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ECG Equipment

Leveraging Real Time ECG Monitoring

One of the main challenges in India is making cardiac solutions available in rural areas, which is now possible through new, portable ECG devices that run on mobile technology and use the cloud platform to transmit patient’s ECG signals instantaneously to a cardiologist.

With heart attacks being reported as the reason for the death of one Indian every 33 seconds, cardiac health has emerged as a chief concern in the country. The advancement of medical technologies has made it possible to assess the risk and take necessary preventive steps to maintain a healthy cardiovascular profile. The industry has come a long way since the time when patients had to travel long distances and wait for hours to get a doctor’s attention. Innovative advancement in communication technologies and low power circuit plan have empowered the development of better and more secure ECG equipment, which are convenient, work with lower force utilization, are more exact, and have the ability to incorporate the latest diagnostic features. Advances such as cloud storage, wireless communications, and advanced data analytics tools have enabled diagnosis even while being in remote areas.

Particularly for heart monitoring purposes, in an emergency situation, an ECG test should be done within the golden hour, but in India, it often takes about 6–8 hours. Also, more than half a million people die of heart attacks each year because of a lack of immediate medical attention. With about 70 percent of the Indian population living in rural areas, and diagnostic centers or hospitals  quite far from the places where they live,  remote monitoring devices are a necessity.

These systems facilitate the process of performing diagnosis and treatment of patients suffering from heart diseases. Using the system the physician can use the cloud platform to diagnose patients at remote locations. The patients can also access their medical records via the cloud. Paper-based reports are often at the risk of being lost or fading in the course of time. Having an affordable 12-lead ECG system on the smart phone will not only boost the digital healthcare space, but this paper-less system will save a huge amount of time, helping the patient and the doctor immensely.

Indian Market Dynamics
The ECG market has seen a major increase, and that too more in the high-end models. While the single channel, 3-channel, and 6- channel are seeing an increase in demand, it is the high-end models, which are earning the brands margins. Prices remained more or less constant. Philips, Schiller, BPL, and GE continue to be the popular brands. Edan, Mindray, Nihon Kohden, Nasan, Bionet, Silverline Meditech, Krishna Medi, Nidek, Skanray, Maestros, and RMS too have presence in the market. Building a strong and equitable healthcare system is an important landmark in a developing country’s journey. That can happen only if quality healthcare is provided to large segments of the population, which today is not the case in India. In 2016, heart diseases were the biggest killer, accounting for 28.1 percent of all deaths in India, according to the Indian Council of Medical Research, the Public Health Foundation of India, and the Institute for Health Metrics and Evaluation. While heart attacks can be detected by a quick ECG test, the country continues to be a victim of two critical issues, that is, most primary care clinics are not equipped with ECG machines and absence of sufficient training.

According to DRG’s Ambulatory ECG Monitoring Devices report, the revenue earned by monitoring companies was over a billion dollars in the US of America in 2016 and growing in double digits for the next few years. While in India, the market (although smaller) is expected to grow at an even higher rate. Healthcare startups are mushrooming in this high-growth space and are trying to deploy solutions that will transform the market. However, one of the main challenges is making quality cardiac solutions available in rural areas. New, portable ECG devices, which  run on mobile technology, can help change things for the better.

Various kinds of ECG recorders are available in the market manufactured by reputed organizations, but till date there are very few devices available which can record the ECG signals and transmit them to a remote database server on cloud.

Agatsa’s SanketLife is a credit card-sized, mobile-based leadless ECG machine. Placing both thumbs on the slots on the device gives a reading comparable to a single-lead ECG with 98 percent accuracy. Not only is SanketLife able to perform a single-lead ECG reading for emergency purposes, like AliveCor’s popular Kardia Mobile ECG monitor, but also has built-in provision to take 12-lead readings just as a conventional ECG machine, which makes it a complete 12-lead ECG solution that is remote, easy-to-handle, cost-effective, without any lead or wire, and accurate. The technology allows it to measure electrical activity of the heart through sensors and to transfer the data to a mobile phone using low-energy Bluetooth technology that can be shared with anyone for consultation over the cloud network

A tele-ECG machine prototype developed by Bhabha Atomic Research Centre (BARC) is being adopted by firms to offer healthcare solutions even for remote areas. Scientists at BARC recently developed the handheld 12-channel tele-ECG device that promises cardiac care at just a click. The prototype is developed to record all the 12-leads of ECG simultaneously and displays the same on mobile screens. The generated report can be immediately shared with experts via mobile phones’ Multimedia Messaging Service (MMS) or any other file sharing apps, thus saving on the time it takes to transport patients from their location to the nearest available cardiac units

