Medical Devices, Interoperability & eHealth Standardization

INTEROPERABILITY OF
MEDICAL DEVICES
in INDIA
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FOREWORD
Continua Health Alliance is the only organization convening global technology industry standards to develop
end-to-end, plug-and-play connectivity for personal connected health systems. Our Design Guidelines and test tools
expedite the deployment of personal connected health devices and systems that will dramatically improve health
management, clinical outcomes and quality of life. At the same time, Continua Design Guidelines are proven to
decrease time to market and reduce development costs.
Our focus is on creating a global market for personal connected health, working with a number of countries and
national health ministries to support the development and implementation of groundbreaking national connected
health initiatives. Continua is pleased to have an established presence in India, to advance end-to-end, plug-and-play
interoperability in this important medical devices market. Continua is a strong voice for personal connected health
technologies among employers, payers, regulatory bodies, government agencies and care providers, and we work
collaboratively with advocacy, legislative and regulatory agencies on behalf of our membership.
Continua is pleased to carry forward our mission and represent our membership to support the e!cient, cost eective
and bene#cial adoption of connected health in India.
Clint McClellan
Board President and Chairman, Continua Health Alliance
Senior Director of Strategic Marketing, Qualcomm Life Inc.
a wholly owned subsidiary of Qualcomm Technologies Inc.

INTEROPERABILITY OF
MEDICAL DEVICES
in INDIA
Chairman’s Message
Greetings from the Continua Health Alliance-India Working Group (IWG).
It gives me immense pleasure to present to you the #rst report of the Continua Health Alliance-India Working Group. This report is also a unique
one since this is the #rst report that brings to fore the subject of interoperability of medical devices in India.
India being the second most populous country in the world is experiencing a boom in its healthcare sector owing to the various demographic
and socio-economic related factors. We are witnessing a time in this country wherein the focus is not only basic issues related to healthcare such
as universal access and equity, but also on quality of care and progressive delivery concepts such as home-based care. With increase in
aordability among a large section of the population, there is an increased demand for care to be delivered and monitored in a technologically
enabled environment. With the spurt in the mHealth, this need has been further exaggerated. These factors have lead to a sharp growth in
manufacturing from both indigenous and multinational medical device companies. With more number of healthcare providers embracing
technology in their care delivery process, this growth is estimated to only increase in the near future.
However, extensive use of such medical devices has their own set of challenges, with interoperability leading the chart. At this pivotal juncture,
our organization would like to present to you the #rst report pertaining to interoperability standards of medical devices in India. I am of the
opinion that interoperability not only brings about standardization of the care delivery and monitoring processes, but also paves the way for
equitable healthcare. In addition to these, adoption of interoperability standards would provide a chance for Indian medical devices
manufacturers to take their products onto the international market thereby driving revenues through exports.
The issue of ‘interoperability’ is missing from the agenda of the industry and the policy makers alike. Imagine hundreds of service providers
delivering healthcare across India and none of their solutions being able to interface seamlessly with other systems? It would spell a disaster for
patients, where data of patients could be lost or not be portable to the other system at all leading to losses beyond any statistical calculations!
Imagine what would have happened if Internet had failed? In 1982, the Internet Protocol suite (TCP/IP) was standardized, and consequently, the
concept of a worldwide network of interconnected TCP/IP networks, called the Internet, was introduced. Internet could not have succeeded had
there been no ‘self regulation’ and without the ‘universally accepted standards’amongst dierent manufacturer’s and service providers. Similarly,
Continua standards are the best example of self-regulation and industry wide accepted standards for interoperability and data security; the
biggest headaches for any healthcare organization as healthcare moves towards automation with technology.
This report has taken about six months of research and interviews with global leaders and decision makers. All this could not have been possible
without support from the industry. It would be inappropriate if I fail to put on record my deep appreciation with thanks for the support from
Continua Health Alliance USA, Boston Scienti#c Corporation, and Allarch Healthcare. Without their support, this report would not have landed
into your hands. I would also like to put on record my immense gratitude to Alice Borrelli, Clint McClellan , Chuck Parker, Debasis Bharadwaj,
Anando Sen Gupta , Vibhav Garg, Dharmendra Ghai , Dr. Chinmya P. Chigateri, the entire team at HealthMinds'and other industry leaders for their
valuable contribution to this report.
At Continua Health Alliance, we will continue to bring many more scienti#c publications covering the key issues in the Indian medical devices
healthcare IT industry. We will continue to work with Policy makers, industry partners and all other stakeholders through many more such useful
reports, certi#cation programs and other activities for the bene#t of all stakeholders, keeping in mind the interest of the patients above all.
I await your kind feedback on our #rst report on India.
With Kind Regards,
Rajendra Pratap Gupta
Chairman, Continua Health Alliance – IWG
www.continuAalliance.org, Email : indiachair@continuaalliance.org, Fax : +91 114582 3355
Rajendra Pratap Gupta
Chairman
Continua Health Alliance – IWG

INTEROPERABILITY OF
MEDICAL DEVICES
in INDIA
Table of contents
Introduction (1)
Global Medical Devices Industry (20)
Indian Medical Devices Industry (33)
Interoperability (48)
Interoperability Standards in India (59)
Conclusions and recommendations (70)
US interoperability case study (73)
Leaders speak (75)
References (80)
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interoperability standards
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regulatory standards
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1 INTEROPERABILITY OF
MEDICAL DEVICES Introduction
in INDIA
Introduction
Background of the white paper
De#nition of interoperability
Bene#ts of interoperability
Background on existing
Barriers and challenges to
interoperability
Global Medical Devices Industry
Indian Medical Devices Industry
Interoperability
Interoperability standards
in India
Conclusions and
recommendations
Medical devices are pivotal in the health care delivery system due to their role in diagnosis,
prevention, management, and treatment of disease conditions. The WHO [1] estimates that over
1.5 million dierent medical devices in more than 10,000 types of generic device groups are
currently available worldwide. According to industry experts, the global medical devices market
will be between US$ 307.7 and 434.4 billion [2, 29] by 2017, with a CAGR of 6.1% during 2011-2017.
Innovations, technological advancements, ballooning populations and rise in demand for standard
healthcare have been the driving factors for this large in$ux of medical devices in the market. In
such a scenario, interoperability of medical devices, i.e. the ability to make one instrument or device
to communicate with another device as well as share data with healthcare information systems
seamlessly, is of utmost importance to achieve patient safety and healthcare e!ciency.
Diagnostic
devices
Monitoring
medical
devices
Treating
devices
1

INTEROPERABILITY OF
MEDICAL DEVICES
Introduction
in INDIA
interoperability
Interoperability
in India
Conclusions and
recommendations
With advanced technologies, medical devices today are equipped to capture critical medical data
even in real time. But their inability to communicate with other devices or lack of plug-and-play
interoperability would seriously compromise patient care.
Absence of interoperability may aect some crucial functions:
The inability to use available data prevents patients from receiving better healthcare delivery. For
example, a signi#cant amount of data is generated in an Emergency Medical Services vehicle
(ambulance) while the patient is being transported. However, lack of interoperability may counter
real time transfer of this data into the emergency medicine department at the receiving hospital. It
delays the initiation of treatment procedure due to lack of medical information [22].
t Synchronisation of patient's respiratory cycle with x-ray machine, especially in the emergency
room, is known to improve quality of image. However, poor quality images are generated due to
lack of interoperability among these devices [22].
t Safety interlock and alert systems could be used to stop the $ow of pain medication from an
infusion pump if a patient showed signs of respiratory distress[22]. Interoperability in this scenario
can be lifesaving. Failure to connect safety interlock and alert system leads to dependency on
manual monitoring, which increases the risk of fatal errors.
Lack of clarity in device interface standards and questionable reliability and performance of patient
data sharing networks are serious challenges to achieving interoperability. A worldwide standard
interoperable guideline can enable health care professionals to provide better patient care through
an integrated system of various medical devices and data sharing with electronic health record
systems. This would ensure eective, economic and time-bound services to patients.
2

