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Stage – ID4: Demonstrate the Benefits

At this stage evidence needs to be presented that the prototype is viable and meets planned design requirements. Building on this evidence, the business plan needs to be finalized and further funding needs to be sourced.

Select a task name below for more information

Task Overview

The final product test results should show that the production devices conform to the proper specifications.

What you need to do:

  • Test any therapeutic products, this may include:
    • Measurement – monitoring of production routes and confirmation of stability.
    • Function – ensure that the product behaves as intended in the hands of users.
    • Safety – both in production and in use, e.g. full biological analysis should confirm safety of materials and design.
    • Sterility – as defined by standard bioburden testing.
    • Packaging – robustness confirmed through drop and other testing.
  • Make sure you test relatively simple products at an appropriate level. In-use evaluation and economic evidence will provide verification that the product meets its intended clinical need.
  • Conduct pre-market clinical studies of the product using initial batches of samples manufactured during the final production process. This will reduce the need to repeat tests later if the product is changed.
  • Depending on how the product is used, the scope of clinical studies may need to be negotiated with the regulatory Competent Authority (eg MHRA) and also the local Ethics Committee.