Sector Profile

INTRODUCTION THE MEDICAL DEVICES AND EQUIPMENT INDUSTRY The Medical Devices and Equipment industry, valued at US$ 2.5 billion contributes only 6% of Indias US$ 40 billion healthcare sector. Moreover, it is growing at a faster annual rate of 15% than 10-12% growth seen in the Healthcare sector in its entirety. A rise in the number of hospitals and the increased requirement for healthcare facilities creates a need for sophisticated devices and equipment, which can provide accurate treatment to individuals. The Medical Electronics segment of this industry incorporates control, conversion, sensing, processing, storage, display, and transfer of information on anatomy and physiology by making use of the Electronics and Communication Technologies. The Medical Equipment industry is quite wide with > 14,000 different products types, as per the Global Medical Device Nomenclature (GMDN). The products range from wound closure pads to stents and IVD machines of medical devices. Further, it can be reasonably said that Medical Electronics is an area, where Electronics and Information Communication Technology play a decisive role. Moreover, significant efforts have been made in the medical technology ecosystem to stimulate innovation in this space so that the opportunities provided in the Indian market can be capitalized by the companies working in this domain and the Indian consumer of healthcare services stands to benefit. In the past, the sector has significantly brought down the incidence of disease among patients,families, society as well as improved the countrys health system, significantly. However, in India the penetration of medical devices is low and inadequate due to the barriers that prevent their usage. Promotion of the Sector by the Government The government is expected to develop a regulatory structure leading to quality products being developed by manufacturers. However, the current regulatory structure lacks active participation from the government but

with the increase in competition in the sector, this is just a matter of time. The last few years have seen an increase in domestic manufacturing of medical equipment. With impetus from Government of India schemes, India is beginning to look forward to being recognized as a manufacturing destination for sophisticated medical technology. The Private and Foreign Investments International companies in this field are also using India as a manufacturing base by either setting up facilities of their own or by acquiring domestic manufacturers. Some examples include 3 M's manufacturing plant in Pune, Becton Dickinson's manufacturing facility in Haryana, Hollister's setting up manufacturing facility in India and Philips Medical Systems' acquisition of Medtronics and Alpha X-Ray Technologies. Medical Technology Parks have been proposed by the Government of India in addition to the existing parks to encourage domestic manufacturing of medical equipment. FDI inflow will spur R&D and manufacturing innovations, in turn increasing the efficiency and effectiveness of medical electronic products. Advancement of medical electronic product quality and associated successful diagnostic rates are expected to create a spurt in adoption.Some of the leading Medical Device and

KEY PLAYERS Medical Electronics Companies Operating in India

1. 3 M 2. India Medtronic 3. Johnson & Johnson 4. Becton Dickinson 5. Abbott Vascular 6. Bausch & Lomb 7. Baxter 8. Zimmer India 9. Edwards Life Sciences 10. St. Jude Medical 11. Stryker 12. Boston Scientific 13. BPL Healthcare India 14. Sushrut Surgicals 15. Trivitron Diagnostics 16. Accurex Biomedical 17. Biopore Surgicals 18. Endomed Technologies

19. Forus Health 20. HD Medical Services (India) 21. Eastern Medikit 22. Harsoria health care 23. Nidhi Meditech System 24. GE Healthcare 25. Philips Medical 26. Wipro Technologies 27. HCL Technologies 28. Texas Instruments

KEY PLAYERS ROLE

Role Played by Major Competitors in the Medical Technology Sector

Medical Technology companies are undertaking a lot of innovations out of India, both, for the domestic as well as the overseas markets. Transasia Biomedicals has developed in-vitro diagnostic equipment through its R&D base in Mumbai. The Sushrut Adler Group has developed an external fixator for the Indian market. Johnson and Johnson has developed a knee implant suitable for the Indian market as well as a reusable stapler for use in surgeries at price points, which are amenable to the Indian market. Roche Diagnostics has developed a screening device for cardio-vascular diseases, which is suitable for use in rural settings. GE Healthcare has developed a low cost ECG machine and a low cost Ultrasound machine for the Indian market. Philips Healthcare is using its recent acquisitions in India to develop and launch a low cost Cath Lab for the Indian market.

