Proof of Concept

Concepts for biomedical technologies and pharmaceuticals evolve from ideas for commercialized products often based on solutions to unmet clinical needs. The development of a concept evolves through many stages before it progresses to human use. One of the first milestones is labeled "Proof of concept", which is defined as the demonstration that a concept is "workable".

Modules of specific components in the concept need to be tested, typically using various simulation techniques. Demonstrating a concept may incorporate numerous different techniques such as computer modeling to prove a working theory. However, creation of computer models does not prove that the theory can be executed into a product. Proving the feasibility of a concept forces the innovator to focus on achieving specific results and helps to identify potential issues that will emerge when the concept transitions to a working model. Until this step is complete, the project risk is high, and may exceed the risk threshold of the developing entity.

In the biomedical industry proof of concept is typically accomplished by constructing and testing a device. This test device may prove entire concepts or critical concept segments. This device is normally referred to as a prototype, or a working model of a concept.

The prototype device is usually created to perform a series of tests to support the proof of a concept. These tests include those executed in a well controlled laboratory environment or may be in an animal or alternate model which approximates the end use environment. Proof of concept may also involve side by side comparison with a device similar in function. Once a prototype is completed and evaluated, the risk profile is significantly reduced.

Occasionally, patients may be enrolled in a regulated approved study. Once complete, the results of the study are evaluated and summarized to show proof of concept.