Dialysis Machines

Challenges and Solutions

Vimal Kumar
A Tata Elxsi Perspective
Dialysis Machines Challenges and Solutions
2
Introduction
Dialysis machine mimics the operation
of kidney using a dialysis uid, which
facilitates the diusion 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 Elxsis 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.
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 purication 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.
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
regulations
Degassing 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
Dialysis Machines Challenges and Solutions
3
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 high-
end electrocardiogram (ECG),
and electroencephalogram (EEG)
equipment, in a BGA package size of
8mm x 8mm).
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
workow
Wireless connectivity in medical devices
will enhance clinical workow 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.
Dialysis Machines Challenges and Solutions
4
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
eld maintenance requirements.
The equipment also must contain
comprehensive 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
ACTUATORS MOTOR
ACTUATOR
MOTOR
ACTUATOR
TO SSP
SENSOR SIGNAL PROCESSOR (SSP)
SERIAL
INTERFACES
MEMORY
CARD
READER
TRANS-
CEIVERS
LOGIC-LEVEL
TRANSLATOR
O
2
SATURATION SENSOR
TO SSP
BATTERY
CHARGER/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
V
CC1
V
CC2
V
CC3
V
CC4
V
CC5
V
CC6
V
CC1
HEATER
DESERIALIZER
DIALYZER
AUDIO
Figure 2: Dialysis machine generic block diagram (courtesy: Maxim semiconductors)
additional circuitry and the use of
components that include self-test
features. Electrical leakage to the
patient is a signicant 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, haemodialtration and
haemoltration equipment.
Dialysis Machines Challenges and Solutions
5
Dialysis trends and workow
As shown in gure 2 clear
understanding of the dialysis workow
is important so as to identify the
pain areas that the medical device
manufacturers are facing. These steps
will also help to nd solutions that will
eventually enhance clinical workow
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 nancial constraints on
healthcare, research will also need to
examine the economic issues related
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.
Figure 3: Dialysis workow
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 hemodynamic
response
Prescription
Parameter setting: dialysate type, treatment time, UF
volume, blood flow, heparin setting, substitution flow rate
(Hemodiafiltration), etc.
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
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 ups
Along with frequent dialysis therapies as suggested by the
nephrologists, every quarter pre-dialysis testing is repeated
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
Monitoring during treatment
Detection of complications blood related,
dialysate related, patient related
Extracorporeal circuit pressures
Anticoagulation
Treatment factors
Charting
Dialysis Machines Challenges and Solutions
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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, exibility 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
Dialysis Machines Challenges and Solutions
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Tata Elxsi approach
for dialysis machine
Tata Elxsis proven expertise in
engineering services is geared to tackle
the challenges and pain areas of dialysis
machines manufacturers. Tata Elxsis
proven expertise in interdisciplinary
domains such as embedded product
design, industrial design, animation,
visual eects 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:
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
Dialysis Machines Challenges and Solutions
8
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
0
1
2
3
4
5
6
7
Usability Alarm speficications New generation
sensors
Monitoring of
dialysate
Battery backup Safety
I
m
p
o
r
t
a
n
c
e

Features
Dialysis Machines Challenges and Solutions
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Figure 7. Global dialysis population
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
suer 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
Indias 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 oered
on machines made by Fresenius
and Baxter, and need options that
dont require as much water and
infrastructure. The challenges are
dierent in emerging economies like
reducing the dependency on ultrapure
water thats 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 nd 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.
ROW 51%
USA 20%
EUR 15%
Japan 14%
Dialysis Machines Challenges and Solutions
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Value engieering framework for dialysis
machines
Tata Elxsis value engineering framework is an excellent methodology to address
the demands of dialysis market especially the needs of emerging market.
Figure 8: Tata Elxsi value engineering framework
Substitute
Innovative & Low cost
sub-systems
Modify
For 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, specific
modules
Manufactured items
PCBs ,enclosures, packaging
Hardware
Software
OS/RTOS GUI
Analyze 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
Dialysis Machines Challenges and Solutions
11
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
Geography
specific
regulatory and
statutory
compliance
support
framework
Product
realization
Market analysis
Competitive
analysis
Feature
enhancement
Product
reengineering
Training module
development
( Product and
process)
Monitoring of
restricted
substance
product and
processes
Value
engineering
frugal design
framework
Tata Elxsi
emerging
market design
solutions
Figure 9: Tata Elxsi emerging market design solution suite
Dialysis Machines Challenges and Solutions
12
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 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-Pacic 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-Pacic
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
dtre for that fraternity.
ECG machine. He leads Tata Elxsis
medical electronics Solution
team which plays a pivotal role in
conceptualizing and developing
service oerings 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 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
Dialysis Machines Challenges and Solutions
13
About Tata Elxsi
Tata Elxsi is a design company that
blends technology, creativity and
engineering to help customers
transform ideas into world-class
products and solutions.
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
oces worldwide. Key services include
embedded product design, industrial
design, animation & visual eects
and systems integration. Tata Elxsi is a
listed company and headquartered in
Bangalore, India.
About Tata Elxsis
medical devices-
engineering services
oerings
Tata Elxsi provides design and
engineering services to the medical
devices industry. We understand
the changing trends in this industry
and oer services such as concept
generation & validation, product
development, verication & validation,
and sustenance engineering.
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.
Contact us
For more information contact:
mebu@tataelxsi.co.in
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.
IEC 60601-2-16 Medical electrical equipment Part 2-16: Particular requirements for the basic safety and essential
performance of haemodialysis, haemodialtration and haemoltration equipment.