According to CDC data, the number of reported US cases of end-stage renal disease increased by 41.8% between 2000 and 2019*. Given the aging population and rising rates of diabetes and hypertension, this trend is likely to continue. There are currently two main treatments for ESRD: kidney transplant or dialysis. In this case study, we’ll focus on dialysis, exploring how modern systems use cutting-edge power, communications, motor control, sensing, audio and processing technologies to improve patient outcomes.
Overview
Dialysis systems are extracorporeal medical devices used to support patients with significantly impaired or non-functional kidneys by replicating the renal function of waste removal, electrolyte balancing, and fluid regulation. These systems work by transferring blood from the patient’s body into a controlled machine environment where metabolic waste products and excess fluids are removed through a filtration membrane and replaced with a balanced electrolyte solution (dialysate).
The main types of dialysis systems include hemodialysis (HD), peritoneal dialysis (PD), and continuous renal replacement therapy (CRRT). HD is the most used modality, requiring an external dialyzer and high-precision blood and dialysate flow control. PD uses the body’s own peritoneal membrane and is more suitable for homebased continuous therapy. CRRT is typically used in intensive care units (ICUs) and provides a slow and continuous filtration for hemodynamically unstable patients. Modern dialysis machines are fully automated with built-in sensors, actuators, control modules, and fluidic circuits to ensure precise treatment delivery, fluid balance, and patient safety. All dialysis types must meet performance and safety criteria outlined in ISO 8637 series, IEC 60601-2-16, and relevant risk and quality management standards.
Figure 1: Classification of dialysis system
Principle of Operation
The dialysis process is governed by three primary physical principles: diffusion, ultrafiltration, and osmosis. In HD systems, the patient’s blood is pumped through a semi-permeable membrane housed in a dialyzer, where solutes (e.g., urea, creatinine, potassium) move from the blood into the dialysate via diffusion, following a concentration gradient. Ultrafiltration removes water by generating a pressure gradient across the membrane. In PD systems, dialysate is instilled into the peritoneal cavity, where the peritoneal membrane acts as the filtration surface. Osmotic gradients created by glucose or icodextrin in the dialysate draw fluid from the bloodstream.
The system block diagram (Figure 2) demonstrates these mechanisms using a closed-loop BLDC blood pump, precision-controlled stepper heparin pump, and dialysate recirculation system with temperature and conductivity sensors. HD systems operate with blood flow rates between 200–500 mL/min, dialysate flow rates of 500–800 mL/min, and maintain a dialysate temperature of 35–39° C. The performance of dialyzers and dialysis fluids must adhere to ISO 23500-5 for chemical and microbial limits, and safety requirements must conform to IEC 60601-2-16, which governs the specific functioning of HD and PD equipment.
Figure 2: System block diagram of a hemodialysis system
Key Components
Dialysis systems are complex, multi-modal devices composed of blood and dialysate pumps, ultrafiltration controllers, pressure sensors, temperature regulators, bubble detectors, heparin infusion systems, air traps, and flow regulators. The dialyzer, also known as an artificial kidney, uses a high-permeability membrane (e.g., polysulfone, polyethersulfone) with surface areas ranging from 0.8 to 2.5 m2. Figure 2 depicts the extracorporeal circuit comprising the arterial and venous pressure sensors, a BLDC-driven blood pump, a stepper-motor-driven heparin pump, an air trap sensor, and dialyzer inlet/ outlet lines.
Additionally, the dialysate system includes a mixing valve, conductivity and temperature sensors, and a separate BLDC dialysate pump. The system also contains an MCU/MPU block interfaced with GPIO, ADC, PWM/DAC, RTC, flash memory, and Bluetooth Low Energy (BLE)/Wi-Fi module, controlling the entire setup and ensuring safe real-time feedback.
The AC-DC converter transforms mains power into a stabilized DC voltage, which is further regulated by the DC-DC regulator to provide different voltage levels (e.g., 12V, 24V, or 48V). For portable applications, the system supports battery operation via a lithium-ion power source (2,000 mAh – 10,000 mAh), ensuring 4 to 12 hours of uninterrupted usage. Additionally, a PMIC (power management IC) manages power distribution, battery charging, voltage regulation, and energy efficiency, optimizing the system’s performance and longevity. The PMIC also supports USB Type-C connectivity for efficient charging and power delivery, ensuring seamless operation in various medical environments. The display module typically consists of LCD or OLED touchscreens that support LVDS/MIPI interfaces with a resolution of at least 128 × 64 pixels, ensuring clear data visualization. The system is powered by a high-performance MCU/MPU (e.g., ARM Cortex-M4 or Cortex-M7, 100–400 MHz), responsible for executing algorithms, handling sensor feedback, and ensuring safety protocols. The real-time clock (RTC) module maintains timing accuracy, while an integrated memory unit (128 KB–2 MB) logs historical data.