INTEROPERABILITY OF
MEDICAL DEVICES Introduction
in INDIA
interoperability
Interoperability
in India
Conclusions and
recommendations
Advice from AAMI in Health Information Technology and Interoperability [HITI][3], supported by
the FDA in the USA, suggests that standardization of interoperability and ensuring implementation
of those standards are the key to achieving interoperability and better patient care.
In line with global eorts, this white paper states the current scenario in global and Indian medical
devices market, overview of interoperability, standards of interoperability in India, gaps and
barriers to its acceptance, outline of Continua Health Alliance guideline and strategies to
collaborate and coordinate with Indian standards.
There are some signi#cant reasons for the introduction of this white paper in India.
Visiongain, a London based business information provider determined that the Indian medical
devices market will reach US$ 11 billion by 2023 [24], largely driven by the following three major
forces:
Population: India is the second most populous nation in the world. The CIA World Fact Book [25]
demographic statistics (as of 2012) divides the age structure of India's population as follows:
15-64 years
65.2%
0-14 years
29.3%
65
years
5.6%
3

MEDICAL DEVICES
Introduction
Background of the white
paper
interoperability
Interoperability
in India
Conclusions and
recommendations
º With the current Indian population of 1.2 billion, each of these age groups contribute signi#cant
numbers to the total. In the 0-14 age group, the focus would be primarily on pre and post natal care,
safe delivery, mother and child health and preventive care. The country's maternal mortality rate
stands at 200 deaths/100,000 live births (2010) and infant mortality rate of 46 deaths/1000 live
births. In the age groups between 15-64 years, the focus would be primarily on non-communicable
life style diseases, especially after the age of 40.
º Women’s health would require greater attention. Although population beyond the 65 year age
group accounts for only 5.6% of the 1.2 billion, it would still amount to 67 million people. Indian
population life expectancy at birth is 67 years and nation spends 2.4% of its GDP (2005) on
healthcare. The country has 0.9 beds for 1000 population. The point underlined is that the nation
needs a huge investment in healthcare sector. With rapid growth expected, it would acts as an
anchor pole for increase in number of medical devices being utilized.
t Health insurance: a major factor driving expenditure in healthcare sector is health insurance. The
Indian Medical Device Market Outlook [24] places health insurance as the fastest growing non-life
segment insurance in the country. Increase in healthcare insurance policy holders will contribute to
providing a better structure to care delivery process in a technologically enabled environment. Due
to customer demand, healthcare providers would need to ensure standard protocols and
standardization across the devices they use.
t 'Medical Tourism': Indian medical tourism industry is currently growing at double digits as per
industry estimates. In order to be on par with global standards, Indian healthcare needs to
modernize and medical equipment form a signi#cant aspect of it.
When the nation is poised to witness a boom in healthcare sector, it is also facing certain challenges
in the #eld of medical devices and their interoperability.
The above scenario con#rms our conviction that now is the time to release a white paper in the #eld
of interoperability of medical devices in India. It will provide clarity to the various opportunities and
issues involved in this area by encouraging all stakeholders to work together to adopt
interoperability standards in India.
INTEROPERABILITY OF
in INDIA
4

MEDICAL DEVICES
Introduction
De!nition of interoperability
interoperability
Interoperability
in India
Conclusions and
recommendations
De#nitions of interoperability
Some de#nitions of interoperability are:
- ’It is the ability of a system or a product to work with other systems or products without any
special eort from the customer’ [4].
- ‘The goal of interoperability is the exchange of computable data between computer systems
which may be owned by dierent organizations they collaborate with to ful#ll a business work$ow'
[5].
Though technically both the de#nitions are accurate, they are generic in nature. Any de#nition of
interoperability needs to be:
t Acceptable to all the stakeholders in the health care industry
t Enduring
t Intelligible even to a non-scienti#c audience.
In a bid to de#ne interoperability in the context of healthcare devices, two major healthcare
information technology organizations, namely, Healthcare Information and Management Systems
Society (HIMSS) and the National Alliance for Health Information Technology (NAHIT) have worked
enormously to develop consensus regarding the de#nition [6].
HIMSS [7] de#nes interoperability as ‘the ability of health information systems to work together
within and across organizational boundaries in order to advance the eective delivery of
healthcare for individuals and communities'. NAHIT has de#ned interoperability as ’the ability of
dierent information technology systems, software applications and networks to communicate,
exchange data accurately, eectively and consistently, and use that information that has been
exchanged.’
INTEROPERABILITY OF
in INDIA
5

MEDICAL DEVICES
Introduction
interoperability
Interoperability
in India
Conclusions and
recommendations
Types of interoperability
The National Committee on Vital and Health Statistics [8] (NCVHS) Report on Uniform Data
Standards for Patient Medical Record Information segregates interoperability into three types:
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other but do not require recipient computer to interpret the message.
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and messages between computers are interpreted at the level of data #eld.
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The three levels of interoperability were further improvised by Turnista. The AAMI has adopted
Turnista Model of Hierarchy [3] which had added two more levels:
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elements of the data, and context of the data. At level 5, there is dynamic interoperability which is
more $exible and allows changing context and relationship over time [3].
Even though the model depicts hierarchical structure of interoperability, the solutions need not be
hierarchical. For example, in a rare situation, it is possible to have semantic interoperability, but not
technical interoperability. The ordering is based on the typical implementation of and historical
approaches to interoperability.
INTEROPERABILITY OF
in INDIA
Interoperability
Level 5
Level 4
Dynamic interoperability
It is $exible and allows for changing contexts and relationships
over time or within the scope of speci#c transactions
Pragmatic interoperability
There is shared understanding of data, the relationships between
elements of the data and the context of the data but it cannot
accommodate changing relationships or context
6

Five levels of interoperability [Courtesy AAMI] [3]
The AAMI Ad Hoc Group on Health Information Technology and Interoperability (HITI) per for med
a detailed survey on concepts of interoperability given by HIMSS, NAHIT and various other
healthcare information organizations. After an in-depth consideration of standards from HL7, IEEE,
ASTM, and through engaging pro#ling, testing, and certi#cation bodies like Continua and IHE, and
consulting speci#c market surveys, a comprehensive de#nition was brought out. It de#ned
interoperability as ’the ability of medical devices, clinical systems or their components to
communicate in order to safely ful#ll an intended purpose.’
The meaning of communication in the above de#nition is interpreted in the broadest sense as
incorporating communication of intent and desire to communicate. I t can be safely concluded
that the de#nition of HITI conveys, after considering both safety of the patient and the intended
purpose of interoperability, a broader meaning that will ser ve as a guideline for further exploring
the concept of interoperability.
INTEROPERABILIT Y OF
MEDICAL DEVICES
Introduction
in INDIA
interoperability
Global Medical Devices Industr y
Indian Medical D evices Industr y
Interoperability
in India
Conclusions and
recommendations
Integrabil ity
Leve l 3
Level 2
Connect ivit y
Level 1
Semantic interoperability
The data have meaning but a full understanding of the
relationships between elements of data and the context of the
data is missing
Functional interoperability
Information is communicated with structure but without any
meaning
Basic interoperability
Two systems have the means to communicate, but neither has a
shared understanding of the structure or meaning of the data
communicated
7

