Healthcare, today, is on the cusp of a new era when MedTech is changing the face of clinical care. From prevention to rehabilitation, it has changed the way healthcare is delivered. Highly accurate diagnostics to more effective and targeted treatments have already moved into clinical practice with remarkable gains and the promise of even more to come. Today healthcare has become more comfortable, less damaging, and less painful with better final outcomes to the patients as compared to the blind and lengthy procedures used earlier.

All of these technologies have been developed over the years on account of tireless efforts of thousands of healthcare experts who have contributed for many years to bring a single product to come into practice. The common thread through all applications of MedTech is the beneficial impact on health, quality of life, and society as a whole. For many patients, medical technologies form an inseparable part of their daily life. Across the world, numerous exciting developments are going on; those technologies hold the promise of even greater success in the complex disease environment.

The life expectancy in India grew from a mere 40 years in 1960 to 63.9 in 2002–2006 to 67.3 in 2014. In some states like Maharashtra, Delhi, Kerala, and Himachal Pradesh, the expected lifespan at present is slightly above 70 years! This is on account of amazing progress in healthcare technology with a large contribution from medical devices.

MedTech is very different from the pharma sector. It is highly capital intensive with a long gestation period of development and needs continual influx of technology and continuous training of the doctors and para medical staff to adapt to the new technology. It requires continuous R&D to produce different versions and variations to match different requirements and geographies. Therefore the scalability of MedTech is much slower than that of pharma. It is also different as there are no generics available in the sector.

Can one think of a hospital without these devices and technologies? Can a surgeon perform without using these technologies and get the desired results? Will the hospitals still be called the temples of health? Can a country afford to ignore such technologies and can it deprive its citizens of getting the benefits? MedTech is miracle technology. It is the time for all stakeholders to come forward for a common purpose: improving, extending, and transforming people's lives. Let us recognize the uniqueness, nuances, and significance of MedTech and how it is making a difference in the healthcare delivery systems.

Growth Opportunities

The Indian MedTech and devices market has been growing at about 15 percent annually for the past five years and is expected to maintain a similar clip in the coming decade as well. The market encompasses a very wide range of products from the relatively low-value items such as surgical instruments or consumables like syringes and needles, to the high-value equipment including CT scan machines, cardiac catheterization lab suite, or MRI, each of which has a price tag of up to 1 crore to 5 crore apiece. In the middle segment, there are implants for knee and hip-replacement surgery, electronic measuring instruments like cardiac monitors, artificial lung machines, anesthesia equipment, and numerous other items.

The market size at present is about USD 4.9 billion (approximately 30,000 crore), which is a tiny part of the total healthcare market of about USD 80 billion but this is likely to record substantial growth in the coming years. Hospital administration professionals often say that a large multispecialty hospital of 100 beds or more needs as many as 2000 different items on a daily basis. Thus, the growth of the medical devices market is closely connected with the expansion of healthcare delivery systems in the country.

Healthcare delivery growth. New hospitals are being built at a rapid pace all over the country, and many existing hospitals are being expanded in many places. There is also a spate of acquisitions of new properties by for-profit hospital companies, nearly half a dozen of which have become publicly listed in the past two years.

Along with large hospitals, single specialty hospitals and diagnostics chains are also making ambitious plans to grow their business.

Apart from the metro cities, hospitals are being built in tier-II and even tier-III towns, some of which are state capitals, district headquarters, or business centers like Indore, Coimbatore, Madurai, and so on. These were relatively underserved regions where healthcare is concerned and a number of large and medium hospital companies are reaching out to the people here.

An important aspect of in-patient hospital outcomes are the medical devices and consumables, used either in the operating room, the ICU, or even in the regular wards. The utilization of high-value medical gadgetry is relatively more in the OR and the ICU. Since many hospitals being built in recent years have a higher proportion of ICU beds, this trend also favors a higher growth trajectory for medical devices.

