Non-Invasive Cardiac Output Monitor.


About C-COM

Developed by renowned Australian anaesthetist, Dr Duncan Campbell, C-COM is a proof of concept non-invasive MedTech device designed to determine the rate of flow of blood from a patient's heart.

Project Summary

The work undertaken by Amatek constituted a Concept Evaluation Program, the aim of which was to determine the following:

  • Whether the client's original design brief had been met and that the device delivered to them functioned as per that brief.
  • Whether the device was fit-for-purpose, i.e. whether or not it did what it was intended to do.
  • Whether it was suitable, in its current format, to be put through clinical trials.
  • If it was unsuitable for trials, what program of works would be required to make it so.
  • What the costs and timeframes of such a program were likely to be.
  • Based on the development and verification program proposed, what sources of funding might be available, and what would be required to pitch to the project to prospective investors.

Amatek was then requested to develop and cost staged engineering and commercialisation prgrams, including:

  • If it was not fit-for-purpose, what would be required to make it so.
  • Once it was fit-for-purpose, what regime of clinical trials would be required before it was ready for TGA approvals.
  • Once approved, what 'Go To Market', i.e. commercialisation, program was recommended, and what would be the ciosts and timeframes.

Outcomes

Amatek initially invstigated whether the device was fit-for-purpose. This required that:

  • The fundamental premises on which the device was based be examined and a determination made as to whether they were valid assumptions.
  • Enhancements to the existing device, or a complete redesign, be developed and costed.

In order to undertake the Concept Evaluation required for this project, Amatek undertook the following activities:

  • Engaging with key medical industry groups, including research and innovation funding organisations.
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After an extensive and exhaustive Concept Evaluation, Amatatek determined the following:

  • Engaging with key medical industry groups, including research and innovation funding organisations.
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