The inadequate access to healthcare facilities and competition from the low-cost domestic market will peg back participants that are looking to establish a toehold in the Indian market.

Indian ECG equipment market has emerged as the most profitable in the patient monitoring segment. The market is benefitting from the rising incidence and awareness of cardiovascular diseases, escalating public expenditure on healthcare services, increasing demand for high-end equity systems, and rapid technological advancements. End users have shown a marked preference for interpretation technology and equipment with more accurate measurements. This has created a wider market for high-end ECG equipment (6- and 12-channel ECGs) market, but shrunk the single-channel ECG market.

Unlike in the case of high-end MedTech devices, where the market is dominated by a few multinational companies, there are a large number of both domestic and foreign companies operating in the Indian ECG equipment market.

Despite the overall vast market potential, participants will face some road blocks while trying to penetrate rural markets. The inadequate access to healthcare facilities and competition from the low-cost domestic market will peg back participants that are looking to establish a toehold in the Indian market. The competition between domestic and major market participants has even led to price wars in the single-channel and three-channel ECG market segments, which have, in turn, eroded the profit margins of prominent market participants.

However, with medical centers in Tier-III cities and towns also looking to provide quality care, Indian companies are also experiencing high demand for their products. Overall, the market is exhibiting a steady growth and promises ample opportunities for all the players operating in the market.

Indian Marketecg

In 2015, the Indian ECG market is estimated at Rs.175 crore, with sales at 28,770 units. The metros and Tier-I show a preference for the 12-channel systems and Tier-II and Tier-III cities are able to afford only the 6-channel and lesser channel machines.

As in other segments, the physician is showing an increased dependence on machines for clinical decision support. There is a marked preference for interpretation technology and equipment with more accurate measurements.

ECG monitoring equipment with enhanced connectivity capabilities has been a primary driver of revenue growth. Smarter, smaller, and lighter ECG devices with Bluetooth-enabled data transfer and cloud-based EMR solutions are gaining steady popularity among corporate healthcare and organized home-healthcare service providers. Advances in ECG interpretation software are also huge game changers that are assisting more and more primary care physicians with quality interpretation backed with credible clinical data.

Worldwide Market

Recent pushes for preventive healthcare along with escalating cardiovascular disorder diagnoses are creating a surge in ECG equipment sales. The global ECG equipment market is expected to reach USD 6.3 billion by 2022. The rising incidences of cardiovascular disorders and government initiatives to make people aware about health check-ups are expected to boost market growth.

North America dominates the global multi-lead ECG machines market, according to Grand View Research. Europe is expected to show low growth rate due to inadequate reimbursement policies for cardiovascular diseases. Asia-Pacific is expected to witness substantial growth owing to the rising incidence rate of heart diseases and growing manufacturing outsourcing in the region.

Increasing geriatric population to propel the need of monitoring devices and technological advancement and remote monitoring in diagnostic ECG devices are some of the key factors driving the growth of global ECG devices market. However, unstable economy and limited reimbursement policies are some of the major factors restraining the growth of global ECG equipment market.

Worldwide Trends

ECG monitoring equipment have high future growth potential owing to changing trend toward preventive care and new product innovations with data integration.

