We are Human

QuickCheck: Aiding Peritonitis diagnosis and reducing risk for Peritoneal Dialysis (PD) patients

GUI & IFU Design | Use Related Risk Assessment  |  Formative Testing (UK) | Summative Testing (USA) 

QuickCheck is a diagnostic device that aids in the diagnosis of peritonitis in seconds rather than in hours or days, using current methods for people living with kidney failure.

Rapid diagnostic specialists MicroBioSensor developed the device in collaboration with Design Innovation Consultancy Smallfry and We are Human.

For patients on peritoneal dialysis, 3 out of 20 deaths are associated with peritonitis.

Peritonitis is a serious condition, that starts with an infection of the peritoneum, a complication of Peritoneal Dialysis (PD). Current Peritonitis diagnostic methods are typically received 48 hours after testing. This puts vulnerable patients at very high risk.

QuickCheck’s rapid technology measures Leukocyte levels and acts as an early warning system. It enables patients to receive treatment much more efficiently and effectively. The compact, portable diagnostic device is designed for nurses to use in clinics or patient’s homes. The instant clear results allow healthcare professionals to determine whether treatment is required, improving patient outcomes.

Usability Engineering to achieve clear, safe and easy to use results.

Across a 12-month period, We are Human worked closely with MicroBioSensor on on the human centred design of the QuickCheck device.

Our consultants conducted initial user research with nurses and clinicians to map out the user journey and task analysis of how the QuickCheck device would be used in Clinical and Community settings.

We worked closely with MicroBioSensor’s risk and product teams to develop a robust Use Related Risk Assessment (URRA) early on in the development process. The URRA was used as direct input by We are Human into the Graphical User Interface (GUI) and Instructions for Use (IFU) design.

We conducted an early stage Human Factors (HF) Formative Usability Test of a high fidelity prototype and IFU with 10 healthcare professionals in the UK. These findings were essential in iterating the IFU and GUI to achieve clear, safe and easy to use results.

The final activity involved the planning and execution of a HF summative (validation) study with 15 intended users in Boston, USA. This confirmed that the QuickCheck meets user’s needs as well as being safe and effective to use. The HF process and activities were documented into a Human Factors Report and Usability Engineering File for UK and US regulatory submissions.

Leukocyte measurement achieved in 6 seconds.

The participant feedback we received during both of the studies was very supportive:

“I wish it was available. I think it would be a great tool…awesome, super easy, user-friendly tool”

“If a patient had this in their home, and they didn’t feel good and they tested, this would be really great for them – they could seek help sooner rather than later”

“This is super easy to use. The minimal buttons are really great. The fact that it’s maybe 5 steps from start to finish is really easy, it’s really quick”

The diagnostic device and IFU allowed for healthcare professionals to safely and effectively use the QuickCheck to achieve a Leukocyte measurement in just 6 seconds. The benefits of this will reduce treatment time, resulting in improved patient outcomes, confidence in reducing risk of infection and savings on resources.

 

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If you are interested in implementing Human Factors or User research into your device development or would like more information about our services at We are Human, we would love to hear from you.