Indian medical device makers seem to be making concerted attempts to get the right pulse of the $200 billion global medical device market. While they are inconsequential in size compared to multinationals like General Electric, Philips or Siemens, few technologies developed by Indian device makers are showing new signs of hope.
Be it medical diagnostics, patient monitoring systems or performance improvement, innovations by Indian device makers are looking at new ways to predict, diagnose, inform, treat and monitor disease. Success still eludes the home-grown medical devices players as market acceptability continues to elude their devices.
Business opportunities abound not only in global market, but a fast growing Indian medical devices market, which currently stands at $3 billion and is expected to grow at a rate of 12 to 16% for the next five years?considered a very attractive opportunity by leading international companies.
Given that electronics is hooked into virtually every aspect of healthcare sector?therapy, surgery, pharmacology, hospitalisation, medical test analysis, implants, and more?there are numerous examples of interesting and innovative breakthroughs in the realm of medical devices.
Here?s a quick snapshot. A little-known Surat-based medical devices company, Sahajanand Medical Technologies, has developed biodegradable polymer stents for angioplasty and priced it economically at Rs 70,000, forcing international medical devices majors to reduce prices of similar offerings from Rs 2-2.5 lakh to Rs 1 lakh.
Another player is Hyderabad-based Relisys Medical Devices with its offerings of drug eluting stents, angioplasty catheters, cardiac surgery disposables and critical care equipment. The company?s chairman, Krishna Reddy says that the industry size for original equipment manufacturers (OEM) in medical devices is about euro 1 billion, but there are only few Indian players who are eyeing this opportunity.
Researchers at IIT Kharagpur have developed an artificial heart gadget, successfully tested it on animals and are seeking the go-ahead from Indian Council of Medical Research (ICMR) for human clinical trials. The miniaturised device comprises a biventricular multi-actuated pumping system and aortic peristaltic pump driven by electric power and controlled by a controller. Mechanical valves present at the inflow and outflow conduits control the flow of blood through the pump and the entire pump system provides blood flow very similar to natural cardiac pumping.
Beauty of the system is its price?Rs 1 lakh compared to a similar device developed in the US, which costs Rs 35 lakh and showed a high rate of failure. ?Our 13-chamber heart is much better and affordable,? claims a researcher from the School of Medical Science and Technology, IIT Kharagpur.
At Narayana Hrudayalaya in Bangalore, doctors are displaying clinical prowess in cardiac care by planting ventricular assist devices (VAD) in patients. Measuring 60 mm in diameter and weighing 298 gm, a VAD is a battery-operated, mechanical pump-type device that is surgically implanted in the lower part of the chest below the heart.
Narayana Hrudayalaya chairman Devi Prasad Shetty is upbeat on introducing artificial heart surgery in the country in a big way. In India, about 20 million patients suffer from heart failure and almost 20% of these patients die each year without aid. With heart transplantation limited by donor availability and exorbitant costs involved, the use of VAD to maintain the normal pumping ability of a heart could find many takers. ?There are only 600 people in the world with artificial hearts and four among them are in Bangalore.
The surgery would cost about Rs 50 lakh,? he claims.
Bigtec Labs is another home-grown device maker grabbing attention. It has developed a DNA-based diagnostics platform which doctors can use at clinics to accurately and rapidly identify pathogens. The affordable platform could be customised to detect a wide range of diseases, claims Chandrasekhar Nair, director, Bigtec Labs. The company has miniaturised advanced medical technologies to create a so-called lab-on-a-chip. Later this year, the company would be rolling out its first product?a lab-on-a-chip with bio micro-electro-mechanical systems (MEMS) for hepatitis-B detection.
?I think that Jaipur foot was one of the most useful devices made in India by Dr Sethi. This simple and cost-effective device enabled many amputees to walk again. Its simplicity and low cost was particularly attractive for Indian patients,? says Anoop Misra, director and head of the department of diabetes and metabolic diseases, Fortis Group of Hospitals, New Delhi. He feels that such simple but useful products are required for India, which could be used for general public and yet would not pinch the pocket. In particular, adaptation to diseases and conditions specific to India are most important issues.
Taking the cue, multinationals like GE Healthcare seem to be the early trend catchers. GE Healthcare products are being designed in India to meet Indian needs. For example, Mac 400 is a battery operated portable ECG system that can interpret ECG in English. It is a perfect screening tool for cardiac diseases whether you are in the remotest village or a metro city.
So is Tejas DR-F, the first digital X-ray system to be manufactured in India. It helps to bring the cost down to one-third compared to an imported digital X-ray system and is ideal for the safe treatment of new born babies.
?GE Healthcare realised the need of local manufacturing way back in 1990 as all the healthcare imaging products were being imported from developed countries and attracted very high level of import duties, making it impossible for local healthcare providers to invest in high end technologies,? says V Raja, president and CEO, GE Healthcare (South Asia). ?We set up a manufacturing facility of ultrasound and CT systems in 1991 to bridge this gap and the local manufacturing brought down the price significantly?as high as 40% and subsequently reduced further due to indigenisation,? he adds.
Nevertheless, medical device makers face daunting challenges. There is a certain level of scepticism, which primarily stems from on overall perception about the ?level of regulation? of the Indian society as a whole, stresses Milind Purandare, associate vice-president?solutions (product engineering services), Patni Computer Systems.
Medical devices are treated very seriously by the developed world and there is a very high level of regulation which governs the design, manufacture and use of such devices. According to Misra, one aspect where we often lag behind is quality control. There is a great need to develop research and development facilities in India, and consolidate and upgrade those which are already established. This would not only ensure better quality control, but introduce more innovations.
?Currently, only a handful of devices are being made in India, and international scientists see and use only a fraction of Indian devices among scores available in international market. If we produce more, people will surely accept India as producer of quality devices,? says Misra.
Pradep Nair, vice-president, global life sciences and healthcare practice, HCL Technologies, feels some of these challenges can be overcome by creating universal designs with local adaptability, meeting stringent global regulations like FDA etc, and maintaining quality of manufacturing and packaging of a product. Though there is a proposal to bring all medical devices under the ambit of the Medical Devices Regulations Act (MDRA), the Bill is yet to be passed by the Parliament.
To establish credibility, India will have to create a very effective and enforceable regulatory framework governing the entire healthcare segment. In the short term, Indian companies can partner with established medical device companies in the developed world and become a trusted partner to such players.
Given the pressure on healthcare costs in the developed world, Indian companies have a unique opportunity to make devices of international quality, at substantially lower costs, using the design and engineering capability readily available in this country and export to these markets.
Experts feel that key to this is quality, lower cost and after sales service capability in the markets to be served.
The opportunity exists for all devices manufacturers that can meet the twin objectives of low cost and high quality. After all, technology and skills go hand in hand, reiterates Raja.