Uber Diagnostics’ Cardiotrack is a handheld ECG monitor that is easy to use, provides clinical grade output, and performs predictive diagnosis to start intervention immediately, thus reducing the need for invasive intervention. It is a network-connected device; wherein a patient’s ECG scan can be instantaneously transmitted to a cardiologist anywhere in the world. Cardiotrack allows doctors to take a 12-point ECG from a patient. It can then be transferred to a smartphone or tablet via Bluetooth and, from there, can be uploaded to the cloud. It also raises an alarm if it detects an irregularity during the test

Tricog, a Bangalore-based start-up, has partnered with GE Healthcare to develop cloud-connected ECG devices that are placed at under-served locations to help doctors detect heart complications. Within minutes of an ECG test, cardiologists at Tricog’s center complete the diagnosis and share the interpretation with both the patient and the local doctor in real time. The system is designed to additionally enable continuity of care at a tertiary center through timely referral. Patients can also see their records and show them to doctors in future

Another firm, Cardiac Design Labs, has also built a similar product like Tricog, which is a low-cost, wearable cardiac monitor, Mircam. The product aids in initial diagnosis and sends alerts to doctors

A clutch of global tech companies are also demonstrating how designing products specifically for India can help crack the Indian market – and make innovative products for the world. Medical device manufacturing giants such as Johnson & Johnson, GE, and Philips have designed and developed Made in India Med-Tech products best suited for local Indian market needs. It is no surprise that GE wants to set up its largest digital hub in India. The company has also introduced an electrocardiogram (EKG) system that is priced 80 percent lower than a similar imported product available in India. Companies including AliveCor, available in India through the Apollo Group of Hospitals; Kito+, a smartphone case run by San Francisco-based company Azio, which also works as a fitness tracker and can even conduct an ECG, can also be seen in the Indian market.

Global Market
The ECG equipment market was valued at USD 4549.71 million in 2017 and is expected to reach USD 6528.5 million by 2025, expanding at a CAGR of 6.1 percent, projects Research and Markets. The precautionary healthcare with emerging cardiovascular diseases analysis is the prominent factor responsible for driving the sales of equipment. Moreover, the growing hospitalization of the older population for the treatment of cardiac diseases has also increased the need for ECG diagnosis, which in turn, is expected to propel the growth of the global ECG devices market over the years. The encouraging regulatory atmosphere for ECG equipment dominates the market size growth. Vacillations in the reimbursement policies, the outlay of equipment, and the inadequacy of the knowledge of the threats involved in the cardiac diseases are few of the restraints for the growth of the market.

Furthermore, increase in investment by various market players and government agencies for development and commercialization of various sensitive and easy-to-use equipment is likely to drive market growth. For instance, in April 2017, CardioComm Solutions Inc entered into a conglomerate with CareSpan USA Inc to incorporate CardioComm’s cloud-based ECG analysis tools into CareSpan’s Virtual Clinic. This would help in remote analysis of 1, 3, and 12-lead ECG data for online patient care. In September 2017, the US FDA approved an app-driven, easy-to-clean, and fully reusable ECG device manufactured by NimbleHeart. The device wraps around the user’s torso and is used without electrolytic gels and adhesive. Hence, the device can be cleaned easily, thereby, making the product ideal for multipatient use.

Price plays a significant role while planning strategies for capturing market share, as customers prefer high-quality products at low price. Particularly for the Indian market, most of the companies are manufacturing low-cost equipment which reflects that the market is highly competitive in nature. For example, Philips launched Effica ECG100, claimed to be a cost-effective cardiograph and improving patient care outcomes at reduced costs.

The resting ECG monitoring systems segment has dominated the global market and accounted for a major part of the overall market share. Factors such as the rising popularity of advanced resting ECG devices with high compatibility, wireless connectivity, and seamless interoperability are the major contributors to the dominance of this segment in the global market. Also, the rise in prevalence of cardiac disorders especially among the older population coupled with the increase in cardiac care and diagnostic centers will further support the market growth.

The ECG equipment market of North America covers almost 45 percent of the global value, and leads in healthcare consumption and increase in the number of heart-related and cardiac patients. Also Asia-Pacific is the fastest growing region with a CAGR of 6.6 percent owing to the scope for development and advantage and medical tourism. The rising middle-class economy and abundant patients result in the growth of the market. Thus, the ECG global market is anticipated to inflate with large reimbursement expense and competitive devices cost in the United States of America and Europe.