Disease Patterns. India carries a two-pronged disease burden. On one hand, the scourge of MDR (multi-drug resistance) TB, malaria, and other infectious diseases are taking a heavy toll on the health of people. On the other hand, the rapid growth of non-communicable diseases such as diabetes, high blood pressure, PCOD (polycystic ovary disease), and cancer that used to afflict the affluent sections of Indian society have travelled down the social ladder to affect more and more people. While effective treatments are available for most of these, they also require a lot of monitoring of health parameters. Lot of people living with diabetes have to check their blood sugar at least once a day, and high blood pressure patients often need to take their readings at home. All of these are likely to swell up the demand for various use-at-home-medical devices in the years to come.

Public private partnership. The need for harnessing the funding capacity of the private sector in healthcare and the necessity of making healthcare services affordable for the maximum number of people has given rise to the concept of the public private partnership (PPP) in healthcare delivery. This throws up the possibility that access to healthcare and the demand for medical devices could increase exponentially and in tandem, if the PPP model could become an industry standard.

Health insurance. In the current scenario in the country, where 70–80 percent of the healthcare expenditure of individual patients is borne by the family itself, affordability is a major question. While the spread of health insurance is much lower than that in the developed countries such as the United States, about 25 percent of the Indian population is covered by some kind of health insurance. This includes publicly funded schemes such as Rashtriya Swasthya Bima Yojana (RSBY), which is operated by the central government and state government-sponsored schemes like Yashaswini in Karnataka and Arogya Raksha in Andhra Pradesh. Likewise, privately funded insurance schemes run by non-life insurance companies such as ICICI Lombard and Bajaj Allianz are expanding steadily year after year.

Technological advances. While hospital growth and increasing affordability among the burgeoning middle class, which currently stands at about 300 million people, offers tremendous opportunities for growth for medical devices in India, technological advancement is creating new avenues for this sector. Thus, portable ECG machines, from which the results can be transmitted to a major hospital with greater ease than before, has enabled healthcare professionals to offer their services at locations far removed from the hospital itself. Bausch & Lomb introduced intra ocular lenses, which could go through a 1.4 mm incision thus helping in faster recovery especially for the diabetic patients in the country. Vygon brought in catheters as thin as threads which became the life-lines for millions of babies worldwide. Stryker allowed dignity and safety to patient in transportation through patient assist beds and chairs which could be made to climb steps. The list is long. Companies from all across the world delivered some spectacular advances in patient care.

Challenges and Threats

The medical device market in India, although worth USD 4.9 billion (30,000 crore) is highly fragmented. This is a relatively small component of the total healthcare industry size of about USD 80 billion. To put it another way, the annual per capita consumption of medical devices and consumables in India is about
USD 3 as compared to USD 28–43 in middle income countries such as Brazil and Russia. There are strong reasons why the medical devices industry in the country has not expanded to its full potential. These include: non-distinctive regulatory structure; price control; draft legislation pending; custom duties increase on products not import substitutable in near future; preferential market access (PMA) which failed in a contiguous sector, being reintroduced; growingly conflicting signals to foreign direct investment; inadequate public spending on healthcare; and poor insurance coverage.

Way Forward

The MedTech industry in India has a remarkable opportunity for growth and expansion but faces rather daunting challenges that currently hold it back. MTaI has made some recommendations that could help the sector break free from its shackles and realize its full potential.

Separate regulatory framework. There is a crying need for a separate regulatory mechanism for medical devices, instead of extending the current systems designed for drugs, and making it applicable to medical technologies as well. All the background work for a separate legislation has been completed; several drafts have been prepared and circulated among various stakeholders. Now it requires steering through the legislature on priority. This will make it possible for the government to set up a suitable regime for regulation and quality control of medical devices. The process of permissions and approvals is divided between different ministries on account of different acts applicable to the devices sector. To avoid procedural delays and hurdles, there should be a system of single window clearance, while the different arms of government should coordinate with each other to work out a consolidated approval for the concerned companies. This will drive Ease of Doing Business and promote growth of the sector.