Interoperability as a concept is currently in its incipient stage [3]. It is expected that the volume of
medical devices that communicate with each other will grow manifold in near future. Setting a
uniform standard in devices interoperability globally will help avoid duplication of eorts among
stakeholders. Simultaneously, it will ensure standard safety protocols, promote eectiveness and
economic viability and allow integrated use of diagnostic and therapeutic equipment by medical
practitioners. Individual components can then interact with each other, keep track of medical
records through connectivity to healthcare system data base and ensure initiation of safe and
eective action.
The principal stakeholders in the bene#ts of interoperability are:
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partnership
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INTEROPERABILITY OF
MEDICAL DEVICES
Introduction
in INDIA
Bene!ts of interoperability
interoperability
Interoperability
in India
Conclusions and
recommendations
Patients Provider
Government Industry
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8

Some of the bene#ts of standard-compliant interoperable medical devices are[3]:
Advantages to the patients
The core bene#t of interoperability is that it ensures patient safety[3]. In an emergency scenario
where time is the most critical factor, prompt decision means favourable clinical outcomes,
thereby positively impacting treatment outcomes. In the USA alone, a staggering 100,000 people
are estimated to lose their lives every year due to preventable medical errors1. Medical device
interoperability is therefore a fundamental issue and not a peripheral one.
The French National Health Insurance Agency opines that there is a new trend where patients wish
to get treated at home [9]. This would result in the use of more sophisticated medical devices that
enable care delivery at the patient’s residence, requiring greater interoperability among them.
Numerous instruments without interoperability will create too many problems for patients.
Therefore interoperability holds the key for safe and e!cient home based care.
Device interoperability will help patients receive the full bene#ts of technological innovation and
enable them to manage their health at aordable prices. [10]
Advantages to healthcare professionals
Although an interoperable device might capture large amount of data pertaining to a patient, it
remains counterproductive unless it enables clinical decision making. The most important aspect
would be to help share patient data among healthcare providers across multi-disciplinary teams to
enable better care services. It can also help improve the economic aspect of healthcare
management by streamlining inventories, billing and record optimization [1].
Medical device connectivity enables automation of information procurement, improves data
precision and facilitates integration of personal medical information into clinical work$ows pattern
seamlessly [10].
INTEROPERABILITY OF
MEDICAL DEVICES
Introduction
in INDIA
interoperability
Interoperability
in India
Conclusions and
recommendations
t
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t
t
t
9

Advantages to industry
With standard guidelines in place, the eort of technology designers can be directed towards
standardizing existing products and encouraging newer innovations. There is a clear #nancial
bene#t, as companies will not need to spend resources on interoperability aspects. Instead they can
focus on new functionality and use standardized interfaces. Healthy competition in research and
development and manufacturing enables production of newer and high quality devices [1].
A plethora of clinical applications like electronic health record, personal health record, clinical work
$ow, clinical decision making systems are con#gured to dierent interfaces. It reduces the bene#ts
of medical devices as data may not be readily usable [11]. Interoperability of medical devices that
enable applications to seamlessly utilize medical data is a demand that has been recognized for
quite some time by the healthcare industry.
It encourages small scale industries that specialize in certain selected devices and segments. This
promotes competition, ensures quality, encourages innovation and reduces cost [10].
Advantages to the government and its collaboration with Millennium
Development Goals
The Global Meet on Government Interoperability Framework (2010) was an eort to explore the
possibility of sharing ingeniousness and knowledge to achieve eective interaction and integration
of information, services and systems [12]. Seamless accessibility of healthcare information between
government and private institutions and both inter and intra institutions can be a new step towards
collaboration to achieve MDG goals.
Margaret Chan, Director General of WHO, opines that to achieve set standards, developing a global
health indicator registry with standards for data, indicators, metadata, and references to analytic
methods enabling tracking of progress of health programmes, are very important. Also
interoperability standards both at the level of individual and aggregate records are signi#cant [13].
INTEROPERABILITY OF
MEDICAL DEVICES
Introduction
in INDIA
interoperability
Interoperability
in India
Conclusions and
recommendations
t
t
t
t
t
10

Medical devices interoperability also helps medical sta devote more time in direct patient care
rather than in mining for available data. It also contributes to numerous direct and indirect bene#ts
in patient care through a cascading eect. Despite the fact that healthcare industry is aware of the
bene#ts of interoperability, the course to achieving interoperability has been a long drawn one. The
need of the hour is to channelize cumulative eorts to overcome the obstacles for its
implementation and share the bene#ts across the spectrum among all the stakeholders.
Background of the existing interoperability
standards
The current scenario presents us with many medical devices interoperability standards provided by
number of standards-developing organizations. These organizations have set the parameters
through pioneering research in their respective #elds. Most of the interoperability standards can be
categorized to follow one or several of these patterns [3].
INTEROPERABILITY OF
MEDICAL DEVICES
Introduction
in INDIA
interoperability
Interoperability
in India
Conclusions and
recommendations
Enterprise and
departmental systems
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First-hop communication
between individual devices
and an intermediate point
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departmental systems and
medical devices
Point-of-care integration
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for patient care
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standard-based communications format. Emergency medical records and nursing $ow sheet
software are two of the common examples of such a system. In such systems, data generated at
the level of patient care need to be synchronized or shared with information from other sources
in order to enable clinical decision making, monitoring or archiving.
11

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intermediate point where information is conveyed through non-standardized vendor and
device-model-speci#c legacy communications methods [3]. For example in gateways between
enterprise systems such as nursing records and medical devices, there are vendors who specialize
in hardware and software for running these one-o protocols.
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devices enabling seamless and $exible connectivity with any clinical system in the hospital IT
infrastructure. The solution supports device connectivity by interfacing with devices that use
proprietary as well as standard based protocols (IEEE 11073/x73) while it uses HL7 for integration
with clinical application.
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information to manage or care for a speci#c patient. In this pattern, multiple devices collaborate
intimately in the care of a particular patient, rather than being relatively simple, send-only data
sources. These are the sorts of clinical scenarios that the ASTM F29.21 committee has advocated [3].
With a brief insight into the modes of operations of these standards, it would also be necessary to
understand the key organizations that play a critical role in setting of such standards for
interoperability. Although there are many such standards-developing organizations, the following
nine are considered the main players.
Broadly, each one of these organizations or committees have de#ned certain standards for medical
devices connectivity [10]. For example, IEEE has largely set standards for device connectivity
through its IEEE 11073 protocol. HL7 has set guidelines for digital exchange of information
between healthcare systems. IHE enables seamless $ow of medical information between
information systems and healthcare enterprises and Continua Health Alliance de#nes benchmark
for personal connected health solutions. Although these organizations have made pioneering
eorts in their respective domains, largely the protocols set by them may or may not have been
accepted and adopted worldwide. The following are the nine organizations or committees that are
considered important.
INTEROPERABILITY OF
MEDICAL DEVICES
Introduction
in INDIA
interoperability
Interoperability
in India
Conclusions and
recommendations
12

Few standards
development
organizations
IEEE-EMBS: IEEE Engineering in Biology and Medical Society [3] has to its credit the development of
several standards in medical device communications. But the most noteworthy contribution is in
the form of IEEE 11073 series. The principal focus is on medical devices semantic standard which
includes:
a) Nomenclature standard ISO/IEEE 11073-10101
b) The Domain Information Model Standard ISO/IEEE 11073-10201
c) Application Pro#le Base (format) Standard ISO/IEEE 11073-20101.
The IEEE 11073 standards are the edi#ce for home health communications standards, such as those
developed by the IEEE 11073 Personal Health Devices (PHD) group and by the Continua Health
Alliance.
INTEROPERABILITY OF
MEDICAL DEVICES
Introduction
in INDIA
interoperability
Interoperability
in India
Conclusions and
recommendations
IEEE
HL7
IHE
NIST
AAMI
HIMSS
Continua
Health
Alliance
West
Wireless
Health
Institute
Underwriter
Laboratories
13

