Dialysis Machines Challenges and Solutions

8/12/2019 Dialysis Machines Challenges and Solutions

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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.

Dialysis Machines Challenges and Solutions

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