The global market is highly fragmented due to the presence of several international and regional players. As a result, vendors adopt various strategies and competitive pricing to sustain themselves in the market and increase their shares. Technological advancements are one of the key focus areas of a majority of international players. The competitive environment in this market is anticipated to intensify with an increase in technological innovations, product extensions, and increase in M&As. Some of the key vendors in the market are GE Healthcare, Hill-Rom, Nihon Kohden, Philips Healthcare, Schiller, Applied Cardiac Systems, Biocare Bio-Medical Equipment, Cardinal Health, and Spacelabs Healthcare.

The handheld device offers a simpler, more affordable means to healthcare, especially for remote parts of India where 24×7 facilities and access to superior healthcare continue to be a challenge. Though it may take time to perfect the system and test its effectiveness, the development of such devices certainly marks a new achievement for healthcare technology in India. Increasing digitization, even in Tier II and Tier III cities as well as rural India, will add a major fillip to healthtech. There is no doubt that startups like Sanket, Uber Diagnostics, and Tricog will have greater relevance over the next couple of years.

Considering the huge market demand, the emergence of healthcare startups, the positive clinical evidence, the acceptance of remote monitoring device by the medical community, and continuous efforts of the industry to improve product design will revolutionize the diagnosis and management of chronic and emergency heart diseases not only in India but perhaps even globally.

Industry Speak

High Demand for High-End ECG Machines

V Balakrishnan
Sr. Vice President,
Schiller Healthcare India Pvt. Ltd.

On market trends
The market has been buoyant with a growth of about 20 percent. The sales of high-end ECG machines yielded highest in total value and the single-channel and three-channel volumes were comparatively lower.

On technology trends
Quite similar to the year 2016, the market saw an upsurge in innovative products leading to an upward market trend in 2017. There was significant interest in the market for the next generation, ultra-portable ECG device in tablet form and enquiries for such devices have been picking up ever since it was introduced in the market.

On key growth drivers
In 2017 the market was primarily driven by a high demand for high-end ECG machines.

On buyer’s perspective
Buyers are always looking for the best technology at the most affordable prices.

On challenges and opportunities
An increase in demand for 12-channel or high-end ECG devices indicates that individual buyers are going in the same direction as corporate buyers. This is expected to increase the focus of all technology driven companies in this segment. The challenge is only to meet the customer demand in terms of pricing.

On future outlook
The three-channel and single-channel ECG devices are expected to become history soon.
The feature like CCAA (culprit coronary artery algorithm) is showing an upcoming trend and demand for this may increase in the near future. This algorithm can predict where exactly the block is located in the coronary artery in case of heart attack or chest pain.

Industry Speak

Emerging Trends in ECG

Arun Dev N
Senior Engineer, R&D,
Skanray Technologies Pvt. Ltd.

In the current fast moving world, to assist doctors in identifying and diagnosing the patient condition we need reliable, faster, and better medical devices. Though ECG as a diagnostic modality has not changed significantly over the years, several emerging technologies are bridging the gap in acquisition and interpretation complexities.

Artificial Intelligence
We are living in the era of AI. As we all know knowledge and experience play a key role in achieving success. The artificial neural network (ANN) also improves with experience. The ECG signal can be fed as input to the neural network and it can test whether it is similar to its trained data or not. The interpretation of abnormalities or accuracy of diagnosis can be improved by the integration of ANN to the current ECG devices. Furthermore, it can assist the doctors to provide better care to the patient.

Smart Cloth
Utilizing the emerging conductive fiber development in the textile industry, the smart cloth embedded with energy efficient sensors is in the design stage. This development can help in acquiring the biosignals from the body. The challenges like motion artifacts in the signal can be eliminated by the use of an accelerometer. By wearing the smart cloth, the vital parameters can be monitored seamlessly and continuously.

SmartPhone
The smartphone can serve as a primary health monitoring platform by using the high-performance computing potentiality of the embedded multi-core SOC (system on chip). Many apps already allow ECG to be recorded on smartphones and store it on the cloud where it can be analyzed and reported.

HRV Monitoring
Efferent outflow from the brain affects the heart and afferent outflow from the heart affects the brain. Importantly, both are connected bi-directionally. HRV (heart rate variability) is one of the vital parameters that can provide valuable information about the functioning of this system. The positive predictive value of abnormalities in the heart can be improved by integrating the ECG interpretation algorithm and the HRV estimation algorithm. Thus, the humble ECG continues to be the modality of choice for diagnosing ailments related to the heart. Improvements in AI, sensors, and computational capabilities are expanding the spectrum of applications of ECG in various settings.

 

 

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