MEDICAL DEVICES Devices semantic standards
HL7: Health Level Seven International [4] has over 2300 members including 500 corporate
members covering more than 90% of information system providers in the healthcare sector. They
provide all-embracing frameworks and standards for digital exchange of information between
healthcare systems. HL7 strives to improve knowledge transfer between healthcare providers,
government agencies, the vendor community, fellow SDOs and patients.
IHE: Integrating the Healthcare Enterprise15 has its main aim to make quality, e!ciency and safety
of clinical care better by making relevant health care information easily available to both providers
and patients. One of the main reasons for its existence is to pro#le HL7 messages and trim down the
range of implementation possibilities allowed by HL7 and make IHE compliment system more
predictable in content and form.
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Nomenclature
standard
The domain
information
standard
Application
pro#le base
(format)
standard
14

The scope of work of IHE
IHE PCD: The IHE Patient Care Device mainly deals with seamless connectivity of medical devices
into healthcare enterprise, point-of-care clinical scenarios, to Emergency Health Record. The IHE
PCD integration pro#les also include Alarm Communication Management, Device Enterprise
Communication (DEC), DEC Patient Identity Binding, DEC Subscribe to Patient Data, Point-of-care
Infusion Veri#cation and Rosetta Terminology Mapping.
CHA: Continua Health Alliance [16] is a consortium comprising over 200 companies dedicated
mainly to ensuring interoperability of personal connected health solutions for better patient care.
The principle is to extend and apply these connected solutions to enable independence and to
empower individuals to better manage their health and wellness needs in a home based setting.
Their core domain is in establishing design guidelines to manufacture home networks, health and
wellness services and tele-health platforms. They also certify products enabling recognition of
interoperability of devices through display of their logo after certi#cation. It collaborates with
government regulatory agencies and leaders in healthcare industry.
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HL7
Ranges of implementation posibilities from HL7
messages are large in number
IHE
Trims down the posibilities allowed by HL7 messages
Predictable content
and form of messages
15

WWHI: West Wireless Health Institute [17] is a non-pro#t organization whose key goal is to lower
health care costs by patient-centred solutions. Medical devices interoperability is a vital
component in reducing cost for delivery of healthcare. Research here is more focussed on #nding
solutions for cost containment in the healthcare system and to cater to expectations of patients,
doctors and health care organizations. They advance cost-eective and cost-saving model of care,
enable an e!cient medical marketplace, promote practical and actionable healthcare policy and
help in liberating healthcare data.
UL: Underwriter Laboratories [18] is a global independent safety science company with expertise
in innovating safety. UL oers the most convenient and complete global regulatory access solution
for medical and IVD device manufacturers [19]. Underwriter Laboratories and AAMI recently joined
hands to collaborate and develop standards in interoperability [20].
NIST[3]: National Institute for Standard and Technology collaborates with IHE on testing for
compatibility of HL7 messages to IHE PCD domain pro#les and works with IEEE 11073 committees,
the IHE PCD Device Point-of-care Integration Work Group and the Continua Health Alliance on
software tools for constructing models of device capabilities.
AAMI[3]: Association for the Advancement of Medical Instruments is a non-pro#t organization
founded in 1967. It is a diverse community of nearly 7,000 healthcare technology professionals
united by one important mission - supporting the healthcare community in the development,
management and use of safe and eective medical technology.
HIMSS[28]: Health Information and Management Systems Society is a not-for-pro#t organization
focused on providing global leadership for the optimal use of information technology (IT) and
management systems for the betterment of healthcare. HIMSS represents nearly 50,000 individual
members, of which more than two-thirds work in healthcare provider, governmental and
not-for-pro#t organizations. HIMSS frames and leads healthcare practices and public policy
through its content expertise, professional development, research initiatives and media vehicles
designed to promote information and management systems' contributions to improving the
quality, safety, access and cost-eectiveness of patient care.
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ASTM Subcommittee F29.21: American Society for Testing and Materials [21] is a globally
recognized leader in the development and delivery of international voluntary consensus standards.
They developed the 'Devices in the Integrated Clinical Environment' under the MD PnP programme
and developed the ASTM F2761,which is a functional architecture describing the operations
necessary to safely support medical devices interoperability in patient-centric applications.
ISO technical committee 21522: strives for standardization in the #eld of information for health,
Health Information and Communications Technology to promote interoperability between
independent systems, to enable compatibility and consistency for health information and data, as
well as to reduce duplication of eort and redundancies. They are involved in data structure and
interchange, semantic content, devices and business requirement for emergency health record
systems.
Barriers and challenges to interoperability
The present scenario presents us with a plethora of devices that are used in hospitals or homes
which function with their unique proprietary protocols determined by the manufacturer. These
devices may use dierent technologies such as USBs, serial ports or Bluetooth to communicate
with each other. Firstly, ensuring interoperability between such stand-alone devices with dierent
propriety protocol presents a herculean challenge to manufacturers. Secondly, making patient
healthcare data stored in Healthcare Information Systems [HIS] easily accessible by the provider but
at the same time ensuring data security and con#dentiality of personal health information is a
major challenge.
Although it is a known fact that medical device interoperability holds a multitude of advantages for
all the stakeholders involved, namely the patient, government, device manufacturers and
standards organizations, there are certain barriers [22] for the easy adoption of standards.
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There are several health delivery organizations and regulatory bodies working at the highest level
to establish standards and regulations to achieve interoperability, but the lack of strict enforcement
is hampering the creation of an interoperable eco-system [22]. Companies get away with lowest
possible denominator of interoperability. The key factor in crossing this hurdle would be to ensure
that all the players are involved in strict adherence to established standards.
The second most important factor is the network eect [22]. Networking in medical devices arena
is like an ecosystem where dierent players co-exist amongst large and smaller network systems.
Larger systems are hesitant to allow smaller systems to interoperate with their devices since they
gain disproportionately with this collaboration. This scenario #nally results in the domination of
certain companies or institutions in order to protect their market shares and commercial interests.
The needs therefore are incentives to both the parties and ensure that gain is symmetrical.
Most of the medical interoperable devices are vertically integrated [22]. Therefore interoperability
remained rooted to that particular environment. The challenge is in lateral integration of medical
devices between dierent players, wherein standards need to be implemented on par with other
universally accepted compatibility norms such as communication protocols. In order to progress in
lateral integration, companies must support their suppliers to buy prefabricated components that
are integrated one level down in the value chain.
Ensuring security and safety [23] associated with medical devices interoperability is a major
challenge to manufacturers. Technically, medical devices may be developed using dierent
programming languages with their own set of software and communicating protocols. For
example, in a given scenario, an enterprise or departmental system like emergency room system or
nursing $ow sheet system may be using Windows or Linux. A medical device like cardiac monitor in
the same emergency room itself may be using dierent processors with an entirely dierent
operating system than that used in the departmental system. The newer mobile devices or tablets
that the physician is using to stay connected may be using android or iOS.
For eective patient care, the data gathered by all these systems must be interoperable. In order to
achieve this, there has been intensi#cation of eort in developing interfacing devices to enable
communication between such stand-alone devices. The pursuit of seamless connectivity therefore
raises fundamental questions of security and safety. In order to ensure this, all the players need to
bring about set standards to negate duplication of eorts and improve safety and security without
compromising e!ciency.
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t
t
t
The major barriers are: 18

