• Question: How do you know if your thing will work on people?

    Asked by Kitkat to Dominic, Maedeh, Matthew, Matt, Monica on 8 Mar 2016.
    • Photo: Matthew Oldfield

      Matthew Oldfield answered on 8 Mar 2016:

      Normally we would test our device in the following order:
      Tissue substitute – like jelly
      Dead animal tissue.
      (Maybe dead human tissue)
      Live animals
      Live humans

      When testing on animals and humans we can’t jump in with both feet. Each step has to be authorised and as safe as possible. We would also test different bits of how the device behaves before we tested the whole system. The aim is to reduce the risk and need to harm animals and humans as much as possible.

    • Photo: Monica Rozeik

      Monica Rozeik answered on 9 Mar 2016:

      You have to go through quite a lot of testing before you have a chance to test on people.

      For heart valves, the new design is compared to an old design. They are tested out in computer models first. Once that’s fine, they’re tested in the lab using machines that act like the heart. Then when you can prove the valve will last 400 million cycles of it opening and closing and is performing better than an old valve, they can be tested in an animal for a few months.

      Animal testing is very strict and you have to treat the animal very well. When these tests are all good you finally test the valves on humans, this last step is known as a clinical trial.

    • Photo: Dominic Eggbeer

      Dominic Eggbeer answered on 18 Mar 2016:

      We have to rigorously test our processes. Since everything I do is custom made for a single person, we rely on having a robust design process that ensure parts are well designed and consider possible problems from the start. Materials we use to make parts have been tested to known standards to ensure they won’t cause harm.

      We also need the surgeon who will use the device to sign it off as suitable. The medical device directive has guidelines that essentially can be summarised as ‘do your best to ensure what you design and make will cause no harm and will do good’.

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