1. Opening ambit as appropriate.
2. Over the last quarter of the 20th century, humanity has witnessed development of an unprecedented and unimaginable capacity that has helped improve healthcare of the people. This amazing progress in healthcare has chiefly been the outcome of phenomenal advances in science and technology:
_ Science that gave us deep understanding of the causes of diseases and the concomitant requirements of healthcare; and
_ Technology that gave us tools to turn that knowledge into actions that help improve sanitation, food quality and quantity, vaccines, drugs and strategies for the diagnosis and delivery to the vast populations and individuals alike.
4. But then, science and technology have only helped to create the
Possibility for healthcare to be taken closer to the people. While advances in healthcare delivery have increased the average life expectancy and helped in eradicating several diseases, the packaging and delivery aspects of healthcare has generally not shown the same improvement and advances over the same time frame. Actually delivering better healthcare to people requires not only resources, but more importantly the commitment and acceptance of the responsibility for it by society.
5. While science and technology offer the opportunities and wherewithal for healthcare for all, it is the society that must realize these on the ground. Thus, despite spectacular advances in science and technology it is estimated that about one third of our population is still unable to derive the benefits of modern healthcare facilities. This has been further accentuated by the technological and financial asymmetry between the richer people and the BPL and low income section of our population. This gap can only be bridged when both the innovation power of science and technology and the will and resources of society to deliver it come into full partnership. This then is the real challenge facing us in India.
6. I believe that we should be talking of healthcare electronics rather than only medical electronics as it could then include under its ambit any device that incorporates electronic components and helps to monitor, diagnose and even treat illnesses at a variety of levels, be it at home, workplace, medical clinic or even a hospital of humans as well as animals. Today, literally millions of electronic products provide the healthcare industry greater efficiency, convenience and productivity that were unimaginable even a decade ago. The range of healthcare electronic devices is vast and varied, starting from the simplest glucometer or the blood pressure monitor that we all have come to accept and use at a personal level, to the whole body scanners used for diagnosis and to the linear accelerators for treatment of cancer generally available in only a few super specialty hospitals.
7. At the other end of the spectrum is the establishment of an all-electronic Hospital at Brampton, in Canada. I am told that it is a fully automated hospital, right from the point of check-in of the patient in the hospital to the stage of lab tests, to bedside care and to even drug dispensing. Electronic kiosks allow patients to register themselves with a swipe of their health cards, get a map directing them to the required department which information is provided in eight languages, from English and French to Italian and even in Hindi. All patient information, such as blood tests, digitized X-rays and other images, bedside monitors etc. is electronically fed to the computers. All of this could easily be recalled by authorized healthcare personnel through hand-held devices anywhere in the hospital, as it is completely structured in a wireless mode! Of course, I am not suggesting that we adopt this model in India but merely saying that we certainly need to enhance the efficiency of our hospitals, especially those in the government sector, through greater intervention and adoption of such electronic devices and instrumentation and systems.
8. This brings home another point too. That is, presently the demand for medical device networking solutions by the Healthcare industry is growing very rapidly. Advances in networking technology and the Internet are opening up the doors to development of network-enabled medical devices, equipment and systems that are capable of communicating with each other – over networks and the Internet – in healthcare environments as diverse as hospitals, nursing homes, outpatient care centers, patients’ homes and even in remote locations. This holds great potential for a country of our size and economic standing where modern healthcare facilities are not available at the desired levels. Telemedicine is merely one manifestation of this; there are other applications as well. And we should be exploring these avenues to reach out modern healthcare facilities to the hitherto un-reached lot. With our established capabilities in the IT and telecom sectors, we should be taking advantage of our intellectual endowments to device innovation solutions.
9. Increased life expectancy has translated into an increase in the number of aged people not only in India but the world over. More and more of us can now expect to survive into our eighth, ninth and tenth decades - our 70s, 80s and even 90s. Most senior citizens now look for simple healthcare devices that could be used at a personal level for monitoring common health parameters. This is confirmed by a study done recently by Accenture of 4000 Americans. It indicates that 80 percent of those surveyed prefer using home healthcare electronic devices — which enables them to monitor, diagnose and treat illnesses in the home - as they not only help in improving their overall health, but save on cost and time too. A few of such home healthcare electronic devices included wearable non-invasive glucose monitor for diabetics, an in-home haemodialysis unit, a do-it-yourself screening test for conditions ranging from high cholesterol to blood-borne infections, etc. I myself suffer from sleep apnea and was thus looking for a device that could help me sleep restfully – I came across one that has been developed by a local innovator and which is programmable. With the existence of a significant population of well-to-do seniors the world over and even in India where it is set to double in the next five years, there is no doubt that the market for such innovative devices would increase tremendously in time to come. Also, in India with rising incomes and medical insurance, which is projected, to cover 300 million people by 2012, more people are looking for quality personal diagnostic and monitoring options. The market for healthcare devices, in India is growing and will continue to grow, for at least a decade if not more, at 15% per annum.
10. I am sure all of you will agree that health care devices technology is truly trans-disciplinary drawing sustenance from many scientific disciplines like material science, electronics, computer science, electrophysiology, mechanical engineering, chemical engineering, structural systems, mathematical modeling, clinicians, biologists and so on. Medical device technologies are subject to rapid obsolescence. With rapid pace of medical innovation, what seemed to be the best practices and state-of-the-art today gets considered as backward and ineffective within a couple of years. Due to the high costs and long lead time of product development and regulatory approvals, profitability in the medical device industry depends on a manufacturer"s ability to design and develop products that have adequate lifespan in the marketplace. R&D has to be encouraged and supported so that we have products that are targeted at the Indian population not only to meet their specific medical needs but also to offer them at prices that are affordable. We have to create an innovation-friendly environment for incremental improvements - a key to medical device and equipment development.
11. You may well ask ‘What are you doing in the Ministry for the industry. In the Department of Biotechnology we have launched a Biodesign programme in collaboration with Stanford University with the objective of creating medical technology innovations. Another programme of DBT, the Bioengineering programme provides support for commercialization of biomedical technologies. In the DSIR we support grassroots innovators under a Technopreneur Promotion programme. Several innovators have come up with novel devices for example, cardiac analyzer, digital X-Ray and other utilitarian devices to assist the physically challenged and others to lead better lives. I would urge my industry friends present here to look and assess these developments and help proliferate their use more widely. Innovative talent in India abounds, we only need to look for it and tap it.
12. Although new products need to be brought to the market as quickly as possible, their quality assurance is as important as speed. The products need to be tested fully and quality standards ensured before being allowed to be marketed. The aim should be for zero tolerance to medical devices failures. The certification mechanism of medical devices should therefore ensure both speed and quality. As of today, medical device regulation is managed by the application of Quality systems in Design, Development and Manufacture and conformity with various other standards. Medical Device Regulations established by other countries have become non-tariff barriers in international trade. Hence promotion and growth of Medical Devices industry in the country requires effective and prudent regulation incorporating the currently accepted principles of GHTF (Global Harmonizing Task Force). We have taken upon ourselves in the Ministry of Science & Technology the task of drafting a new legislation so that we are able to enforce uniform and effective standards throughout the country for all medical devices including healthcare electronics. I am sure this will also ensure that substandard devices are not exported, especially to other developing countries, which do not have medical devices regulation in place. In the Bill, we seek to create a Regulatory Authority that will seek to establish and maintain a national system of certification relating to quality, safety, efficacy and availability of medical devices. I am sure when it becomes an Act; it will give a sound footing and an impetus to the growth of medical devices industry in the country.
13. Closing ambit as appropriate.