More than just a heartbeat

The ubiquitous stethoscope has a very long history. It was in 1816 when French physician René Laënnec invented the device, partly driven by the fact that he was uncomfortable with the practice of doctors placing their ears on the chests of patients, especially women. Arthur Leared created a two ear piece binaural stethoscope in 1851, and the design was later perfected by George Cammann in 1852.

The stethoscope has not seen any major innovation since then but that’s changing in an Internet of Things (IoT) world. Adarsha K, Tapas Pandey and Rupesh Ghyar, three IIT Bombay researchers, are looking to make the conventional stethoscope smarter and interconnected. Ayu Devices, a start-up incubated this April by the duo, has created a device called AyuLynk to provide effective auscultation for diagnosis of heart and lung diseases. The start-up is operating out of IIT Bombay’s technology business incubator, Society for Innovation and Entrepreneurship (SINE). The prototype is a compact module which can amplify heart and lung sounds when attached to a conventional stethoscope.

“After our device is attached to a stethoscope, the heart and lung sounds are sharper and clearer,” says Adarsha. The device can also record the sounds and convert them into an audio file which can be transferred across platforms.

According to Amgad Makaryus, associate professor at Northwell Health, New York State’s largest health care provider, turbulent blood flow manifests as murmurs in the coronary artery and conventional stethoscopes lack the auscultation power to detect these murmurs. “A digital stethoscope can convert acoustic sounds to electronic signals, and, further amplify these sounds for optimal listening,” explains Makaryus.

Inception of an idea

The researchers’ journey to create the device began at MEDIC, a five-day hackathon organised by Biomedical Engineering and Technology incubation Centre (BETiC) three years ago. Adarsha and Pandey, along with Dr. Nambiraj Konar, were given the task of transferring heart and lung sound waves from one place to another. On the final day of the hackathon, the trio cracked the test. After their success, the researchers were approached by a BETiC professor, Ravi B, who offered them a fellowship to convert their findings into a product. “It was an easy decision. We decided to quit our jobs and join the laboratory,” says Adarsha, who was then working with L&T Infotech.

The engineers met several doctors to understand the challenges faced by the medicos during auscultation. “Doctors told us it’s not easy to spot abnormality in the heart or the lungs using a conventional stethoscope,” says Adarsha. The researchers, then, decided to create a high quality and low-cost device to help the doctors.

The duo, thus, developed a device with features such as noise filtering, sound amplification, recording, playback, and visual representation of auscultated sounds (see: Loud and clear). “Existing digital stethoscopes come as single units whereas ours is an attachment to an existing stethoscope to make it digital and smart,” adds Adarsha.

Heart of the matter

Cardiovascular disease is the leading cause of death in India, claiming around 1.7 million lives annually, according to a report from Global Burden of Disease, a collaboration of over 1,800 researchers from 127 countries. Structural defects in patients’ hearts cannot be detected through an ECG test. They need to undergo 2D echocardiography, MRI or CT scan, which are either costly or inaccessible in remote areas. 

While India has been successful in curbing deaths due to infectious diseases, it is facing challenges due to the rise in non-communicable diseases such as chronic obstructive pulmonary disease (COPD). The country accounts for a quarter of deaths caused worldwide by the two most chronic respiratory diseases — COPD and asthma, according to the report. COPD was the second leading cause of death in India in 2016, claiming 848,000 lives. The disease is caused by chronic smoking and air pollution. In rural India, women exposed to biomass combustion fuels inside their homes are also susceptible to the disease.

Dr. Lancelot Pinto, a consultant respirologist at Hinduja Hospital, asserts that it is vital to detect lung diseases at an early stage. “A lot of respiratory diseases are progressive, and as times goes by, they get worse. If you diagnose it an early stage, you have the potential to intervene. At the onset of interstitial lung diseases, there are very subtle crackles, which most average physicians are not able to detect,” he says.

Adarsha claims that with the help of their device, physicians and doctors will be well-equipped to detect abnormal heart and lung sounds at an early stage and could be even used by primary healthcare personnel such as Accredited Social Health Activists (ASHA) in rural regions. “In rural India, there is a shortage of doctors. The device will be helpful for patients in villages. ASHA workers can collect the sounds and transfer it to urban healthcare centres,” says Adarsha.

Dr. Konar, who helped the engineers to conceptualise the device and works as an anaesthesiology consultant at Reliance Hospital, says the device has the potential to bring down the cost of healthcare in rural India. “It will cut down travel and accommodation costs of patients who stay in remote areas. There wouldn’t be any need to travel to urban centres just for diagnoses.”

Getting the basics right

Ayu Devices is targeting both B2B customers such as telemedicine centres and B2C clients such as medical students, chest physicians and cardiac surgeons. There are currently 900,000 doctors in India with an annual addition of 50,000 medical students. “We are focusing on both rural healthcare centres and urban hospitals. We believe there is huge potential for digital medical devices in India,” says Adarsha.

