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Medical Devices, Interoperability & eHealth Standardization

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This is a comprehensive report on medical devices interoperability in India

This report covers global developments in interoperability of medical devices

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Medical Devices, Interoperability & eHealth Standardization

  1. 1. INTEROPERABILITY OF MEDICAL DEVICES in INDIA 3UHYDOHQFHr3URMHFWLRQVr3URVSHFWV
  2. 2. Science, no matter how advanced, is only as meaningful as the lives it transforms. At Boston Scientific, we believe that only an innovation realized can improve health, change an outlook or transform a life. That’s why we’re committed to pioneering, innovating and advancing science. Our heritage of discovery continues to drive our passion for meaningful innovations that address unmet clinical needs across a wide range of medical conditions and help patients live healthier, longer lives. Visit www.bostonscientific.com to learn more. ® 2013 Boston Scientific Corporation and its affiliates. All rights reserved. CORP-148904-AA March 2013
  3. 3. 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.
  4. 4. 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
  5. 5. 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) t#BDLHSPVOEPGUIFXIJUFQBQFS t%FöOJUJPOPGJOUFSPQFSBCJMJUZ t#FOFöUTPGJOUFSPQFSBCJMJUZ t#BDLHSPVOEPOFYJTUJOHJOUFSPQFSBCJMJUZTUBOEBSET t#BSSJFSTBOEDIBMMFOHFTUPJOUFSPQFSBCJMJUZ t0WFSWJFXPGJOUFSPQFSBCJMJUZ t$POUJOVBMMJBODFEFöOJUJPOPJOUFSPQFSBCJMJUZ t$POUJOVBTQSJODJQMFTPGJOUFSPQFSBCJMJUZ t$POUJOVBT%FTJHO(VJEFMJOFT t5IFHBQBOECBSSJFSTUPBDDFQUBODF t*OUSPEVDUJPOPGJOUFSPQFSBCJMJUZTUBOEBSET t0WFSDPNJOHUIFDIBMMFOHFTPGJOUSPEVDJOH interoperability standards t$PMMBCPSBUJPOPG$POUJOVBTUBOEBSETXJUI*OEJBO regulatory standards t*NQBDUPGJOUSPEVDJOHJOUFSPQFSBCJMJUZTUBOEBSE in India t0WFSWJFX t1SFWBMFOUNBSLFUDPOEJUJPOT t*OOPWBUJPOT t(MPCBMTDFOBSJPPOJOUFSPQFSBCJMJUZ t0WFSWJFX t1SFWBMFOUNBSLFUDPOEJUJPOT t.BSLFUEZOBNJDT t1SPNJOFOUQMBZFSTPGUIFNFEJDBMEFWJDFTNBSLFU t3FTFBSDIBOEEFWFMPQNFOUJOUIFNFEJDBM devices space t0WFSWJFXPGUIFSFHVMBUPSZTUBOEBSET t$BTFTUVEJFTPGBUUFNQUTNBEFBUJOUSPEVDJOH interoperability standards
  6. 6. 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 interoperability standards 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
  7. 7. INTEROPERABILITY OF MEDICAL DEVICES Introduction in INDIA Background of the white paper De#nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards 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
  8. 8. INTEROPERABILITY OF Background of the white paper MEDICAL DEVICES Introduction in INDIA Background of the white paper De#nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards 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
  9. 9. MEDICAL DEVICES Introduction Background of the white paper De#nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards 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
  10. 10. MEDICAL DEVICES Introduction Background of the white paper De!nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards 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
  11. 11. MEDICAL DEVICES Introduction Background of the white paper De!nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards 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: t5IFCBTJDJOUFSPQFSBCJMJUZXIFSFUXPDPNQVUFSTNBZFYDIBOHFEBUBPSNFTTBHFTCFUXFFOFBDI other but do not require recipient computer to interpret the message. tOJOUFSNFEJBUFWBSJFUZDBMMFEGVODUJPOBMXIFSFTUSVDUVSFPSGPSNBUPGUIFNFTTBHFJTEFöOFE and messages between computers are interpreted at the level of data #eld. t5IFTFNBOUJDJOUFSPQFSBCJMJUZXIFSFJUQSPWJEFTGPSDPNNPOJOUFSQSFUBCJMJUZ 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: t U MFWFM UIFSF JT QSBHNBUJD JOUFSPQFSBCJMJUZ XIJDI FOBCMFT TIBSFE VOEFSTUBOEJOH PG EBUB 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
  12. 12. 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 Background of the white paper De!nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industr y Indian Medical D evices Industr y Interoperability Interoperability standards 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
  13. 13. Bene#ts of interoperability 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: tOIBODFTTBGFUZ t3FEVDFTDPTUPGUSFBUNFOU t1SPWJEFTUJNFMZDBSF tDIJFWFT.JMMFOJVN t%FWFMPQNFOU(PBMT t1SPNPUFTQVCMJDQSJWBUF partnership tODPVSBHFTJOOPWBUJPOT t1SPNPUFTTNBMMTDBMFJOEVTUSJFT t4UBOEBSEJ[FTOPSNT INTEROPERABILITY OF MEDICAL DEVICES Introduction in INDIA Background of the white paper De#nition of interoperability Bene!ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations Patients Provider Government Industry t4BWFTUJNF t1SPWJEFTTFBNMFTTBDDFTT t*NQSPWFTNBOBHFNFOU 8