tLoss of valuable time where clinicians are left to wait for vendors to release drivers in order to use
a set of interoperability devices [3] is an indirect barrier. In such scenarios the overall quality of
delivery of healthcare to the patient is compromised due to technical issues. Also the system
integration procedures may be extremely costly and ultimately, the burden is passed on to the
patient.
t On the part of the vendors, a common view held is a lack of foreseeable returns for their
investment. Lack of tangible incentives for achieving interoperability provides no commercial
incentives to manufactures in supporting medical devices interoperability.
It is important to realize among all the stakeholders that the onus is on all of them to work together
to overcome these barriers to achieve medical device interoperability. The long term bene#ts of
interoperability hold promise to all the stakeholders. Establishing set standards that enable both
vertical and horizontal interoperability holds huge potential to all the players with main bene#ciary
being the patient.
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Overview
Global market scenario
Geography speci#c market
conditions
Innovations in the domain 2Global medical devices industry
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Overview
Medical devices are an inseparable part of the healthcare system and they play an inimitable role in
prevention, diagnosis, monitoring, treatment and rehabilitation of diseases and disorders [1,2,3]. It
is estimated that every day more than 50,000 types of medical devices are used in healthcare
settings globally [1]. Although patient safety is the most important concern in healthcare delivery,
improved e!cacy without cost escalation is also a tremendous challenge [4]. Therefore to ensure
reliability, safety and performance across the spectrum, medical devices standardization is the
need of the hour.
As part of the USA endeavor, the Association for the Advancement of Medical Instrumentation
(AAMI) was established in 1967 with a vision to support the healthcare fraternity in the
development, management and use of medical instruments 5. It is a non-pro#t organization and
forms the primary source of consensus and timely information on medical instrumentation and
technology [6]. As part of the global eorts, The Global Harmonization Task Force was founded by
the governments of Australia, Japan, Canada, EU and the USA in 1993 to address issues related to
safety, performance and quality of medical devices [7].
Classi!cation based on use
Based on their use, devices can be broadly classi#ed into electro medical devices, electro
therapeutic devices and irradiation equipment. Electro medical devices are used for diagnosis of
disease, electro therapeutic devices are meant for treatment purposes and irradiation devices
operate by the high energy electromagnetic waves to serve both the therapeutic and diagnostic
purposes.
Classi!cation based on !eld of application
Based on the #eld of intended application, medical devices can be classi#ed as spinal devices,
cardiovascular devices, neuro-modulation devices, diabetes devices, urology devices, and surgical
technologies among others.
20

Industry research has reported that by 2017, the global market value of medical equipment and
devices may range between US$ 307.7 and 434.4 billion, [9, 10] equal to a per capita US$ 67, and
growth at a CAGR of 7.1% for the period between 2012-2017 [9].The USA is the world's largest
market valued at $120.4 billion [2012], followed by Japan and Germany which hold the second and
third largest market shares. The BRIC (Brazil, Russia, India, and China) nations collectively occupied
a market share of 8.5% of the global market in 20129. In India, the medical devices and equipment
industry is valued at US$ 2.5 billion and it contributes to only 6% of total healthcare market.
Encouragingly, Indian medical devices market currently has witnessed an annual growth rate of
15% compared to 10-12% growth in the overall healthcare sector [11].
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Medical devices
Electromedical
devices
Electro
therapeutic
devices
Irradiation
equipment
45
40
35
30
25
20
15
10
5
0
2012 Medical devices market shares as per Espicom report
USA(US$120.40B) Japan(US$31.5B) BRIC(US$26.2B) Germany(US$23.3B)
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According to an Espicom report, better opportunities for growth are in Asia, Latin America and
Central/Eastern Europe, whereas traditional western markets represent more steady performers.
With the prospect of accelerated growth and expansion of market for the medical devices industry,
newer challenges have emerged and there is a need for ground work to overcome them.
Some of the major challenges are regarding safe handling and use of a vast and dynamic data base,
founding of novel technology to replace established communication systems, security and privacy
of a wide range of data, updating current regulatory and standardization status, developing
infrastructure and mitigating socio-economic imbalances, to name a few [12,13,14,15]. With the
realizaton of the fact that interconnected healthcare is the right of every individual and not a
privilege, the application of interoperability is gaining signi#cance [16].
Geography speci#c market conditions
Industry research on the medical devices markets promise substantial growth rates in the near
future. As mentioned in Chapter1, increased awareness and attention towards healthcare, rapid
growth of insurance sector, population explosion in developing nations and increasing trend of
medical tourism are a few of the reasons that have accelerated the investments in this domain.
Major markets such as the USA, European Union (EU), Japan and Canada may have to face slow
annual growth rate in the coming years due to delays in regulatory approvals. In contrast,
developing countries such as India and China, which are the emerging powerhouses of the devices
market are oering double digit growth rates [17].
The USA market
The USA is now the market leader in production of medical devices with a turnover of US$120.4
billion in 2012 [18]. The USA medical devices market segmentation by revenue is represented in the
following #gure. In spite of being the world’s largest market, America’s dominance in the sector has
witnessed a downturn due to increase in the time required by the FDA for approval of medical
devices from 90 days in 2005 to 140 days in 2010. Though the medical devices market has been
estimated to grow at an average of 6.6% per year from 2012 to 2017, long drawn regulatory barriers
are expected to be the primary reasons for the slowdown in this sector after 2016 [8,19].
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It has also been observed that over the past decade, the quantum of import of medical devices has
increased in the USA, with China being the major supplier country. In 2010 the import and export
of medical devices in the USA were US$ 27.3 billion and US$ 29.8 billion respectively.
The USA medical devices market is composed mainly of small enterprises with a few larger
companies such as Abott, Baxter, Care Fusion, DENTSPLY, Edwards operating in the areas of
diversi#ed medical products, immune disorder-infection, infusion, supply management, dental,
heart valves respectively [20]. In 2007, out of 5300 medical device companies in the USA, 73% had
less than 20 employees and only 15% had a maximum of 100 employees [20]. Companies are
spread throughout the USA, mostly in California, New York, Pennsylvania, Michigan, Massachusetts,
Illinois and Minnesota.
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Medical devices product segmentation by revenue
3
18
6
5
3
22
10
$ 64.7 billion
Other medical and therapeutic devices
Spinal devices
Cardiovascular devices
Neuromodulation devices
Diabetes devices
Urology devices
Surgical technology
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23

Selected medical devices compaines which are showing accelerated growth in particular domains
are listed below:
Illumina Nu Vasive Intuitive Surgical
Personalized medicine;
analysis of genetic
Minimally disruptive
surgical products for
the spine
Hologic Alere
Robotic assisted
minimally invasive
surgery
Women’s health Broad‐based, in over
100 disease categories
Masimo Life Technologies
variation
Instrument and
lab supplies
Noninvasive patient
monitoring
Integra LifeSciences ResMed Thermo Fisher
Surgical products
in orthopaedics
Sleep medicine and
noninvasive ventilation
Analytical instruments,
lab equipment
One of the signi#cant announcements made by the FDA in December 2012 was on starting a
public-private partnership venture to develop regulatory sciences that will speed up patient access
to new medical devices technologies [21]. The new Medical Device Innovation Consortium (MDIC)
was formed as an independent, non-pro#t corporation, receiving valuable inputs from all the
stakeholders, with an aim to simplifying the process of medical devices design and pathway to
market these innovations. MDIC may enable the medical devices industry to launch safe and
eective devices to the market at a quicker pace and at a lower price. The establishment of MDIC
probably would help mitigate the long drawn barriers for regulatory time which is considered a
hindrance for faster market expansion.
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MEDICAL DEVICES North American Industry Classi#cation System (NAICS) codes
European Union(EU) market
Europe is the second largest market for medical devices globally. It was reported that in 2007, the
total turnover of the medical devices market was approximately €72.6 billion [23]. According to
industry reports in 2009, Germany and France formed the larger markets with an estimated sales of
€22.8 billion and €19 billion respectively [24].The United Kingdom and Italy form the other
prominent markets of the region. According to Espicom report, the UK and Italy medical devices
markets were sized at US$ 8.9 billion and US$ 8.4 billion respectively in 2012 [25,26].
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25
20
15
10
5
0
European Union medical devices market 2012(US$ billions)
23.2
13.3
8.9 8.4
Germany France UK Italy
25

