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Dialysis MachinesChallenges and Solutions
Vimal Kumar
A Tata Elxsi Perspective
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Dialysis Machines Challenges and Solutions 2
Introduction
Dialysis machine mimics the operationof kidney using a dialysis fluid, whichfacilitates the diffusion process. Themachine monitors treatment andensures that the equipment reverts toa fail safe condition in the event ofmalfunction, thereby protecting thepatient.
The purpose of this paper is to review
the status quo of dialysis machinetechnology, emerging trends andTata Elxsis approach to answer thedialysis machine market needs from atechnological perspective. This paperattempts to encompass the basic blocksof a dialysis machine within the productdesign framework and aims to align itwith our expertise.
Haemodialysis is a lifesavingintervention. Patients with renal diseaseundergo a progressive loss in renalfunction which eventually necessitatesdialysis therapy to sustain life. Whilelife sustaining in many circumstances,haemodialysis can be catastrophic ifappropriate care is not taken as it is avery complex therapeutic procedure.
Dialysis is a blood purification processwhich removes waste productsresulting from metabolism and foodintake. It can also correct electrolyteabnormalities and acid-base balance.Fluid gained in between treatments isalso removed during dialysis.
Arterial and
venous line
clamp Control
Blood unit
Arterial blood
pressure
monitoring
Venous blood
pressure
Monitoring
Blood Pump
Air Detection
Anticoagulant
Administration
Priming Detection
D
I
A
L
Y
Z
E
R
M
E
M
B
R
A
N
E
Fluid Unit
Inlet Pressure monitoring
and regulation
Temperature Monitoring
and regulation
Concentrate/
disinfectents intake
Conductivity monitoring
and regulation
UF measuring and
regulationsDegassing pressure and
flow regulation
TMP monitoring Blood leak detection
Clearance measurement
(optional)
pH Measurement of fluid
(optional)
Power supply Unit
DC Supply Generator
AC/DC Converter
Operator Panel Unit
Buttons Flow Path Display
Alarms Time Display
Information Display
Figure 1:Functional blocks of dialysis device
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Medical device
market drivers andtheir impact ondialysis machineMedical device technology is wellknown for its ability to adapt to otherdisciplines of knowledge, which isindeed the reason for its enhancement.Developments in aerospaceapplications, consumer electronics,and semiconductor technologies
have all triggered the avalanche ofinnovation in medical devices.
MiniaturizationMany of the complex circuitries canbe integrated into a single chip, whichreduces the real estate of PCBs, therebyrealizing products with smaller formfactors.
(For example, the fully-integrated
analog front end (AFE) chipwhich can be used for patientmonitoring, portable and high-end electrocardiogram (ECG),and electroencephalogram (EEG)equipment, in a BGA package size of8mm x 8mm).
Enhanced portability
Miniaturization of the medical devicehas, in turn, enhanced the portabilityof the medical device, which will helpin monitoring the condition of thepatient at any given point of time likeduring the transportation of the patientfrom one health care facility to another,shifting the patient from one place toanother, ambulatory monitoring etc.
Low power designs
Developments in Bioelectronics andsemiconductor technologies havemade it possible to design circuitsthat consume less power. This willalso allow for smaller battery size andlonger backup time. Smaller batterysize will reduce the weight and enhanceportability.
Enhanced clinical
workflowWireless connectivity in medical deviceswill enhance clinical workflow as themedical device need not be tetheredfor internet connectivity for an EMR orremote monitoring. Dialysis machineslike many other medical devices haveundergone enormous changes thanksto the technological developments. Thechanging technology, market dynamics,disease patterns have all contributedto the metamorphosis of dialysis
machines. The stringent regulatory andstatutory compliance requirementsalso catalyzed the innovation trendof dialysis machines. It is of greatimportance to understand the medicaldevice market drivers so as to assess itsimpact on dialysis machines.
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Dialysis machines architecture overview
The block diagram portrays thecomplex electromechanical challengesthat are addressed in the systemdesign of a typical dialysis machine.The design complexity gets anotherexponent when patient safety has tobe considered. The criticality of theprocedure while ensuring safety ofthe patient with, enhanced usabilitymake the design task a challenge forthe device designer. But then shipsare not made to be barnacle crested
but to go out in the rough sea. This isthe challenge that the medical devicedesign must be prepared for.