  14. 14. 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 Background of the white paper De#nition of interoperability Bene!ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations t t t t t 9
  15. 15. 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 Background of the white paper De#nition of interoperability Bene!ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations t t t t t 10
  16. 16. 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 Background of the white paper De#nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations Enterprise and departmental systems t.3TZTUFNT t/VSTJOHøPXTIFFUTZTUFNT t5SJBHFTIFFUTZTUFNT First-hop communication between individual devices and an intermediate point t(BUFXBZCFUXFFO departmental systems and medical devices Point-of-care integration t.VMUJQMFEFWJDFDPMMBCPSBUJPO for patient care t5IFFOUFSQSJTFBOEEFQBSUNFOUBMTZTUFNTVTVBMMZOFFEJOUFSNFEJBSZHBUFXBZUPUSBOTMBUFJOUP 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
  17. 17. t 5IF öSTUIPQ WBSJFUZ JT B DPNNVOJDBUJPO TZTUFN CFUXFFO JOEJWJEVBM EFWJDFT BOE BO 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. t .3(BUFXBZ JT B TPGUXBSF TPMVUJPO UIBU BVUPNBUFT UIF QSBDUJDF PG DPOOFDUJOH EJòFSFOU 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. t5IFMBTUWBSJFUZJTUIFhQPJOUPGDBSFJOUFHSBUJPOhXIFSFNBOZEFWJDFTBSFJODPMMBCPSBUJPOTIBSJOH 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 Background of the white paper De#nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 12
  18. 18. 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 Background of the white paper De#nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations IEEE HL7 IHE NIST AAMI HIMSS Continua Health Alliance West Wireless Health Institute Underwriter Laboratories 13
  19. 19. 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. INTEROPERABILITY OF Introduction in INDIA Background of the white paper De#nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations Nomenclature standard The domain information standard Application pro#le base (format) standard 14
  20. 20. 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. INTEROPERABILITY OF MEDICAL DEVICES Introduction in INDIA Background of the white paper De#nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 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
  21. 21. 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. INTEROPERABILITY OF MEDICAL DEVICES Introduction in INDIA Background of the white paper De#nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 16
  22. 22. 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. INTEROPERABILITY OF MEDICAL DEVICES Introduction in INDIA Background of the white paper De#nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 17
  23. 23. 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. INTEROPERABILITY OF MEDICAL DEVICES t Introduction in INDIA Background of the white paper De#nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations t t t t The major barriers are: 18
  24. 24. 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. INTEROPERABILITY OF MEDICAL DEVICES Introduction in INDIA Background of the white paper De#nition of interoperability Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 19
  25. 25. Overview Global market scenario Geography speci#c market conditions Innovations in the domain 2Global medical devices industry INTEROPERABILITY OF MEDICAL DEVICES in INDIA Introduction Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 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
  26. 26. Global market scenario 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]. INTEROPERABILITY OF MEDICAL DEVICES in INDIA 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) Introduction Global Medical Devices Industry Overview Global market scenario Geography speci#c market conditions Innovations in the domain Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 21
  27. 27. 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$120.4 billion in 2012 [18]. The USA medical devices market segmentation by revenue is represented in the following #gure. In spite of being the world’s largest market, America’s dominance in the sector has witnessed a downturn due to increase in the time required by the FDA for approval of medical devices from 90 days in 2005 to 140 days in 2010. Though the medical devices market has been estimated to grow at an average of 6.6% per year from 2012 to 2017, long drawn regulatory barriers are expected to be the primary reasons for the slowdown in this sector after 2016 [8,19]. INTEROPERABILITY OF MEDICAL DEVICES in INDIA Introduction Global Medical Devices Industry Overview Global market scenario Geography speci#c market conditions Innovations in the domain Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 22