Asian market
As per Espicom report the Asian market in 2012 was valued at US$ 65.3 billion and is expected to
exceed US$ 71 billion by 2015 [29,30]. The Asian market is complex and diverse due to the varying
economic conditions of its constituent countries. One end of the spectrum is Japan not only
leading the rest of the region with its largest market size, it is also the second largest market in the
world. On the other end of the spectrum lie countries such as Bangladesh with negligible market
exposure. Therefore, Asia oers a mixed bag of innovation, aordability and immense opportunity.
25000 23922.0 Asian medical devices market 2010(US$ millions)
20000
15000
10000
5000
Japan
Singapore
Bangladesh
As mentioned previously, Japan stands apart from the rest in terms of market size for medical
devices in the world and Asia. Additionally, Japan is also the third largest importer of medical
equipment after the USA and Germany. Among the export markets in this segment, the country is
the eighth largest in the world [31].
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2352.0 1517.1 1089.4 514.8 430.2 235.2 136.7
7445.9
Japan
China
India
Taiwan
Malaysia
Vietnam
Indonesia
26

India
The Indian medical devices market is among the top 20 in world [33]. With its estimated size of
about US$ 5.2 billion, it is basically import driven. Around 30% of the import is from the USA
[34].The Indian medical devices market is a blend of a large number of small and medium sized
companies focussed on producing equipment that are more cost eective than those
manufactured by their global counterparts.
According to a report by KPMG, the medical devices market in the country is expected to grow by
23% to reach US$ 6 billion by the end of 2013 [35]. Some of the key players in the Indian medical
devices market are B. Braun Pvt. Ltd., Johnson Johnson Medical India (JJMI) Ltd., Nicholas Piramal
India Ltd., Wipro GE Medical Systems, Medtronics and Boston Scienti#c [36]. Apart from those there
are almost 700 Indian medical equipment companies that make aordable alternatives of the
products oered by the giant players such as Phoenix Medical Systems and Per#nt Healthcare [34].
Other emerging markets
Rigorous regulatory processes, stringent reimbursement policies and ambitious procurement
strategies are raising costs to manufacture and market medical devices in the developed world. In
order to achieve cost containment, companies in developed countries are seeking to outsource
some aspects of this develoment activty to countries outside the USA, mainly to the BRIC nations
[37].
Some of the driving factors for growth in emerging markets [38]:
t %FNPHSBQIJD JNQBDU o PWFSBMM JODSFBTF JO QPQVMBUJPO BOE JODSFBTF JO UIF OVNCFS PG BHFJOH
population are driving the demand for medical care.
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healthcare services delivered in a technologically enabled environment, resulting in increased
demand for healthcare IT related products and medical devices.
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healthcare infrastructure indirectly impacting the medical devices market.
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Process ow of rise of emerging market
Phase I
MNCs de#ne the market
and enter with high quality,
usually imported devices
not available locally
For example, Chinese vascular and ultrasound market, Brazilian hospital bed market, Indian
orthopaedic market are dominated by local players rather than MNCs. These products which are
produced by the local manufacturers are comparable in quality with the MNC products but are
available at a lower price. As a result, it oers a lucrative growth oppurtunity for the medical devices
market [38].
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Source: McKinsey Co.
Phase II
Local companies identify
the opportunity and reverse
engineer/adapt to local
requirements and get
prepared to compete
with the MNCs
Phase III
Survival of the #ttest
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The innovation process involves extensive research and planning with a set of goals that the
product should not only satisfy the market needs, but should also be #nancially pro#table for the
manufacturer. Before initiating the innovation process, ample groundwork needs to be conducted.
The major clinical demands are evaluated to analyse the market size, the extent of clinical impact
and to the extent the product would satisfy the healthcare need. Information about the IP status of
the intended device and its associated regulatory compliances need to be analysed. Subsequent
to this foundation, the actual course of developmental action would commence. The entire course
of action can be divided in the following phases.
This is a collective endeavour of multi-disciplinary teams such as research and development,
marketing, legal, regulatory, reimbursement strategists, manufacturing, quality control and sales
departments. Their contributions associated with the various phases of development are [39].
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c market
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Source: The Medical Device Innovation Process; John H. Linehan, PhD; Jan B. Pietzsch, PhD, Stanford University - Program in
Biodesign [39].
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Phase 1: Initial opportunity and
risk analysis
Phase 1a: List of clinical needs
Phase 1b: Market size, clinical impact
Phase 1c: IP analysis
Phase 1d: Detailed market analysis
Phase 1e: Regulatory, reimbursement
Phase 2: Formulation concept and feasibility phase
Phase 3: Design and development veri#cation and validation phase
Phase 4: Final validation, product launch
Phase 5: Product launch and post launch assessment
29

100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
Global scenario in medical devices innovation
With growth in the demand for medical devices in emerging markets gaining momentum, the
global perception towards innovation in medical devices technology has been changing in
tandem. Though the USA still maintains its leading position in innovation, a steep rise in
contributions by countries such as Brazil, India and China are tipping the scales and enormous
growth is expected in these countries in this decade. The PWC Medical Technology Innovation
scorecard has reported the relative status of advance in medical devices research #elds in the USA,
UK, Germany, Japan, France, China, India, Israel and Brazil and is depicted in the #gure below [40].
It has been graded on #ve comparable parameters such as patents, number of researchers,
publications, university and ease of regulatory approval.
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Overview
Global Global market market scenario
scenario
conditions
Beneconditions
#ts of interoperability
Background Innovations on in existing
the domain
interoperability
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Reimbursement
0%
R D
Marketing
Legal
Regulatory
Manufacturing
Quality
Clinical
Sales
Phase5
Phase4
Phase3
Phase2
Phase1
% Time breakdown per func onal group per phase
30

10
Examples of a few breakthrough innovations in the medical devices industry
A few examples of outstanding achievents are listed below.
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measure glucose level in blood non-invasively [41]. C8 MediSensors use Raman Spectroscopy to
non-invasively detect glucose level in the body [42].
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º Microsponges: Microsponges are biologically inert materials, made from synthetic polymers.
These can store and protect the drug from the environment and provide a slow and sustained
release [43].
º Implantable infusion pump: Implantable infusion pump is used to provide prolonged and
intermittent drug action. They are used to deliver drug for the treatment of primary liver cancer,
head/neck cancer, metastatic colorectal cancer, intrathecal therapy [44,45]. Medtronic
SynchroMed® II programmable infusion pump is an intraspinal cathetar and can benon-invasively
programmed [45].
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0 1 2 3 4 5 6 7 8 9
US
Japan
Germany
China
UK
France
Israel
India
Brazil Patents
Researchers
PublicaƟons
UniversiƟes
Ease of regulatory
approval
31

tPET scan: Positron Emission Tomography was considered the medical innovation of the year 2000
by Time magazine. It brings new hope to cancer patients by early detection of the tumour in the
body [41].
tMedical device interoperability: For obtaining e!cient real time electronic data transfer in
healthcare, intercommunication of medical devices are the need of the hour. Interoperability or
plug and play connectivity will improve synchronization, safety interlock and closed loop device
control minimising the transcription error [46].
Barriers towards innovation
There is a sharp dierence in innovation rates between developed countries and developing
countries. Dierences in research infrastructure, economic conditions, national and international
regulatory status, cultural and social contexts are barriers and challenges to achieving the desired
goals [47].
Few of the barriers are listed graphically below [47]:
Few additonal assertions
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medical domain experts contributing to achieve a high quality and integrated result.
t*UTIPVMEFNQIBTJTFQVCMJDIFBMUIQSJPSJUJFTUPJNQSPWFUIFDPTUFòFDUJWFOFTT
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in INDIA
Introduction
Industry
Introduction
Industry
Overview
Overview
Global Global market market scenario
scenario
Geography conditions
speci#c market
conditions
Innovations Background on in existing
the domain
interoperability
Interoperability
in India
Conclusions and
recommendations
Interoperability
in India
interviews
Infrastructure
*Insu!cient sta
*Poor maintenance
and repair quality
*Limited access to
technical information
*Lack of training
*Lack of funding
Regulatory status
*Dierence in time of
approval
*Literature not translated
into national language
*Weak management
culture
Barriers
Cultural and social
aspects
Economy
32