Dialysis machines are medicalequipment whose design andmanufacture is regulated by theFood and Drug Administration (FDA).They come under FDA device ClassII . This means that their design andconstruction must follow preciselydocumented processes, and theirperformance must meet stringentdocumentation, developmenttesting, production testing, andfield maintenance requirements.
The equipment also must containcomprehensive self-test and fault-indication capabilities, which require
BLOOD
PUMP
BICARBONATE
CARTRIDGE
AND DELIVERY
MECHANISM
HEPARIN
SYRINGE
PUMP
USED
DIALYSATE
BLOOD FROM PATIENT
LCD DISPLAY MODULE
BACKLIGHT
WATER
MCU
LVDS
ARTERIAL
PRESSURE
SENSOR
MOTOR DRIVE,
HEATER, VALVE
CONTROLLER
TOUCH-SCREEN OR
KEYBOARD
TOUCH-SCREEN OR
KEYBOARD
CONTROLLER
AIR TRAP,
AIR
SENSOR
VENOUS
PRESSURE
SENSOR
BLOOD TO PATIENT
BLOOD
PRESSURE
SENSOR
AC LINE
OFFLINE
SWITCHER
LDO OR DC-DC
LDO OR DC-DC
LDO OR DC-DC
MOTOR
ACTUATOR
DIALYSATE
PRESSURE
SENSOR
NEW
DIALYSATE
DIALYSATE
PUMP
CONTROL SIGNAL FROM MOTOR
DRIVE CONTROLLER
TO MOTOR
ACTUATORSMOTOR
ACTUATOR
MOTOR
ACTUATOR
TO SSP
SENSOR SIGNAL PROCESSOR (SSP)
SERIAL
INTERFACES
MEMORY
CARD
READER
TRANS-
CEIVERS
LOGIC-LEVEL
TRANSLATOR
O2SATURATION SENSOR
TO SSP
BATTERYCHARGER/FUEL
GAUGE
HEATER
ACTUATOR
FROM HEATER
CONTROLLER
MIXING
VALVE
MIXING
VALVE
TO VALVE
ACTUATORS
TEMP
SENSOR
TEMP
SENSOR,
FAN
CONTROLLER
AMP
MULTIVOLTAGE
SUPERVISOR
TO MCU
WATCH-
DOG
SYSTEM
HALL-
EFFECT
SENSOR
HALL-EFFECT
SENSOR
FILTER
ADC
ADC
ADC
INSTRUMENTATION
AMP
DAC
DAC
DAC
DAC
TO HEATER
ACTUATOR
SERIALIZER
BACKLIGHT
DRIVER
OP AMP
CURRENT-
SENSE
AMP
CURRENT-SENSE AMP
TO SSP
TO SSP
CURRENT-SENSE AMP
MUX
COMPARATOR
VREF
DIGIPOT
CONTRAST
ADJUST
CURRENT
LIMITER
ESD
PROTECTION
UART
RTC
I/O
EXPANDER
MIC AMP
AUDIO
CODEC
VCC1
VCC2
VCC3
VCC4
VCC5
VCC6
VCC1
HEATER
DESERIALIZER
DIALYZER
AUDIO
Figure 2: Dialysis machine generic block diagram (courtesy: Maxim semiconductors)
additional circuitry and the use ofcomponents that include self-testfeatures. Electrical leakage to thepatient is a significant concern.Medical device developers must meetthe requirements of the IEC 60601-1product safety standard for electricalmedical equipment. In addition to thisthe dialysis machine must comply tothe standard IEC 60601-2-16 Medicalelectrical equipment Part 2-16:Particular requirements for the basic
safety and essential performance ofhaemodialysis, haemodiafiltration andhaemofiltration equipment.
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Dialysis trends and workflow
As shown in figure 2 clearunderstanding of the dialysis workflowis important so as to identify thepain areas that the medical devicemanufacturers are facing. These stepswill also help to find solutions that willeventually enhance clinical workflowand result in better quality of life forthose undergoing dialysis procedure.