  28. 28. It has also been observed that over the past decade, the quantum of import of medical devices has increased in the USA, with China being the major supplier country. In 2010 the import and export of medical devices in the USA were US$ 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. INTEROPERABILITY OF MEDICAL DEVICES in INDIA 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 Introduction Global Medical Devices Industry Overview Global market scenario Geography speci#c market conditions Innovations in the domain Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 23
  29. 29. 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. INTEROPERABILITY OF MEDICAL DEVICES in INDIA Introduction Global Medical Devices Industry Overview Global market scenario Geography speci#c market conditions Innovations in the domain Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 24
  30. 30. 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]. INTEROPERABILITY OF in INDIA t*O7JUSP%JBHOPTUJD4VCTUBODFT.BOVGBDUVSJOH t GPSNFSMZ MFDUSP.FEJDBMBOEMFDUSP5IFSBQFVUJDQQBSBUVT.BOVGBDUVSJOH t GPSNFSMZ *SSBEJBUJPOQQBSBUVT.BOVGBDUVSJOH t GPSNFSMZ 4VSHJDBMBOE.FEJDBM*OTUSVNFOU.BOVGBDUVSJOH t GPSNFSMZ 4VSHJDBMQQMJBODFTBOE4VQQMJFT.BOVGBDUVSJOH t%FOUBMRVJQNFOUBOE4VQQMJFT.BOVGBDUVSJOH t0QIUIBMNJD(PPET.BOVGBDUVSJOH t%FOUBM-BCPSBUPSJFT Introduction Global Medical Devices Industry Overview Global market scenario Geography speci#c market conditions Innovations in the domain Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 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
  31. 31. 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]. INTEROPERABILITY OF MEDICAL DEVICES in INDIA Introduction Global Medical Devices Industry Overview Global market scenario Geography speci#c market conditions Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 0 2352.0 1517.1 1089.4 514.8 430.2 235.2 136.7 7445.9 Japan China India Taiwan Malaysia Vietnam Indonesia 26
  32. 32. 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. t*NQSPWFEBòPSEBCJMJUZoXJUISJTFJOJODPNFMFWFMT UIFSFJTBOJODSFBTFEEFNBOEGPSIJHIRVBMJUZ healthcare services delivered in a technologically enabled environment, resulting in increased demand for healthcare IT related products and medical devices. t8JUI MBSHF JOWFTUNFOUT CFJOH NBEF JO UIF BSFB PG IFBMUIDBSF UIF GPDVT JT OPX PO JNQSPWJOH healthcare infrastructure indirectly impacting the medical devices market. t%FNBOEGPSTUBOEBSEJ[BUJPOPGIFBMUIDBSFEFMJWFSZQSPDFTTFT INTEROPERABILITY OF MEDICAL DEVICES in INDIA Introduction Global Medical Devices Industry Overview Global market scenario Geography speci#c market conditions Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry opinions through interviews 27
  33. 33. 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]. INTEROPERABILITY OF INTEROPERABILITY OF MEDICAL DEVICES MEDICAL DEVICES in INDIA in INDIA Introduction Global Medical Devices Industry Overview Global market scenario Geography speci#c market conditions Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Overview Global market scenario Geography speci#c market conditions Innovations in the domain Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through interviews 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 Introduction Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry opinions through interviews 28
  34. 34. Innovations in the domain 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]. INTEROPERABILITY OF INTEROPERABILITY OF MEDICAL DEVICES MEDICAL DEVICES in INDIA in INDIA Introduction Global Medical Devices Industry Overview Global market scenario Geography Geography specispeci#c #market c market conditions conditions Bene#ts of interoperability Innovations in the domain Background on existing interoperability standards Barriers and challenges to interoperability Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through interviews Source: The Medical Device Innovation Process; John H. Linehan, PhD; Jan B. Pietzsch, PhD, Stanford University - Program in Biodesign [39]. Introduction Indian Medical Devices Industry Interoperability Interoperability standards in India Industry opinions through interviews 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
