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.
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.
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
Team staff on project
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
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.
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
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.
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.