Amtz Issue eHEALTH Special Issue August 2016

SPECIAL INTERVIEWS

Dr Kamineni Srinivas Hon'ble Health Minister Andhra Pradesh

Shri Nara Chandrababu Naidu Hon'ble Chief Minister Andhra Pradesh

Dr Poonam Malakondaiah

Principal Secretary Department of Health Medical & Family Welfare Government of Andhra Pradesh

Dr Jitendar Sharma CEO Andhra MedTech Zone

Andhra Pradesh MedTech Zone Shri N Chandrababu Naidu Hon'bleManufacturing Chief Minister New Chapter in India’s Medical Device Growth Story Andhra Pradesh

Asia’s first Monthly Magazine on the enterprise of healthcare Volume 11 Issue 08 August - Special Issue 2016

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Contents

august 2016 Special Issue | VOLUME - 11 | ISSUE - 08

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Cover Story

A Leap for Indian Healthcare The goal of Andhra Pradesh MedTech Zone (AMTZ) is to make Andhra Pradesh an internationally recognised manufacturing hub for medical devices and contribute to volume-generated cost reduction of medical devices for patients

Special Interview

Special Interview

AMTZ: Ready to Boost State’s Economy

AMTZ: Defining Success Roadmap for Andhra Pradesh via Three USPs

Special Interview

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Kamineni Srinivas

Dr Poonam Malakondaiah

Dr Jitendar Sharma

Hon’ble Minister Health and Medical Education Government of Andhra Pradesh

16 Dr Pankaj Parashar

Principal Secretary Department of Health and Family Welfare Government of Andhra Pradesh

18 Manish Gangal

Vice President (Technical) AMTZ

AMTZ: Unique Facility for Sunshine Industry

20 Nitin Bharadwaj

Vice President (Operations) AMTZ

Chief Executive Officer Andhra Pradesh MedTech Zone (AMTZ)

21 Vipin Das Ramachandran

VP (Human Resource & Administration), AMTZ

VP (Finance) AMTZ

22 Deepak Agarkhed VP (Planning) AMTZ

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24 Himanshu Baid MD Poly Medicure Ltd

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26 Gurmit Singh Chugh Managing Director Translumina Therapeutics

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28 K Chandrasekhar Founder & CEO Forus Health Pvt Ltd

30 Gyanesh Pandey

Chairman & Managing Director HSCC (India) Ltd

Medical Device Regulatory Reforms – Ready to Boost Business & Quality Care via Improved Quality

editorial

Government of Andhra Pradesh – taking people where they ought to be The southeastern state of Andhra Pradesh has been always way ahead of other states in comprehending the value of innovation and other scientific & technological advancements. Setting example one after another, the Government of Andhra Pradesh has proven to be truly a great democratic state striving towards leveraging the benefits of scientific advancements across all industries.

Under the effective leadership of Chief Minister Nara Chandrababu Naidu, hailed both within India and globally for his diligence & for initiating projects way ahead of their time, the Government of Andhra Pradesh has been effectively translating its vision into reality. Nara Chandrababu Naidu has steered Andhra Pradesh to a level where the benefits all state-of-the-art projects is trickling down to the common masses. It has emerged as the frontrunner in not just growing the state, but also the national economy.

In similar veins, the Government of Andhra Pradesh has once again set a sterling example before other states by setting the foundation stone of the mammoth Andhra Pradesh MedTech Zone (AMTZ) in Visakhapatnam.

With renowned experts like Dr Jitendar Sharma, CEO, AMTZ, who is also known as the ‘MedTech Man’ of India, leading the entire project, AMTZ is all prepared to dazzle the entire healthcare industry. Unlike other projects, the AMTZ project has been crossing each and every level with ease due to adequate preparedness of the decision-makers to ensure realization of AMTZ to trickle down the benefits to all stakeholders in the healthcare sector.

With the recent emergence of medical device as the national agenda, AMTZ, a first-of-its-kind medical equipment testing & manufacturing facility open to all manufacturers & innovators, will encourage innovation & indigenous manufacturing of medical devices by providing access to common infrastructure for research & testing. The Government o f Andhra Pradesh, which has never been afraid of change in order to do something, better, has overcome all the hiccups by involving industry experts from both the government and private sector. eHEALTH Magazine is extremely proud to be part of such a landmark project which will be an excellent confluence of progressive decisionmaking, sophisticated infrastructure, expertise, etc. The special issue to be launched by none other than Chief Minister of Andhra Pradesh Nara Chandrababu Naidu on 19 August 2016 during the 1-day summit, including Foundation Laying ceremony of AMTZ, includes exclusive interviews of all key people who have willingly embraced the challenge of turning AMTZ into an opportunity for self-reliance in medical device manufacturing.

Dr Ravi Gupta ravi.gupta@elets.in

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AMTZ

Cover Story

A Leap for Indian Healthcare The goal of Andhra Pradesh MedTech Zone (AMTZ) is to make Andhra Pradesh an internationally recognised manufacturing hub for medical devices and contribute to volume-generated cost reduction of medical devices for patients, shares Sudheer Goutham of Elets News Network (ENN)

A

ndhra Pradesh is on a new mission. Nara Chandrababu Naidu-led government is setting up a dedicated industrial park for the manufacture of medical devices in Andhra Pradesh. He sees this as a tremendous opportunity for Andhra Pradesh, especially in the areas of industrial development and employment generation, while addressing a decadeold problem that India is facing in the healthcare sector.

The healthcare industry in India is on a high-growth trajectory, having evolved significantly in the last decade.

However, healthcare provision remains inequitable and challenges in access to quality, affordable healthcare persist in large parts of the country. The medical devices sector has also grown considerably during this period and plays a critical role at each stage of the healthcare continuum. Although it has been instrumental in improving access and affordability of healthcare services,

a number of ecosystem constraints have led to a high dependence on imports for addressing the domestic demand.

Kamineni Srinivas, Minister for Health and Medical Education, Government of Andhra Pradesh shares, “Lack of domestic manufacturing of medical devices is the main reason for the import dependency and high cost of medical products and services in India. It is the vision of N Chandrababu Naidu to develop a dedicated industrial park for the manufacture of medical

Role of Medical Devices • Will help reduce the cost of production of medical devices • Will help small & medium companies in medical devices to become global players

devices in Andhra Pradesh.”

The goal of Andhra Pradesh MedTech Zone (AMTZ) is to make Andhra Pradesh an internationally recognised manufacturing hub for medical devices, help in national agenda of import substitution and contribute to volumegenerated cost reduction of medical devices for patients.

What is AMTZ? The Andhra Pradesh MedTech Zone (AMTZ) is India’s first manufacturing hub for medical devices. Being set up in Visakhapatnam, the port city of Andhra Pradesh, the AMTZ will be developed in 270 acres of land. This prestigious industrial park will accommodate around 200 independent manufacturing units, each of a built-in ready-to-use of 1 to 2 acres of land. The zone will provide for certain capital-intensive facilities required by most medical device manufacturers and modern state-of-art-facilities.