  35. 35. 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. INTEROPERABILITY OF INTEROPERABILITY OF MEDICAL DEVICES MEDICAL DEVICES in INDIA in INDIA Introduction Global Medical Devices Industry Introduction Global Medical Devices Industry Overview Overview Global Global market market scenario scenario Geography speci#c market conditions Geography speci#c market Beneconditions #ts of interoperability Background Innovations on in existing the domain interoperability standards Barriers and challenges to interoperability Indian Medical Devices Industry Interoperability Interoperability standards in India Industry opinions through interviews Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through interviews 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
  36. 36. 10 Examples of a few breakthrough innovations in the medical devices industry A few examples of outstanding achievents are listed below. t/POJOWBTJWFHMVDPTFNPOJUPS6MUSBTPOJD FMFDUSPNBHOFUJDBOEUIFSNBMUFDIOPMPHJFTBSFVTFEUP measure glucose level in blood non-invasively [41]. C8 MediSensors use Raman Spectroscopy to non-invasively detect glucose level in the body [42]. t.FEJDBMEFWJDFTGPSOPWFMESVHEFMJWFSZTZTUFN 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]. INTEROPERABILITY OF INTEROPERABILITY OF MEDICAL DEVICES MEDICAL DEVICES in INDIA in INDIA Introduction Global Medical Devices Industry Introduction Global Medical Devices Industry Overview Global market scenario Geography speci#c market conditions Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to interoperability Overview Global market scenario Geography speci#c market conditions Innovations in the domain Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through interviews 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
  37. 37. 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 t*OOPWBUJPOTIPVMETBUJTGZUIFOFFEPGUIFQBUJFOUTBOETIPVMECFEFNBOEESJWFO t /FFET UP JOWPMWF B NVMUJEJTDJQMJOBSZ BQQSPBDI XJUI UFBNT PG *5 NBUFSJBMT FOHJOFFSJOH BOE medical domain experts contributing to achieve a high quality and integrated result. t*UTIPVMEFNQIBTJTFQVCMJDIFBMUIQSJPSJUJFTUPJNQSPWFUIFDPTUFòFDUJWFOFTT INTEROPERABILITY OF INTEROPERABILITY OF MEDICAL DEVICES MEDICAL DEVICES in INDIA in INDIA Introduction Global Medical Devices Industry Introduction Global Medical Devices Industry Overview Overview Global Global market market scenario scenario Geography speci#c market Geography conditions speci#c market conditions Bene#ts of interoperability Innovations Background on in existing the domain interoperability standards Barriers and challenges to interoperability Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through 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
  38. 38. 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 Global Medical Devices Industry 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 Interoperability standards 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
  39. 39. INTEROPERABILITY OF INTEROPERABILITY OF MEDICAL DEVICES MEDICAL DEVICES in INDIA in INDIA Global Medical Devices Industry Indian Medical Devices Industry Overview Global market scenario Geography speci#c market conditions Bene#ts of interoperability Background on existing interoperability standards Barriers and challenges to 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 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 Interoperability standards in India Industry Opinions through interviews Classi!cation of medical devices in India Medical devices in India are broadly divided into three main categories [1]: t.FEJDBMFRVJQNFOU t.FEJDBMJNQMBOUT t.FEJDBMEJTQPTBCMFTBOEGVSOJUVSF 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 Global Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through 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 Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 34
  40. 40. INTEROPERABILITY OF INTEROPERABILITY OF MEDICAL DEVICES MEDICAL DEVICES in INDIA in INDIA Global Medical Devices Industry Indian Medical Devices Industry Overview Overview Global market scenario Geography Global market speciscenario #c market conditions Geography speci#c market Beneconditions #ts of interoperability Innovations in the domain Background on existing interoperability standards Barriers and challenges to interoperability 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 Interoperability standards in India Industry Opinions through 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 Global Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through interviews Population demand tCJMMJPOQFPQMF tPGUIFQPQVMBUJPOFTUJNBUFE to be middle class by 2020 tNJMMJPOJOUIFHFSJBUSJDBHFHSPVQ Inadequate and unequal resource allocation tEPDUPSTGPSFWFSZ *OEJBOT t CFETUPCFBEEFEFWFSZZFBS to meet demand for next 5 years t%PDUPSTBOEIPTQJUBMTBSF concentrated in cities High disease burden t)JHIJOGBOUNPSUBMJUZSBUF (58/1000 births) t*O*OEJBBDDPVOUFEGPSPG the world’s pregnancy related deaths. t)JHIFTUCVSEFOPGDPNNVOJDBCMF diseases - TB, malaria leading causes of deaths t(SPXJOHOPODPNNVOJDBCMFEJTFBTFT India diabetes capital of the world t-FTTUIBOPGUIFQPQVMBUJPO covered by health insurance Need for medical devices Introduction Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 35
