Reverse innovation, coupled with development of affordable and portable ECG systems, which is rapidly moving away ECG testing from the cardiologist's domain to the general physician's is creating new opportunities for this segment.

Earlier ECG systems were confined to heart stations/cardiology departments in hospitals. This status has gradually changed, with ECG monitoring moving into non-cardiology departments such as nursing, emergency departments, electrophysiology labs, and even into respiratory therapy. These changes have meant that different departments demand different capabilities in their devices. Adoption of ECG equipment in the physician office space has increased; these users too have a different need.

ECG equipment targeting the physician office space has to be more affordable while meeting the desired capabilities. As a result, vendors must now customize their ECG equipment to fit the needs of different end-users. As the physician office market for ECG systems continues to grow and vendors vie for market share, customers in this market will be offered more choices at lower prices.

The penetration of ECG monitors into different departments has resulted in a growing demand for ECG data management solutions for collecting data and streamlining report generation. Many vendors are, therefore, adding an ECG data management component to their other IT products in an effort to increase the competitiveness of their technologies. Using this type of bundling solutions, buyers can make just one purchase, eliminating the need to acquire a stand-alone ECG data management solution, and limiting sales of ECG data management solutions. The widespread adoption of electronic medical record (EMR) systems will also contribute to expansion of the ECG data management solution market.

Although the market for ECG monitoring equipment and solutions is mature and well established, changes in device capabilities, customer demands and reimbursement, continue to reshape the landscape in this market.

Indian Market Dynamics

The Indian ECG market in 2014 is estimated at Rs.158 crore, with sales at 26,345 units. The high-end machines continue to dominate the market with sales at Rs.87.3 crore, with 12-channel machines finding the maximum application. The stress ECG and Holter systems continue to have their own niche.

In the low-end segment, 3-channel segment saw maximum growth in 2014. With prices becoming more competitive, single-channel systems are losing market share rapidly.

GE, Philips, and Schiller have an appreciable market share. BPL in an R&D tie-up with Cadolina, Italy, is setting up a manufacturing facility, and 2015 shall see the venture cater to the global market. The vendor is also working toward bringing in next-gen and more clinically validated ECG interpretation software. BPL is also enhancing the quality of its consumables and introducing complete standardization here. Skanray, Nasan, Maestros, Edan, and Mediline are other aggressive players.

Technology Trends

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. This includes increased mobility, ease of use, streamlined workflow and interoperability, so data can easily be interfaced with electronic medical records. There has been a trend over the past decade toward smaller, more compact, mobile ECG monitoring systems. 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.

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 the Holter monitoring and consumer market 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.

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.

Interoperability model. The interoperability component is becoming increasingly important. Integrating numerous pieces of available 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 system (CVIS) and electronic medical record (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.

Workflow improvements. 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.

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 future development, it is possible to integrate more bio-sensors such as blood pressure sensor, breath sensor, SpO2 sensor into an integrated circuit to provide multiple parameters monitoring simultaneously via a single chip.

Indian Market Dynamics is based on market research conducted by Medical Buyer in March 2015.

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