With interoperability demands from healthcare reform, all vendors have made greater efforts to integrate with other vendors systems. Industry players are constantly fueling the market with newer technologies or upgrading existing technology.

As electronic medical records (EMRs) become more sophisticated and healthcare moves to an increasingly paperless system, electrocardiogram (ECG) integration has become a priority for many hospitals. For hospitals that have been using ECG management systems, many are upgrading to newer systems that offer improved workflow efficiencies, greater interoperability, and integration into cardiovascular information systems (CVIS), vendor-agnostic integration of multiple vendor's ECG system data, or offer Web and mobile access to waveforms.

The biggest demand today in ECG management systems is the need for workflow efficiencies and the need for interoperability between EMRs, CVIS, and various vendors' ECG systems.

With interoperability demands from healthcare reform, all vendors have made greater efforts to integrate with other vendors' systems. This includes eliminating proprietary coding and using open standards such as HL7 and DICOM.

Some ECG management system vendors have offered systems built on open standards to start with, so they can easily integrate as a module into another vendor's CVIS.

Several vendors have added smartphone interoperability to their systems, so ECG waveforms can be sent for immediate review by a physician, regardless of where they are. This has had a particular impact on emergency patient evaluations, such as those presenting to the emergency department with chest pain or suspected ST-elevated myocardial infarction (STEMI). The rapid diagnosis on smartphone enables earlier activation in the catheterization lab, leading to better patient outcomes in STEMI cases. The technology is especially helpful to connect with cardiologists who are not near an ECG system workstation or at home in off-hours.

Hospitals could make sure the system will be able to accept inputs from all the ECG systems they use. At health systems that have gone through consolidation with several hospitals, this often means each facility may have several legacy ECG systems from various vendors that need to have their data integrated. Hospitals shopping for new systems could look at workflow to see how many clicks it takes to perform normal tasks.

Indian Market Dynamics

The Indian ECG equipment market grew by about 11 percent in volume and value terms. GE, Philips, and Schiller continue to dominate with a combined market share of about 65 percent. BPL is aggressive in this segment. Mindray, Nihon Kohden, Nasan, JK Medical (Bionet), Silver Meditech, Krishna Medi, and Nidek have major presence in this segment. Many other Chinese and other brands also co-exist.

2016 saw an upward revision in the customs duty by 7 percent from 11 percent in 2015 to 19 percent in 2016. Whereas Philips and Schiller passed on the increase in customs duty partly and increased prices by 3–4 percent, other brands absorbed the hike.

The total occlusion of epicardial coronary artery leads to myocardial infarction (MI). It is being manifested in electrocardiogram (ECG) as ST segment elevation in the leads records electrical activity from that region. Because there can be topographic variations in blood supply of the three major epicardial coronary arteries from person-to-person and the predilection of involvement of particular sites of conduction system with different coronary arteries, the clinical presentation, morbidity, and mortality vary with the artery involved, in cases of acute MI. Hence, early identification of the culprit artery gives a bird's eye view for the clinician in managing the life-threatening disease. A 12-lead ECG is a simple noninvasive tool used for diagnosing the acute MI. By adding algorithm to identify the culprit artery in ECG, it empowers it into a more efficient modality. Schiller and Philips offer the CCAA (culprit coronary artery algorithm) software that helps correctly identify the site of obstruction in the coronary artery. However, these systems have yet to gain popularity with the physicians, who often prefer the alternatives as angioplasty and angiography.

The low-end stress machines are typically procured by private cardiologists, while the discerning corporate chains of hospitals buy dedicated high-end systems.

Global Market Dynamics

The global ECG market is currently at a stable stage with certain periodic technological innovations and improvements taking place in device features and characters. This market with a large number of device manufacturers is highly fragmented and competitive.

The global ECG equipment market was valued at USD 330 million in 2016. The market is projected to grow at a CAGR of
6–7 percent in the period 2017–2024. Preventive healthcare with escalating cardiovascular disorder diagnoses are the major key factors in driving the ECG equipment sales.

The resting ECG monitoring system dominates the global ECG market with an approximate share of 65 percent. The demand for Holter monitoring systems is growing at an approximate CAGR of 9.5 percent. Holter monitoring systems generate data that help in early detection of cardiac abnormalities like ischemia. The rise in heart diseases and an increase in adoption of ECG products aids in the adoption of the resting ECG systems. The resting ECG system enables the provision of effective ECG analysis and data connectivity. The performance of two reimbursable tests with one device is enabled due to the optional spirometry module which improves the workflow, saves time, and aids in the efficient management of patient's information. ECG stress testing system leads the global market. The acceleration in the need for comprehensive data management and flexible stress systems is driving the market.

