Instrument Tool

This version of the NtK Model is to guide the creation and deployment of an Instrument/Tool project output (a defined solution to a defined problem), which are not intended for mass production in the commercial marketplace. 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: Hardware means any device comprised in whole or in part of tangible bio-electro-mechanical components. Instrument/Tool means an implement designed to perform a specific function in a valid and reliable manner. An Instrument is used for data collection, storage, analysis, management or monitoring, while a Tool is used to measure, manipulate or fabricate any type of material.

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

Communicating 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 — Development

The Development Phase (Stages & Gates 4 — 5) involves transforming Conceptual Discoveries about validated Problems and feasible Solutions, into working prototypes of the envisioned Instrument or Tool, 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

Implement Engineering Development Plan to build, test and refine prototypes to derive final design of Instrument/Tool.

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

For Prototype Invention Outputs

Whether or not project continues, pursue this second opportunity to initiate Knowledge Translation activities which preserves the potential for any project outputs generated to be put into practice by other stakeholders. The linked Knowledge to Action diagram and table provide more detail reaching external knowledge user groups.

If the decision is to discontinue development of a functional Instrument/Tool, consider shifting to the Freeware NtK Model's Innovation Phase whereby a set of instructions for building and testing the intended Instrument/Tool might be taken up by others.

Steps KTA 5.A through KTA 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.

Stage and Gate 6

Activity Stage 6

Assemble components and disseminate availability of Instrument or Tool.

Steps 6.1 through 6.6

Knowledge Translation Opportunity

Communicating Availability of Instument/Tool Innovation Output

The promotion of the completed Instrument/Tool is the third opportunity to initiate Knowledge Translation activities in the hope of generating stakeholder awareness, interest and use. The linked Knowledge to Action diagram and table provide more detail reaching external knowledge user groups.

Steps KTA 6.A through KTA 6.G

Decision Gate 6

Should the project continue and go to Production Planning? Continue Instrument/Tool Production or Kit Assembly?

Instrument Tool