QuickCheck: Rapid & Portable Peritonitis Diagnostic Device
Expert Review | URRAs | GUI & IFU Design | Formative Testing | Summative Testing | Standards & Regulations
QuickCheck is a device that instantly and accurately detects Peritonitis in PD patients, providing results 10,000 x faster than current methods.
Rapid diagnostic specialists MicroBioSensor worked in partnership with Design Innovation Consultancy, Smallfry to design and engineer the device. We are Human were called upon to support with the device development; to ensure it met users needs and FDA standards through Human Factors and Usability testing.
Background
Peritonitis is a serious condition, that starts with an infection of the peritoneum, a complication of Peritoneal Dialysis (PD). With current diagnostic methods, results for Peritonitis are typically received 48 hours after testing. This puts vulnerable patients at a high risk with 3 in 20 Peritonitis episodes resulting in death of the PD Patient.
QuickCheck’s rapid technology accurately measures Leukocyte levels and acts as an early warning system. It enables patients to receive treatment much more efficiently and effectively. The compact, portable 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.
Our approach
Across a 12 month period, We are Human worked closely with MicroBioSensor and Smallfry on development and testing using range of our services.
Our consultants conducted expert reviews to reinforce the Use Related Risk Assessment development. This led to the design, creation, and testing of Instructions for Use.
Through Formative Research with the user groups, we were able to iterate and evolve the Instructions for Use and Graphic User Interface of the device to achieve clear, safe and easy to use results.
We undertook a validation study to confirm QuickCheck meets users’ needs in a manner that meets the FDA’s Quality System Regulation. The interviews with nurses and patient care givers consisted of device use and knowledge based assessments on the comprehension of the GUI of the device and the Instructions for use.
The Results
The feedback we received from the participants during the study was very supportive:
“It was easy to follow. Pretty simple. Low risk to myself. No harm or distress to the patient.”
“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 device and easy to follow Instructions for Use allow healthcare professionals to safely and effectively use QuickCheck to achieve a measurement, in just 6 seconds. The benefits of this reduced treatment time result in improved patient outcomes, confidence in reducing risk of infection and savings on resources.
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.