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Cover Story

AMTZ

All investment towards land development, and building of common facilities as above would be done by the Government of Andhra Pradesh through formation of special purpose vehicle (SPV). The AMTZ would include the following facilities over an area of 50 acres: • Component testing centre • Electromagnetic interference laboratory • Medical-grade low vacuum molding, cabinet molding and injection molding centres • 3D designing and printing for medicalgrade products • Sterilisation & toxicity testing centre • Radiation testing centre • Warehousing • Regulator’s office • Other facilities commonly required in the manufacturing of medical devices “The AMTZ is very unique project and the first-of-its-kind in the world,” says Dr Jitendar Sharma, CEO of AMTZ, who is the brains behind this prestigious initiative. He says the project provides as a package of all scientific facilities that are critial to medical device manufacturing.

His mandate is to commence the operations of AMTZ that can accommodate 200 plus manufacturing units and establish scientific facilities required for device manufacturers.

All these tasks are to be completed within 18 months. “The AMTZ has three main unique selling points (USPs) – scientific facilities, affordable space and plug-andplay ecosystem,” says Dr Poonam Malakondaiah, Principal Secretary, Department of Health and Family

AMTZ will enable manufacturers to produce cost-effective high-end devices

Welfare, Government of Andhra Pradesh, who is the Chairperson of the Board of Directors of the Andhra Pradesh MedTech Zone.

“I am extremely thankful to Chief Minister Mr Chandrababu Naidu for recognising the opportunity and taking a quick and firm decision to set up India’s first medical device park in his state,” says Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AIMED) and Joint Managing Director of Hindustan Syringes & Medical Devices.

From Manufacturing to Destination The industry park is being built scientifically keeping the international quality standards for manufacturing of medical devices in mind. The domestic and global markets will depend on two factors - Quality and Cost. As all the scientific facilities in AMTZ are being provided by the government, the cost of production for the manufacturer will go down. With quality and cost-effective devices, the manufacturers will become competitive in the domestic market.

Andhra Pradesh MedTech Zone (AMTZ) Key Takeaways • India’s first manufacturing hub for medical devices.

• Will be developed in 270 acres of land.

• Will accommodate around 200 independent manufacturing units, each of a built-in ready-to-use of 1-2 acres of land.

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They will also be able compete with China, Korea and Taiwan imported medical technologies in India. The AMTZ approach towards national market is cost reduction, which will lead to a better competitive pricing.

For international market, it is not just pricing, but also the concept of international benchmark quality.

Dr Poonam Malakondaiah says, “We set three goals for AMTZ, achieving them in five years. They are: 1) To build AMTZ as Indian Hub in medical device manufacturing; 2) To make AMTZ in its core area as Asian Hub while competing with other esteemed Asian market leaders – China, Korea, Taiwan, etc; and 3) To reach the prestigious status of Global Hub. Here we will not only have to compete with the South East Asian nations but also contend with global markets such as – Russia, Germany, Italy, France, USA, etc.”

Market Scenario It may be noted that Indian medical device industry is worth over Rs 60,000 crore. And country’s humungous import bill for this segment amounts to over Rs 23,000 crore (approximately USD 4 billion) while export amounts to only over Rs 7,000 crore (USD 1.1 billion). India’s import dependency on high-end medical devices is over 80 per cent and 60 to 70 per cent for other devices. And, this is where the dedicated medical device park would be of great value - reducing humongous

AMTZ

import dependency, and increasing export while generating wealth and employment within.

However, the Indian healthcare system continues to be impacted by different aspects of healthcare, such as availability, affordability and quality of health services. Given these, India lags behind the averages of Brazil, Russia, India and China (BRIC) countries. A key area of concern for India is the proportion of non-communicable diseases which is expected to rise in the next decade.

The total healthcare expenditure in India was only 3.9 per cent of GDP, compared to 8.9 per cent for Brazil, 6.2 per cent for Russia and 5.2 per cent for China. Out-of-pocket expenditure is as high as 61 per cent, with only 25 per cent of the population being covered by health insurance. While the government and value chain participants have undertaken several steps to address the issues of healthcare access, quality and affordability, these have been executed in silos. Specifically, while medical device companies have focused largely on extending life expectancy and improving quality of care, there is a need to increase affordability for a widespread impact.

The challenge therefore for companies in India is to produce medical devices that are both cost competitive and effective to increase penetration and use. It is in this context that the Make in India initiative becomes significant for the medical devices industry Medical devices play a role not only in screening, diagnosing and treating patients, but also in restoring patients to normal lives and in regularly monitoring health indicators to prevent diseases.

With technological advancements, the role of medical devices is now expanding to improve quality of care across each stage of the healthcare continuum.

According to an industry report, in India, the medical devices industry is small, with a disproportionate reliance on imports and a complex regulatory environment. The global medical devices and technology market is expected to grow to USD 520 billion by 2020 from

an estimated USD 3.7 billion in 2014.

The Indian market is among the top 20 in the world by market size, and fourth in Asia after Japan, China and South Korea. However, the per capita spend on medical devices in India is the lowest among the BRIC countries at USD 3 (USD 7 in China, USD 21 in Brazil and USD 42 in Russia). It is significantly behind developed economies like the United States (US) (USD 340). This current under – penetration of medical devices in India represents a sizeable growth opportunity.

The inflow of foreign direct investment (FDI) in medical devices was USD 90 million between December 2014 and August 2015, post the government permitting 100 per cent FDI under the automatic route. Several MNCs have been increasing their manufacturing footprint and locating research centres in India to serve both the Indian and global markets.

Increased funding and investments have also reflected in other supply-side changes in healthcare delivery in India, such as:

Overall growth in healthcare infrastructure • There is a significant increase in the number of hospitals and hospital beds in India. Bed strength had increased from 0.8 million in 2002 to 1.6 million in 2012, and is further expected to increase to around 2.9 million by 2025. This increase has been driven primarily by the growing presence of corporate hospital chains, international companies and service providers entering tier-II and tier-III cities.

• There is an increasing presence of diagnostics laboratory chains focusing on imaging and pathology. It is estimated that there are more than 100,000 diagnostic laboratories across the country, with the number expected to grow at a rate of 15 to 20 per cent.

• The healthcare industry is also witnessing the emergence of new formats, such as the chains of multispeciality outpatient clinics, mother-and-child hospitals,

Cover Story

Medical Device Industry in India • Small with a disproportionate reliance on imports & a complex regulatory environment • Among the top 20 in the world by market size • Fourth in Asia after Japan, China & South Korea short-stay surgery centres, IVF centers, etc., which are driving demand for medical devices

What Next?

“Our roadmap for next 5 years is ready,” says Dr Jitendar Sharma. The AMTZ has strategised year-wise outlook for AMTZ. Between first and second year, the interested manufacturers in AMTZ will set up their assembly units. The first year will go for us to establish AMTZ and the second year will take manufacturers to set up their brand-specific interior assembly units. Between third and fourth year, the AMTZ will be established into a manufacturing hub that will be able to meet the medical device requirement in India. It is expecting over 200 to 300 manufacturing factories in AMTZ, each worth Rs 50 crore. On average, it means total factories worth Rs 15,000 crore.

The total import dependency of India is Rs 24,000 crore. In the fifth year, it will exceed the capacity to meet the entire domestic requirement while also trying to be exporter in the global market.