Hospital is the dominant end-user for the global ECG equipment and is projected to expand in the coming years. The market size expansion will be due to accelerated adoption of the technologically advanced ECG equipment. Holter cardiac examination, resting ECG monitoring systems, and ECG stress testing systems are adopted extensively in the cardiology market, leading to market growth. ECG equipment, Treadmill, Holter cardiac set, and variety of ECG devices are not only useful screening instruments but also cost-efficient and easily operated. The global end-user market of hospitals is projected to grow significantly during and after the forecast years due to a reduction in healthcare cost and adoption of ECG equipment.

The global ECG equipment market by home/ambulatory care is anticipated to expand due to the huge adoption of technologically advanced ECG equipment.

The North American ECG equipment market holds approximately 45 percent of the global market share. North America dominates the highest healthcare spending and increase in the numbers of the cardiac and heart-related patients. Asia-Pacific is the second-largest ECG equipment market with high healthcare spending and is growing at an approximate CAGR of 7 percent. The APAC ECG market is booming due to medical tourism and scope for growth and advantage. The growing middle-class economy and large number of patients have resulted in boosting
the ECG equipment market. Thus, the global ECG market is projected to inflate with high reimbursement costs and competitive devices pricing in the Europe and the US.

There has been an increase in the cardiovascular diseases, cardiac arrests, and other heart-related problems due to change in lifestyles leading to an increase in the death rate. The use of monitoring devices rise with acceleration in geriatric population, remote monitoring of the equipment and the technological advancements with an increase in global healthcare spending are the major driving factors for market growth. The supportive regulatory atmosphere for ECG equipment leads the growth of market size. Fluctuations in the reimbursement policies, the cost of equipment, and the lack of awareness of the risks involved in the cardiovascular diseases are some of the restraints for the market growth.

The major players are GE Healthcare, Philips Healthcare, Cardiac Science Corp, Mortara Instruments, Nihon Kohden, Spacelabs Healthcare, Schiller AG, Welch Allyn, Dr. Lee, and Johnson & Johnson.

Vendor Update

GE Healthcare. The company has released its MUSE ECG management platform, MUSE v9. Its new capabilities allow clinicians better access to all ECG waveforms and related data from multiple vendors, devices, and test types. From resting ECG to stress to new devices like Holter monitor patches and wearables, cardiologists can now review all test types of ECGs consolidated under a single patient record. The platform has also opened its doors to multiple communication protocols and now uses HL7 or DICOM to access orders and send test results to the hospital EMRs and archival systems. Other key benefits include a new A/D Connect (LDAP) capability and an enhanced audit and configuration change logging to simplify user management and improve security and privacy compliance.

AirStrip. The US Food and Drug Administration (FDA) has issued 510(K) Class II clearance to a web client for the AirStrip One mobile interoperability platform and application. The system can be run on desktops and laptops using Internet Explorer and Google Chrome. The company also recently received a US patent for new functionality: ECG waveform visual calipers within AirStrip One that allow clinicians to make measurements on digital waveforms, combine measurements, create waveform snippets, and append documentation. The information collected using AirStrip One with visual calipers can then be constructed into a single document or booklet to document more complex events, which can be exported into the electronic medical record (EMR). Structured data elements can also be sent into the EMR or a document management system.

Heart Test Laboratories. Heart Test Laboratories Inc. has successfully raised USD 12 million by way of a common stock private placement offering. The offering was significantly over-subscribed and provides HTL with a strong financial base entering into 2017. The company expects to commence the international launch of its MyoVista product in the first quarter.

The MyoVista is a technologically advanced electrocardiography (ECG) device that uses proprietary technology to assist in the early detection of heart disease. It uses standard 12-lead resting ECG protocols to provide both a traditional ECG incorporating interpretive analysis, as well as further proprietary informatics that facilitate the early identification of ischemic and other myocardial dysfunctions.

Technology Trends

Remote ECG monitoring systems are becoming commonplace for remote heart monitoring. In recent years, remote ECG monitoring systems have been applied in the monitoring of various kinds of heart diseases, and the quality of the transmission and reception of the ECG signals during remote process have kept advancing. However, there remain accompanying challenges.

Wearable systems. A wearable health monitoring system can be based on a microprocessor and customization platform, smart textiles, body area network, commercial Bluetooth sensor, mobile phone, etc. However, the variables involved in the performance of these systems are usually antagonistic, and therefore the design of usable wearable systems in real clinical applications entails a number of challenges that have yet to be addressed including sensor contact, location, rotation, signal correlation, and patient comfort, and two objective functions including functionality and wearability. These variables were optimized using linear and nonlinear models to simultaneously maximize the objective functions. The methodology and results demonstrated that it is possible to overcome most of the design barriers that have thus far prevented wearable sensor systems from being used in everyday clinical practice.

Additionally, future wearable devices should rely on the body's own energy to operate. How to improve durability without reducing performance or increasing the size of the device is the challenge of designing a wearable device.

