Executive Summary:

HD was engaged by Sirus Diagnostics to develop a novel technology demonstrator prototype, for the simplification of blood sampling and anti-body testing. The diagnostic device focused on the users experience by combining several technologies and features to make the testing process much simpler, safer and user friendly than other comparable devices.

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The demonstrator was developed quickly with working designs and prototypes available for review by stakeholders within two months of approaching HD. Our client was able to use the design information and prototypes to make patent applications to protect their IP, and subsequently arrange further funding to explore numerous business opportunities for further development of the device.

HD have developed a novel solution that will dramatically improve the ease of self-testing and blood sampling for people all over the world – Sirus Diagnostics, 2020.

Sirus Diagnostics approached Haughton Design to help innovate and simplify existing test kits.

Existing solutions utilise multiple components and processes that are conducted in a specific order, resulting in issues with usability and safety. Hierarchical task analysis identified there were on average 14 separate user steps required to complete the process of self-testing. Typical test kits included numerous independent components i.e. test cassette, lancet, pipette and buffer solution amongst many others. Adherence to the instructions for use and accurate handling of key components required certain levels of understanding and dexterity from the user. Reducing the complexity and number of user steps was a key requirement of our brief.

Throughout early 2020, NHS test kits were recalled due to the poor reliability of the results primarily due to incorrect use. The safety lancets were variable in performance and also presented a potential hazard due to needle stick injury. Compounding of these factors resulted in an increased prevalence of contamination and invalid test results.  During the research process a clear need was soon identified to produce a desirable, safe, user-friendly device, and to increase self-test access in point-of-care and home-test environments.

Haughton Design worked with Sirus Diagnostics to consolidate all of the essential piece part components into an all-in-one device platform. The user process was reduced from 14 typical steps down to just 3; place finger, press button, observe results. Once fired, the lancet retracts and is secured in the device which can be disposed of safely. Consolidation of the technologies and components resulted in a significant reduction in packaging and waste to landfill. The design considered a circular economy model with all parts designed to be compact and simple to manufacture. The devices were packaged in a compact cardboard outer-case printed with large and easy to read IFU’s to replace individual plastic bags and excess packaging.

In addition to the design being an all-in-one device platform which significantly reduces user steps, it poses the ability to change the LFA from COVID-19 to HIV, Malaria, Syphilis and a number of other diseases, thus bringing significant health and economic benefits.

A patent application has recently been filed with the UK patent office, securing intellectual property for Sirus Diagnostics. Sirus Diagnostics have gained early funding from investors and are looking for additional business, finance, and growth investment to further develop this device.

If you would like to learn more about this project or would like to seek to help with funding, please get in touch for more information.

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