Need to Knowledge Model for Commercial Devices

This variant of the Need to Knowledge (NtK) model is a guide to innovation for technology-based commercial devices. Click on the links below to explore the stages, gates and steps involved in generating commercial devices.

PHASE I — Research

The Research Phase (Stages and Gates 1 through 3) involves conducting primary and secondary market research to identify end users’ unmet needs and assess the feasibility of envisioned solutions to those needs. 

The scientific research methodology may then be used where necessary to generate new-to-the-world findings that address unmet needs and/or lend themselves to the proposed solutions. The Research Phase output is new knowledge in the state of Conceptual Discoveries, represented as the results from market, business, and technical analyses, scoping reviews of existing scholarly literature, or findings from original scientific research studies.

Stages and Gates 1 through 3

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.

The project leader has three options: 1) Proceed directly to Stage 2; 2) Reiterate Stage 1 if any of the critical elements are not fully validated; or 3) Terminate the project due to inability to clearly articulate critical elements including: Problem, Solution, Target Audience, Project Path, or Intended Output. Key Questions include: Does the proposed problem/solution set appear to be novel in state of practice; generally feasible to implement; will envisioned output will be useful to target audience; and is there a clear path from project output to the beneficiary stakeholders? 

Conduct intensive screens to ensure novelty, feasibility and utility of the concept. Use the resulting information to create a business case to share with potential commercial partners.

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 valuability assessments and SWOT analysis. Once a decision to continue is made, the project leader must then consider if the project can be conducted within the current state of scientific knowledge, or if this specific project requires the generation of new to the world knowledge. If new to the world knowledge is needed, the project leader should pursue funding to design and conduct scientific research to generate this new knowledge. If all the necessary knowledge already exists, it should be acquired, translated and absorbed for project purposes to complete Stage 3. A key question is: Does the proposed solution and path to output/outcome seem feasible to implement and accomplish? 

Conduct scientific research to generate required new conceptual discoveries. Or acquire, translate, absorb, and apply existing science-based knowledge from qualified sources.

The project leader must 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, either revisit Stage 2 to check for changes in business, market, or technical feasibility and consider reiterating Research Phase; or terminate project and apply knowledge translation principles to effectively communicate Conceptual Discovery to all relevant stakeholders. The key question asks: Begin Invention Phase or conclude project with Knowledge to Action process? (See below)

Knowledge Translation Opportunity — for Conceptual Discovery Outputs: Whether or not project continues, pursue this opportunity to initiate knowledge translation activities to ensure the knowledge created in the state of a Conceptual Discovery is shared with all potential users, while taking care to protect enabling elements of that knowledge that might constitute 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 KTA Diagram for Conceptual Discovery Outputs will provide more detail for tailoring and targeting the project outputs to effectively communicate them to external stakeholders.

For more detail on ways to reach each knowledge user group, see KTA Table for Discovery Outputs. This table lists six stakeholder groups who may be knowledge users, and answers the questions “What to share with each knowledge user group”, and “How to reach each knowledge user group”, while also describing  the anticipated knowledge translation outcomes from engaging with each group.

PHASE II — Development

The Development Phase (Stages and Gates 4 through 6) first involves establishing a business plan based on the new conceptual knowledge generated in Phase I — Research. 

The engineering development methodology is then applied to reduce the Phase I conceptual knowledge to practical form through design, building and testing procedures. The output of the Development Phase is new knowledge in the state of a Prototype Invention that has been tested by end users and approved by other relevant stakeholders.

Stages and Gates 4 through 6

Build business case for commercial product, identify product specifications, and establish engineering development plan.

Project leader and external partners consider 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. Key Question is: Should the development plan be implemented?

Implement engineering development plan.

Project leader and external partners determine if the beta prototype will solve the problem and do so in a form that is feasible to deploy in the marketplace. If yes, continue to Stage 6. If no, terminate or reiterate Stage 5. Key Question asks: Should the project continue and go to beta prototype testing?

Generate invention through iterative testing and validation.

Project leader and partners 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. The Key Question asks: Should the project continue and go to Production Planning?

Knowledge Translation Opportunity — for Prototype Invention Outputs: Whether or not project continues, pursue this second opportunity to initiate Knowledge Translation activities to ensure the knowledge created in the state of a tangible Prototype Invention is shared with all potential users (i.e. potential product consumers; or intermediary stakeholders such as a Tech Transfer Officer 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 KTA Diagram for Prototype Invention Outputs will provide more detail reaching external knowledge user groups.

For more detail on ways to reach each knowledge user group, see KTA Table for Invention Outputs. This table lists six stakeholder groups who may be knowledge users, and answers the questions “What to share with each knowledge user group”, and “How to reach each knowledge user group”, while also describing  the anticipated knowledge translation outcomes from engaging with each group.

PHASE III — Production

The Production Phase (Stages and Gates 7 through 9) calls for the application of business best practices through the 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. The Production Phase output is new knowledge in the state of a Commercial Innovation deployed in the marketplace.

Stages and Gates 7 through 9

Conduct test marketing, finalize manufacturing process, establish sales and distribution channels, implement marketing plans, and prepare for 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. The key question is Go to Product Launch?

Knowledge Translation Opportunity — for Unlaunched Innovation Outputs: If the decision is to not launch the innovation into the marketplace, then the innovation phase ends at Stage 7. Pursue this final opportunity to initiate Knowledge Translation activities to ensure the knowledge created in the state of a commercial innovation is shared with all potential users. This ensures that the resources expended and outputs generated have some chance of being put into practice by other stakeholders. The KTA Diagram for Unlaunched Innovation Outputs will provide more detail for tailoring and targeting the project outputs to effectively communicate them to external stakeholders.

Sell product in the marketplace and respond to consumer inquiries and problems. The Innovation Outputs Table lists six stakeholder groups who may be knowledge users, and answers the questions “What to share with each knowledge user group”, and “How to reach each knowledge user group”, while also describing the anticipated knowledge translation outcomes from engaging with each group.

Project leader or partners review product performance in market to decide whether to sustain resource commitment in context of other business opportunities. If yes, proceed with Stage 9. The key question is: Should production continue, based on the post-production assessment?

Continue to monitor sales and service inquiries to determine if and when modifications or discontinuance are appropriate.

Project Leader or partners 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. The key question is: Should production continue?

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.