Challenge

To develop a hand-held, point-of-care diagnostics instrument which could run fluorometric, multiplex immunoassays using microfluidic consumables. 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

We brought together a multi-disciplinary team which included engineers, designers, physicists, and also biochemists, digital design experts and human factors specialists. This cross-functional team worked closely with the client’s assay development scientists and consumable manufacturing engineers, iterating quickly and efficiently to prove out all the aspects of the system from the embedded software to the product usability and integration with electronic medical records.

Outcome

The diagnostics device was developed, tested, transferred to manufacture and CE marked in less than three years. It has already created a seismic shift in expectation of the performance, connectivity and usability of a PoC diagnostics system.

The images of the device in this case study are purely illustrative.

At a glance

Client
Confidential

Sector
Diagnostics

Services
Electronics
Software
Systems Engineering
Industrial Design
Human Factors

Launch date
November 2018

Team staff on project
40

Transforming diagnostics

poc diagnostics device for blood testing in use showing function

The client partnered with Team to design and develop its Point-of-Care (PoC) instruments. Critically – the client understood that cost reduction of care 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.

The client brought Team into the programme in the early stages to design and develop the instrument. Over the next three years, Team created the first-generation instrument; from the intuitive graphical user interface (GUI) and externals, through to hardware, and system software. The result is a robust, CE marked instrument, poised to change the entire landscape of PoC diagnostics. The quality and attention to detail extends beyond the physical instrument and the test consumables – the cloud-connectivity is equally intuitive, providing a secure means to transfer results directly into a patient’s electronic record.

A simple and robust user interface

Image showing the point of care diagnostics device UX interface function

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

Point of care diagnostics device UX interface in action to show how it works

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

Ben Cox, Head of Digital Design

Embedded software development

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

Stathis Louridas, Head of Electronics and Software Group
A man walking past some point of care diagnostics software being developed
A woman smiling whilst conducting some point of care diagnostics integration testing

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 dataflows that fit with existing clinical practises.

Drawing showing how the point of care diagnostics device cloud connectivity works

We know that 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 point-of-care.

Ben Cox, Head of Digital Design

Visual look and feel

The client was keen that the visual look and feel of the instrument drew design cues from high end consumer electronics to support the whole user experience goal. The challenge was to balance this aspiration with the requirement to make the device robust and easy to clean as the user would potentially handle infected blood.

 

A point of care diagnostics medical device engineered by team consulting to test blood