The challenge for future research in thearea of dialysis machines technology is
to generate controlled clinical studiesto support its application. With theimpact of financial constraints onhealthcare, research will also need toexamine the economic issues related
to the application of newer modes ofmechanical dialysis. Integrating thevital signs monitoring with dialysis inconjunction with other assessmentparameters may prove to be usefultools to measure the impact on patientsundergoing dialysis. Proliferation ofwireless technologies, tech savvypatients, modern sensors have madestrong impact on dialysis.
There is a strong drive to enhance
quality of life of patients undergoingdialysis. Portable dialysis machinethat can be carried in a suitcase isparamount example for this.
Figure 3:Dialysis workflow
Pre - dialysis testing Dialysis tests
Liver function testing
Viral marking
Lipid profile
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
Patient details (new patient)Patients weight, height, age,
gender, hematocrit value are
registered in a patient card to
arrive at Kt/V
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 hemodynamicresponse
PrescriptionParameter setting: dialysate type, treatment time, UF
volume, blood flow, heparin setting, substitution flow rate
(Hemodiafiltration), etc.
Pre dialysis patient evaluationDialysis 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
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
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.
Follow upsAlong with frequent dialysis therapies as suggested by the
nephrologists, every quarter pre-dialysis testing is repeated
Actual procedureGraft/Fistula Select sites Disinfect Anesthetize Insert
needles
Catheters Disinfect catheter limbs Aspirate heparin from
limbs Evaluate patency
Draw BloodWork Prior to administering heparin From
arterial port Administer heparin post draw
Initiate Blood Flow to Dialyzer Connect lines Start at low
BFR
Monitoring during treatment Detection of complications blood related,
dialysate related, patient related
Extracorporeal circuit pressures
Anticoagulation
Treatment factors
Charting
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Market drivers for dialysis machine
The market drivers for medical devicesmay be applied to dialysis machinetoo. Emergence of new generationsensors, single chip solutions and newgeneration components have impactedthe design architectures of dialysismachine. Patient and operator safetyis prime importance which has beenregulated by the certifying authoritieswhich has imposed huge challengesfor the medical device manufacturers.Better understanding of physiology,
anatomy and disease patterns are alsotriggering a new wave of innovation indialysis.
NxStage System One PORTABLEHEMODIALYSIS MACHINE provide thesimplicity, flexibility and portability tomake home hemodialysis a practicalreality, without compromising safety isan excellent example demonstratingproduct design that answers thedemands of dialysis market.
Figure 4: NxStage portable dialysis machine
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Tata Elxsi approach
for dialysis machineTata Elxsis proven expertise inengineering services is geared to tacklethe challenges and pain areas of dialysismachines manufacturers. Tata Elxsisproven expertise in interdisciplinarydomains such as embedded productdesign, industrial design, animation,visual effects and systems integrationbacked by an in-depth understandingof technology and mature processesand systems.
Case study: VOC
dialysis machines offutureTata Elxsi conducted VOC study withleading nephrologists to understandthe possible need for the dialysismachines of the future. Below are thehiglights:
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.
TEL conducted VOC study Head of Nephrology at Mumbai Hospital. Below mentioned are key highlights:
Figure 5:VOC case study - summary
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Figure 6.Emerging market design framework
Though dialysis is done under close observation, to assess the dialysis andintegrate vital signs is important as integrating vital signs monitoring into thedialysis 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 vitalparameters
0
1
2
3
4
5
6
7
Usability Alarm speficications New generationsensors
Monitoring ofdialysate
Battery backup Safety
Importance
Features
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Figure 7. Global dialysis population
Tata Elxsi emerging market framework
Emerging market dynamics play amajor role in the success of medicaldevice manufacturers. The graphicbelow clearly depicts the demands ofthe dialysis market.
About 10 percent of adults in Indiasuffer from kidney disease and almost200,000 patients develop end-stagedisease ever year. Davita, Inc. ofTorrance CA has already entered India
in the services market. Now MedtronicInc. of Minnesota will enter the kidneydialysis business in collaboration withIndias Apollo Hospitals Enterprise Ltd.