  • In February 2014, Medtronic launched its FDA-approved Reveal LINQ. The upgraded version of Reveal XT offers patient heart monitoring for 3 years with 20 percent more data memory than its previous version.
  • ECG stress testing system is one of the dominating segments of the global market. The growing need for flexible stress systems and comprehensive data management is driving the market for this segment. Quinton 9500 series from Cardiac Science portable system allows physicians to optimize the examination space and enables more data integrations. In 2013, Cardiac Science sold its diagnostic cardiology product line to Mortara Instrument, including the Burdick and Quinton brands.
  • Holter monitoring system is another segment expected to gain significant market share due to the fact that the system assists in identifying arrhythmias that takes place during certain activities such as exercise, stress, bowel movements, sleep, eating, and stress.ecg
  • In March 2015, Philips launched Effica ECG100, which is a cost-effective cardiograph that improves patient care and also reduces the cost. Such kinds of technological advancements are leading to market growth.
  • 2M Engineering Ltd. launched the VitaMove 2S ExG movement and ECG recorder, which is equipped with 3-lead ECG Holter that combines daily activities with heart rate events/trends, ECG, and derivatives such as heart rate variability (HRV).
  • With major industry players situated in North America, the innovations and upgrading rates are higher as compared to other regions. In August 2015, InfoBionic along with Safeguard Scientists raised USD 8 million to commercialize Mome Kardia - a remote patient monitoring system based on cloud technology that could be worn around the neck.
  • Data integration - with computers, smartphones, or tablets - has led to product innovation in preventive care, both for doctors and patients.
  • GE introduced its Muse system and Mac 2000 resting ECG system at the American College of Cardiology (ACC) 2014 meeting. Through its i2 ECG Connect interface, Muse enables integration of ECG data from devices manufactured by Philips, Mortara, Nihon Kohden, Edan, and Schiller.
  • As interoperability becomes a priority with most healthcare systems, ECG manufacturers have started to partner with ECG management, CVIS, and EMR vendors to develop better interoperability. An example of this includes Philips Healthcare and ScImage Inc. creating an integration option between ScImage's PicomEnterprise CVIS and the Philips PageWriter TC series ECGs. Another is Cerner partnering with Mortara Instrument to introduce CareAware waveform management earlier this year. The system displays waveforms and other physiological data from patient monitoring systems and integrates them into the EMR.
  • Industry players are constantly fueling the market with newer technologies or upgrading existing technology. In May 2015, CardioComm Solutions, Inc. launched HeartCheck pen. This Bluetooth wireless connectivity pen could be connected for data acquisition with Android and Apple smartphones.
  • Apart from technology innovations, many industry players are also expanding their global presence by signing distribution agreements with domestic distributors. In October 2015, iNeedMD Holdings, Inc. signed a distribution agreement with Clifton Africa Ltd. This one-year distribution agreement is worth USD 1.5 million.

Technology Update

The resting ECG has been used as a basic cardiac diagnostic for a century, and while the premise remains the same, testing systems are evolving to meet today's technology demands. There has been a trend over the past decade toward smaller, more compact, mobile ECG monitoring systems. These can be used either inside a hospital, clinic, or on the road with a visiting nurse or on a cart for mobility between patient rooms. Another innovation offered by several vendors includes small box systems that connect via a USB to convert a standard PC or tablet computer into a resting ECG system.

Automation for diagnosis and anatomical detection. ECG interpretation algorithms now come standard on many systems. These use gender- and age-specific criteria to provide a virtual second opinion for resting ECG interpretation. This includes ST segment elevation myocardial infarction (STEMI) detection and diagnostic aids to provide interpretation of rhythm and morphology for a variety of patient populations. Some systems include critical values, ST maps, and culprit artery identification. Some systems have anatomical interfaces to help reduce improper lead placement or detection systems for the presence of a pacemaker.

Workflow improvements. ECG systems have been simplified to ease workflow. Examples of this include simplified step-by-step operation, introduction of touch-screen systems, and better connectivity with ECG management systems, electronic medical records (EMRs), and cardiovascular information systems (CVIS). The interoperability component will become increasingly important, as healthcare reforms and meaningful use requirements for information technology (IT) systems call for tight integration and easy interoperability to enable paperless healthcare and free flow of all patient data among departments, hospitals, and referring physicians. A major roadblock to interoperability has been that older-generation ECG systems were not built using proprietary software and the fact that there is no standard format for waveforms. Vendors are now addressing these issues and creating systems with more open IT standards to enable easier integration, even into software systems produced by other vendors.ecg

Need to standardize ECG formats. Unlike medical imaging and data that have standardized on DICOM and HL7 formats, there is no standard format for ECG waveforms. The result is an array of file formats for ECGs, including DICOM, XML, TIFF, JPEG, GDT, PDF, ZIP, UNIPRO, DVD, and others. The variety of formats may cause interoperability issues when attempting to save ECGs to a CVIS, or if attempting to data-mine patient information for ECG reports saved as JPEGs. The bidirectional transmission options for ECGs also come in a variety of interfaces, including USB, internal modem, GSM/GPRS mobile, LAN, or WLAN. Some vendors now offer wireless ECG acquisition, so patients no longer need to be tethered to the ECG system. Departments will want to address these formats and transmission options with a vendor ahead of installation to ensure the waveforms generated by the ECG systems can be transferred into the cardiology department's ECG management system and/or CVIS. This data should in turn be easily shared in a usable format with the hospital EMR.

Remote access. One advantage of paperless ECG review through an electronic ECG management system is the ability to access ECGs and enable remote viewing and reporting outside of the traditional workstation. Most modern CVIS offer remote, anywhere Web-based access to the ECG management system. This functionality includes access to ECGs and fully enabled reporting functions at home or anywhere in the hospital or clinics where a cardiologist finds some time to read cases.

In addition to improved physician workflow, remote access and mobile device access to dynamic waveforms is a trend to enable faster reads on suspected STEMI cases. Immediate reads on mobile devices can help enable lower door-to-balloon times for heart attack patients with earlier cath lab activation times.

