Dialysis Machines Challenges and Solutions A Tata Elxsi Perspective Vimal Kumar

Introduction Haemodialysis is a lifesaving intervention. Patients with renal disease undergo a progressive loss in renal function which eventually necessitates dialysis therapy to sustain life. While life sustaining in many circumstances, haemodialysis can be catastrophic if appropriate care is not taken as it is a very complex therapeutic procedure. Dialysis is a blood purification process which removes waste products resulting from metabolism and food intake. It can also correct electrolyte abnormalities and acid-base balance. Fluid gained in between treatments is also removed during dialysis.

Blood unit Arterial and venous line clamp Control

Blood Pump

Air Detection Arterial blood pressure monitoring Venous blood pressure Monitoring

Priming Detection

Dialysis machine mimics the operation of kidney using a dialysis fluid, which facilitates the diffusion process. The machine monitors treatment and ensures that the equipment reverts to a “fail safe condition” in the event of malfunction, thereby protecting the patient. The purpose of this paper is to review the status quo of dialysis machine technology, emerging trends and Tata Elxsi’s approach to answer the dialysis machine market needs from a technological perspective. This paper attempts to encompass the basic blocks of a dialysis machine within the product design framework and aims to align it with our expertise.

Fluid Unit D I A L Y Z E R

M E M B R A N E

Anticoagulant Administration

Inlet Pressure monitoring and regulation

Temperature Monitoring and regulation

Concentrate/ disinfectents intake

Conductivity monitoring and regulation

UF measuring and regulations

Degassing pressure and flow regulation

TMP monitoring

Blood leak detection

Clearance measurement (optional)

pH Measurement of fluid (optional)

Power supply Unit

Operator Panel Unit

DC Supply Generator AC/DC Converter

Buttons

Flow Path Display

Alarms

Time Display Information Display

Figure 1: Functional blocks of dialysis device

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Medical device market drivers and their impact on dialysis machine Medical device technology is well known for its ability to adapt to other disciplines of knowledge, which is indeed the reason for its enhancement. Developments in aerospace applications, consumer electronics, and semiconductor technologies have all triggered the avalanche of innovation in medical devices.

Miniaturization Many of the complex circuitries can be integrated into a single chip, which reduces the real estate of PCBs, thereby realizing products with smaller form factors. (For example, the fully-integrated analog front end (AFE) chip which can be used for patient monitoring, portable and highend electrocardiogram (ECG), and electroencephalogram (EEG) equipment, in a BGA package size of 8mm x 8mm).

Dialysis Machines Challenges and Solutions

Enhanced portability Miniaturization of the medical device has, in turn, enhanced the portability of the medical device, which will help in monitoring the condition of the patient at any given point of time like during the transportation of the patient from one health care facility to another, shifting the patient from one place to another, ambulatory monitoring etc.

Low power designs Developments in Bioelectronics and semiconductor technologies have made it possible to design circuits that consume less power. This will also allow for smaller battery size and longer backup time. Smaller battery size will reduce the weight and enhance portability.

Enhanced clinical workflow Wireless connectivity in medical devices will enhance clinical workflow as the medical device need not be tethered for internet connectivity for an EMR or remote monitoring. Dialysis machines like many other medical devices have undergone enormous changes thanks to the technological developments. The changing technology, market dynamics, disease patterns have all contributed to the metamorphosis of dialysis machines. The stringent regulatory and statutory compliance requirements also catalyzed the innovation trend of dialysis machines. It is of great importance to understand the medical device market drivers so as to assess its impact on dialysis machines.

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Dialysis machines – architecture overview The block diagram portrays the complex electromechanical challenges that are addressed in the system design of a typical dialysis machine. The design complexity gets another exponent when patient safety has to be considered. The criticality of the procedure while ensuring safety of the patient with, enhanced usability make the design task a challenge for the device designer. But then ships are not made to be barnacle crested but to go out in the rough sea. This is the challenge that the medical device design must be prepared for.

