/customers must be involved from the beginning and throughout the process.

Definition: The written documentation of practices, methods, processes or criteria which are adopted as convention by a governing body, regulatory agency or professional practice group, through formal directives, voluntary compliance or generally accepted norms. Industry Standards codify the requirement and specifications for delivering consistent quality in materials, products and processes. Clinical Guidelines codify the characteristics and procedures for delivering consistent quality in treatments and services.

PHASE I — Discovery

Generating Conceptual Discoveries through Scientific and Market Research Methodologies

The Discovery Phase (Activity Stages and Decision Gates 1 through 3) necessarily begins with the conduct of primary and secondary market research activity to validate an unmet need of end users (e.g., persons with disabilities), and to define the need in the context of a problem amenable to a technology-based solution (Stage & Gate 1). The next task (Stage & Gate 2) is to assess the feasibility of deploying some envisioned product interventions as a solution to the defined problem. After the problem and solution are both defined and validated, the Scientific Research methodology may then be applied as necessary (Stage & Gate 3) to fill in any critical knowledge gaps with new-to-the-world findings. The Discovery Phase compiles knowledge from market, business, and technical analyses, scoping reviews of existing scholarly literature, along with or findings from original scientific research studies. The problem and solution set are defined in the context of an underlying need as defined by the target group which is intended to benefit from features/functions of project output. These targeted consumers/customers must be involved from the beginning and throughout the process.

Stages and Gates 1 through 3

Activity Stage 1

Define Problem and Solution: Define the problem from the perspective of the eventual target consumer. Then describe the solution in objective "new to world" terms, not subjective "new to me/us" terms. The problem/solution set may represent an improvement in the features/functions of current market offerings, or it may represent an entirely new category of feature/function enabled by some new technological capability.

*NOTE: Any "R&D" proposal that does not include evidence of a rigorous Stage 1 & Stage 2 should be rejected because it is driven by subjective opinions rather than objective facts. An individuals bright idea is likely subjective and insufficient justification for a new project.

Steps 1.1 through 1.5

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.

Activity Stage 2

Project Scoping: Conduct intensive screen to validate novelty, feasibility and utility of envisioned project to commercial partner and within the competitive marketplace.

Steps 2.1 through 2.3

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.

Activity Stage 3

Research: Conduct Secondary Archival Research to identify, acquire, translate, absorb, and apply existing science-based knowledge from qualified sources. Then, if and as necessary, conduct Primary Scientific Research to generate required new conceptual discoveries.

Steps 3.1 through 3.9

Decision Gate 3

Is the Project Team qualified to puruse the downstream requirements? If so, are they prepared to commit the time and effort necessary to complete the downstream requirements for the Invention Phase and Innovation Phase? If not the team lacks the required expertise, commitment or prior commitment, what lessons can be drawn from completed work and shared with others qualified to continue? Determine if the Discovery Phase reaffirmed the potential for the envisioned solution to address the validated problem. If so, either continue project into the Invention Phase (Stages 4 — 6), or identify appropriate partner to initiate those activities. If neither option is viable terminate project and implement Knowledge Translation Opportunity to effectively communicate the project's Conceptual Discovery to all relevant stakeholders.

Knowledge Translation Opportunity — for Conceptual Discovery Outputs

Whether or not project continues initiate knowledge translation activities to ensure the knowledge output created through this Phase is shared with all potential users, while taking care to protect Intellectual Property. This ensures that the time, money and effort expended — and project outputs generated to this point — have some chance of being put into practice by other stakeholders. The Knowledge to Action (KTA) diagram and table provide more detail for tailoring and targeting the project outputs to effectively communicate them to external knowledge users.

Steps KTA 3.A through KTA 3.G

PHASE II — Invention

The Invention Phase (Stages & Gates 4 — 5) involves transforming Conceptual Discoveries about validated Problems and feasible Solutions, into working prototypes of the envisioned Industry Standard or Clinical Guideline, by rigorously applying the appropriate engineering development methods to the iterative design, construction, testing and revision to address all specified requirements.

Stages and Gates 4 through 5

Activity Stage 4

Begin Development Effort: Build business case for commercial product & establish development plan based on established engineering methods.

Steps 4.1 through 4.13

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.

Activity Stage 5 — Build and Test Prototype

Implement Work Group Plan to specify, test and refine alpha draft Standard or Guideline.

Steps 5.1 through 5.4

Decision Gate 5

Should the project continue and go to beta prototype testing? Determine if the beta prototype will solve the problem and is feasible to deploy in the marketplace. Does it demonstrate sufficient value — efficacy/effectiveness/economies — according to the preliminary assessments in Phase I? If yes, continue to Stage 6. If no, terminate or reiterate Stage 5.

Knowledge Translation Opportunity

Communicating Prototype Invention Outputs

Whether or not project continues, pursue this second opportunity to initiate Knowledge Translation activities to preserve the potential for the knowledge outputs generated to have some chance of being put into practice by other stakeholders. The Knowledge to Action (KTA) diagram and table provide more detail reaching external knowledge user groups.

KTA Steps 5.A through 5.G

Phase III — Industrial Production

The Production Phase (Stage and Gate 6) requires a shift to the application of Industrial Production methodology.

Activities include planning for all aspects of production — from manufacturing processes through after-sales service-and the execution of activities related to test marketing, launch, and on-going monitoring of the product and market conditions. Project leaders and partners need to ensure participants have the appropriate skill sets and experience to implement all of these required activities. The Production Phase output is new knowledge in the state of a Commercial Innovation deployed in the marketplace.

Consider how these Standards/Guidelines may be adopted and used by other regulatory or professional agencies, beyond those targeted within this project.

Stage and Gate 6

Activity Stage 6 — Beta Testing

Publish and Disseminate Industry Standard or Clinical Guideline.

Steps 6.1 through 6.4

Knowledge Translation Opportunity — Communicating Availability of Published Innovation Outputs

The promotion of the published Standard/Guideline is the third opportunity to initiate Knowledge Translation activities to preserve the potential for the knowledge created in the state of the Final Draft Standard/Guideline to be shared with potential users. The linked Knowledge to Action (KTA) diagram and table provide more detail reaching external knowledge user groups.

The creation of success cases drawn from early adopters can be promulgated to encourage broader adoption and use. For Clinical Guidelines see: Graham, ID & MB Harrison, (2005) Evaluation and Adoption of Clinical Practice Guidelines, Evidence Based Nursing (http://ebn.bmj.com/content/8/3/68.full)

KTA Steps 6.A through 6.G

Decision Gate 6

Should the project continue and go to Production Planning? Post-Publication Review.

Governing agency has three options to continue existing Standard/Guideline, initiate Working Group process to revise it, or withdraw it completely. The decision to withdraw will likely progress through several levels of agency review, similar to the process for approving the original publication.

Under International Harmonized Stage Codes, the post-publication review process continues through the following options: Confirm International Standard as is (90.93); Decision to Revise (90.92), Decision to Withdraw (90.99). The ISO Withdrawal Stage 95 includes the initiation of the withdrawal ballot (95.20); close of voting (95.60); decision to withdraw (95.92) and official withdrawal of International Standard (95.99).

Standards/Guidelines