Need to Knowledge Model for Commercial Devices

The NtK Model includes three Phases — Discovery via Research, Invention via Development, and Innovation via Production. Each Phase contains discrete Activity Stages and Decision Gates. The NtK also includes opportunities to conduct knowledge translation to improve communication and information sharing between parties in academic, industry and government sectors.

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

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.

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.

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 — Development

The Development Phase (Stages and Gates 4 through 6) first involves establishing a business plan for the envisioned product defined under Phase I — Research.

In Phase II — The engineering development methodology is then applied to transform the Phase I output (knowledge in the state of a conceptual discovery) into new knowledge in the state of a tangible prototype invention. This transformation occurs through design, building and testing procedures involving end users and approved by other relevant stakeholders.

Stages and Gates 4 through 6

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.

Stage 5

Build and Test Prototype: Implement engineering development plan.

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.

Stage 6

Beta Testing: Generate final form of invention through iterative testing and validation.

Steps 6.1 through 6.4

Decision Gate 6

Should the project continue and go to Production Planning? Determine if the beta prototype invention demonstrates sufficient value (customer and market value), according to the preliminary assessments, SLOT analysis and business case. If yes, continue to Innovation Phase (Stages 7 — 9). If not, terminate project and apply KT principles to effectively communicate Prototype Invention output to all relevant stakeholders.

Knowledge Translation Opportunity

For Prototype Invention 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 (i.e. potential product consumers; or intermediary stakeholders such as a Tech Transfer Office or manufacturer). This assumes that proper safeguards are in place for any proprietary information (Step 4.4). The KT activity ensures that the public funding expended and the project outputs generated 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.

Steps KTA 6.A through KTA 6.G

PHASE III — Industrial Production

The Production Phase (Stages and Gates 7 through 9) 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.

Stages & Gates 7 through 9

Stage 7

Production Planning & Preparation: Determine final manufacturing processes pricing and marketing strategies, and test launch activities.

Steps 7.1 through 7.13

Decision Gate 7

Go to Product Launch? Proceed to Commercial Product deployment if the financial projections and logistical plans support continuation, and the Stage 2 Scoping remains valid. The decision to continue involves higher resource and longer time commitments — and higher risk — than all prior Stages.

Knowledge Translation Opportunity

For Commercial Innovation 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. This ensures that the outputs generated have some chance of being put into practice by other stakeholders. There are two paths at this point:

Path 1: If the decision is to launch the device innovation into the marketplace, the KTA and innovation phase now converge. In fact, Stages 8 and 9 closely mirror the Action Cycle of the KTA process, as shown in KTA for launched innovation output and described in KTA Table for Launched Innovation Outputs.

Path 2: If the decision is to not launch the device innovation into the marketplace, then the innovation phase ends at Stage 7, and the KTA process (KTA 3) diverges, as shown in KTA for an un-launched innovation output.

Steps KTA 7.A through KTA 7.G

Stage 8

Launch Product Innovation: Sell product in the marketplace and respond to consumer inquiries and problems.

Steps 8.1 through 8.4

Decision Gate 8

Should production continue, based on the post-production assessment? Review product performance in market to decide whether to sustain resource commitment in context of other business opportunities. If yes, proceed with Stage 9.

Stage 9

Post-Launch Review: Continue to monitor sales and service inquiries to determine if and when modifications or discontinuance are appropriate.

Steps 9.1 through 9.3

Decision Gate 9

Should production continue? Review performance data and market/competition factors to inform future decisions. If yes, production/delivery continues until a pre-determined milestone to revisit Decision Gate 9. If no, decide if product requires revision, replacement or abandonment, which would determine if process should return to the Discovery Phase, Invention Phase or Production Phase.

Notes

At each gate the PI must check to ensure that the goal is still novel, feasible, and useful, that the PI's role will make a meaningful contribution and that there is a link between the PI's role and the ultimate goal. If not, the PI must terminate or reiterate.
Throughout every stage the PI or partner will either be allocating existing internal funds, or seeking external financing (grants, venture capital, etc). An inability to obtain financing either by failing to meet internal criteria required for the allocation of funds, or by failing to obtain external financing will terminate the project.
Although not depicted as such, this is an iterative process. A no-go decision at any gate may result in termination of the process or reiteration of many or all previous steps and tasks.