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Transforming Point of Care diagnostics

Challenge

To develop a hand-held, Point of Care (PoC) instrument which could run fluorometric, multiplex immunoassays using microfluidic strips. The instrument also had to deliver an outstanding user experience – comparable to the best consumer electronics – along with fully secure cloud connectivity to electronic health records.

Approach

With LumiraDx, we formed a multi-disciplinary team which didn’t just include engineers, designers and physicists, but also biochemists, digital design experts and human factors specialists. The skills and experience of the group at Team Consulting complimented the client’s experience and knowledge, particularly in assay development, consumables and instrumentation. The teams worked closely together iterating quickly and efficiently to prove all the aspects of the system from the embedded software and microfluidic control, to the product usability and integration with electronic medical records.

Outcome

The LumiraDX platform was developed, tested, CE marked and transferred to manufacture in less than three years.

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A step change in PoC
diagnostics

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LumiraDx selected Team Consulting as a partner to support them in the design and development of its first generation PoC instrument for commercial launch.

At the beginning of the project, LumiraDx was 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. Cost of PoC tests are typically 10-fold greater than a comparable test done in a central lab. If the benefits of PoC could be delivered for a comparable price, with a fantastic user experience and seamless connectivity into electronic medical records, then PoC would finally gain the widespread adoption which has been promised for decades.

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A simple and robust user interface

The user interface guides the user through various workflows. It remains the same regardless of test type and use setting, whether used in an emergency room or as part of everyday diagnostic testing.

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The user experience needed to be familiar and consistent with a robust flow that just works whether using the instrument standalone or as part of large networked system.

Chris Davies, UX Design Specialist, Team Consulting
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Embedded software development

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
woman in front of a screen running coding scripts

We used an agile development process and automated much of the software integration testing which saved a great deal of time.

Seamless and secure cloud connectivity

The connectivity allows central management, configuration of instrument settings and integration with electronic health records, providing efficient and secure data flows that fit with existing clinical practices.

Connectivity is sometimes a challenge in today’s hospital and healthcare settings so we designed 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 and the instrument together act as a pump able to move and mix the fluid on a micro scale.

consumable strip showing microfluidic channels

The door design challenge

The door protects the strip during a test and ensures that the sample port is easy to access when open. All of the surfaces below the strip are free of dirt traps and easy to clean.

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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

The LumiraDx device already created a seismic shift in performance, cost, connectivity and usability compared to other similar devices, transforming PoC diagnostics.

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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