INTEROPERABILITY OF
Indian medical devices industry
MEDICAL DEVICES in INDIA
3Overview
India is a signatory to the Millennium Development Goals (MDG), a community of nations and
international organizations representing comprehensive and speci#c objectives agreed upon by
the world to be achieved by 2015. To achieve its goals, India has to gear up its healthcare systems,
a sector which dominates the MDG agenda, wherein 3 out of 8 goals, 6 out of 21 targets and 16
out of 80 indicators are speci#c for the healthcare sector [1].
India, one of the fastest growing economies has seen a con#dent and resurgent growth in its
healthcare sector over a period of time. Indian medical equipment industry is one of the most
remunerative in the world. According to industry reports, the medical devices industry contributes
about 9% of the cumulative healthcare revenues in the country.
Introduction
Indian Medical Devices
Industry
Overview
Prevalent market conditions
Market dynamics
Prominent players in medical
devices market
Research and development in
the medical devices domain
Overview of the regulatory
standards in India
Case studies of attempts made
at introducing interoperability
standards
Interoperability
in India
Conclusions and
recommendations
Revenue split by healthcare sectors in India
71%
4%
9%
13%
3%
Diagnostics
Pharmaceuticals
Medical Insurance
Medical equipment and supplies
Hospitals
Source: India Brand Equity Foundation, November 2011
33

INTEROPERABILITY OF
INTEROPERABILITY OF
MEDICAL DEVICES
MEDICAL DEVICES
in INDIA
in INDIA
Industry
Overview
conditions
interoperability
Overview
Overview
Prevalent Global market market scenario
conditions
Market Geography dynamics
speci#c market
Prominent conditions
players in devices Innovations market
in the domain
medical
standards in India
standards
Interoperability
in India
interviews
Classi!cation of medical devices in India
Medical devices in India are broadly divided into three main categories [1]:
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Market share of medical devices
Medical equipment segment holds 55% of the total market share in medical technology. Medical
imaging equipment such as SPECT, MRI, CT, in-vitro diagnostic and therapeutic equipment such as
linear accelerators, gamma knives, etc. are a few among them.
Medical implants constitute the second biggest segment sharing 25% of the total market share.
This segment includes stents, pacemakers, cardiac equipment, orthopaedics, eye, ear and dental
implants.
Disposables and furniture contribute to the remaining 20% of the total medical technology market.
Introduction
Industry
Interoperability
in India
interviews
Medical technology market
55%
25%
20%
Medical equipment
Medical implants
Medical disposables and furniture
Source: NIPER Ahmedabad Medical Devices Sector Analysis 2009 [1]
Introduction
Industry
Interoperability
in India
Conclusions and
recommendations
34

INTEROPERABILITY OF
INTEROPERABILITY OF
MEDICAL DEVICES
MEDICAL DEVICES
in INDIA
in INDIA
Industry
Overview
Overview
Geography Global market speciscenario
#c market
conditions
Beneconditions
interoperability
Overview
Market dynamics
devices market
standards in India
standards
Interoperability
in India
interviews
Need for increase in use of medical devices in India [3]
India can be a classic example of the need for increased use of medical technology and devices for
providing better healthcare services.
Introduction
Industry
Interoperability
in India
interviews
Population demand
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tPGUIFQPQVMBUJPOFTUJNBUFE
to be middle class by 2020
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Inadequate and unequal
resource allocation
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to meet demand for next 5 years
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concentrated in cities
High disease burden
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(58/1000 births)
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the world’s pregnancy related deaths.
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diseases - TB, malaria leading causes of
deaths
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India diabetes capital of the world
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covered by health insurance
Need for
medical
devices
Introduction
Industry
Interoperability
in India
Conclusions and
recommendations
35

INTEROPERABILITY OF
MEDICAL DEVICES
in INDIA
Introduction
Industry
Industry
Overview
Overview
#c market
conditions
Beneconditions
interoperability
Overview
Market dynamics
devices market
standards in India
standards
Interoperability
in India
interviews
The Indian medical devices market being valued at about US$ 1 billion in 2009-10 has been
witnessing a growth at a CAGR of 17% for the past two years [4].
Most of the demand for increased use of medical devices in healthcare is from India’s ever
expanding middle class and the a(uent class. This segment of society is growing at 17% annually
and will probably continue a similar growth pattern for the next seven years [5]. In spite of a
substantial presence of domestic device providers with more than 700 companies in this market,
the medical devices industry in India continues to be dominated by multinationals, especially in
high end medical devices space.
However, the domestic manufacturers enjoy their control over low value chain products like
medical supplies and disposables [6]. Few of the devices that are witnessing accelerated growth
rates are ophthalmic, dental, prosthetics, high and mid-tech equipment for endoscopy and
cardiovascular devices [3].
Introduction
Industry
Interoperability
in India
interviews
Interoperability
in India
Conclusions and
recommendations
Medical devices - market size Medical devices - market pro!le
(estimated)
38%
7%
1%
18%
30%
4%2%
100
90
80
Disposables
Consumables
70
60
Surgical instruments
50
Medical electronics
40
30
Hospital equipment
20
Implants
10
Diagnostics 0
Disposables
Consumables
Surgical instruments
Medical electronics
Hospital equipment
Indigenous percentage (%)
Implants
Diagnostics
Imports percentage (%)
Source: Association of indian Medical Device Industry
36

INTEROPERABILITY OF
INTEROPERABILITY OF
MEDICAL DEVICES
MEDICAL DEVICES
in INDIA
in INDIA
Introduction
Industry
Industry
Overview
Overview
#c market
conditions
Beneconditions
interoperability
Overview
Market dynamics
devices market
standards in India
standards
Interoperability
in India
interviews
Import of medical devices in India
India is one of the major markets for import of medical devices from established companies, mainly
composed of high value products. India relies on imports for about 75% of its medical devices
demands, the main contributing nations being the USA and EU countries [7].
Export of medical devices
Even though 75% of high end medical technology products are imported, 60% of the products
manufactured in the domestic market, mainly composed of low end products, are being exported
[8]. Indian domestic medical devices market is focusing on exports in the product segment such as
ophthalmic and laboratory equipment. According to a Business Standard Report, there are 200
medical devices manufacturers in Gujarat and 25-30% of their devices production is exported [9].
Market dynamics
Though India is listed among the top 20 medical equipment markets, the per capita spending of
US$ 2 in 2011 keeps the market size relatively small. There has been a growing demand for medical
devices, especially in the private healthcare sector, resulting in the medical devices industry
gaining momentum [10].
Industry drivers [8]
tDemographic factors
Varied population characteristics have contributed to the medical technology industry:
º The population above the age of 60 is estimated to increase from 89 million in 2009 to 316
million by 2050 [11].
º Increase in non-communicable diseases (NCDs) such as diabetes, cardiovascular diseases
and cancers, contributing to over 42% overall mortality in India have also positively impacted
the medical technology revenue generation [8].
Introduction
Industry
Interoperability
in India
interviews
Interoperability
in India
Conclusions and
recommendations
37