Dialysis machines are medical equipment whose design and manufacture is regulated by the Food and Drug Administration (FDA). They come under FDA device Class II . This means that their design and construction must follow precisely documented processes, and their performance must meet stringent documentation, development testing, production testing, and field maintenance requirements. The equipment also must contain comprehensive self-test and faultindication capabilities, which require

additional circuitry and the use of components that include self-test features. Electrical leakage to the patient is a significant concern. Medical device developers must meet the requirements of the IEC 60601-1 product safety standard for electrical medical equipment. In addition to this the dialysis machine must comply to the standard IEC 60601-2-16 Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.

BACKLIGHT

CURRENT-SENSE AMP TO SSP CONTROL SIGNAL FROM MOTOR DRIVE CONTROLLER

BLOOD TO PATIENT TO SSP

VENOUS PRESSURE SENSOR

AIR TRAP, AIR SENSOR

MOTOR ACTUATOR

TOUCH-SCREEN OR KEYBOARD CONTROLLER DIALYSATE PRESSURE SENSOR

MIXING VALVE

LVDS VREF

DIALYZER

MUX

VCC1

FROM HEATER CONTROLLER

ADC

CURRENT LIMITER

ADC

LOGIC-LEVEL TRANSLATOR

OP AMP

WATER

HEATER ACTUATOR

SERIALIZER

INSTRUMENTATION AMP FILTER

BICARBONATE CARTRIDGE AND DELIVERY MECHANISM

HEATER

BACKLIGHT DRIVER

DESERIALIZER

COMPARATOR

DIALYSATE PUMP

TEMP SENSOR

DIGIPOT CONTRAST ADJUST

SENSOR SIGNAL PROCESSOR (SSP)

HALLEFFECT SENSOR NEW DIALYSATE

LCD DISPLAY MODULE

TOUCH-SCREEN OR KEYBOARD

O2 SATURATION SENSOR

USED DIALYSATE

MIXING VALVE

BLOOD PUMP

TO SSP ARTERIAL PRESSURE SENSOR

BLOOD PRESSURE SENSOR

RTC

CURRENTSENSE AMP

ADC WATCHDOG SYSTEM

MOTOR ACTUATOR

HEPARIN SYRINGE PUMP

HALL-EFFECT SENSOR

I/O EXPANDER

BLOOD FROM PATIENT

TO MOTOR ACTUATORS

MOTOR ACTUATOR

MCU

CURRENT-SENSE AMP

DAC

OFFLINE SWITCHER

LDO OR DC-DC

TO HEATER ACTUATOR

LDO OR DC-DC CHARGER/FUEL GAUGE

AUDIO CODEC DAC

VCC6

VCC3

BATTERY

TO VALVE ACTUATORS MULTIVOLTAGE SUPERVISOR

SERIAL INTERFACES

AUDIO AMP

VCC5

VCC2

ESD PROTECTION

TEMP SENSOR, FAN CONTROLLER

DAC

VCC4

LDO OR DC-DC

AC LINE

UART

TRANSCEIVERS

TO SSP VCC1

MEMORY CARD READER

DAC

MOTOR DRIVE, HEATER, VALVE CONTROLLER

MIC AMP

TO MCU

Figure 2: Dialysis machine generic block diagram (courtesy: Maxim semiconductors)

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Dialysis trends and workflow As shown in figure 2 clear understanding of the dialysis workflow is important so as to identify the pain areas that the medical device manufacturers are facing. These steps will also help to find solutions that will eventually enhance clinical workflow and result in better quality of life for those undergoing dialysis procedure. The challenge for future research in the area of dialysis machines technology is to generate controlled clinical studies to support its application. With the impact of financial constraints on healthcare, research will also need to examine the economic issues related

• • • •

Pre - dialysis testing Dialysis tests Liver function testing Viral marking Lipid profile

Patient details (new patient)

Patient’s weight, height, age, gender, hematocrit value are registered in a patient card to arrive at Kt/V

Aggregate data

• Access to pre-dialysis lab test reports from information system (IS): Na, K, Ca, Urea, Creatinine, Blood pressure, Body weight & Haemogram • Access post dialysis test results from same IS • Parameters set versus the achieved ones • Analysis of prescription compliance

to the application of newer modes of mechanical dialysis. Integrating the vital signs monitoring with dialysis in conjunction with other assessment parameters may prove to be useful tools to measure the impact on patients undergoing dialysis. Proliferation of wireless technologies, tech savvy patients, modern sensors have made strong impact on dialysis. There is a strong drive to enhance quality of life of patients undergoing dialysis. Portable dialysis machine that can be carried in a suitcase is paramount example for this.