GROWTH RATE Drivers for Growth of Medical Technology Sector in India

in Healthcare

Sector on

cturing

requirement

Recommendations for Government to Improve Sector

nization Task Forces (GHTF) definition and rules-based classification of medical devices. rehensive Medical Device Regulations. skill up gradation.

calibration, testing, quality control, waste management etc. hence, creating an ecosystem for the benefit of SMEs focusing on medical technology. e public spending in healthcare from 1% of GDP to 3% of GDP to radically alter the provision of healthcare services. ween medical centers and technology universities. training received by medical and paramedical staff thereby providing creative resources for leading medical innovation efforts. y education within the medical curriculum with assistance from agencies like NIPER.

consistent interpretation of regulatory approval processes for which partnership with Industry associations maybe considered as a practice instead of sporadic efforts. Usher further reform in the insurance sector to stimulate health insurance thereby providing the financial incentives for medical technology innovation. nvestment fund to address the lack of early stage venture capital

Bright prospects for medical devices industry

Dr K V Krishnan, Thursday, May 26, 2011, 08:00 Hrs [IST] Medical devices have made significant contributions to health and quality of human life and they have undoubtedly changed the mainstream practice of medicine. These devices extend the ability of physicians to diagnose and treat diseases in an enhanced way. The five largest global markets for medical devices are U.S., Japan, Germany, France, and Italy. They account for 13.1 per cent of global population and 76 per cent of global medical device use. The U.S. has a share of 50 per cent in recent years of the world medical device market. Conversely, the five most populous countries in the world China, India, Indonesia, Brazil and Pakistan account for nearly half of the global population. But they account for only 4.4 per cent of global medical device use.

Global devices market Geography-wise

The medical device market is quite diverse; it includes medical and diagnostic equipment; medical implants and plastic disposables. Medical devices segment also includes analytical techniques like Chromatography, Nuclear Magnetic Resonance (NMR), Polymerase Chain Reaction (PCR) in addition to medical imaging and diagnostic devices.

The medical devices industry is being constantly challenged by a host of factors such as:
Increasing regulatory implications Interoperability of devices Need for advanced electronic records and Portability of devices The major factors that drive the global medical devices market are: Innovation in the treatment and diagnosis front; Growing aging population and Shifting disease pattern which needs long term medical care and diagnosis There has been a technological revolution in the medical device industry in recent years. The pace of medical invention is accelerating with the convergence of many scientific and technology breakthroughs. These medical technology innovations are bound to fundamentally transform the above scenario by providing new solutions that will challenge the existing paradigms. This naturally inspires hope for better clinical outcomes with less invasive procedures and shorter recovery times, all in lower cost settings. Developments in the medical device industry are affected by many different trends in society, health care

policies, regulatory decisions and new technologies. There are very clear trends that are visiblein the medical devices market and they can be broadly classified as: Interoperability the ability of diverse information technology (IT) systems and medical devices to inter-operate (work together). Currently, in the vast majority of hospitals, the healthcare environment is crowded with disparate, selfcontained devices, technologies, and IT systems that do not communicate with each other. Advanced RFID systems - Through the combined technologies of the new healthcare supply chain: wireless networks, radio frequency identification (RFID), and medical device/instrument connectivity. These technologies are laying the infrastructure for the 21st century medical delivery system. Wireless Support the presence of wireless communication within healthcare is escalating. Though radio technology is being used today, wireless is a growing technology within this sector. The rapid growth of the technologies extends the potential for exploitation of wireless medical application market. Nowadays, thanks to the large-scale wireless network and mobile computing solutions, such as cellular 3G and beyond, WiFi mesh and WiMAX, caregivers can access vital information anywhere and at any time within the healthcare networks. The presence of pervasive computing, consisting of RFID, Bluetooth, ZigBee and wireless sensor network gives innovative medium for data transmission for medical applications. Zigbee is projected to be one of the leading wireless technologies of future medical devices. The areas where Zigbee is expected to dominate are: Implantable radio that communicates with devices implanted within the body of the patient (e.g.: cardio devices, artificial sight) High intensity transmission of still and video images (e.g.: point of care solutions, remote

monitoring) Closed loop dosing (e.g.: Asthma inhaler, diabetes/glucose monitor) Self-treatment at home with monitoring by physician remotely. Smartphones and Healthcare Apps: As of 2010, 5805 health, medical and fitness applications are available with the Apple Appstore. Medical iPhone Apps With the increase incidences of lifestyle diseases and increasing general awareness, the handheld, simple, convenient, user- friendly devices for measuring and monitoring various healthcare parameters are on the rise. Medical devices that offer less invasive treatment options, with better clinical outcomes and shorter recovery times, will create tremendous value in the next few years. Indian scenario The Indian market scenario is quite complex in many ways. Domestic manufacturers mainly dominate low value medical supplies and disposables whereas importers dominate the costly and high end medical equipment market. The local market is still dominated by either imports or large MNCs whereas the local manufacturers act as only small players in this market. Imports constitute over 50% of the market and most imported products have high gross margins. The main issues that cripple the Indian medical devices industry are India's dependency on imports for supply of medical devices, strict industry regulatory environment, low level of healthcare insurance and low levels of healthcare facilities and awareness especially in rural areas. The primary challenges facing the local manufacturers are: Poor infrastructure for R&D and testing facility for efficacy and safety testing. Lack of trained personnel for serving in this industry with sufficient technical knowledge.