Road Ahead

While the traditional 12-lead ECG system will remain a mainstay in cardiac diagnostics in the clinical or hospital setting, the future of cardiac assessment may shift to patients triaging themselves before requiring analysis by these more complex systems. There is a trend in the Holter monitoring and consumer markets toward inexpensive wearable or smartphone-based ECG monitors.

Unlike traditional Holter and cardiac event recorders, the new-generation devices are inexpensive or even disposable, and are much easier to use - with the elimination of electrode wires, devices are simply stuck on the patient's chest.

Some new devices interface with cell phones to eliminate the need for an external base station hardwired in the patient's home. These devices - combined with consumer-grade, app-based ECG monitors that interface directly with a patient's smartphone - will likely result in widespread expansion of basic ECG monitoring and represent a novel method for patient engagement in cardiology.

IT systems that currently handle ECG management may need to include ways to record data from these types of remote devices to include in a patient's EMR. This may be required to meet future patient engagement, remote monitoring, and other mandated health IT interoperability standards to enable full reimbursement from insurance providers.

Hisao Masuda, Managing Director, Omron Healthcare India
Industry Speak
Portable and Cordless Single-Channel Monitor

The incidence of cardiovascular diseases in India is rising by the day. As per WHO (World Health Organization, 2015) of the 30 million heart patients in India, 14 million reside in urban areas and 16 million in rural areas. The growth of heart diseases is dependent on a number of interlinked factors such as aging, changing lifestyles, bad eating habits, and rapidly evolving socio-economic determinants including access to healthcare. Growth of heart diseases affects not just the urban and economically well-off but also the under-privileged. To decrease the possibility of heart problems, it is vital to take preventive measures at home as well. With the help of medical devices designed specifically for home use, patients can now keep a check at blood pressure, track sugar level, and even ECG to monitor the heart rate.

Over the years, Omron has established reputation on monitoring of blood pressure at home as well as in hospital settings. The company has developed a new HeartScan ECG monitor that senses the heart waveform and indicates potential ECG.

The ECG waveform from the heart shows when heart contracts and relaxes and gives the heart rhythm of consecutive heartbeats. Symptoms such as heart pain, palpitations, and shortness of breath may be signs of heart diseases such as angina or cardiac infarction. With the Omron portable HeartScan ECG monitor, a recording of about 30 seconds can be made when symptoms occur whether at home or away. These recordings can then be shown for information to the doctor, who can examine them and use them for correct diagnosis. From analysis of the waveform, some information can be obtained on the presence of arrhythmia or ST-level deviations related to ischemic heart disease and abnormalities.

Hisao Masuda
Managing Director,
Omron Healthcare India

James Wang, General Manager-International Business Center, Shenzhen Biocare Bio-Medical Equipment Co. Ltd.
Industry Speak
Offering Ideal Solutions to Cardiologists

In the past two decades, Shenzhen Biocare Bio-Medical Equipment Co. Ltd. has been dedicating herself to design and develop high-performance medical equipment to offer ideal solutions to cardiologists and physicians who are seeking best value and reliable equipment. Recently, the physician's new feature-rich and reasonably priced assistants, single-channel and three-channel ECG machines with CE and FDA 510(K) clearance, were launched and are ready to serve patients worldwide. Single-channel ECG iE 101 and three-channel ECG iE 300 possess exceptional quality standards and state-of-the-art design. The products are bundled with rich features such as high-resolution display of 5 inches, highly accurate interpretation through CardioPro analysis software, strong battery backup for more than 4 hours of continuous operation, up to 300 seconds of rhythm analysis, and simultaneous acquisition of all 12 channels with a preview on display. Through ECG-1000 (the professional ECG data management PC software), they are capable to act as 12-channel ECGs, and print out 12 channels on standard A4 paper through common USB printers. They are beyond what they are.

As the foregoer of Chinese ECG industry and one of the major manufacturers in China, Biocare devotes full strength and tremendous amount of investment to provide medical products including full range of ECG solutions, bedside multi-parameter patient monitors, fetal and maternal monitors, as well as infusion and syringe pumps, which integrate top-grade technologies, nevertheless in excellent cost performance. With rich experience of working with WHO in developing countries, and appreciation of all R&D staff's hard work, the company is going to launch a series of new products in 2016, which are modular patient monitor, mobile ECG test system, home-use ECG device, and worldwide unique portable smart fetal monitoring system. It will benefit a huge number of private and government hospitals, medical examination stations as well as charitable organizations in India. All these products are coming from the company's vision Where heart beats, where Biocare is. The company has been witnessing the development of Indian medical equipment industry since many years. Many opportunities and challenges were experienced by the company and our local partners. We do appreciate our partners' support and cooperation. With the total Rs.10 lakh crore healthcare market and 16 percent annual increase rate, India now is the most active and the fastest-growing healthcare market in the world. In future, Biocare will cater to Indian market with more energy, investment, and active strategy. The company will keep working with reputable local partners to ensure best service and bringing high-level products to serve millions of Indian patients and professional physicians.