Treatment plan

• Nephrologists decides appropriate dialysis treatment based on the nature of the renal injury(reduced nitrogen metabolism, urine output etc ) • Nephrologists reviews all the test results and decides on the type and line of treatment (hemodialysis, hemo filtration, hemo diafiltration) & frequency • Set various parameters in such a way so as to achieve the maximum efficiency of dialysis and hemodynamic response

Follow ups

Along with frequent dialysis therapies as suggested by the nephrologists, every quarter pre-dialysis testing is repeated

• • • • • • •

Prescription

Parameter setting: dialysate type, treatment time, UF volume, blood flow, heparin setting, substitution flow rate (Hemodiafiltration), etc.

Web based remote monitoring

Prescription download Remote-access & dashboard reports Quality control Auto vascular access surveillance Lab test reports and drug details (IS) Live access to machine data during usage including alarms Remote access for software upgrades and possible failure diagnosis using monitor logs.

Post dialysis

• Values delivered – patient body weight, urea, creatinine, vital signs during treatment • Patient compliance to prescription • Early detection of abnormal trends via live access to data and alarms, for corrective action • BioScan to analyze treatment quality and support modifications to prescription for max efficiency of dialysis

Pre dialysis patient evaluation Dialysis procedure is initiated after the technologist reenters patient body weight & dialysis duration in the hemodialysis m/c Safety checks Temperature, Resistivity, Prescribed dialyzer, Active alarms, Residual disinfectant

Monitoring during treatment

• Detection of complications – blood related, dialysate related, patient related • Extracorporeal circuit pressures • Anticoagulation • Treatment factors • Charting

Actual procedure

Graft/Fistula • Select sites • Disinfect • Anesthetize • Insert needles Catheters • Disinfect catheter limbs • Aspirate heparin from limbs • Evaluate patency Draw Blood Work • Prior to administering heparin • From arterial port • Administer heparin post draw Initiate Blood Flow to Dialyzer • Connect lines • Start at low BFR

Figure 3: Dialysis workflow

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Market drivers for dialysis machine The market drivers for medical devices may be applied to dialysis machine too. Emergence of new generation sensors, single chip solutions and new generation components have impacted the design architectures of dialysis machine. Patient and operator safety is prime importance which has been regulated by the certifying authorities which has imposed huge challenges for the medical device manufacturers. Better understanding of physiology, anatomy and disease patterns are also triggering a new wave of innovation in dialysis.

NxStage System One PORTABLE HEMODIALYSIS MACHINE provide the simplicity, flexibility and portability to make home hemodialysis a practical reality, without compromising safety is an excellent example demonstrating product design that answers the demands of dialysis market.

Figure 4: NxStage portable dialysis machine

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Tata Elxsi approach for dialysis machine Tata Elxsi’s proven expertise in engineering services is geared to tackle the challenges and pain areas of dialysis machines manufacturers. Tata Elxsi’s proven expertise in interdisciplinary domains such as embedded product design, industrial design, animation, visual effects and systems integration backed by an in-depth understanding of technology and mature processes and systems.

Case study: VOC dialysis machines of future Tata Elxsi conducted VOC study with leading nephrologists to understand the possible need for the dialysis machines of the future. Below are the higlights: 

TEL conducted VOC study – Head of Nephrology at Mumbai Hospital. Below mentioned are key highlights: Alarm requirements •

The range and sensitivity of the alarms should be internally set as default

•

Operator should only be able to operate within the set range without being able to alter these settings, especially while HD is in progress.

