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

Ivory Tower.

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

Evil Lab.

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

jungle.