Quick links

Stage – ID2: Design the Solution

Design is a vital part of the product development process, and can be defined as the formulation of an idea as a solution to a problem, or as a way of doing things better. In this context companies providing project, business or technology management services can be said to be involved in design.

Select a task name below for more information

Task Overview

Having established a clinical need and a basis for moving forward you should plan for gathering clinical evidence and pre-market testing for regulatory approval. Then you will be ready for post-market testing to demonstrate clinical and economic benefit.

What you need to do:

  • Find out if the materials are already used and if they are comparable to those used in existing products. If so, there should be safety evidence relevant to your new product. Novel materials or existing materials used in new ways will require much greater testing, and therefore be riskier and more costly to introduce.
  • Open a technical file in which to organise the information and evidence you will need to meet regulatory compliance requirements. Include:
    • materials/technologies to be used
    • potential benefits to users and purchasers
    • relevant regulations and standards
    • what tests apply to your product
  • Conduct or commission patent searches:
    • to confirm novelty of your technical ideas (many apparently novel ideas are already patented)
    • to ensure you are not infringing patents for other materials or technologies you intend to use
    • to review published literature again and double-check that your ideas have not been tried before.