Price control. Ideally, un-nuanced price control should not be imposed on MedTech at all. If it is to be imposed, it should have the proper checks and balances and should not blanket cap for all generational categories. Price control slapped in a haphazard manner, without taking into account the dynamics of the healthcare sector, as proven in the case of stents, will bring no better access for the patient and may just end up smothering this dynamic and vital industry.

Make in India. The government's push toward Make in India is unquestionable. However, it is impractical to plan to make in India the entire range of products. This we-will make all approach has the risk of missing out on building competencies that are vital for sustained growth, survival, and reputation building for the industry. Countries, which have improved their manufacturing footprint in medical devices have moved forward progressively with their product mix. In fact the objective to import substitute should be replaced with the aim of achieving global competitiveness (through export promotion and global quality). Make in India should be implemented in a phased manner, allowing sufficient time for new and advanced technology to be brought into the country. It should focus on those devices that can be manufactured in India in the short term, rather than the advanced technologies for which the ecosystem and know-how may not be available within India for several years into the future.

Though this sector is not employment intensive, it can really help in employment generation in a surrogate role: through Healthcare Worker training. Besides the vacancies of doctors and nurses, the number of allied HCW vacancies is huge. About 65 lakh vacancies exist in allied healthcare such as dental technicians, medical laboratory technicians, emergency technicians, phlebotomists, serologists, sonographers, and radiographers and many others. Almost all HCWs are trained and made patient-ready by the MedTech industry. This contribution of the sector should not be inadvertently compromised through any policy.

Level playing field. The PMA system should be restricted to those items which are already being manufactured by Indian companies. To implement this across the board would be detrimental to patient interest. Besides, the public hospitals should also buy the products of the best quality available in the market, rather than just be guided by origin of manufacture.

Taxes and customs duties. The customs duties regime should be designed in such a way that it does not affect the availability of quality critical care products. There is an urgent need to do the micro-analysis of the sub-sectors. Wherever import substitution of an acceptable quality level is not likely in the near term, a duty roll-back to previous levels should be made. Besides the duty structure should be at par with the tariffs in the neighboring countries so that the duty differential does not lead to a possibility of smuggling.

Another point to note is that even in segments like consumables where countries like China have near self-sufficiency, they have had to reduce duties from 4 percent to 3.3 percent for several products. Nuances in deciding tariffs are necessary to make sure that it should not so happen that the manufacture of medical devices actually happens in the distant future whereas the cost is paid many years in advance by the patient. Subsectoring medical devices, based on engineering complexity, is a must for policy decision and clarity.

Health technology assessment (HTA). The government must initiate a process by which ICMR/DHR is established as the sole authority for HTA in the country. Any HTA request for any MedTech by any government body should be routed through the proposed MTAB (Medical Technology Assessment Board) under the aegis of ICMR/DHR. This will also ensure a holistic assessment of the situation and therefore help in the formulation of a process which will better safeguard the overall interest of the patient, without making the industry unviable.

Fiscal incentives and infrastructure for R&D. To give India a sustainable leadership in the MedTech space, the government needs to provide fiscal incentives and infrastructure for medical device innovation and R&D.

Scale up demand. Real time scale up of universal healthcare to expand bed capacity of India is required. It will automatically increase medical device penetration and market size.

MedTech of the Future

Progress in MedTech is continuous and gradual, often taking a decade or more to traverse from laboratory to marketplace. At the same time, for every new technology that actually reaches the market, there are many that fall by the wayside, for a variety of reasons – feasibility, ease of use, training requirements, cost to the end user, etc.

Lab on chip device for blood plasma separation. Blood plasma separation has to be done to subject the liquid component of blood to a number of diagnostic tests for various diseases. Until now, this process would be done in a laboratory, using sophisticated equipment and it would take a considerable amount of time. Through a process named acoustophoresis, the RBCs concentrate at the channel center (node) and cell free plasma collects at walls (antinode) which is separated by a trifurcated channel. The proposed techniques have potential application in point-of-care diagnostics and can help in accurate assessment and diagnosis of diseases. These devices will increase the quality, reproducibility, and reliability of the assay results. The cost-effective, self-driven capillary-driven plasma separation device will serve resource poor settings such as rural areas and military camps. The high-throughput acoustophoretic device will help in continuous monitoring of plasma analysis in ICU patients. The device has not yet been commercialized, but research projects are underway at IIT Madras and IIT Mumbai.