•

Alarms should be visible clearly from at least 2 meters, but also easily audible.

•

All blood alarms (air detector, arterial, venous, blood leak, trans membrane pressure, blood pump torque) should automatically shut off the blood pump, clamp the venous return line, and stop UF, thus isolating the patient.

Safety •

Equipment should programmed to automatically switch to ‘‘safe mode’’ thus, essentially isolating the patient from the HD machine.

•

Usage of heated citric acid as disinfectant is highly recommended.

Battery Backup Battery backup may be provided to the blood pump module.

New generation sensors and dialysate monitoring Introducing pH sensors may improve the safety of patients as uncontrolled pH values have caused fatalities in the past.

Figure 5: VOC case study - summary

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7 6

Importance

5 4 3 2 1 0

Usability

Alarm speficications

New generation sensors

Monitoring of dialysate

Battery backup

Safety

Features Figure 6. Emerging market design framework

Though dialysis is done under close observation, to assess the dialysis and integrate vital signs is important as integrating vital signs monitoring into the dialysis machines also precious time in the event of any irregularities. Tata Elxsi visualizes a concept of Encompassed dialysis in which: •

Assessment of dialysis

•

Monitoring of dialysate

•

Integration of vital parameters

•

Dialysis index parameter based on Assessment during dialysis and vital parameters

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Tata Elxsi emerging market framework Emerging market dynamics play a major role in the success of medical device manufacturers. The graphic below clearly depicts the demands of the dialysis market. About 10 percent of adults in India suffer from kidney disease and almost 200,000 patients develop end-stage disease ever year. Davita, Inc. of Torrance CA has already entered India in the services market. Now Medtronic Inc. of Minnesota will enter the kidney dialysis business in collaboration with India’s Apollo Hospitals Enterprise Ltd.

Medtronic is developing a low-cost, portable approach for patients in the developing world who are less likely to have access to service offered on machines made by Fresenius and Baxter, and need options that don’t require as much water and infrastructure. The challenges are different in emerging economies like reducing the dependency on ultrapure water that’s required by current dialysis machines. There is hardly enough water to nourish human beings and get food on the table in developing nations and designer must find a way to work on constraints. What this means is that MNCs are ready to experiment with new approaches that could address a large incremental market and these market experiments will be replicated in other emerging economies.

Japan 14%

EUR 15% ROW 51%

USA 20%

Figure 7. Global dialysis population

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Value engieering framework for dialysis machines Tata Elxsi’s value engineering framework is an excellent methodology to address the demands of dialysis market especially the needs of emerging market.

Product redesign goals definition System level study and understanding define focus areas Eliminate Bells and Whistles Identification and elimination

Modify For technology upgrade

Substitute Innovative & Low cost sub-systems

Feature enhancement Develop or acquire

Hardware software trade off analysis Software

Hardware Study existing design and specification and map functions and modules COTS Power supplies, motors, specific modules

Manufactured items PCBs ,enclosures, packaging

Study existing design and specifications and map functions and software modules

OS/RTOS

Analyze Software/ firmware/application Computation requirement and & Code Size

GUI

Features

Evaluate component / module against product redesign goals

Evaluate against product redesign goals

Cost per function approximation

Cost per function approximation

Explore to incorporate avenues like single chip solutions, new generation components and modules, technology upgrade high level integration

Explore possible modified HW configurations against SW architecture, including HW and communication drivers

High-level design specifications as per the defined product redesign goals

Figure 8: Tata Elxsi value engineering framework

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In addition to the typical value engineering concept, Tata Elxsi has developed a solution suite that will answer the questions raised by the emerging markets. This solution suite is equipped with tailor made solutions for the emerging market.

