MicroBioSensor launches QUICKCHECK™ a medical device designed in partnership with Smallfry
A device that can help speed the diagnosis of peritonitis in vulnerable kidney and liver failure patients. With results 10,000x faster than current methods, this portable and rapid detection device now means that nurses can carry out an instant leukocyte count at the patient’s home. Providing convenience to the patient and supporting rapid detection and treatment pathways.
Born out of collaboration between Smallfry and the team at MicroBioSensor, QuickCheck™ rapidly identifies Leukocyte levels in peritoneal effluent. No longer shrouded in ambiguity, the device provides a clear answer as to whether ISPD threshold levels of leukocytes have been exceeded, providing crucial information to help clinical teams decide whether patients need to be admitted to hospital.
THE CLIENT
MicroBioSensor specialise in shrinking and simplifying complex microbiology and with the help of Smallfry, have developed a portable testing device that not only maintains accuracy levels equal to hospital laboratory testing, but also delivers rapid results, is easy to use, affordable and helps improve patient outcomes. With current testing methods taking up to 48 hours, this new device can act as an early warning system for microbial infection to ensure patients receive early treatment.
IMPROVING PATIENT OUTCOMES
Chronic kidney disease affects around 10% of the world’s population with 4M requiring haemodialysis (HD) or peritoneal dialysis (PD). Peritoneal Dialysis is a process used to treat kidney failure by exchanging the fluid surrounding the internal organs within the peritoneal membrane. Dialysate fluid is pumped into the abdominal cavity through a catheter, after a period of time this fluid is drained taking impurities with it. Unfortunately, one of the more frequent complications undermining the success of PD is peritonitis, an inflammation of the peritoneum or peritoneal membrane.
Although patients are trained to be thorough in hygiene throughout the process, infections can still happen. With one in 20 peritonitis episodes resulting in the death of the PD patient, prevention and prompt and appropriate management of the condition is essential for the long-term success of peritoneal dialysis.
The ISPD recommended method of diagnosis is the presence of elevated levels of leukocytes, in combination either with patient symptoms or a bacterial culture. The current method is to send samples away for testing which takes time and resource. Once received at the Lab, results typically take several hours to obtain a White Blood Cell Count (WBC count) and confirm infection.
“The diagnostic results usually arrive 48h too late to have a meaningful impact on patient treatment…”
Anand Vardhan, Consultant Nephrologist, MRI.
With the help of Smallfry, MicroBioSensor are developing products to address this unmet need in peritonitis diagnosis.
EFFORTLESS, INTUITIVE AND FOOL-PROOF TO USE
Every interaction point was thoroughly considered throughout the design process to ensure the device provided a seamless, accurate and hassle-free process. By understanding the condition in conjunction with the user journey, the design process ensured the device was simple and clear to use. Free from dirt traps and easy to keep clean.
CHANGING LIVES THROUGH DESIGN AND ENGINEERING
QuickCheck™ can detect white blood cells in peritoneal dialysis effluent in 6 seconds, helping clinicians make treatment decisions at the point of care. With automated results and a digital readout, this new device is more accurate and precise than current cell counting methods used in hospital testing laboratories.
With regular testing, the device provides an early warning system for infection or, conversely, provides reassurance when there is no significant infection risk. The resulting outcomes include improved patient care, resource savings and help in the battle against rising antimicrobial resistance.
DESIGNED THROUGH TO PRODUCTION
The development journey for QuickCheck™ began with research. To understand Peritonitis and its effect on patients, to analyse existing Peritoneal Dialysis equipment and fully assess the user journey. This knowledge resulted in initial efforts focusing on the development of a cassette and reader to analyse Peritoneal Fluid at point of care.
A range of pump cassette concepts were created which included looking at the effects of bubble build-up. The team also explored potential methods for pumping fluid samples into a disposable sampling cassette and providing agitation to mix an optional reporter chemistry into the sample before analysis. However, due to the accuracy required in geometry and positioning of components and the need for rapid results, development switched from chemistry to a laser-based optical detector and the design focus shifted to a larger static chamber and cassette.
Once laser reading capability was identified as the preferred route for analysis, the team worked with a laser expert to further develop the device and focused on identifying infection by monitoring the body’s response to pathogens: generating white blood cells to fight the infection.
Key Development Stages
- Analysis of refractions and scatter angles to optimise photodiode positions
- Testing of 3D printed transparent samples
- Prototyped flow through cassettes with acrylic windows with labyrinth entry/exit points to keep light out
- Manufactured prototype housings to test laser set ups
- Concepts generated for laser reader units
Route to Manufacture
Although initial designs included a horizontal static cassette, issues with the clarity of lenses during prototyping prevented the team from manufacturing bespoke optical components. The use of stock lenses resulted in changing the cassette from a horizontal to a vertical format.
Smallfry made use of in-house medical grade rapid prototyping capability to support quick and iterative development. Prototyped versions for the vertical cassette were created and control electronics and photodiode boards combined to simplify electronics and remove noise. This changed the format of the reader to a taller T shape, whilst iterations of laser component size and configuration took place. Significant prototyping methods were utilised to generate new cassette and reader concepts, device housings, set PCB positions, and laser positioning and adjustment to refine the device.
- 3D printed prototype units with additional test pieces
- 4x CNC machined prototype units to verify the design route
- 10x CNC / PU moulded pre-production units
Once fully validated, manufacturing CAD and Drawings were finalised along with assembly instructions.
Summary
With an overwhelmed healthcare system and resources being stretched beyond their limits, devices like QuickCheck™ provide a genuine opportunity to not only relieve pressure but also dramatically improve patient outcomes with rapid diagnosis and treatment time. With more innovation and development in the pipeline, there is hope for the future of PD patients.
With significant expertise in medical device development and design, get in touch with us to see if we can support your next project. From research through to production, email Kelly for more info. Design@Smallfry.com