Majority of the Indian medical device market is dominated by the specialty medical dental and surgical instruments and appliances such as ophthalmic, dental and other physiological classes. This segment accounts for 55% of the total market and is followed by medical implants and disposable segments accounting for approximately 25% and 20%, respectively of the total market. Medical supplies (bandages and disposables like syringes, needles and catheters) constitute 20% of the total market largely met by local production. Diagnostic kits constitute a high growth segment in the medical devices market with a growth rate of 30% and Indian companies like Nicholas, Piramal, Orchid have significantly consolidated their market position in this segment. The fast growing segment is the largest medical equipment segment still largely dependent on imports. European and USA medical devices manufacturers are actively considering outsourcing or relocating their manufacturing to Asia especially India and China to take advantage of its significantly lower costs for skilled labor that prevails in these countries. If India could provide these medical devicesthat meet quality requirements and international standards, then it would be highly attractive to an increasing number of healthcare providers in western countries who are presently struggling to contain costs and facing tightening budgetary restraints. With India being the preferred outsourcing destination for other services, it can attract more foreign companies for contract manufacturing of medical devices, once the above-mentioned constraints and apprehensions are addressed. Indian medical devices manufacturing industry is bound to benefit largely from the outsourcing activity of medical device manufacturing in future. - The author is Practice Head Life Sciences, Mindteck http://www.pharmabiz.com/PrintArticle.aspx?aid=63097&sid=9

ENTRY AND EXIT BARRIERS

Market entry The probability of firm entry in a given year is influenced, both positively and negatively, by the number of prior entries. A higher number of prior entries exerts a positive, legitimizing effect on new market entry, allowing startups to acquire the resources needed to grow and survive. On the other hand, the number of prior entries exerts a negative effect via heightened competition.11 In a similar fashion, market entry is positively associated with prior merger and acquisition (M&A) activity in the sector, the number and valuation of prior IPOs for firms in that sector, and the amount of venture capital funding invested in firms in that sector. All of these provide additional legitimizing effects for new entrants and strong signals of the likelihood of good exits for investors. Conversely, market entry in one sector may be negatively associated with similar activity in another sector, which can serve to siphon off capital and investor interest. Finally, new entry can be influenced by environmental conditions, such as cyclical swings in the U.S. economy, which can increase or decrease access to capital. Market exit Different types of exit (bankruptcy, M&A, IPO) likely have different correlates. In the interest of parsimony and exposition, we collapse M&A and IPO, label them as good exits (from the firms perspective), and contrast them with bankruptcy (bad exits). We further assume that factors positively associated with one are negatively associated with the other. In contrast to market entry, analyses of market exit include firm-level as well as marketlevel factors. As with prior entries, the number of prior exits exerts both positive and negative effects on market exit: the presence of few exits suggests high prospects for survival, while the presence of many exits suggests that there is room for new entrants. Other market or environmental factors that might influence exit include the broader economic cycle (which is tied to industry M&A levels) and the presence of geographic clusters (hot spots). At the firm level, the companys age can influence market exit in various ways. Firms can suffer from liabilities of newness (exit is more likely among younger firms), obsolescence (exit is more likely among older firms), and adolescence (exit is more likely among middle-aged firms). Different processes underlie these different patterns.12 Liabilities of newness arise from the firms small size and difficulty in attracting labor and capital. Liabilities of obsolescence arise from firm inertia and unresponsiveness to changing market conditions. 13 Because success in resource acquisition figures so prominently in the effects of firm age, we also consider the impact of capital and human resource stocks on market exit. Firms with more rounds and greater levels of venture capital financing, as well as a greater number of venture capital investors, are more likely to have a successful exit. With regard to internal human capital, successful exits may be more likely among firms with larger boards and more experienced executives. With regard to external human capital, successful exits may be more likely among firms whose venture capital funders have more rounds of investment experience and experience with more companies. Finally, successful exits may be more likely among start-up firms that have a track record of acquiring other firms. Such firms may have built up either scale advantages or product portfolios that public investors and larger firms find attractive.

REGULATORY BODY: http://www.aimedindia.com/

COMPANY : MEDTRONIC http://www.medicards.in/userpage/manufacturer.php?company_id=1291