Cultural design framework Value engineering frugal design framework

Monitoring of restricted substance product and processes

Geography specific regulatory and statutory compliance support framework

Product realization

Tata Elxsi emerging market design solutions

Training module development ( Product and process)

Market analysis

Product reengineering

Competitive analysis Feature enhancement

Figure 9: Tata Elxsi emerging market design solution suite

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Conclusion The global dialysis market is estimated at $61.60 billion in 2013 and is poised to grow at a CAGR of 6.2% from 2013 to 2018, to reach $83.21 billion by 2018. A number of factors such as the increasing number of end stage renal disease (ESRD) patients and rising prevalence of diabetes and hypertension are stimulating the demand for dialysis treatment. Furthermore, growth in aging population, low preference of patients for kidney transplantation, technological advancements, and substantial government healthcare expenditure on the treatment of ESRD are propelling the growth of the products and services of Hemodialysis Market &Peritoneal Dialysis Market. Evolution of new dialysis modalities (such as home hemodialysis and nocturnal dialysis) and emerging

markets such as China and India represent high growth opportunities for market players. As of 2013, North America (comprising the U.S. and Canada) holds the largest share of the global Dialysis Market. This large share is attributed to the presence of a large number of dialysis patients in the U.S., high reimbursement rates, and the high adoption rate of new technologies in the North American Dialysis Market. However, the Asia-Pacific Dialysis Market is expected to witness the highest growth in the forecast period. A number of factors such as the increasing number of independent dialysis centers, increasing awareness about dialysis treatment modalities, and favorable changes in the reimbursement and healthcare

insurance policies are propelling the demand for dialysis products and services in the Asia-Pacific region. The major players in the global Dialysis Market include Fresenius Medical Care AG & Co. KGaA (Germany), DaVita Healthcare Partners, Inc. (U.S.), Gambro AB (Sweden), Baxter International, Inc. (U.S.), B. Braun Melsungen AG (Germany), Nipro Corporation (Japan), Diaverum Deutschland GmbH (Germany), Medical Components, Inc. (U.S.), Covidien (Ireland), and NxStage Medical, Inc. (U.S.) The gargantuan proportion of the patients needing dialysis is putting enormous pressure on the medical device manufacturers and they have no other choice but to turn to engineering service providers for help which in turn is the raison d’être for that fraternity.

About the author Vimal Kumar has 23 years of experience in Biomedical design, automated functional testing of Aircraft engines and turbines and also techno commercial business development. He holds an Indian Patent (No: 3035/ CHE/2010) for the smallest 3 lead

ECG machine. He leads Tata Elxsi’s medical electronics Solution team which plays a pivotal role in conceptualizing and developing service offerings for the medical device domain.

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Contact us For more information contact: [email protected]

About Tata Elxsi’s medical devicesengineering services offerings

About Tata Elxsi

Tata Elxsi provides design and engineering services to the medical devices industry. We understand the changing trends in this industry and offer services such as concept generation & validation, product development, verification & validation, and sustenance engineering.

A part of the $100 billion Tata group, Tata Elxsi addresses the communications, consumer products, defence, health care, media & entertainment, semiconductor and transportation sectors. This is supported by a network of design studios, development centers and offices worldwide. Key services include embedded product design, industrial design, animation & visual effects and systems integration. Tata Elxsi is a listed company and headquartered in Bangalore, India.

With a unique focus on product design and engineering services, we provide services across the product development lifecycle. We have leveraged our cross functional domain expertise in the areas of connectivity technologies (Bluetooth, Wi-Fi, wireless), mobility solutions, and industrial design to provide cutting edge solutions to our clients spanning Diagnostic & imaging, ventilator, infusion pump, therapeutic, surgical equipments, point of care, endoscopy, diabetes devices and tele-health solutions.

Tata Elxsi is a design company that blends technology, creativity and engineering to help customers transform ideas into world-class products and solutions.

References: •

Prnewswire report Dialysis Market [(Hemodialysis - Machine, Dialyzer, Bloodlines, Concentrates, Services), (Peritoneal Dialysis - Cycler, Catheter, Dialysate, CCPD, CAPD, IPD), (End Users - Hospital, Independent Dialysis Center, Home Dialysis)] Global Forecast to 2018.

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IEC 60601-2-16 Medical electrical equipment – Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment.

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