  41. 41. INTEROPERABILITY OF MEDICAL DEVICES in INDIA Introduction Global Medical Devices Industry Indian Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Overview Overview Global market scenario Geography Global market speciscenario #c market conditions Geography speci#c market Beneconditions #ts of interoperability Innovations in the domain Background on existing interoperability standards Barriers and challenges to interoperability 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 Interoperability standards in India Industry Opinions through interviews Prevalent market conditions 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 Global Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through interviews Interoperability Interoperability standards 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
  42. 42. INTEROPERABILITY OF INTEROPERABILITY OF MEDICAL DEVICES MEDICAL DEVICES in INDIA in INDIA Introduction Global Medical Devices Industry Indian Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Overview Overview Global market scenario Geography Global market speciscenario #c market conditions Geography speci#c market Beneconditions #ts of interoperability Innovations in the domain Background on existing interoperability standards Barriers and challenges to interoperability 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 Interoperability standards in India Industry Opinions through 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 Global Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through interviews Interoperability Interoperability standards in India Conclusions and recommendations 37
  43. 43. INTEROPERABILITY OF INTEROPERABILITY OF MEDICAL DEVICES MEDICAL DEVICES in INDIA in INDIA Introduction Global Medical Devices Industry Indian Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Overview Overview Global market scenario Geography Global market speciscenario #c market conditions Geography speci#c market Beneconditions #ts of interoperability Innovations in the domain Background on existing interoperability standards Barriers and challenges to interoperability 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 Interoperability standards in India Industry Opinions through interviews t*ODSFBTFJOQFSDBQJUBJODPNFoJUJTFTUJNBUFEUIBUUIFBWFSBHFIPVTFIPMETQFOEJOHPOIFBMUIDBSF will increase from 8% currently to 13% by 2020, thereby resulting in increased demand for high quality health services [12]. t*ODSFBTFJOQVCMJDPVUMBZJOCVEHFUoJUIBTCFFOQSPQPTFECZUIF(PWFSONFOUPG*OEJBJOJUTUI 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]. t)FBMUIJOTVSBODFoDVSSFOUMZPGUIFQPQVMBUJPOJTDPWFSFECZIFBMUIJOTVSBODF5PJODMVEF 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]. t.FEJDBMJOGSBTUSVDUVSFoNBJOMZESJWFOCZUIFQSJWBUFTFDUPS SBQJEHSPXUIJONFEJDBMJOGSBTUSVDUVSF 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]. t.FEJDBMUPVSJTNo*OEJBJTCFDPNJOHUIFQSFGFSSFEEFTUJOBUJPOGPSQBUJFOUTGSPNBSPVOEUIFXPSME 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]. t3FHVMBUPSZGBDUPSToBGFXHPWFSONFOUJOJUJBUJWFTBSFCFJOHQSPQPTFETVDIBTTQFDJBMTUBUVTUPUIF 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]. t.FSHFSTBOEBDRVJTJUJPOToBDRVJTJUJPOT BMMJBODFTBOEQBSUOFSTIJQTCFUXFFONVMUJOBUJPOBMBOE Indian companies are some of the tools to penetrate and capture opportunities in the potential devices market [9]. Few examples are: Introduction Global Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through interviews Interoperability Interoperability standards in India Conclusions and recommendations 38