Dr. Pinto, who currently uses the device, says a digital stethoscope can be extremely helpful for young, inexperienced doctors. “If a doctor is still in the process of learning, it’s not easy to detect abnormal sounds. There are a lot of subtle sounds which you cannot detect unless you are tuned to them or they are amplified,” says Dr. Pinto. Apart from him, the device is being used by Dr. Konar and Dr. Anvey Mulay, a cardiac surgeon who works at Fortis Hospital.

The other significant development is that hospitals and clinics have now started using electronic medical records (EMR) as the preferred method to store patient information. The rules of Clinical Establishments Act 2010 mandate the maintenance and provision of EMR for every patient. “India is shifting towards digital medical record for patients. Hospitals and doctors can document the sound of patients’ hearts and lungs. If an expert clinician or GP has records of the medical history of a patient, it will be helpful to provide quick treatment,” elaborates Adarsha.

Ayu Devices is in talks with telemedicine centres such as YOLO Health and Care Expert, which operate in remote areas such as Chhattisgarh’s Sukma and Dantewada districts and Karnataka’s Kolar district. Currently, there are 105 telemedicine centres set up across India. The staff at these centres can record heart and lung sounds of the patients and send it to doctors in urban centres for diagnoses.

A3 Remote Monitoring Technologies (A3 RMT), a company which provides telemedicine treatment in remote areas, recently bought AyuLynk. “We have used other digital stethoscopes and found that AyuLynk is more suitable for us. AyuLynk’s output is better than other digital stethoscopes that were extremely costly. The device provides sound amplification and clarity,” says Dr. Shrikant Parikh, CEO and co-founder of A3 RMT. He also says that AyuLynk can help telemedicine centres to grow. 

Right economics

Ayu Devices has currently received orders from doctors working in private hospitals and rural healthcare centres to make 65 devices and are targeting to sell 1,000 units by the end of FY19. “Once we scale up our operations, SINE will give us a bigger space to manufacture our devices. We will also hire more engineers to manufacture devices,” says Adarsha.

While the device is priced at Rs.11,000, an imported digital stethoscope ranges between Rs.25,000 and Rs.50,000. American Diagnostic Corporation, 3M, GF Health Products, Medline Industries and Rudolf Riester are some of the key global players.

Ayu Devices’ rival in India, MUSEinc’s flagship product, Taal, is sold at around Rs.3,400. Arvind Badrinarayanan and Sumukh Mysore manufacture Taal, which consists of a sensitive microphone for recording heartbeat. It processes and amplifies sounds by passing it through various sound filters. Taal also comprises a circular hardware device, which is paired with a smartphone app to function across species from hummingbirds to humans.

Unperturbed by competition, Adarsha says AyuLynk has an edge over its competitors. “All other digital stethoscopes come with microphones and have completely altered the look of a stethoscope. Our device has maintained the look and feel of a stethoscope. Doctors won’t accept any new technology if the traditional look of stethoscope changes.”

Adarsha states that the existing imported devices are costly, and therefore, not suitable for the price-sensitive Indian market. He also asserts that their device is designed based on the functional requirements of Indian doctors. “Public hospitals’ OPDs are extremely crowded and noisy, and hence doctors find it difficult to detect abnormal sound. Thanks to its noise filtering feature, minor abnormal sounds can be detected,” says Dr. Pinto.

Dr. Konar believes devices such as AyuLynk can also help to bring down the use of tests such as ECG, 2D echocardiography and MRI. “You cannot record sound through a conventional stethoscope, so usually doctors ask patients to undergo tests to confirm the diagnoses. But with the help of a digital stethoscope, a doctor can repeatedly hear the sound waves and determine whether or not to proceed with tests,” he says.

Beat is on

Ayu Devices, which initially received a Biotechnology Ignition Grant of Rs.5 million, is also eyeing private investors to raise fresh funds for expansion. “We are in talks but haven’t finalised any deal yet,” says Adarsha. SINE has invested Rs.500,000 and has offered to invest a further Rs.3 million for a larger stake in the company.

The researchers want to further upgrade their device by installing Bluetooth for wireless connectivity. They also plan to install a software which will help doctors detect abnormalities while the examination is underway. “We are also looking to provide analytics through algorithms,” says Adarsha.

Currently, it takes 15-20 years of practice for any doctor to become an expert at spotting abnormalities in heartbeats and lungs. “But with the help of the device and app, medicos will be able to defect abnormalities effectively and faster,” says Adarsha. How quickly Ayu Devices will be able to scale up its operations will depend on how fast the medical fraternity warms up to the invention, but for now it has got the rhythm going.