The creation of such a zone is based on the fact that medical devices manufacturing requires certain high investment facilities which are too capital intensive for individual manufactures to invest upon. The AMTZ with in-house high investment scientific facilities would help manufacturers reduce the cost of manufacturing by more than 40 to 50 per cent. The AMTZ is expected to be operational by the year 2017-2018.

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Special Interview

AMTZ: Ready to Boost State’s Economy Andhra Pradesh MedTech Zone Ltd (AMTZ) is a new chapter in India’s medical device manufacturing growth story. Kamineni Srinivas, Minister for Health and Medical Education, Government of Andhra Pradesh, shares the State Government’s vision for the medical device manufacturing park and its benefits for the ecosystem – manufacturers (global medical device industry), service providers or users (healthcare industry), professionals (scientists and medical fraternity) and local people, in an exclusive interview with Sudheer Goutham of Elets News Network (ENN)

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Special Interview

How was the concept of AMTZ evolved?

The idea was developed in one of the review meetings of the Department of Health sometime ago. We realised that there is a need for strengthening health service delivery and promoting the medical technology industry, which should go hand in hand. As commonly known, the pharmaceutical industry is already on the rise in Andhra Pradesh. On similar lines, we aim to lay a foundation for the medical device industry in India with AMTZ.

On what basis Visakhapatnam was chosen as the destination for the AMTZ? The AMTZ is a prestigious project and has the potential to connect the global markets. Obviously, any city that you choose should have good connectivity (transport – road,

AMTZ – Key Takeaways • Will help generate job opportunities for approximately 25,000 people across 200-250 manufacturing units • Will ensure both import substitution & export promotion • Will promote the medical device industry along with all likeminded partners • Will play the role of a facilitator rail, air and water) for travel, as well as export and import, and a favourable ecosystem, such as good infrastructure, quality manpower, etc. On all these aspects, the city of Visakhapatnam is an obvious choice.

What are the benefits one can expect from AMTZ in future?

There are many benefits directly and indirectly from the AMTZ. Of all the benefits, employment growth is one benefit and empowerment of the ancillary industry, spare part market of the medical device industry and logistics industry is another. It is

Employment generation and empowerment of the ancillary industry, spare part market of the medical device and logistics industry are some of the benefits expected from the foundation of Andhra Pradesh MedTech Zone Ltd. (AMTZ) estimated that the AMTZ is expected to help generate job opportunities for approximately 25,000 people across 200 to 250 manufacturing units, which will be set up in the manufacturing park. Overall, the business activity will boost the economy of the State in a phased manner. The real gain will be in the import substitution and export promotion as India accounts to 78 per cent imports of medical devices to the tune of Rs. 30,000 crore.

What role does AMTZ play?

The AMTZ under the Government of Andhra Pradesh will promote the medical device industry along with all likeminded partners and also play the role of a facilitator.

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Special Interview

AMTZ: Defining Success Roadmap for Andhra Pradesh via Three USPs Dr Poonam Malakondaiah, Principal Secretary, Department of Health and Family Welfare, Government of Andhra Pradesh, is the Chairperson of the Board of Directors of Andhra Pradesh MedTech Zone (AMTZ). She shares the key drivers and differentiators for the growth of the AMTZ, location advantage and roadmap of the prestigious project, in an interview with Sudheer Goutham of Elets News Network (ENN) What are the long term goals of AMTZ? We have set three goals for AMTZ, and they are: 1) To build AMTZ as Indian Hub in medical device manufacturing; 2) To make AMTZ as Asian Hub while competing with other esteemed Asian market leaders – China, Korea, Taiwan, etc; and 3) To reach the

prestigious status of Global Hub. Here we will not only have to compete with the Southeast Asian nations but also contend with global markets such as – Russia, Germany, Italy, France, United States (US), etc. The project therefore looks at volume production, cost reduction and quality benchmarking at methods to attain the goals.

Which are the medical device manufacturing companies expected to be part of AMTZ? How was your experience visiting Shanghai MedTech Zone?

We (a delegation from State Government) visited Shanghai MedTech Zone in China and other medical device manufacturing zones.

The visit was a great experience in understanding the operations of MedTech Zones. We will invite all medical device manufacturing companies for setting up their facilities at AMTZ and availing the market benefits. The AMTZ and its ecosystem will help reducing the cost of production of medical devices and will help even small and medium scale companies in medical devices to become global players. In this regard, we are working with the industry apex bodies in attracting the top medical device manufacturers.

What is the USP of AMTZ? There are three main USPs of AMTZ.

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Special Interview

1) It provides for required scientific facilities without any capital cost to the medical device manufacturers.

Scientific facilities will run on a user fee model; 2) The zone has good and affordable space; and 3) It has plug-and-play model- ready to use manufacturing facilities. Readymade factory with power and water amenities is part of it. Further, the State Government will assist in all statutory procedures like registration and approvals.

How do you position AMTZ? What are your thoughts for linking medical tourism with AMTZ? We want AMTZ to be a low-cost medical equipment manufacturing facility without compromising the quality and standards and a facility of global innovation. One of the scientific facilities planned for innovation in the zone is Rapid-Prototyping and medtech innovation centre. These innovative products could aid in holistic services.

Medical tourism itself needs a lot of innovation. We are looking at making the experience unique to not just medical tourists, but also to industrial tourists. AMTZ therefore aims to create “industrial tourism”. Chief Minister N Chandrababu Naidu believes in the creation of holistic healing through Yoga, naturopathy, modern medicine and modern diagnostics. Collectively, AMTZ will contribute greatly to the vision of Andhra Pradesh.

What are the timelines of AMTZ?

AMTZ – Key Takeaways • Will help reduce the cost of production of medical devices • Will help small & medium companies in medical devices to become global players

An ecosystem comprising of scientific, cost-effective and affordable manufacturing units and plugand-play models are the three major differentiators of the Andhra Pradesh MedTech Zone Ltd What is the estimated cost of AMTZ? The AMTZ is estimated to be ready by October 15, 2017. The participating companies in AMTZ will need at least 6 to 12 months to set up their assembly units and start operations. Hence, AMTZ would be operational by the beginning of 2018. It is estimated that Rs 400 to 500 crore would be the cost of project establishment, although the total cost of the project needs to be calculated, for which a detailed project report is in the making.

Can you please explain the strategic location of the AMTZ? The proximity to port is a key factor to the success of medical equipment sector, given that many components are imported and heavy machinery in the form of finished goods are exported. For instance, the location of Shanghai MedTech Zone in China is next to the port. For a country like India where currently a large proportion of the spare parts and equipment is imported, port connectivity is critical. Heavy machineries like MRI and CT scanners are transported to their destined country through waterways.

Fortunately, AMTZ is not only close to water port, but also to the airport and the highway. The surrounding part of AMTZ is a mountain area which will prove crucial to its scientific facilities like electro magnetic interference, radiation safety testing and others, which need an isolated environment.

Hence, the geographical location of AMTZ gives the strategic approach to port, airport and highway which is critical, while the landscapes makes it more valuable and can be exploited for various characteristic requirements.

