Need to Improve Public Accessibility

Newer defibrillator models not only have the capability to transmit ECG via Wi-Fi or cellular connection to the healthcare facility but can also be used as full-fledged patient monitors.

Heart failure is growing at an alarming rate in India and has almost attained epidemic proportions. It is projected that there are at least 8–10 million patients with heart failure in the country with a prevalence of about one percent adult population. Out of the people who die from heart attack, about 50 percent die within an hour of their initial symptoms before they reach the hospital. And the only treatment for such sudden cardiac arrest is a shock to the heart, or defibrillation!

Various advancements have been observed in defibrillator technology over the years – from manual to automated, and external to implantable defibrillators so as to ensure constant care for patients suffering from ischemic heart disease or those at high risk of cardiac arrest. The rising demand for handling cardiovascular conditions is leading to innovation in implantable as well as external devices. Innovation with regards to implantable defibrillators include products, such as, subcutaneous and transvenous patches, that aim to increase the comfort level of patients. Defibrillators are so important not only because they can save lives with defibrillation but can also be used as transport monitors. Most defibrillators are configured with ECG, most have external pacing capability, pulse oximetry, and even CO2 monitoring. They are one of the most important and versatile devices in the hospital.

Defibrillators have also improved significantly in terms of cost, size reduction, and ease of operation. Two of the most important of these advancements are development of automated external defibrillator (AED) and implantable cardioverter defibrillator (ICD). These devices help prevent cardiac attacks, with little or no external assistance irrespective of the time and location in case of any major variations in heartbeat. However, cases of inappropriate functioning leading to hospitalization or even death of the patient have led to implementation of stringent regulations for approval and usage of the devices at potential patient sites. The US FDA has already issued an order to include pre-marketing approval (PMA) submission for all the prevalent and new defibrillators.

Indian Market Dynamics
The Indian market for defibrillators, on a steady 15 percent annual growth, is estimated at 114 crore in 2016, with biphasic models at an almost 50 percent share, by quantityw. Ambulances continue to be a good market for defibrillators. New hospitals are also regular buyers.

Philips and Schiller dominate the market. BPL has aggressive presence. Other major players are Mindray and Nihon Kohden, which is now planning to exit the segment. GE too has phased out this product over the last two years.

In another development, Philips North America LLC has reached an agreement on a consent decree with the U.S. Department of Justice, representing the Food and Drug Administration (FDA), related to compliance with current good manufacturing practice requirements arising from past inspections in and before 2015, focusing primarily on Philips’ emergency care & resuscitation (ECR) business operations in Andover (Massachusetts, U.S.) and Bothell (Washington, U.S.). Under the decree, Philips will suspend the manufacture and distribution of external defibrillators manufactured at these facilities, subject to certain exceptions, until FDA certifies through inspection the facilities’ compliance with the Quality System Regulation. The decree allows Philips to continue the manufacture and distribution of certain automated external defibrillator (AED) models and Philips will continue to service ECR devices and provide consumables and relevant accessories, to ensure uninterrupted availability of these highly reliable life-saving devices in the United States. Philips will also continue to export ECR devices once certain requirements have been met. Philips will continue to manufacture and distribute the products of the other patient care businesses at these facilities

The market in India is anticipated to grow because of technological advancements, product innovations, and government interventions. Campaigns increasing the awareness about the disease and rising demand for treatment of cardiovascular diseases and sudden cardiac arrest are expected to increase the demand for these devices over the years. The ongoing training programs by both government and non-government organizations may also be responsible for substantial increase in the demand for home care, alternate care, and public access defibrillators. However their high prices and impact of GST are expected to limit their usage.

Increasing prevalence of lifestyle diseases, such as cardiac disorders is causing an increase in non-communicable diseases (NCDs) in the country. One of the major segments of NCD is cardiovascular diseases. The government of India has launched the National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) for interventions up to district level under the National Health Mission. The program aims at providing early diagnosis and management of common NCDs by building capacity at various levels of healthcare facilities for their prevention, diagnosis, and treatment and setting up NCD clinics in district hospitals and Community Health Centers (CHCs). Under the program, 356 district NCD cells and 356 district NCD clinics have been established. Also 103 cardiac care units, 71 day care centers, and 1871 CHC level NCD clinics have been set up across the country.

Global Market
The global defibrillator market is expected to reach USD 21.92 billion by 2025 from USD 12.1 billion in 2016, reflecting a CAGR of 6.8 percent, predicts Grand View Research. Increasing demand of defibrillators due to supportive legislation policies by the government of developed countries is a major driver responsible for growth of the market. The healthcare expenditure at a global level is rising, along with increasing penetration of public and private health insurance. This rise is expected to further fuel the demand for defibrillators across various end-user segments.

Developed countries such as the United States and the United Kingdom are making it mandatory for certain public places which include sports arenas, schools, government facilities, and institutes to store and maintain AEDs, making them more cardio-friendly. The most common cause of death due to sudden cardiac arrest is the unavailability of these devices. Such changes in the legislation of a country help upsurge availability and access, thereby increasing the market size of this industry.

However, various factors like patient safety risks due to chances of infection and other complications while using defibrillators, lack of awareness on sudden cardiac arrests limit the growth of the market. The threats for the market include lack of cybersecurity in ICD and increasing number of defibrillator device recalls due to FDA mandates.