To enable remote monitoring and integration with hospital networks, the system includes BLE, WiFi (IEEE 802.11), and a dashboard/app interface for real-time dialysis tracking. The antenna communication module ensures stable transmission across 2.4 GHz and 5 GHz bands. Data security is maintained per HIPAA (Health Insurance Portability and Accountability Act) and IEC 80001-1 (Risk Management for IT Networks Incorporating Medical Devices). Some advanced models feature NFC (Near Field Communication) for quick device pairing and USB Type-C connectivity for seamless data logging and firmware updates.
Current Technology Trends
Dialysis systems are increasingly being integrated with advanced electronics, connectivity, and intelligent software. IoT technologies have enabled BLE, Wi-Fi, and NBIoT connectivity, allowing remote monitoring, treatment logging, and cloud-based analytics. Embedded controllers typically use 32-bit ARM Cortex-M or Cortex-A processors, supported by secure flash memory, real-time OS, and analog front ends (AFEs) for sensor integration. The reviewed block diagram highlights this trend by showcasing a wireless module (BLE/Wi-Fi), data dashboard, and audio/visual alert system, enabling real-time monitoring and alarms. PMIC-based power regulation and coin cell backup for RTC are incorporated for reliability. AI-based algorithms are now being incorporated for predictive analytics, such as detecting blood pressure drops or intradialytic hypotension.
Regulatory frameworks such as IEC 62304 govern the software development life cycle, while ISO 62366 ensures usability engineering for safe human-system interaction. Devices that process or transmit patient data over networks must also comply with HIPAA in the U.S. and GDPR in the EU for data security and privacy. Edge computing and machine learning models are increasingly embedded to automate decision support and dosage adjustment.
Applications
Dialysis systems are used across multiple clinical environments. HD is primarily delivered in hospitals and outpatient centers, typically three times per week for 3–5 hours per session. PD is commonly used at home and offers patients greater autonomy, with daily exchanges lasting 4–6 hours (CAPD) or overnight cycles (APD). In critical care, CRRT is preferred, operating continuously over 24–72 hours with low blood flow rates (~100–200 mL/min) to avoid cardiovascular stress. Devices in these environments must operate reliably under ambient conditions of 10–40° C, with fluid pressure regulation below 600 mmHg.
The system block diagram demonstrates suitability for both hospital and remote use, with its touch display, audiovisual alarms, wireless remote interface, and built-in disinfection/mixing mechanism. For remote applications and home use, devices must include automated disinfection, touchscreen interfaces, secure data logging, and cloud syncing capabilities. These systems must conform to IEC 60601-1 for electrical safety, ISO 13485 for quality management systems, and IEC 60601-1-8 for medical alarm safety and effectiveness.
Future Directions
The future of dialysis is centered on personalization, portability, and automation. Researchers are advancing wearable dialysis technologies, such as the WAK (Wearable Artificial Kidney), which uses sorbent technology for dialysate regeneration, allowing mobility and continuous therapy. Bioartificial kidneys, which incorporate living renal cells with synthetic membranes, are under development and aim to fully replace machine-based dialysis. AI-driven, closed-loop control systems are being integrated to adjust therapy parameters in real time, using feedback from vital signs and blood chemistry sensors. As seen in the system block diagram, modern architectures are already integrating sensor-rich feedback loops, modular electronics, and cloud-enabled dashboards, all of which form the building blocks for predictive and autonomous dialysis.
Regulatory strategies are evolving to cover these technologies, with the FDA’s Software as a Medical Device (SaMD) guidance and IEC 81001- 5-1 focusing on cybersecurity for health software. As the demand for decentralized care rises, these next-generation systems will emphasize interoperability, autonomous decision-making, and adherence to advanced regulatory controls for AI and connected medical devices.
eInfochips, an Arrow Electronics company, is a leading engineering service provider for end-to-end medical product/software development life-cycle (PDLC/ SDLC) with in-house ISO 13485-certified and FDA 21 CFR 820-ready quality management systems (QMS). eInfochips has deep technical expertise in IoT/IoMT, AI/ ML, security, sensors, silicon, wireless, cloud, and power design. Connect with us to discuss how we can accelerate your product development and time to market.
Download a complimentary copy of the Dialysis Systems application brief by clicking below.
DOWNLOAD PDF APPLICATION BRIEF
Dialysis System Design Support
Please fill out the form below and an Arrow representative will reach out to support you with your design as soon as possible.
By submitting this form, you acknowledge that use of arrow.com is subject to Arrow’s Terms of Use and Privacy Policy.
Sources
*https://www.cdc.gov/mmwr/volumes/71/wr/mm7111a3.htm#:~:
text=During%202000%20and%202019%2C%20for,of%20prevalent%20cases%20approximately%20doubled