Potential scientific application to defined problems is articulated.

The hypothesis is generated. Research plan or protocols are developed, peer-reviewed and approved.

Initial proof of concept for device or therapeutic candidates is demonstrated in a limited number of laboratory models and these may include animal studies.

Proof of concept and safety of candidate devices, systems or therapeutics demonstrated in a defined laboratory or animal models.

Review by the regulatory body to determine that the clinical investigation may begin. Preliminary findings should suggest the device or therapeutic will be substantially equivalent to a predicate device or therapeutic.

Data from the initial clinical investigation demonstrate that the device or therapeutic meets safety requirements and supports proceeding to clinical safety and effectiveness trials. For drug development, pharmacokinetic and pharmacodynamics data must meet clinical safety requirements.

The information and data demonstrate substantial equivalence to a predicate device or therapeutic and safe use in an operational environment.

Medical devices:

Investigation of final Class III prototype in clinical trials.

Drug development:

Food and Drug Administration (FDA), European Medicines Agency (EMA) or equivalent body review and an approval letter is issued.

Medical devices:

Production and distribution, with additional post-marketing studies and surveillance as required.

Drug development

The pharmaceutical drug can now be distributed and marketed.

Post-marketing safety surveillance studies (non-clinical or clinical, phase 4) may be required.

An idea or concept for a mobile application, online platform, or software product or service, which has commercial potential has been formulated.

Market research is undertaken to prove the feasibility of the idea and ensure that it addresses a need in the market.

Experimental proof of concept or a rudimentary minimum viable product (MVP).

The basic concepts on the MVP have been tested and found able to meet the need.

Technology development

Develop a prototype, escalate it to a more realistic representation of the commercial product. Iterative versions to improve the product have been tested to achieve full functionality and a commercial feasibility study is being developed.

Demonstrate the technology

Technology or product is tested by expert users in the real world. Adjusting the product to suit the identified market. The model contains all the elements of the final product. The industrial strength and performance of the product is tested.

Developing the basic graphic user interface (GUI) and the programming to meet internet service provider (ISP) standards.

Final system or subsystem development, testing and testing new iterations

Install, run and evaluate the product in an actual environment. Demonstrate use by clients.

The evaluation is completed by target representative clients. Complete GUIs, users, manuals, training software support complete. Allow user driven “bug hunting” to detect faults.

Technology test, launch and operations

The product has proven, completely successful operations in a real-world setting.

Basic research

The scientific knowledge underpinning the technology or the principles and concepts are demonstrated.

Applied research

Practical application is identified, the experimental proof or detailed analysis to support the conjecture must be established.

Proof of concept

Laboratory demonstrations, modelling and simulation validate analytical prediction. The results are repeatable.

Lab demonstration

Component and/or system validation in a laboratory setting.

Lab scale validation

Early prototype or system is validated in the relevant environment or setting.

Prototype demonstration

Pilot system extensively tested in relevant setting.

Pilot system demonstrated

Capability validated on economic (real-world) runs.

System incorporated in commercial design

Actual system completed, tested and demonstrated.

Proven system ready for deployment

The final product is successfully operated in an actual environment and ready to go to market.

An idea or concept for a product or service has been formulated, which may become a commercial opportunity or a business.

Developing a method to produce a product or service and developing a business proposition/value proposition.

An experimental proof of concept or a rudimentary minimum viable product (MVP) exists, and a market has been identified.

A prototype has been developed but it only works in a controlled/experimental environment. Commercial feasibility is being established by conducting product market fit studies.

Testing the prototype in a controlled setting and developing a business plan in terms of addressing the market and revenue.

Testing prototype in real-world settings and it works most of the time. Validating a business model in terms of the businesses partners, resources, key activities, and cost structure.

Fine-tuning the prototype’s performance under different real-world conditions and refining the business model in its entirety.

Completed rigorous real-world testing, validated and certified the product or service and ready for market.

Selling a complete product or service routinely, the business model is showing success with traction in the market. Considering licensing your IP or onboarding additional partners.