Hardware. The portable ECG monitor is developing toward a multi-channel, new record, digital, intelligent, network-sharing device that will use digital technology to improve work efficiency and accelerate timeliness. This will significantly improve the accuracy of clinical diagnoses. The research and development trends of ECG detection and analysis systems mainly include the following aspects: a compact instrument, and an acquisition synchronization of 12 channels. The portable ECG Holter system and the heart beeper are products of this developmental trend. Eventually, the multi-guide synchronous ECG detection system and the twelve-guide synchronous ECG detection system will replace the current application of a wide range of single-guide ECG detection systems.

ECG automated analysis. At present, the application of ECG automatic diagnosis technology is not very extensive; it still lacks a complete set of suitable algorithms. Therefore, more research is needed in the field of automatic ECG analysis.

As long-term ECG recording devices continue to increase in normalcy, driven in part by the ease of remote monitoring technology, the need for automated ECG analysis also continues to grow. In a recent study, a model-based ECG filtering approach to ECG data from healthy subjects was applied to facilitate accurate online filtering and analysis of physiological signals. An extension of this approach was proposed, which modeled not only normal and ventricular heartbeats, but also morphologies not previously encountered. A switching Kalman filter approach was introduced to enable the automatic selection of the most likely mode (beat type), while simultaneously filtering the signal using appropriate prior knowledge. Novelty detection was also made possible by incorporating a third mode for the detection of unknown (not previously observed) morphologies, denoted as the X-factor. Wrobel, et al., in their study Pregnancy Telemonitoring with Smart Control of Algorithms for Signal Analysis presented a system for fetal home telemonitoring with a smart selection of algorithms for signal analysis. Novelty of the proposed approach relied on smart fitting of the algorithms for analysis of abdominal signals in mobile instrumentation as well as control of the fetal monitoring session from the surveillance center. These actions were performed automatically based on the continuous analysis of signal quality and evaluation of the reliability of the quantitative descriptive parameters determined for the recorded signals. Using this approach, the amount and content of data transmitted through remote channels to the surveillance center could be controlled to ensure the most reliable assessment of fetal well-being at the lowest data throughput.

In the constrained resources of telemedicine systems, complex algorithms, delay of restrictions, and the characteristic wave location search time window should be suitably decreased for the real-time processing of dynamic ECG signals. ECG signals in the time domain, frequency domain, and wavelet domain of feature information will be extracted. The man-machine interface will be friendly and easy to operate. The pre-processing algorithm will demonstrate effective noise removal, accurate QRS wave detection, and strong anti-infection and robustness when used for the detection of unusually tall P waves and RR intervals in a large variety of abnormal waves, and also successfully suppress the effects of tall T waves, big P wave misdetection of R waves, ventricular tachycardia, and ventricular fibrillation. Furthermore, the algorithms will have the advantage in terms of false detection and missed detection rates.

Future wearable equipment will pay more attention to the wearer's psychology and emotional state. These devices will not only collect information, but also regulate information. Wearable medical devices will not only detect the wearer's psychological and physiological parameters, but also make regulations to the body according to the collected information. They will have more implantable and separated equipment. The terminal will also be able to collect data to be processed and send an alert of sudden illness to the patient's family via the transmission of data.

Future Outlook

Developing nations will witness high growth opportunity in comparison with developed countries owing to the fact that the market of developed nations is almost saturated. Favorable government policies and increasing expenditure in healthcare are also favoring growth in the market. Latest advances in ECG interpretation software are a huge game changer that is assisting more and more primary care physicians with quality interpretation backed with credible clinical data. However, increased demand has spurred the entry of various players into the market offering machines at a very low profit margin, but whose quality could be uncertain.

Current advancements in computing power, digital signal processing techniques, and data communications have helped to usher in a new era in the delivery of medicine and patient management. In the future, there shall be an increased reliance on mobile technology and with it the potential to offer additional services including home-based care models, remote and personal consultations, and others not yet fully realized. While the advent of electronic remote health monitoring systems has promised to revolutionize the conventional healthcare methods, integrating the IoT paradigm into these systems can further increase intelligence, flexibility, and interoperability.

V Balakrishna,Sr. Vice President, Schiller Healthcare India Pvt. Ltd.
Industry Speak
Market Still Prefers Three- and Single-Channel ECG

On market trends

The market has been sluggish in 2016 with a growth of about 10 percent. While 3-channel ECG sales were highest in terms of volume, the high-end ECG machine sales yielded highest in total value. Even though the government increased the customs duty to 20 percent, some of the companies absorbed the same in their cost while market leaders increased their prices. Thus the price to the market has remained the same in average. When the goods are manufactured, the customs duty on imported components has been reduced to only 2.5 percent.

