Case Study: QuickCheck™ – Integrative Innovation in Peritonitis Diagnosis

Project Background and Problem Statement

Chronic kidney disease affects approximately 10% of the global population, with many patients requiring regular peritoneal dialysis (PD). PD involves the infusion and drainage of dialysate fluids to and from the peritoneal cavity, a process complicated by the high risk of peritonitis—a potentially life-threatening infection. Traditionally, diagnosing peritonitis has relied on methods that are slow—taking up to 48 hours for results—and cumbersome, involving sending samples to laboratories for leukocyte analysis. This delay in diagnosis can lead to worsened patient outcomes and, in some cases, fatalities.

To address this critical issue, MicroBioSensor (MBS), a company specialising in innovative diagnostic solutions, partnered with Datalink Electronics and Smallfry to develop QuickCheck™. This device enables rapid, on-site leukocyte measurement directly from peritoneal effluent, providing immediate results and facilitating faster treatment decisions.

Scope of the Problem

The scope of the problem extended beyond merely speeding up diagnosis. The device had to be:

• Accurate and Reliable: Matching the precision of laboratory-grade equipment.
• User-Friendly: Simple enough for use by nurses in clinics or in a patient’s home, without specialised training.
• Robust and Safe: Capable of operating reliably in a home environment, compliant with medical safety standards.

Collaborative Development Funded by Innovate UK

The development of QuickCheck™ was supported by an Innovate UK grant, which helped fund the collaboration between Datalink Electronics, Smallfry, and MBS. This funding was instrumental in allowing the partners to innovate and push technological boundaries.

Datalink Electronics’ Involvement

1. Expertise in Class B Medical Software Development: Datalink Electronics brought critical software engineering expertise to the QuickCheck™ project, developing embedded software in compliance with IEC 62304 Medical Device Software standards for Class B products. This standard ensures that software is capable of performing safely without posing an unacceptable risk to patients, should an error occur. This experience was crucial in ensuring that QuickCheck™ software was robust, reliable, and effective.
2. Initial Conceptualisation and Prototyping: Datalink engaged deeply from the outset, understanding the medical and operational requirements. They worked in concert with Smallfry, who utilised their in-house medical grade rapid prototyping capabilities to iterate the design of the cassette and reader. Datalink’s electronics expertise was crucial in simplifying the electronics to reduce noise and enhance signal clarity, essential for accurate leukocyte detection.
3. Design Refinement and Engineering: As Smallfry developed the housing and mechanical components, Datalink focused on refining the electronic interfaces and ensuring the control electronics were robust enough for medical use. This phase involved extensive testing and refinement to meet strict medical standards, including compliance with ISO 13485 for medical devices.
4. Final Testing and Manufacturing Readiness: The final prototypes were rigorously tested in real-world scenarios to ensure reliability and user satisfaction. Datalink supported the scale-up to manufacturing, preparing detailed CAD drawings, assembly instructions, and ensuring that all components could be reliably sourced and assembled.

Impact and Outcomes

The QuickCheck™ device has dramatically transformed the landscape of peritonitis management in peritoneal dialysis. By providing immediate results, it enables quicker treatment, potentially saving lives and significantly improving patient outcomes. The collaboration between Datalink Electronics, Smallfry, and MBS was instrumental in achieving a design that is not only innovative but also practical and aligned with the real-world needs of patients and healthcare providers.

Conclusion

The development of QuickCheck™ showcases the power of collaborative innovation in tackling significant healthcare challenges. Datalink Electronics’ role was pivotal in ensuring that the electronic design and manufacturing aspects of the project met the highest standards of quality and safety, directly contributing to the device’s success in the market.