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Special Interview

AMTZ: Unique Facility for Sunshine Industry

The forthcoming Andhra Pradesh MedTech Zone (AMTZ) in Visakhapatnam of Andhra Pradesh is a unique project. Dr Jitendar Sharma, CEO, AMTZ, the brains behind the project, who is also known as the ‘MedTech Man’ of India, shares the finer aspects of the ambitious project in an exclusive interview with Sudheer Goutham of Elets News Network (ENN) As CEO of AMTZ, what is your mandate?

My mandate is to start AMTZ facility that can accommodate 200 plus manufacturing unit and establish scientific facility required for device manufacturers. Most importantly, we need to understand the purpose why the AMTZ was envisaged.

The AMTZ was conceived because India is import-dependent market in terms of medical devices technology to the extent of over 75 per cent. AMTZ aims to make India a self-sufficient and in fact an exporter of good quality and costeffective medical technology. I hope to make AMTZ the nodal centre for that activity.

What is your approach towards AMTZ in the wake of established MedTech Zone elsewhere globally?

When we say the countries are leaders in medical device manufacturing, what does it mean? It points to two different models –there might be manufacturers in different cities in states of a country and hence that country becomes hub of manufacturers due to their collective production capacity. The second model is that, there might exist clusters of medical devices manufacturing facilities – all condensed in a special zone or trade hub.

In AMTZ, we are adapting the cluster approach, where the manufacturers are not asked to

Key Takeaways - Andhra MedTech Zone (AMTZ) • Follows a cluster approach where the manufacturers are not asked to go & work out in isolation • Creates scientific and social infrastructure • Provides all scientific facilities critical to medical device manufacturing as a package • Will encourage international certifying agencies, national regulatory offices and quality support institutions to set up their offices

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go and work out in isolation. They become part of an ecosystem where they thrive and survive together. And to support them, we are creating scientific, commercial and social infrastructure within the zone.

Overall, no medical device manufacturing zone that is exclusive for medical devices exists in the world as large as we are planning AMTZ to be. They all exist in a large zone where medical device manufacturing is a small portion like in the case of Shanghai MedTech Zone in China or Jebel Ali Trade Free Zone in Dubai.

What is the roadmap of AMTZ for the next 5 years?

Our roadmap for the next 5 years is ready. We have strategised yearwise deliverables for AMTZ. The first year will lead to the establishment of AMTZ and the second year will take manufacturers to set up their brand-specific interior assembly units. Between the third and fourth year, AMTZ would intend to saturate the domestic requirement and the internal markets within the country.

Overall, we are expecting over 200 to 300 manufacturing factories in AMTZ, with each reaching a turnover of Rs 50 crore.

Special Interview

Dr Jitendar Sharma conducting a survey of the land allotted to the first-of-its-kind AMTZ

On average, it means the units within the zone would contribute to equipment worth Rs 15,000 crore. The total import dependency of India is Rs 24,000 crore. Therefore, we can say that in the first 4 years, 75 per cent import dependency of India will be neutralised. In the fifth year, we will exceed the capacity to meet global demands and help our manufacturers lead the global export market.

What is the nature of national and international market you are targeting at?

The domestic and global markets will depend on two factors - Quality and Cost. As all the scientific facilities in AMTZ are being provided by the Government, the cost of production for the manufacturer will go down.

With quality and cost-effective devices, the manufacturers will become competitive in the domestic market. Through AMTZ, approach towards the national market would be cost reduction, which will lead to a better competitive pricing compared to even imported products.

For international market, it is not just pricing, but also the concept of internationally benchmarked quality.

In AMTZ, we are going to encourage the international certifying agencies,

AMTZ coming up in Visakhapatnam of Andhra Pradesh is very unique project that provides all scientific facilities critical to medical device manufacturing as a package national regulatory offices and quality support institutions to set up their offices. The approach would be to help manufacturers achieve the quality of international standards.

What are the top five challenges you see in driving AMTZ to a desired level?

As we go ahead, I see only opportunities of medical devices sector flourishing in India. For AMTZ, we have only pooled the existing central and state government schemes to support the zone. Going forward, I would like to share the five opportunities that we see:

• Get to the small and medium enterprises, build and support them so that they become exporters, essentially meaning strengthening of the micro, small & medium enterprise (MSME) sector.

• Better collective utilisation of central and state schemes (schemes under pharmaceuticals, electronics, commerce, MSME, health, etc.), to harness the collective synergies.

• Ability to provide hands-on experience to a large number of engineering students.

• Cost reduction in the health services as an outcome of reduced cost of manufacturing. For instance, a computed tomography (CT) scanner at an approximate price of Rs 60 to 80 lakh against the existing Rs 1.5 crore from AMTZ, could lead to reduced cost of CT scan services itself.

• Under ‘Make in India’ campaign of the government, medical device manufacturing will emerge as ‘Sunshine’ segment in the manufacturing sector of the country. It will in turn contribute to the overall overall gross domestic product (GDP) or economy of the country, as well as the Andhra Pradesh state.

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Interview

VP (Technical)

AMTZ: Offering High-End Product at Cost-Effective Price

One of the main agenda of Andhra Pradesh MedTech Zone (AMTZ) is producing high-end medical technology devices at a cost-effective price. The Technical Department of the zone mainly focuses on ensuring the same by facilitating multiple provisions within the park.

Dr Pankaj Parashar, Vice President (Technical), AMTZ shares more in an interaction with Sudheer Goutham of Elets News Network (ENN) What would be the role of Technical Department of AMTZ? Technical Department of AMTZ would support the manufacturers setting up their factories in the park. One of the supports would be help them reduce cost of production while maintaining the best quality standards. Every industry needs to have its own machinery to manufacture products.

However, high-end machineries that are commonly used by the factories in the park would be facilitated by the AMTZ in a common technical facility and allow factories to use the services at a nominal fee. For instance, all the electronic medical device manufacturing companies would need circuit board designing, soldering, testing and other machineries in common.

In AMTZ, all these high-end machineries will be provided in

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standard assurance of the product would be provided within the AMTZ premises, so that the manufactures need not go to other countries to get the work done. As a result, cost of transport and travel is saved and end result would be reduction in cost of production. These facilities would be set up in the public-private partnership (PPP) model. Overall, the main idea of the concept is to monitor the quality and cost of the products that will come out of the zone.

common scientific facilities, which will also ensure output of best quality products from the small, medium to large factories that will be set up in the zone. Similarly, common legal facilities for the intellectual property issues and international agencies for global

Can you tell us about the ancillary industries that would be dependent on AMTZ? While AMTZ will be producing the core medical technology devices, there are six to seven segments within the medical sector that will depend and thrive on the AMTZ output.

Some of them would be diagnostic disposable kits, infrastructure like beds, components, boards, capacitors, transducers and many others. All of these products have a huge market within the country, but is being imported from other countries. At the consumer end the overall cost of these imported products are passed on to the patients. However, the ancillary industries which would be manufacturing these products would grow around the AMTZ fulfilling the need of the market.

EVENTS LANDSCAPE

2016-17

EVENT NAME

PLACE

MONTH

URBAN SECTOR Smart City-Karnal

Haryana

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Interview

VP (Operations)

AMTZ: On the Road of Creating World-Class Products In this first-of-its-kind medical device park, we are looking at a threepronged strategy, including import substitution, export promotion and using the economy of scale to reduce the cost of healthcare, shares Manish Gangal, Vice President (Operations), AMTZ in an exclusive interview with Sudheer Goutham of Elets News Network (ENN)

Please share the details of Andhra MedTech Zone (AMTZ).