Medtronic is developing a low-cost,portable approach for patients inthe developing world who are lesslikely to have access to service offeredon machines made by Freseniusand Baxter, and need options thatdont require as much water andinfrastructure. The challenges aredifferent in emerging economies likereducing the dependency on ultrapurewater thats required by current dialysis
machines. There is hardly enough waterto nourish human beings and get foodon the table in developing nations anddesigner must find a way to work onconstraints.
What this means is that MNCs are readyto experiment with new approachesthat could address a large incrementalmarket and these market experimentswill be replicated in other emergingeconomies.
ROW 51%
USA 20%
EUR 15%
Japan 14%
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Value engieering framework for dialysis
machinesTata Elxsis value engineering framework is an excellent methodology to addressthe demands of dialysis market especially the needs of emerging market.
Figure 8:Tata Elxsi value engineering framework
SubstituteInnovative & Low cost
sub-systems
ModifyFor technology
upgrade
High-level design specifications as per the defined product redesign goals
Eliminate
Bells and Whistles
Identification and
elimination
System level study and understanding define focus areas
Product redesign goals definition
Feature enhancement
Develop or acquire
Evaluate component / module against product redesign goals
Explore to incorporate avenues like single chip solutions, new
generation components and modules, technology upgrade high
level integration
Study existing design and specification and map functions and
modules
COTS
Power supplies, motors, specificmodules
Manufactured items
PCBs ,enclosures, packaging
Hardware Software
OS/RTOS GUIAnalyze Software/ firmware/application
Computation requirement and & Code Size Features
Hardware
software trade
off analysis
Study existing design and specifications and map functions and software modules
Evaluate against product redesign goals
Explore possible modified HW configurations against SW architecture, including HW
and communication drivers
Cost per function approximation Cost per function approximation
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In addition to the typical value engineering concept, Tata Elxsi has developed asolution 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 designframework Geography
specificregulatory and
statutorycompliance
support
framework
Productrealization
Market analysis
Competitiveanalysis
Featureenhancement
Productreengineering
Training moduledevelopment
( Product andprocess)
Monitoring ofrestrictedsubstance
product andprocesses
Valueengineeringfrugal design
framework
Tata Elxsiemerging
market designsolutions
Figure 9:Tata Elxsi emerging market design solution suite
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Conclusion
About the author
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 thepresence 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 HealthcarePartners, 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
dtre for that fraternity.
ECG machine. He leadsTata Elxsis
medical electronics Solution
team which plays a pivotal role in
conceptualizing and developing
service offerings for the medical
device domain.
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
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 andrising 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
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About Tata Elxsi
Tata Elxsi is a design company thatblends technology, creativity andengineering to help customerstransform ideas into world-classproducts and solutions.
A part of the $100 billion Tatagroup, Tata Elxsi addresses thecommunications, consumer products,defence, health care, media &entertainment, semiconductorand transportation sectors. This issupported by a network of design
studios, development centers andoffices worldwide. Key services includeembedded product design, industrialdesign, animation & visual effectsand systems integration. Tata Elxsi is alisted company and headquartered inBangalore, India.
About Tata Elxsis
medical devices-engineering services
offeringsTata Elxsi provides design andengineering services to the medicaldevices industry. We understandthe changing trends in this industryand offer services such as conceptgeneration & validation, productdevelopment, verification & validation,
and sustenance engineering.With a unique focus on productdesign and engineering services,we provide services across theproduct development lifecycle. Wehave leveraged our cross functionaldomain expertise in the areas ofconnectivity technologies (Bluetooth,Wi-Fi, wireless), mobility solutions, andindustrial design to provide cuttingedge solutions to our clients spanningDiagnostic & imaging, ventilator,
infusion pump, therapeutic, surgicalequipments, point of care, endoscopy,diabetes devices and tele-healthsolutions.
Contact us
For more information contact:[email protected]
References:
Prnewswire report Dialysis Market [(Hemodialysis - Machine, Dialyzer, Bloodlines, Concentrates, Services), (PeritonealDialysis - Cycler, Catheter, Dialysate, CCPD, CAPD, IPD), (End Users - Hospital, Independent Dialysis Center, Home Dialysis)] -
Global Forecast to 2018.
IEC 60601-2-16 Medical electrical equipment Part 2-16: Particular requirements for the basic safety and essentialperformance of haemodialysis, haemodiafiltration and haemofiltration equipment.
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