  44. 44. INTEROPERABILITY OF INTEROPERABILITY OF MEDICAL DEVICES MEDICAL DEVICES in INDIA in INDIA Introduction Global Medical Devices Industry Indian Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Overview Overview Global market scenario Geography Global market speciscenario #c market conditions Geography speci#c market Beneconditions #ts of interoperability Innovations in the domain Background on existing interoperability standards Barriers and challenges to interoperability 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 Interoperability standards in India Industry Opinions through 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] t$PNQMFY OPOUSBOTQBSFOUBOEJODPODMVTJWFSFHVMBUPSZFOWJSPONFOU t-BDLPG3%GVOEJOH t%FöDJFOUTLJMMTFUT t-BHHJOHEPNFTUJDJOEVTUSZQBSUJDJQBUJPO t%JóEFOUJOOPWBUJPOBDUJWJUZ t-PXFSQFOFUSBUJPOPGNFEJDBMEFWJDFUFDIOPMPHJFTJOTNBMMFSDJUJFT UPXOTBOESVSBMBSFBT t-PXEPNFTUJDNBOVGBDUVSJOHPGIJHIWBMVFNFEJDBMEFWJDFT t-BDLPGBXBSFOFTTBCPVUNFEJDBMUFDIOPMPHZBNPOHSVSBMQPQVMBUJPO t4PDJPFDPOPNJDJOFRVBMJUZSFTVMUJOHJOBMBSHFTFDUJPOPGUIFQPQVMBUJPOOPUCFJOHBCMFUPBòPSE high-tech healthcare. The market dynamics are bound to change with government initiatives for improving healthcare in India. Some of the noteworthy government initiatives to boost the healthcare sector have been in the 12th Five Year Plan, 2012-13 to 2016-17, which has its main focus on development of health care facilities. Introduction Global Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through interviews Interoperability Interoperability standards in India Conclusions and recommendations 39
  45. 45. The Planning Commission has devised the #ve year plan strategy based on the vision of ‘Universal Health Coverage’ as de#ned by the High Level Expert Working Group. The plan envisions aordable healthcare with access to essential medical treatments and drugs for a large percentage of the population [15]. The government has permitted 100% FDI in healthcare (hospitals and diagnostic centers) and with prior approval from the government, for manufacturing and trading of medical equipment as well [16]. There have been a few research partnerships between indigenous companies and private #nancial institutions encouraging local manufacturers to develop aordable diagnostic technologies. t TUBSUVQ CBTFE JO .ZTPSF 4LBOSBZ B CFOFöDJBSZ PG GVOEJOH GSPN UIF (PWFSONFOU PG *OEJBT technology board, purchased the medical equipment business from Larson and Tubro (LT) in 2012. t/FX%FMIJT$POTVSF.FEJDBMTJTBTUBSUVQXIJDIIBTSFTVMUFEGSPNBGFMMPXTIJQQSPHSBNNFKPJOUMZ funded by Department of Biotechnology (DBT), Stanford University and others. t1FSöOU)FBMUIDBSF $IFOOBJ t#JHUFDI-BCT t'PSVT)FBMUI #BOHBMPSF 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 Global Medical Devices Industry Indian Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Overview Overview Global market scenario Geography Global market speciscenario #c market conditions Geography speci#c market Beneconditions #ts of interoperability Innovations in the domain Background on existing interoperability standards Barriers and challenges to interoperability 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 Med tech companies in Ind i a Interoperability Interoperability standards in India Industry Opinions through interviews Prominent players in the medical devices market Introduction Global Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through interviews Interoperability Interoperability standards 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
  46. 46. INTEROPERABILITY OF INTEROPERABILITY OF MEDICAL DEVICES MEDICAL DEVICES in INDIA in INDIA Introduction Global Medical Devices Industry Indian Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Overview Overview Global market scenario Geography Global market speciscenario #c market conditions Geography speci#c market Beneconditions #ts of interoperability Innovations in the domain Background on existing interoperability standards Barriers and challenges to interoperability 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 Interoperability standards in India Industry Opinions through 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 Global Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through interviews Interoperability Interoperability standards in India Conclusions and recommendations 41
  47. 47. INTEROPERABILITY OF INTEROPERABILITY OF MEDICAL DEVICES MEDICAL DEVICES in INDIA in INDIA Introduction Global Medical Devices Industry Global Medical Devices Industry Indian Medical Devices Industry Overview Overview Global market scenario Geography Global market speciscenario #c market conditions Geography speci#c market Beneconditions #ts of interoperability Innovations in the domain Background on existing interoperability standards Barriers and challenges to interoperability 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 Interoperability standards in India Industry Opinions through interviews Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Industry Opinions through 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 Global Medical Devices Industry Indian Medical Devices Industry Interoperability Interoperability standards in India Conclusions and recommendations 42

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