Overall, AMTZ will have two major areas. This includes the common scientific facilities that will comprise of high end laboratories and the other part would be manufacturing units.

The manufacturing area is totally dedicated to the manufacturers, who will have the complete freedom to choose their products and manufacturing processes. In total, we are aiming to host around 300 manufacturing units in the AMTZ. Since manufacturers will be able to use the common facilities, the idea is not everyone needs to spend a lot of money or capital expenditure on machines or costly equipment.

They can use the shared facilities to reduce the cost of manufacturing.

Given that these scientific facilities are very capital expensive it may not make sense for manufacturers to invest in them individually.

What kind of measures have been undertaken to ensure quality across the products to be manufactured at AMTZ? From the direction of quality, the Association of Medical Device Industry (AIMED) has already adopted a voluntary standard IC-MED which is in line with the

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global standards.

Additionally, certain benchmarks have also been established to ensure that our products are at par with the worldclass products.

All the scientific facilities in the AMTZ will provide certifications with proper documentation to the manufacturers stating that their products subscribe to international quality which includes those required for electromagnetic interference certification, radiation testing etc.

Overall, the driving idea is to ensure cost reduction by providing common facilities to all the manufacturers.

Please provide details of other facilities to be established in the AMTZ. As this facility is spread over 270 acres, there will be common areas in terms of administration, warehouse with a big parking facility, scientific facilities related to radiation and electromagnetic testing, and similar facilities. Additionally, there is a dedicated area for manufacturers.

These areas have been determined in terms of functionality. Each area will support a dedicated function.

In the entire AMTZ project, what will be your role & vision?

Please specify.

Looking at the scale of the project, a lot many people will have to share many responsibilities. We need to ensure that these facilities are monitored for its functionality. As such, we are going to operate most of the things in the public–private partnership (PPP) mode. The entire project involves other people who need to be oriented towards the AMTZ vision. My goal will include monitoring of all these functions.

What are the key benefits of AMTZ for the entire Indian

VP (Operations)

medical device industry?

AMTZ is a limited company, with 100 per cent of ownership with the Department of Health, Government of Andhra Pradesh. In terms of medical devices, we still witness a very scattered approach across the Indian market, mostly labourintensive products or technologies with low spectrum. Overall, we need to learn how to become selfreliant on technologies that are of a high spectrum. The provision of common facilities is one of the most important factors that can address the above challenge, otherwise at an organizational level, manufacturers need to bear huge capital expenditure. We can prevent such a huge expenditure and even simultaneously ensure that they get to use the common facilities. There are dedicated parks in other countries, such as Germany and China, and smaller parks in Taiwan and other countries.

However, looking at the size of the requirement, the AMTZ will offer a great opportunity for self-reliance and to reduce the cost of healthcare to the common patients.

Additionally, about 75 per cent of the medical devices (consumables) are imported. Therefore, there is a lot that can be done through import substitution, which is close to Rs

Key Features - Andhra MedTech Zone (AMTZ) • Includes two major areas - common scientific facilities & laboratories or scientific testing • Expecting 100 to 200 manufacturers • Has established benchmarks to manufacture worldclass products

Interview

Cost Reduction in Manufactured Medical Devices Constituents of product costs

Factors aimed at reducing the cost Comprehensive Ecosystem, Suitable for Medical Devices

Costs Associated with Sourcing Components, Software, FirmWare and Such Services

On-Site Showrooms/Offices for Suppliers, Developers, Experts and Solution Providers

Machines & Skilled Labour

Common Scientific Facilities, Operated by Skilled People on Pay for Use Basis

Costs Associated with Design/Trials

On-Site Design & Rapid Prototyping Facility

Cost of Infrastructure

Developed Land with Ready to Move-in Structure at Nominal Charges

Sterilisation

On-Site Sterilisation, Including Gamma Irradiation Facilities

Testing & Certifications Costs, Logistics and Delays

On-Site, Cost Effective Accredited Test and Certification Facilities

Cost of Warehousing

On-Site Common Warehousing with Cold Chain

Logistics Costs

Proximity to Rail, Road, Air and Port Facilities

Costs Associated with Client Education, Training

On-Site Expo Hall and Convention Center

20,000 to 25,000 crore. At the same time, we have export potential, which is close to Rs 6,000 to Rs 7,000 crore. If we are manufacturing globally accepted qualitative products by ensuring cost reduction, it will definitely assist us in terms of improving our export performance.

If we have good import substitution and export potential, we can benefit from the scale of economy, which will also reduce the availability of products for the domestic market. That’s the reason, we are looking at a threepronged strategy, including import substitution, export promotion and using the economy of scale to reduce the cost of healthcare. It is first-ofits kind medical device park in India.

At this particular point in time, the import and export figures together are in the range of Rs 25,000 to Rs 30,000 crore.

The import of medical devices

ranges from consumables to high-end machines, everything in between. Therefore, our dependence on import is very high from the angle of all products. As each product requires its own specific machines, trained pool of people, etc., at AMTZ, we would give facilities that are common and certifications that are easy. It’s not going to be very capital-intensive activity for the manufacturers.

What is the vision of the State Government on the entire AMTZ project?

The Government wants to see Andhra Pradesh as the manufacturing hub of medical devices in India and globally producing world-class products benefitting the entire humanity.

The land has already been given to AMTZ. The AIMED has already has pledged its support to the AMTZ project.

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Intrerview

VP (Human Resource & Administration)

AMTZ: Offering Skilled Workforce for Employment Andhra Pradesh MedTech Zone (AMTZ) is set to create 20,00030,000 direct employment and a much higher number of indirect employment through ancillary industries. The ambitious project will continuously create trained workforce supporting government’s ‘Skill India’ movement, shares Nitin Bharadwaj, VP (Human Resource & Administration), AMTZ in an exclusive interview with Sudheer Goutham of Elets News Network (ENN) Andhra Pradesh MedTech Zone (AMTZ) is an ambitious project that requires a large size of talent pool. What are the numbers that will be taken in this ecosystem?

The growth and prospects of employment are pretty high and it is not limited to the AMTZ. A lot of manufacturing units (approximately 200 to 300) would be set up in the zone. These factories would recruit their own set of human resources.

However, these talent pools that will be brought in by the individual factories would work in alignment with the vision of AMTZ.

How do you plan to source the talent pool?

We would do that through multiple channels. Since it is a government project, it will be done through approved channels, including print, electronic and multimedia social platforms. For specialised talent, we would follow focused approach. As it is a specialised sector needing specific skills sets, there are multiple avenues we have planned for continuous training and learning.

Do you have any numbers

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planned for recruitment?

In first few months’ recruitment of at least 50 to 100 will take place for AMTZ. In this connection, we have already given public notifications in the local and national newspapers and the recruitment process is on for senior managers and other position.

If the overall direct employment in the zone is looked at, it could be anywhere between 20,000 to 30,000 individuals.

