Smarter ECG devices are leading to new business models in connected healthcare, thus providing remote specialist access at primary healthcare levels and in smaller towns.

ECG has a highly competitive market due to its ability to offer high-quality diagnostic information, ease-of-use, portability, and low cost. Starting from curative purpose to preventive one, ECG equipment 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, including digital 3-channel ECG recording with 12-lead simultaneous acquisitions through auto-summary, LCD display of patient demographics, real-time ECG data option, portability, and Li-ion rechargeable battery among others.

Smarter ECG devices are leading to new business models in connected healthcare where groups of general physicians and primary healthcare providers are now able to seamlessly connect with specialist doctors in larger cities, share ECG data online, and seek specialist opinion, and referral instantly, thus providing remote specialist access at primary healthcare levels and in smaller towns. Although ECG is one of the oldest and most mature markets, advancements in technologies and device capabilities along with the ever-growing needs of customers are constantly reshaping the products and solutions offered in this space.

Indian Market

In 2015, the Indian ECG market is estimated at Rs.175 crore, with sales at 28,770 units. The year saw a distinct shift in preference from single-channel to 3-channel and from 6-channel to 12-channel machines. The 3-channel segment has emerged as the entry level, and is catered to by GE, Schiller, Nihon Kohden, BPL, and Skanray.

The 6-channel segment had sales of about 3970 units in 2015, with GE, Schiller, BPL, Nihon Kohden, Nasan, and Maestros aggressive in the market.

The high-end segment is dominated by 12-channel machines, with Philips, Schiller, Nihon Kohden, and GE dominating the market.

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.

Technology Trends

As the medical field is moving toward more automated and intelligent systems, requirement for better methods of ECG signal analysis and interpretation are becoming very crucial. Smaller, less bulky, less costly, ECG equipment have been developed which provide freedom to the patients and account for continuous monitoring of ECG in a wireless and remote environment. 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.

Wearable and remote ECG monitoring. 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 Holter monitoring and consumer markets toward inexpensive wearable or smartphone-based ECG monitors. Unlike traditional Holter and cardiac event recorders, the new generations of 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.

Interoperability model. The interoperability component is becoming increasingly important. Integrating the ECG equipment to the citizen's electronic health record is a major challenge for the users of ECG interoperability standards, since most ECG equipment implement protocols and file formats in ways that hinder the open interchange of ECGs and hamper analysis, processing, and serial comparison. ECG manufacturers have started to partner with ECG management, cardiovascular information systems (CVIS), and electronic medical records (EMR) vendors to develop better interoperability. There are a number of health informatics standards that apply to the interoperability of ECG equipment in various clinical settings. The HL7 standard originated from the health administration world and the DICOM standard from diagnostic radiology attempt to address interoperability in the whole enterprise. FDA efforts address ECG data formatting in general, and although XML is popular and portable, the FDA effort needs more time to complete.

Remote access to ECGs. Advantage of 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.

Advancements in workflow. With the introduction of digital system, the change in workflow enables immediate ECG access, better medical and legal documentation of the ECG test, an immediate report in the medical record, and better catchment of all ECGs performed. This represents a fairly dramatic workflow improvement with fewer steps and a more streamlined and efficient process. Digital systems offer the potential to ensure data accuracy, data accessibility, and data consistency. These systems can help track every ECG performed across the medical system and ensure that there is an order and official interpretation for each ECG performed.

Market Trends

Dr Sharat D Hegde, Consultant Physician, The Bangalore Hospital, Bangalore

A classic apparatus contains three limb leads, three augmented limb leads, and six chest leads tracing known as 12-lead ECG; tracing taken over a carbonated paper which has square boxes marked for various measurements. Paper speed is set at 25 mm/sec for a normal recording. Speed of 50 mm/sec is also available as an option in special situations. A 1 mV will give a deflection of 10 mm on the ECG tracing, based on which various calculations are made. This deflection recorded on the ECG paper prior to the tracing is called standardization.{mosimage}

Commercially available machines have standard operating instructions and settings and have become indispensable and integral part of every medical establishment for quick referral.

Dr Sharat D Hegde
Consultant Physician,
The Bangalore Hospital, Bangalore

The trend is moving toward miniaturization and improved portability. Apart from technology innovations, many industry players are also expanding their global presence by signing distribution agreements with domestic distributors. 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.

Way Ahead

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.

In future development, textiles that incorporate sensors within the fabric that seamlessly deliver patient data to doctors may see expanded usage. It may be possible to integrate more bio-sensors including blood pressure sensor, breath sensor, and SpO2 sensor into an integrated circuit to provide multiple parameters monitoring simultaneously via a single chip. Solutions that use Bluetooth technology to track elderly patients' movements and send health measurements to caregivers might also be widely used.


 

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