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Taking a PoC instrument from concept to commercial launch

Our client, LumiraDx, wanted to develop a hand-held, Point of Care (PoC) instrument which could run fluorometric, multiplex immunoassays using microfluidic strips. They needed a device that would deliver an outstanding user experience – comparable to the best consumer electronics – along with fully secure cloud connectivity to electronic health records.

LumiraDx brought Team into their programme in the early stages to design and develop their strip reader. Over the next three years, Team helped create the first-generation instrument; from the intuitive graphical user interface (GUI) and externals, right down to the hardware, software, and fluid control system. The result is a robust, beautifully designed, CE marked instrument, poised to change the entire landscape of PoC diagnostics.

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A step change in PoC diagnostics

LumiraDx came to Team Consulting as a start-up diagnostics business with a difference. Its founders had created several diagnostics businesses, which equipped them with a unique understanding of what was needed to bring about a step change of uptake in PoC diagnostics.

Critically – LumiraDx understood that cost reduction was crucial to increase adoption of PoC diagnostics. PoC tests costs are typically 10-fold greater than a comparable test done in a central lab. The aim behind the LumiraDx Platform was to deliver the benefits of PoC at a comparable price to the lab, all while offering a fantastic user experience and seamless connectivity into electronic medical records.

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A simple and robust user interface

The user experience needed to be familiar and consistent, with a robust workflow that works whether using the instrument standalone or as part of a large networked system. We designed a simple user interface which guides the user through various workflows and remains consistent regardless of test type and use setting, whether that’s an emergency room or as part of everyday diagnostic testing.


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Embedded software development

To save time, we used an agile development process and automated much of the software integration testing. This allowed us to greatly reduce the time required to verify software releases and played an important role in achieving CE marking of the device within strict commercial timescales.

The software development required us to consider the entire system, including the hardware design and processor selection, through to the data security and automated testing required for validation.

Stathis Louridas, Director of Systems, Team Consulting
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Seamless and secure cloud connectivity

We added device connectivity to allow central management of the platform as well as configuration of instrument settings and integration with electronic health records. The outcome was a system that provides efficient and secure data flows that fit with existing clinical practices.

Connectivity is sometimes a challenge in today’s hospital and healthcare settings. We designed the platform for specific use cases, to ensure the system and its users could benefit from two-way cloud connectivity without being reliant on it, so testing is always possible at the PoC.

Ben Cox, Head of Digital Health, Team Consulting

Microfluidic control

The strip works together with the instrument to act as a pump, that is able to move and mix the fluid on a micro scale.

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Practical design elements

All aspects of the device were built to improve usability and ensure correct handling and maintenance of the instrument. This included a door design which protects the strip while running a test, and ensures that the sample port is easy to access when open. Every surface below the strip was also carefully designed to be free of dirt traps and easy to clean.

The development of the door involved many rounds of prototyping and testing to find the best possible solution – it was vital that it didn’t impact the usability of the strips and the display. When we settled on the current design it was a real eureka moment – it just worked.

Alex Driver, Head of Industrial Design, Team Consulting
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Outcome

Since its commercial launch, the LumiraDx Platform has already created a seismic shift in performance, cost, connectivity and usability compared to other similar devices, transforming PoC diagnostics.

Media coverage

Roche enters into a definitive agreement to acquire LumiraDx’s Point of Care technology combining multiple diagnostic modalities on a single platform.

This diagnostic, the LumiraDx, is amazing! It’s an innovation cheaper and smaller than the diagnostic devices that came before. Countries can take it up to remote areas and get the results in just 12 minutes.

Bill Gates

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