INTEROPERABILITY OF
INTEROPERABILITY OF
MEDICAL DEVICES
MEDICAL DEVICES
in INDIA
in INDIA
Introduction
Industry
Industry
Overview
Overview
#c market
conditions
Beneconditions
interoperability
Overview
Market dynamics
devices market
standards in India
standards
Interoperability
in India
interviews
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will increase from 8% currently to 13% by 2020, thereby resulting in increased demand for high
quality health services [12].
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Five Year Plan spanning 2012-13 to 2016-17 to increase the spending on healthcare from 1.4% to
2.5% of the GDP [13].
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low socioeconomic population groups and to boost coverage, the government has been taking
initiatives such as Employee State Insurance Scheme, Yashaswani, RSBY and various other
insurance programmes. With the increase in number of people included in the ambit of insurance,
the volumes for healthcare delivery would increase signi#cantly, thereby creating a demand for
high quality medical devices [8].
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also has contributed to the increasing revenue for the devices sector. Industry reports have
estimated that 95% of new bed additions to the ecosystem will be driven by private players [14].
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to avail aordable and high quality health care. Accreditations such as Joint Commission
International (JCI) and National Accreditation Board of Hospitals (NABH) are helping hospitals to
achieve desired international quality standards, thereby gaining a larger share of medical tourist
market [8].
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medical devices industry and establishment of a separate regulatory body for standards
development, accreditations and certi#cations that may favorably impact and facilitate growth of
this industry [8].
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Indian companies are some of the tools to penetrate and capture opportunities in the potential
devices market [9]. Few examples are:
Introduction
Industry
Interoperability
in India
interviews
Interoperability
in India
Conclusions and
recommendations
38

INTEROPERABILITY OF
INTEROPERABILITY OF
MEDICAL DEVICES
MEDICAL DEVICES
in INDIA
in INDIA
Introduction
Industry
Industry
Overview
Overview
#c market
conditions
Beneconditions
interoperability
Overview
Market dynamics
devices market
standards in India
standards
Interoperability
in India
interviews
º Oyster Medisafe, a Hyderabad based medical devices manufacturer was acquired for its
controlling stake by B. Braun.
º Trivitron Healthcare, a Chennai based medical technology company has acquired 100% stake in
Finland based Ani Labsystems.
º L T’s medical equipment business was acquired by Skanray Healthcare.
º Transasia Biomedicals, leader in in-vitro diagnostics in India acquired France based Maxmat S. A.
This acquisition was made through Transasia’s Chezh subsidiary. Two USA based companies namely
Drew scienti#c and JAS Diagnostics were acquired by Transasia, acilitated by Transasia Diagnostics- US
unit.
º Bayer Pharma A.G’s (Germany) molecular imaging research and development portfolio was
acquired by Piramal Healthcare.
Challenges in the Indian medical technology industry [8]
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high-tech healthcare.
The market dynamics are bound to change with government initiatives for improving healthcare in
India. Some of the noteworthy government initiatives to boost the healthcare sector have been in the
12th Five Year Plan, 2012-13 to 2016-17, which has its main focus on development of health care
facilities.
Introduction
Industry
Interoperability
in India
interviews
Interoperability
in India
Conclusions and
recommendations
39

The Planning Commission has devised the #ve year plan strategy based on the vision of ‘Universal
Health Coverage’ as de#ned by the High Level Expert Working Group. The plan envisions aordable
healthcare with access to essential medical treatments and drugs for a large percentage of the
population [15]. The government has permitted 100% FDI in healthcare (hospitals and diagnostic
centers) and with prior approval from the government, for manufacturing and trading of medical
equipment as well [16].
There have been a few research partnerships between indigenous companies and private #nancial
institutions encouraging local manufacturers to develop aordable diagnostic technologies.
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technology board, purchased the medical equipment business from Larson and Tubro (LT) in 2012.
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funded by Department of Biotechnology (DBT), Stanford University and others.
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The last three companies have either availed soft loans from government bodies, or have been
funded by the Indian Institutes of Sciences or the Indian Institutes of Technology [17].
INTEROPERABILITY OF
INTEROPERABILITY OF
MEDICAL DEVICES
MEDICAL DEVICES
in INDIA
in INDIA
Introduction
Industry
Industry
Overview
Overview
#c market
conditions
Beneconditions
interoperability
Overview
Market dynamics
devices market
standards in India
standards Med tech companies in Ind i a
Interoperability
in India
interviews
Prominent players in the medical devices market
Introduction
Industry
Interoperability
in India
interviews
Interoperability
in India
Conclusions and
recommendations
Edwards Life Sciences
3 M
India Medtronic St. Jude Medical
Johnson Johnson Stryker
Becton Dickinson Boston Scienti#c
Abbott Vascular Sushrut Surgicals
Bausch Lomb Trivitron Diagnostics
Baxter Accurex Biomedical
Zimmer India Endomed Technologies
Surgicals Biopore HD Medical Services (India)
Forus Health Harsoria Health Care
Eastern Medikit GE Healthcare
Nidhi Meditech System Wipro Technologies
Philips Medical Texas Instruments
HCL Technologies
40

INTEROPERABILITY OF
INTEROPERABILITY OF
MEDICAL DEVICES
MEDICAL DEVICES
in INDIA
in INDIA
Introduction
Industry
Industry
Overview
Overview
#c market
conditions
Beneconditions
interoperability
Overview
Market dynamics
devices market
standards in India
standards
Interoperability
in India
interviews
Research and development in the medical
devices domain
The USA in the 20th century was one of the leaders in medical technology innovation due to its
conducive environment for RD activity. However, there has been a slowdown in the USA market
enabling other nations to intensify their activities and level the playing #eld with their own RD
[19]. The Indian medical technology industry is now drawing the attention of investors, resulting in
a growth spurt.
Innovation derived breakthrough products and their application in developing their respective
business models can drive companies to venture into newer markets [14]. India is the second most
populous country in the world and its healthcare sector has fallen short of indigenous supply of
equipment. The need for innovation is the key to provide aordable healthcare service to its rising
population. Frugal innovation would help assist inexpensive innovation methodologies to meet
the demands during resource scarcity [8].
Innovation in India [20]
According to the PwC innovation scorecard tool, the Indian research statistics on the medical
devices domain and investment in RD are still very low compared to other industrialized
countries. To drive innovation in medical technology it is crucial to invest in research and
development, which will encourage the domestic manufacturers to develop innovative products.
Innovation requires active collaborations between key entities and stakeholders. Leveraging
medical technology to provide better outcomes is the sole purpose of innovation. Manufacturers
have to work in tandem with hospitals, academicians and clinicians in India to develop new
products.
Introduction
Industry
Interoperability
in India
interviews
Interoperability
in India
Conclusions and
recommendations
41

INTEROPERABILITY OF
INTEROPERABILITY OF
MEDICAL DEVICES
MEDICAL DEVICES
in INDIA
in INDIA
Introduction
Industry
Industry
Overview
Overview
#c market
conditions
Beneconditions
interoperability
Overview
Market dynamics
devices market
standards in India
standards
Interoperability
in India
interviews
Interoperability
in India
interviews
Expenditure on RD as per % GDP
3.5
3
2.5
2
1.5
1
0.5
0
0.8
1.49
3.45
2.55 2.67
India
China
Germany
Japan
USA
Researchers per million inhabitants
6000
5000
4000
3000
2000
1000
0
1071
3453
4663
137
5573
India
China
Germany
Japan
USA
Introduction
Industry
Interoperability
in India
Conclusions and
recommendations
42

Medical Devices, Interoperability & eHealth Standardization

Medical Devices, Interoperability & eHealth Standardization

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