With over 200 to 300 factories coming up in the park, each will recruit at least 100 individuals. As a result, AMTZ will be producing trained workforce that would come and can serve other similar

factories. This, in a way supports the ‘Skill India’ movement. Meanwhile, indirect employment will be much bigger in number, as many ancillary industries will grow while supporting the AMTZ. A number of ancillary products, such as screws, films and others, required in the service will be produced by the ancillary industries.

Which stream of graduates would directly benefit in the recruitment process for AMTZ? Majority of the engineers from mechanical, biomedical engineering, chemical and electrical engineering go abroad looking for the right opportunity or migrate into other lucrative disciplines such as IT. However, now the major chunk of these talent pools can be taken in AMTZ which offers world-class R&D and manufacturing facilities, ensuring sufficient scientific exposure at better salaries. Manufacturing organisations who will benefit from AMTZ by spending lesser on manufacturing costs can invest more on good quality human resources. The talent pools can then directly contribute to R&D and in producing quality products as per the best industrial standard.

VP (Finance)

Interview

AMTZ: Creating Excellent Synergy in Public-PrivatePartnership

The cost for the setting up of scientific infrastructure and different highend machineries will be around Rs.200 Crore, which would be taken care by the Government. This will bring down the production cost to the manufacturers by 30 to 45 per cent, which can be ultimately passed on to the end users (patients and their families), shares Vipin Das Ramachandran, VP (Finance), AMTZ exclusively with Sudheer Goutham of Elets News Network (ENN)

Can you tell us the financial model the Government of Andhra Pradesh has taken up for Andhra Pradesh MedTech Zone (AMTZ)?

The synergy between the public and private sectors is the financial model for AMTZ and is also the key factor for the success. The real trouble the manufacturers face is the capital expenditure. In order to set up a manufacturing unit, they need to invest huge capital. For addressing this issue, the Government is going to invest on the land, infrastructure and to an extent on machinery for scientific facilities. This will bring down the need of huge capital investment and several entrepreneurs or industrialists would come forward to set up their factories as the biggest problem is solved. It is a wonderful approach that the Government of Andhra Pradesh has taken up to identify the gap and reach out to the manufacturers.

Can you tell us about the research that went into studying small-, medium- and largescale industrialists for AMTZ?

model, it can be replicated in other sectors as well.

Can you identify the financial aspects that the Government is investing in for the manufacturers who can set up their units?

We did research on manufacturers who have come up with several innovative products, but they are not able to scale up their production or bring the product to the market. In order to do that they have to borrow loans and take the financial burden.

Many are backing off considering the risk factor. However, through AMTZ the Government is coming to the aid of even small-, medium- and largescale industrialists and bridging the gap. Looking at the success of the

The major cost of investment for the manufacturers will be the land for the factory. The Government will be providing the land along with built up area, on lease and the terms are being worked out. The cost for the setting up of factories, infrastructure and different high-end machineries will be around Rs. 200 crore for scientific facilities along and anther 200 crore for manufacturing units, which would be taken care by the Government. This will bring down the production cost to the manufacturers by 30 to 45 per cent, which can be ultimately passed on to the end users (patients and their families). Apart from this, the Government will take care of the overall operational and maintenance cost which will make operational smooth and risk free for the thriving manufacturing cluster within AMTZ.

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Intrerview

VP (Planning)

AMTZ: Implementing Strategic Planning to Overcome Operational Inefficiencies Unlike other projects, Andhra Pradesh MedTech Zone (AMTZ) aims to address all operational inefficiencies in an increasingly detailed manner with each phase to create a word-class manufacturing unit, shares Deepak Agarkhed, VP (Planning) of AMTZ in an exclusive interview with Sudheer Goutham of Elets News Network Could you please walk us through your key responsibilities on the entire Andhra Pradesh MedTech Zone (AMTZ)?

My role involves planning of the medical technology park. Planning plays a very important role because ultimately what you are trying to achieve is to produce a product which is very cost-effective.

For this, the ingredient required is a very good set-up, where the operational costs are minimum.

As we all know, one can witness large operational costs (unnecessary cost due to energy consumption and other factors). In order to keep a check on such operational gaps, we need to assure that all planning activities are done thoroughly and after considering all the aspects within the timeline.

Likewise, at the time of the planning stage, we are likely to witness such operational challenges. By considering the inputs coming from different

The actual plan, including micro-level detailing will be done now. The planning will include strategies and information to enhance operational efficiency, such as cost reduction, reduction of energy consumption, etc.

What are your expectations from AMTZ?

quarters, definitely a new set-up, which is better than any other set-up in the world can be created. Additionally, we need thorough planning and an execution which is in line with what has been planned. If this could be achieved, then we can undoubtedly achieve better quality products at par with the products at the world level with ultimate benefits to the patients.

What are your key objectives by creating AMTZ? We strive to compete with the international markets, such as the United States (US), Europe, etc., not only on the cost-effectiveness front but also on maintaining the quality.

For this, we took consulting support of KPMG for create the initial plan.

However, this is just the baseline.

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As such, this park will set an example for others and highlight the talent pool of India. Moreover, this park will make a difference by attracting the talent pool. It will ensure cost effectiveness and no compromise on the quality.

More importantly, as most of the equipment is imported, a customs duty burden is involved in the current practice. Once the domestic products sets in, this economic drain can be substantially reduced.

AMTZ as a world-class facility will address all such challenges. With a common manufacturing unit available, manufacturers have to not go other places to test the quality of their products, including all certification procedures. Moreover, these products will have the potential to be sold abroad.

Since we have the talent pool, raw material, facilities and other ancillary facilities, we can definitely produce great results. As the rental cost would be negligible, AMTZ will prove really competitive.

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Medical Devices

Poly Medicure Ltd

POLYMED Aims to Innovate, Invest, Upgrade Skills & Scale Up Products To Stay Ahead

With technical and product training, our staff is well capable to create high-quality and innovative solutions for the medical devices industry, says Himanshu Baid, MD, Poly Medicure Ltd to Elets News Network (ENN) Please describe in detail the infrastructure and research and development (R&D) facilities available at Poly Medicure Limited (POLYMED) to meet the ever-changing market requirements and other healthrelated challenges?

The following are the facilities available at POLYMED to meet constantly changing needs of the market: • Total five manufacturing facilities in India (two facilities in Faridabad, two in Jaipur and one in Haridwar) and two facilities overseas (one in China – wholly owned subsidiary and one joint venture in Egypt) • Over 400,000 square feet of manufacturing area with 100,000 + square feet of a clean room area and state-of-the-art facilities with capacity to expand rapidly • All manufacturing facilities are certified by the European Union (EU) (Conformité Européene (CE) Certification); one facility is the United States (US) Food and Drug Administration (USFDA) audited

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• Manufacturing process capabilities include injection moulding, extrusion, insert moulding, compression moulding, blow moulding, ultrasonic welding, radio frequency (RF) & high frequency (HF) welding, ultraviolet (UV) bonding, laser welding, etc.

• Include Design for Six Sigma (DFSS), failure mode and effects analysis (FMEA), lean manufacturing and advanced product quality planning (APQP) • Rapid prototyping using a threedimensional (3-D) printer, process validation and customisation of products • R&D facility approved by the Ministry of Science & Technology, Government of India • 20 engineers in new product development/design • 15 engineers in value engineering, operational excellence and automation • Over 95 patents granted and over 300 patents filed internationally • New investment of Rs 60 crore in a new green field project at Institute

of Management & Technology (IMT) Faridabad in Haryana and is geared up to launch a slew of products in the third quarter of 2017 with all statutory approvals

What measures are being undertaken by POLYMED to ensure staff members stay technically competent and well trained to create high-quality and innovative solutions?

