Turning a rapid molecular test into a diagnostic device for home use

Challenge

We helped a start-up turn their laboratory-based diagnostics COVID-19 test into a point of care (PoC) device for home use at minimal cost.

Approach

The diagnostic device needed to be low-cost and manufactured in high-volume. The multi-disciplinary team brainstormed concepts that would use existing technologies where possible. We selected the most cost-effective option, tested the chosen concept and developed a proof-of-principle rig to test the assay in the most representative way possible.

Outcome

We developed and prototyped a self-contained, point-of-care (PoC), disposable device in under a year. This enabled our client to test and prove their assay and technology. The start-up has now been acquired by another company.

What’s your diagnostics challenge?

Let’s chat

Sector
Diagnostics

Services
Human factors
Industrial design
Mechanical engineering
Applied science

 

Develop a COVID-19 molecular testing concept
using existing technologies

Team Consulting was approached by a start-up who wanted to turn a novel laboratory-based rapid molecular testing option for COVID-19 into a small, low-cost and disposable PoC medical device for home use. The challenge was to develop a concept using existing technologies where possible. This allowed us to minimise risk and ensure the concept was suitable for high-volume manufacture. We then developed the hardware and test materials so that the chemistry was contained and disposable, avoiding cross-contamination.

From concept brainstorm to product testing

Following an initial concept brainstorm, our project team developed a matrix of various device architectures and deployment schemes. The different concepts were evaluated based on technology risk, usability and commercial factors (cost per test, scale-up volume and sustainability).
Together with the client, a lead concept was selected, with the cost per test identified as the key factor. This concept used existing packaging technologies to create a fluid transfer system allowing the sample to proceed through the assay steps. Typically, rigid plastic components are used with precision fluidic channels, so our novel approach enabled us to develop a low-cost product without compromising performance.

people brainstorming next to a moodboard

To reduce the project risks and ensure the robustness of our concept, we produced individual test rigs to demonstrate the key principles as stand-alone elements. During this process, the project team was able to show that the laboratory process could be simplified thanks to the device construction and the packaging materials used. This allowed controlled and direct fluid transfer between assay steps, while minimising the risk of contamination.

Testing the key elements of our diagnostic concept early in the project identified ways to refine the process (compared to the laboratory method). This meant that our prototype met our client’s requirement for a low-cost and small size PoC device.

Pete Wilson, Senior Engineering Consultant, Team Consulting

The next step was to develop a laboratory-based proof of principle rig to enable the assay to be tested and evaluated in a representative way, integrating the key elements together for the first time. This stage proved invaluable as it highlighted potential issues with the concept while still being able to provide our client with the test data from the proposed system layout.

A systems engineering approach

The challenge was integrating multiple functions and requirements into a small device while keeping usability at the heart of the design. This included integrating storage of multiple reagents, the ability to introduce the sample and transfer it between assay steps such as metering, mixing and timed heating before delivering the result onto an assay strip which could be clearly read by the user. Once the sample had been applied, everything had to be contained within the medical device to prevent cross contamination.

By considering the device and the user as a system, we balanced the requirements of the device with the capability and understanding of the user. We delivered a system that is usable, easy to interpret and low-cost.

The chosen concept used a skeleton plastic frame to support the fluidic elements which were partly made using laminate materials usually associated with packaging. A PCB for the heating elements provided the main structural support. Introduction of the sample was based on actions familiar to the user and subsequent interactions were minimised to keep the overall user experience as simple as possible.

Creating medical device concepts for
high-volume manufacture

It was clear that this test could be made in very high volumes so we started this project with manufacture in mind from the very start. In addition to considering the production of the device in the initial brainstorms, we also engaged with process equipment suppliers to gain feedback on our designs throughout the whole development. This close relationship with suppliers was instrumental in designing a device that could be manufactured with processes that are familiar and proven in other applications. It also allowed the addition of the reagents, assay strip and electronics to be achieved within the production sequence.

manufacturing process equipment

The ability to rapidly ramp up production and future scalability were also key requirements that we factored into the device design. For example, we used simple assembly steps which could be achieved using minimal equipment during the early stages of production and ensured the devices were not contingent on high capital cost automated processes such as web-handling.

It is always incredibly valuable to be able to engage with process equipment suppliers early in the development process and it was great that this yielded a design that everyone supported and considered highly feasible.

Matt Chandler, Director of Mechanical Engineering, Team Consulting

Outcome

Our multi-disciplinary project team helped our client turn their technology from a laboratory bench to a functioning, disposable device for home use which was tested and proved in under a year.

Explore

Cybersecurity illustration: padlocks and coding symbols for data protection
Diagnostics

Creating a cybersecure diagnostics platform

Item Related
multiple devices displaying cloud connections
Diagnostics

Enabling cloud connectivity for a diagnostic device

Item Related

Wonder how we could help?

Let’s start working together on your next challenge.

Let's chat