Robotic surgery. Robotic surgery has come into India a few years ago, and is slowly being used in treatment of cancer of the head and neck, lung, colon, and rectum apart from some gynecological malignancies.

Robotic surgery offers some clear advantages over conventional surgery – reduced blood loss, faster recovery from the operation, shorter stay in hospital, and less likelihood of post-surgical depression. Internationally, thousands of cancer patients have been treated with success using the da Vinci surgical system created by Intuit Surgical, an American company. It was approved by the US FDA several years ago. The cumulative worldwide figure for robotic surgeries conducted till 2015 was 625,000. In India, the technology is still at a nascent stage, with about 47 hospitals, spread across about 20 metro cities, conducting the procedure. Until recently, there were just about 250 surgeons trained in this technology, and they had conducted about 4000 surgical procedures between them. Compared to three million cancer patients in the country who need surgery, the number treated till now is miniscule. The US-based Vatikutti Foundation has embarked upon a major campaign to popularize the technology in India as well as to train as many surgeons as possible in different parts of the country. Apart from training of surgeons in robotic procedures, the Vatikutti Foundation is also working with the manufacturing company to work about special price points at which the system can be installed at government medical colleges and public healthcare facilities. They have a target of making the system have 20 new hospitals in India by the end of 2018.

Automated respiration monitor. A portable device that looks like a wrist watch is promising to change the way pneumonia is diagnosed and managed in children under five years of age. The prime indicators of improvement or worsening of a child's condition are an increased breathing rate and shallow breathing.

On World Pneumonia Day (November 12) 2015, Royal Philips has introduced a device known as the Children's Automated Respiration Monitor, which can give an accurate picture of how a child is breathing. This is crucial in deciding whether a child's pneumonia is getting better or worse, and whether the child is going to live or die. The device has an excellent potential for making a huge difference in the healthcare outcomes in the under-five age group. Since the product is the first of its kind, Philips is working both with local end users, as well as key stakeholders in the global health community to ensure that the monitor design and functionality will meet their needs on the ground.

3D Bioprinting for Tissues and Organs. Recent advances have enabled 3D printing of biocompatible materials, cells, and supporting components into complex 3D functional living tissues. 3D bioprinting is being applied to regenerative medicine to address the need for tissues and organs suitable for transplantation. Compared with non-biological printing, 3D bioprinting involves additional complexities, such as the choice of materials, cell types, growth and differentiation factors, and technical challenges related to the sensitivities of living cells and the construction of tissues.

Nanorobots living in blood stream. In the distant future, microscopic robots on the nanoscale could live in our bloodstream and prevent any diseases by alerting the patient when a condition is about to develop. They could interact with our organs, measure every health parameter, and intervene when needed. Though still an emerging field of science, nanoparticles are gaining something of a reputation as potential multitools for combating diseases like infections, cancer, Type I diabetes, and even opening up the blood–brain barrier. But they generally cannot be simply inserted into the body and left to their own devices, which is why we are seeing the development of techniques aimed at getting them to where they need to go.

Health sensors – portable diagnostics. If smartphones could be used as biosensors and wearable devices enabling patients to measure almost any health parameter at home, much health related information would be available at the user's home. This way, patients would have a chance for a better health management. Lifestyle could also be gamified with these devices to make it healthier. These can measure oxygen saturation; pulse variability, ECG, EEG, and much more. Like the tricorder in Star Trek, portable diagnostic devices do not only measure health parameters but also help diagnose the patient using smart algorithms or quick, digital access to medical professionals. The advantage that these developments can bring to telemedicine in a qualified manpower deficient country like India can well be imagined.

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