I am hoping that the first batch of devices will be available in 24 to 36 months: Dr Rajesh Palani
Bengaluru-based Dr Rajesh Palani has developed a non-invasive medical diagnostic device that analyses bodily sounds to diagnose multiple medical conditions. He has also received a patent from the USPTO for this device. In an exclusive interview with Lakshmipriya Nair, he speaks on how the device can serve unmet healthcare needs and divulges his plans for making the device available globally and at an affordable price
Can you give us an overview on the evolving diagnostics requirements of the country? 
According to Make in India’s website, the medical devices industry in India is currently valued at $5.2 billion and growing at a CAGR of 15.8 per cent. A component of this is diagnostic equipment. According to a media report, India accounts for just one percent of the global diagnostic industry which is growing at a CAGR of 20 per cent and expected to reach $32 billion by 2022. With India having the world’s second largest population and the highest disease burden, the cost of healthcare will continue to grow, putting a lot of pressure on our resources. The need for cost-effective, accurate and early diagnostics is therefore extremely important and critical for a country like ours.
Take TB, which is the ninth leading cause of death worldwide, as an example. WHO says that an estimated 53 million lives were saved through TB diagnosis and treatment between 2000 and 2016. For a diseases whose social and economic cost is high, early diagnosis and treatment of TB can not just save lives but also save resources that could be allocated to other healthcare priorities. We therefore need more investment in researching diagnostic devices to meet the unique healthcare requirements of our country.
Presently, TB diagnosis is based on a sputum examination under a microscope, or by culturing the sample. A chest X-ray may also help in diagnosis. More recently, the Gene Xpert technique is being used to diagnose this deadly disease. However, the microscope exam is not 100 per cent reliable and sputum culturing is time consuming and takes weeks to get a result. Although Gene Xpert is capable of producing results in minutes, it is very expensive and not easily available. None of the above mentioned diagnostic tools come handy as a handheld device. Hence, there is a need for a cost-effective, improved, fast, handy diagnostic and screening tool that will help in the diagnosis and epidemic screening of tuberculosis.
You have developed a hand-held diagnostic device. Tell us the science behind it. How does it operate?
Just as one can find the fuel level of a motorcycle by percussing its fuel tank and assessing the sound it produces, similarly, for about 400 years doctors have been using the percussion technique on certain anatomical areas (example the chest) of a patient during physical examination to get a diagnostic clue based on variations in the resonated sounds. My device has a mechanism that produces percussion sounds when placed on a patient which is then analysed by an in-built analyser and the results are then displayed on a screen.
What inspired you to come up with this diagnostic device?
As a doctor, and on humanitarian grounds, I have an innate interest in finding affordable solutions for epidemic diseases common in underdeveloped and developing countries. It all started back in med school (JJM Medical College in Karnataka, India). One morning, while performing the percussion technique on a patient as part of a physical examination, I got the idea of using resonant sounds from the human body to develop an economical, diagnostic medical device. I developed the first prototype in 2003 — which occupied an entire table — with a rotating drum to record the resonant sound readings. When I created this first prototype, I realised that further modifications to this device could potentially lead to a novel, handheld screening device for respiratory diseases.
How does it meet an unmet need in Indian healthcare? Can it applied for different therapeutic areas?
India has a need for affordable medical devices to address diseases that are common in our country. For example, as per WHO, India accounts for about a quarter of the global TB burden and has the highest burden of this disease1. There is therefore a need for a rapid, handheld, economical TB diagnostic/screening tool.
Since the device is pocket-sized, works quickly and safely, and is economical, it has the potential to be a mass screening device for many respiratory diseases like pneumonia or tuberculosis. As it is very economical, this device can also be used in primary healthcare centres and rural hospitals. In an emergency, this device could come in handy to diagnose pulmonary edema, pleural effusion in heart failure condition, etc. In a war zone, it can be used to diagnose warfare chest injuries, like hemothorax.
Physicians/medical students can use the device as a better diagnostic tool and as a replacement for the percussion technique in the physical examination of patients. A stethoscope is for auscultation sounds — or sounds from the heart, lungs, or other organs — while this device is for percussion sounds, or how the sound resonates to determine the underlying structure. My hope is that a day will come when I see a stethoscope around a doctor’s neck, and my device in the pocket.
This device is yet to be clinically tested. The complete potential of this device will be realised once we do clinical trials. Since this device is based on the analysis of differences in resonated sounds, I hope all the different diseases and medical conditions that produce variations in resonated sounds by nature can be diagnosed using this device.
How will it disrupt or transform diagnostics to improve it efficacy, accuracy and affordability?
For a medical device, size, cost, accuracy, portability, simplicity, speed (rapid testing) and safety matter. This device is developed based on all these considerations. For example, I hope this device will provide better results to screen respiratory diseases like pneumonia and pulmonary TB as compared to the age-old sputum analysis test. It is also safer than X-rays, and hopefully will be the cheapest of all available screening devices, thus reducing the global economic burden due to these diseases.
What are your go-to-market strategies for this product? How soon do you plan to commercialise it?
One of the important objectives of this invention is to make it affordable for people in underdeveloped and developing countries. Hence, different strategies will need to be implemented for different geographies.
For underdeveloped and developing nations, the focus will need to be on public-private partnerships, partnership with global public health agencies, other NGOs, CSR initiatives and other strategic partnerships. For developed nations, strategic partnerships, branding and distribution will be key. I am hoping that the first batch of devices will be available in 24 to 36 months.
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