The market is broadly divided into ICDs and external defibrillators, based on products. ICDs contributed to more than 50 percent of the overall market in 2016. The scope of these devices has increased due to the integration of other technologies, such as pacemakers with defibrillators. As ICDs are used for managing arrhythmias for an extended period, this segment is anticipated to exhibit significant growth.

External defibrillators are used mainly for resuscitation purposes in cases of sudden cardiac arrest. They are also used to stabilize patients until they reach the hospital or medical help arrives. This segment is expected to grow at a lucrative rate owing to supportive legislative policies in developed countries and increasing awareness and training programs pertaining to external devices.

The defibrillator market is driven by innovative processes. For instance, a program under trial in Sweden is likely to deliver AEDs via drones. This is anticipated to reduce the delivery time for defibrillators, thus saving more lives. The market is highly competitive in nature and all the existing players in this market are involved in developing new and advanced products to maintain their market shares. The growth of this industry can also be attributed to mergers and acquisitions, and rising market penetration. In 2017, Abbott acquired St. Jude Medical with an aim to strengthen its presence in the cardiovascular segment.

Technology Trends
If one wants to see what science has brought in healthcare, there is one element that is the best example of how advanced we are in terms of health and technology. The defibrillator devices have now evolved from using transvenous leads to subcutaneous leads, and from transvenous pacemakers to leadless pacemakers. However, the advances eliminated pacing for the subcutaneous ICDs and allowed only single-chamber pacing for leadless pacemakers. The defibrillators have also now moved to single-coil defibrillator leads instead of dual-coil ones.

Remote patient monitoring. One of the major change over time is in the way patient follow-ups are done. Now remote monitoring of patients is done to augment in-person checks. The device telemetry could only travel a few inches, but now it transmits several yards. Most recently, Bluetooth was used for telemetry. Patients are almost uniformly monitored with a transmitter device plugged in at their bedside that uses long-range telemetry while they sleep.

The ICD uplinks to the bedside monitor, which uses cellular technology to link to central databases and uses the Internet to send the information to the physicians. The patient does not have to do anything but sleep. This has revolutionized the way patients are checked. The patients can travel all over the world and still be in touch with what is going on with them.

MRI compatibility. In the past, individuals with ICDs were limited in terms of full body magnetic resonance imaging (MRI) and were often prevented from undergoing chest scans. Fortunately, recent advancements have allowed for the creation of MRI-compatible ICDs. Leading manufacturers have released devices that allow individuals to undergo full body scans, even after implantation.

The year 2016 saw the expansion of additional FDA-approved MRI-conditional CIEDs and lead systems, including CRT-D systems, additional pacing systems, and some conventional pacing leads approved for MRI use with MRI-compatible devices. MRI capability is now approved for some systems for total body use without exclusion of chest MRI, and in some systems for up to 3 Tesla scans. However, the effect of the devices on image quality remains to be ascertained and is under study.

Wireless data transmission and feedback technology. Many of the newest defibrillators now have wireless capability. This is used for recording events during codes and can be used to create reports of the actions taken during a code event. Most of the defibrillators now can also do automatic internal diagnostics usually once a day to ensure the defibrillator is working properly. Some also test the battery and report the status back to a central computer.

Newer models have the capability to transmit ECG via Wi-Fi or cellular connection to the healthcare facility before the patient arrives. Many can be used as a full-fledged patient monitor with some having 12 lead ECG, pulse oximetry, and CO2 monitoring. CPR feedback is of the newer advancements that most manufacturers are adopting and SpCO measurement for pre-hospital models is also becoming popular.

Advances in ICD. Modern ICDs are sophisticated devices that are able to perform two general functions: record the heart’s activity and treat dangerous ventricular arrhythmias with a shock. Most defibrillators also work as a pacemaker, should marked slowing of heart rate occur, and can deliver antitachycardia pacing should VT occur to terminate it without delivering a shock.

Some ICDs have multiple pacing leads to deliver cardiac resynchronization therapy (CRT) to treat heart failure. The demographics of patients who get ICDs have also changed. Originally defibrillators were mostly implanted in patients with ischemic heart disease, and now they are used more in non-ischemic disease.

Outlook
By 2030 India alone will account for 60 percent of the world’s cardiac patients, nearly four times its share of the world’s population. Over 10 million deaths occur by sudden cardiac arrests in the country. With the window from collapse to shock being as less as five minutes, every passing minute reduces the chances of the patient’s survival by 7–10 percent. They most commonly happen outside the hospital and immediate support with an AED or PAD (public access defibrillator) is the only treatment available.

When only a few seconds separate life from death, a clear medical device instruction label is crucial. The new technology and updates in defibrillators have made them a lot easier to be handled, visible at simple glance, with easy instructions to be followed, compact in size, and with display adaptable to any area. Advanced technology from its display to the battery use and charge make these devices reliable and easy to use even by a nonmedical person.

Installing AEDs in public places is of utmost importance as the timely use increases a patient’s survival chance by 74 percent. A stitch in time saves nine says an adage and when it comes to last minute efforts in saving lives, every second counts!

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