The innovation is meaningful if it is accepted by the buyers and end-users. In many industries, usually, we developed many useful standards and also imposed the certification to ensure quality. However, our design is an emergency supportive device of the last instance (when other solutions failed or are not available) to be done by local tech-communities, we care about all above-mentioned aspects. So if you have knowledge or ambition in the areas of acceptance, standards, or certification, feel free to join the challenge.
The challenge combines all possible aspects: medical, mechanical design, electronic design or firmware improvement/optimisation.
- In the field of acceptance, the improvement in the field of human-machine interaction is mostly accepted, but the focus can be given to the performance factors, which improves trust-ability, improvement in durability (by any method), design, or any other aspect;
- In the field of standard, tackling the challenge of compliance with relevant standards for a medical device is expected;
- In the field of the certification, we expect, that the team utilizes their unique knowledge about CE / FDA approval procedure and focus on the improvement of design or operation with a focus to fulfil some specific aspect in the certification process;
In the Acceptance challenge, we foresee the presentation of (as advance as possible) improvement which leads to improvement of acceptance by the stakeholders. The reasoning ( why the change leads to improved acceptance) can not be (due to the Hackathon format) confirmed by the co-creation methods, so the literature evidence shall be provided.
In the Standard challenge, we foresee the presentation of (as advance as possible) improvement which incorporates the device's design some of the relevant medical devices, rapid prototyping, health, or coding standards.
In the Certification challenge, we foresee the presentation of (as advance as possible) improvement, which tackles specific requirement(s) of the CE/FDA certification process for medical devices.