Do you think POLYMED’s manpower stands on par with those globally?

• Regular training programmes for our staff members • Best human resources (HR) practices focusing on continuous training, key result areas (KRAs), Kaizen, 5S, leadership skills, Six Sigma, etc. are being adopted • Training programmes led by the experts from the industry • End user – nurses and doctors are also involved and are getting valuable feedback • Constant interaction with the R&D team by visiting hospitals to

Poly Medicure Ltd

develop new products/technology and improve the existing products • In December 2015, we conducted a ‘Global Training Program’ for our business partners all over the world Yes, POLYMED’s manpower stands on par with those globally, as we have over 1,500 full-time employees working at different facilities. With technical and product training, they are well capable to create highquality and innovative solutions for the medical devices industry.

blow molding, ultrasonic welding, RF & HF welding, UV bonding, laser welding, etc.

POLYMED stands out because of its large range of product basket compared with competitors

sterilisation facilities

Is POLYMED looking forward to any new business strategies and partnerships to counter increasing competition in the medical device manufacturing and testing segment? If yes, please provide details.

• We are adding new products in gastrology and nephrology, including machines • Scheduled to add more diethylhexyl-phthalate (DEHP) & polyvinyl chloride (PVC) free range of products in the portfolio which will provide better patient care and safety • Created separate verticals and sales team for blood bags and diagnostics • Appointment of POLYMED’s representative in some hot spots and territories worldwide for more product intelligence

Where does POLYMED stand in the med tech ecosystem vis a vis its competitors? What are the key features that make POLYMED stand out from others. Please explain.

Please describe the measures undertaken by POLYMED to meet design-related challenges when it comes to manufacturing world-class medical devices, especially in a country like India.

• In-house R&D facility • Rapid prototyping using 3-D printer, process validation & customisation of products • In-house design, manufacture and maintenance of injection moulds and semi-automatic assembly lines using computer (or computerised) numerical control (CNC) machine tools • Manufacturing process capabilities include injection moulding, extrusion, insert moulding, compression moulding,

Medical Devices

• Highly experienced and trained manpower consisting of over 75 engineers • DFSS, FMEA, lean manufacturing and APQP • Equipment and machinery sourced from reputed suppliers worldwide • Semi-automatic and automatic assembly machines designed using the latest technology and developed in-house using wellequipped tooling facility • In-house ethylene oxide and steam

We stand out in the med tech system due to the following reasons: • Strong R&D facilities • Manufacturing facilities – 100,000 + square feet of clean room to meet high volume demand • A large range of product basket compared with competitors • Our core values – W I S E W – We care as we cure for our people, planet & prosperity of our stakeholder I – Innovation in everything we do S – Safety in Product & Processes E – Excellence in quality of

Leadership, People, Processes & Products

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Medical Devices

Translumina Therapeutics: Strategic Partnership is Key to Business Growth

For us, it’s not about business, but about creating a movement that will empower patients of all economics strata to get quality treatment, states Gurmit Singh Chugh, Managing Director, Translumina Therapeutics exclusively to Elets News Network (ENN) Please provide details of the path-breaking technologies and projects that Translumina Therapeutics has been part of in the field of cardiac devices.

etc. What measures and partnerships are being undertaken by Translumina Therapeutics to ensure such facilities are available?

In the treatment of coronary blockage, it was evident that drug-eluting stents significantly reduced the incidence of restenosis compared with bare-metal stent, but by the late 2000s, the Data Encryption Standard (DES) emerged with its own set of problems with the usage of polymer - the drug-binding agent and the drug coating.

Translumina Therapeutics entered the field of interventional cardiology with the drug-eluting stents having microporous surface and one-fourth polymeric load that have safely reduced the late events. The efficacy of drug has also been improved by abluminal coating on the stent. This is the first patented technology from India for the world.

As a company, we strongly believe in innovations with quality at affordable pricing. Translumina Therapeutics has world-class state-of-the-art CEcertified manufacturing facility in Dehradun, India. We manufacture a wide range of quality products to treat cardiovascular aliments of patients. These products adhere to stringent quality controls at all levels of production to ensure highest

In order to ensure world-class innovations, one needs best infrastructural facilities/labs for clinical trials, compliance with international standards,

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Achievements • Drug-eluting stents is one of the most cutting-edge, nonsurgical techniques that save lives • Already in the preclinical phase of developing valves to treat structural heart diseases

standards. Our organisation has wellexperienced and trained personnel managing various key production and quality control departments.

In today’s global scenario, the key to growth is partnerships that enable synergy of competencies of each partner. Translumina Therapeutics has strategic partnership with Translumina GmbH, Germany for creating world-class products with the highest standard of quality and clinical significance. The research and development (R&D) is jointly carried at Translumina GmbH’s facility in Hechingen, Germany.

Translumina GmbH and Translumina Therapeutics co-manufacture Yukon Choice PC in their respective facilities.

Translumina Therapeutics also shares a partnership with the German Heart Centre Munich, Germany for conducting clinical evaluations of newer technologies. German Heart Centre has created some landmark research on various technologies and procedures in interventional cardiology to enable cardiologists around the world to optimise their clinical outcomes.

Medical Devices

Yukon Choice PC, our flagship product, as a technology has undergone the highest level of clinical evaluation at German Heart Centre and the data is published in the top international journals, such as Journal of American College of cardiology, European Heart Journal, Eurointervention, etc.

You have vast experience in the field of interventional cardiology, but now we are witnessing a major shift from invasive to noninvasive procedures. Please provide details of the newer technologies and solutions that Translumina Therapeutics has.

The field shift from invasive to minimally invasive procedures in coronary and peripheral vascular procedures is one of the significant innovations over the years that have revolutionised the field of interventional cardiology. Whether you were born with a structural heart defect, or develop a form of heart disease later in life, it can be treated without a major surgery.

Our drug-eluting stents is one of the most cutting-edge, non-surgical techniques that save lives. In addition to that, we are already in the preclinical phase of developing valves to treat structural heart diseases.

Do you think an ecosystem enabling effective confluence of all stakeholders is emerging in India?

Yes, with the advent of ‘Make in India’ campaign in healthcare and its alignment with the key government initiatives, technology has created a strong impact on public health.

Translumina Therapeutics was incorporated with an objective of creating technologies which help the physicians in enhancing their clinical outcomes whilst making it affordable for the patients. For the last few decades, most of the

Key Takeaways • World-class state-of-the-art CE-certified manufacturing facility in Dehradun, India • Products adhere to stringent quality controls at all levels of production • Strategic partnership with Translumina GmbH, Germany for creating world-class products • Joint R&D by Translumina GmbH and Translumina Therapeutics • Partnership with the German Heart Centre Munich for conducting clinical evaluations of newer technologies newer technologies in interventional cardiology were launched by the United States (US) multinationals, as they had the expertise and the funding needed to create such radical innovations. Most of these technologies have definitely improved the treatment of coronary artery diseases and have been very successful. However, there has been an inheriting limitation in terms of their affordability in developing countries where the insurance and state-run reimbursement schemes only cover a small population and most of the patients have to fund their treatment themselves. In addition, there is also a tremendous cost burden on the insurance and reimbursement sectors in developed countries to sustain such costly treatments. This resulted in search for cost-effective solutions which were met by either outdated technologies of these US multinationals or some smaller companies mushrooming out of Asia and Europe which started offering such complex technologies without the needed clinical evaluation of these products.