James Wang
General Manager-International Business Center,
Shenzhen Biocare Bio-Medical Equipment Co. Ltd.

Mohith Manoj, Assistant Manager-R&D, Skanray Technologies
Industry Speak
Emerging Trends in ECG

During their century-old existence, ECG systems have undergone tremendous advancements in terms of miniaturization, patient safety, and remote diagnosis. A host of ECG monitoring and diagnostic products are now available for regular diagnosis, cardiac stress analysis, post-operative monitoring, and home monitoring.

The advanced ECG analysis algorithms available today are being effectively utilized for screening large segment of population susceptible to potential heart diseases. The intelligent algorithms take into account the patient's age, gender, and ethnicity to accurately analyze the ECG data.

Miniaturization has played a key role in bringing out products that can be worn by the patient while he is actively involved in his daily routine. Electrodes incorporated into the fabric make setting up of the electrodes as easy as wearing a shirt. With advancements in cellular communication technology, Holter ECG systems are now able to monitor and analyze the ECG in real time and signal the care giver at the very first onset of an arrhythmia which the patient may be oblivious to. Such mobile cardiac outpatient telemetry (MCOT) systems allow hospitals to offer quicker discharge to their patients resulting in better utilization of resources.

With the increase in penetration of ECG devices into the in-patient and out-patient care segments and increased popularity of electronic medical records, the ECG data management solutions market is growing by leaps and bounds. Data security, confidentiality, reliability, and availability are keywords of such systems that attract patients and doctors alike.

Although ECG is one of the oldest and most mature markets, advancements in technologies and device capabilities along with the ever-growing needs of the customers are constantly reshaping the products and solutions offered in this space.

Mohith Manoj
Assistant Manager-R&D,
Skanray Technologies

Dr Hem Chandra, Prof. & Head Department of Hospital Administration, Sanjay Gandhi PGIMS, Lucknow
Second Opinion
ECG Machine - Phenomenal Use and Growth

ECG is the most widely performed cardiac test in the world. ECG machines are simple to use and precise, thus, making the diagnosis easy to perform and analyze. ECG machines are available in several models suited to the physician's and patient's needs. High-end medical equipment technology has led to reduction of errors in diagnosis, thereby improving care delivery altogether and saving countless lives.

The global diagnostic ECG market is estimated to reach USD 5435 million by 2020 at a high CAGR during the forecast period. The factors driving this market include the increasing geriatric population, rising incidences of lifestyle diseases, technological advancements in diagnostic ECG devices, and high growth rate in developing countries.

Offering high-quality diagnostic information, ease-of-use, portability, and a low unit cost, the ECG machine is a highly competitive product in this market. Starting from curative purpose to preventive one, now it has reached from urban areas to rural. Rapid growth and technological improvements varying from sector to sector since the past 3-5 years is witnessed by certain advanced specifications of the machine, such as digital 3-channel ECG recording with 12-lead simultaneous acquisitions with auto summary, LCD display of patient demographics, real-time ECG data option, portability, Li-ion rechargeable battery, etc.

The explosive expansion of private healthcare sector, which accounts for 78 percent patients being treated, presence of ECG machines in every ICU, emergency room, and even in general wards, multidisciplinary approach toward patient care, current trend toward practice of defensive medicine are main growth drivers of the ECG machine market.

Following are some of the challenges and opportunities.

Challenges

  • Increased demand has spurred the entry into the market of various players offering machines at a very low profit margin, whose quality could be doubtful.
  • Increasing use of telemetry devices that offer prolonged cardiac activity monitoring with date recording directly to the cardiologist.

Opportunities

  • Increased demand from previously non-cardiac patient care activities.
  • Emergence of remote location consultations, telemedicine, and tele-reporting services.
  • Trend toward miniaturization and improved portability.

The Sanjay Gandhi PGIMS, Lucknow, UP, a tertiary care hospital, procures and uses the latest technology-based equipment.

Dr Hem Chandra
Prof. & Head Department of Hospital Administration,
Sanjay Gandhi PGIMS, Lucknow


 

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