On technology trends

Innovation will be the driving factor for an upward market trend in the coming months. Next-generation ultra-portable ECG devices in tablet form are going to be the highlight of the year. However, it may take some time for doctors to accept newer technologies like CCAA (culprit coronary artery algorithm), which can predict the correct location of blocks in the coronary artery. Earlier, angiography was the only tool available to predict the location of blocks in the coronary artery; now the same is available in ECG devices too.

On key growth drivers

The market was largely driven by a high demand for 3-channel and single-channel ECG machines. There are constant education programs being conducted by many of the pharma and devices companies on importance of 12-channel ECG; the market still prefers 3-channel and single-channel ECG due to cost effectiveness. Thus, the change may happen slowly and steadily over a period of time.

On buyer's perspective

Always look for cost-effective solutions without looking for the advancement in technology and various analysis tools available.

On challenges and opportunities

While new technology comes with significant advantages in terms of accuracy, it also has its own challenges of educating the customers about the product and enabling them to get oriented with its advantages.

On future outlook

There is lot of hope that this market will change and go for better technologies and realize the differences in terms of low-end and high-end ECG devices.

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

Sayan Biswas,Senior Design Engineer-Design & Development, Skanray Technologies
Industry Speak
Technological Advancements and Emerging Trends

The incidence of cardiovascular diseases is on the rise around the world and is one of the main concerns of public health in many countries. The advancement of medical technologies has made it possible for the doctors and the common man to assess the risk and take necessary preventive steps to maintain a healthy cardiovascular profile.

We have come a long way since the time ECG machines used to provide only the wave form and heart rate information. Today's ECG systems are capable of measuring various parameters of an ECG waveform, e.g., P, R wave amplitudes, QRS and T wave duration, the axis measurements, etc., each having its own significance. All this information aids the cardiologist in better diagnosis.

Manufacturers have made the current ECG systems more intelligent to assist the cardiologists in diagnosis. Now, the ECG machines can interpret the waveform, and check for arrhythmia. Various measurements are collaborated to result in an interpretative message displayed by the ECG machine. These messages are suggestive in nature to help the cardiologist in diagnosis. Arrhythmia is reported by analyzing the wave form morphology of the ECG.

As the features in the machines have increased over the years, the size of the machine has been shrinking gradually. There are many handheld ECG machines available in the market today, which make it easier to be carried around. Storage and transfer of patient data has become one of the basic requirements of the modern-day ECG equipment. The ability to transfer a patient's recorded ECG from the ECG equipment to a common database using USB device or LAN connection will help to serve the common man, where they might not be able to directly contact a cardiologist. With telemedicine application and adoption growing steadily, getting opinions of specialists across different locations will definitely improve the standard of health and have a tremendous positive impact on the healthcare costs.

Sayan Biswas,
Senior Design Engineer-Design & Development,
Skanray Technologies

Anil Srivastava,National Sales Manager-Medical Equipment, Nihon Kohden
Industry Speak
Synthesized 18-Lead ECG

The most common ECG exam is the standard 12-lead ECG. It is simple to measure, has low burden on the body, and observing the heart from these 12 directions provides lot of information which has a wide range of clinical applications. However, some areas, especially pathological change in the right ventricle and the posterior wall, cannot be observed from the 12-lead ECG.

In order to actually measure the right chest (V3R, V4R, V5R) and back (V7, V8, V9) areas, it is necessary to use different electrode positions than the standard 12-lead ECG. In particular, electrodes must also be attached to the patient's back so that normal suction cup electrodes cannot be used. Also, the patient must be turned over in some cases and in an emergency, it is often difficult to use back electrodes. This complicates the exam procedure.

Synthesized 18-lead ECG uses the 12-lead ECG waveforms to mathematically derive the waveforms of the right chest leads (V3R, V4R, V5R) and back leads (V7, V8, V9).

Positive predictive value (PPV) for AMI (ST elevated group)

  • l6 leads = 69.1 percent
  • l12 leads= 88.4 percent
  • l18 leads= 96.8 percent
Nihon_fmt

Possibilities of missing MI decreases from 11.6 to 3.2 percent drastically by using 18-lead compared to standard 12-lead ECGs.

The measurement procedure is the same as the standard 12-lead ECG but more information can be obtained. 18-lead synthesized ECG is expected to be useful in detecting right side and posterior infarction. Possibilities of missing MI decreases from 11.6 to 3.2 percent drastically by using 18-lead compared to standard 12-lead ECGs.

Standard 12-lead is not the best method to find STEMI, and accuracy can be improved by additional leads for posterior and right ventricular.

Synthesized 18-lead ECG is available on Nihon Kohden Electrocardiograph ECG-2350 and Electrocardiograph ECG-2550.

Clinician won't miss the MI even if the ischemia is located at the right-side or back-side of the heart. synECi18 can improve AMI diagnosis quality.

Anil Srivastava,
National Sales Manager-Medical Equipment,
Nihon Kohden


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