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Stage – ID3: Develop the Opportunity

Following on from design are those activities that ensure a product is fit for purpose over time, that it is reliable, of consistent quality and performance, and cost effective. Development therefore includes further market analysis, proof of concept, prototyping and design for manufacture - which is where businesses with specialised equipment and skills come in.

Select a task name below for more information

Task Overview

A working product is useless without proper background documentation of research questions, methodology and resulting evidence.

What you need to do:

  • Does the prototype confirm that the product will meet regulatory requirements as well as work?
  • Add test findings from tests on prototypes to the technical file. Results could include:
    • Physical properties of the materials used - this information may already be available.
    • Biological properties (biocompatibility) of the materials used - important for implantable materials
    • Electromagnetic properties - important in electrical monitors and therapeutics
  • Consider repeat testing if you do not have any valid, reliable information or proper documentation.