With our rich experience of working with various multinationals in healthcare for more than 16 years, we decided to start Translumina Therapeutics with an objective to manufacture world-class technologies with the highest level of quality and clinical evaluation at an affordable

price. For us, it’s not about business, but about creating movement that will empower patients of all economics strata to get quality treatment.

With cardiac and lifestyle diseases emerging as one the leading causes of casualties in India, do you see adoption of new-age machines and solution by both public and medical institutes?

The true test of technology and innovation is when it helps the society at large to live a better life and your peers think why they could not think of this idea. In the time to come, the world shall belong to people whose simple ideas backed by relentless execution shall change the way people live and that shall be the true progress of science. The adoption of new-age machines and technology is important for both the public and private entities for the better and cost-effective treatment in India.

The first and the foremost need of the hour is ‘patient awareness’. We are working relentlessly to ensure that the patient is aware about the disease which helps in early diagnosis.

We also distribute booklets and other information at the clinical and on our websites to ensure that the patient gets the correct information about the treatment and all his or her questions are answered.

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Medical Devices

Forus Health Pvt Ltd

Forus Health: Creation and Deployment of Products Require Innovation Our strategy is to use emerging technologies offering scope for improvement and at the same time, keep it affordable, says K Chandrasekhar, Founder & CEO, Forus Health Pvt Ltd to Nilender Kumar and Kusum Kumari of Elets News Network (ENN)

What are the key objectives of Forus Health in the Indian market? Please describe in detail the infrastructure and research and development (R&D) facilities available?

Our mission is to play a role in eradicating preventable blindness. We did not want to build a medical device company, the idea was to solve the problem and the medical device is the consequence of that thought process.

Given that India has only 20,000 ophthalmologists for a 1.3 billion population, we felt the need

of bridging this ratio skew using technology. We came up with the mantra of “Innovate, Implement and Impact”.

Our products or solutions are result of our innovation. The Forus Health team, including optical engineers, hardware engineers, software engineers, quality engineers and manufacturing engineers, ensure we create worldclass products completely “Made in India”.

Our R&D lab is the Department of Scientific and Industrial Research (DSIR) registered and our in-house manufacturing is ISO 13485 approved

Key Takeaways • Designs, manufactures and sells products • Creates costeffective devices adequate for identifying a problem • Integrates multiple features in products with the state-of-the-art facilities. We have filed over 14 patents, of which four have already been granted. We also collaborate with leading clinical institutions to create world-class products.

Please highlight the parameters on which Forus Health products stand apart from those offered by the competing service providers?

The differentiating factor for Forus Health is that we create medical devices as a consequence of addressing the mission of ‘preventable blindness’. The way we approach our product is very different from other manufacturers.

We make affordable devices that are adequate and appropriate for identifying a problem. Our products are integrated, portable, rugged and affordable, which can be operated

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Forus Health Pvt Ltd

by a minimally trained technician and has an integrated telemedicine module for remote screening. Most of the above features differentiate us from our competitors. However, these features have been built not to differentiate our products, but to actually solve the problem. These features enable devices to be operated even in tier-IV areas, wherein users can send the images to the doctors located in cities for screening.

There are some challenges specifically in the Indian market in terms of regulations and designing due to the climate as debated on different discussion forums. Please share your opinion?

Forus Health implies “healthcare for us; my community and I. As such, our key goal has always been to solve the problems of our community. Our solutions integrate many factors, such as ruggedness, portability and usage of less power to suite the Indian conditions. We make “world-class products” from India; hence, our products do have a global market.

Our company is ISO 13485 certified, and 3nethra Classic is CE marked and the United States (US) Food and Drug Administration (FDA) registered.

As a result of all these factors, we automatically build quality into the overall system. This combined with the fact our products have been created for the Indian market makes Forus Health and its services scalable.

How cost-effective are Forus Health ’ products to become an integrated part of medical facilities not just located in metropolitan cities, but also in tier-I and tier-II cities? Please provide details.

Our focus has been to make very affordable products that are appropriate and adequate for doctors to screen eye problems. We have been able to reach tier-II and tier-III

Medical Devices

Key Principles • Innovate, Implement &Impact • Create world-class products • Solve the problems of the community • Integration of emerging technologies • Modular designs to migrate to next-generation products seamlessly • Make products adoptable by people & doctors cities. In about 4 years, our installed base is more than 1,100 devices in over 25 countries. In India, out of the installed base of over 950 devices (which is the largest installed base in India), 60 per cent are in tier II and tier III cities. Therefore, we see a positive trend for our business in the Indian market. We have always got positive encouragement from Indian ophthalmologists in terms of adopting our products.

Has Forus Health got adequate labs for testing the devices, as we have faced the problem of devices not working in the real scenario?

As reiterated, our products have been designed keeping the Indian conditions in mind.

We have our own labs and we also use third-party labs to validate the reliability, safety and ruggedness of the product. We are an ISO 13485 certified company, which is the international standard for medical devices. The standard mandates that we verify and validate the products

Achievements • Sold 1,100 devices • Reached tier-II and tier-III cities • Raised two rounds of funding - almost $13 million

before releasing to the market.

We all know the fact that technology is getting smarter and simpler with time. In the light of the above, what measures are being undertaken by Forus Health to upgrade its offerings and staff?

I think two things are very important.

Firstly, we have to build a product, which will actually solve the problem.

Secondly, whatever solutions one makes, they have to be seamlessly integrated with the behaviour of the people and doctors adopting the devices.

We use emerging technologies, such as cloud computing, for remote diagnosis, which helps us to scale and also be cost-effective. We were one of the early adopters of complementary metal-oxide semiconductor (CMOS) sensors in our designs, which is also an emerging technology trend. Our designs are modular and hence can help us to migrate to next-generation products seamlessly.

What are the regulatory roadblocks in the Indian market?

When we create products for selling in India, we always keep the basic quality and hygiene factor as CE certification. Moreover, our devices are non-invasive. Our product is CE marked and US FDA registered.

Hence, we do not see any roadblocks in terms of regulatory for the Indian market.

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Special Article

HSCC

HSCC (India) Ltd: Enhancing Healthcare Space via Innovative Patient Management Technology Accelerating the ‘Digital India’ campaign, HSCC has been in a true sense enabling medical facilities in delivering ‘smart healthcare’ by facilitating advanced technologies & integrating ICT systems recognised globally for transforming healthcare space

O

ne of the vital elements of ‘Smart Healthcare’ is integration of Internet technologies and other advanced smart systems in the infrastructure of medical facilities to enable access to quality care to the end users. Through the appropriate use of information and communication technology (ICT), not only many lives can be saved but the level of patient care can be to a large extent improved and cost reduced. The current driving principle for all policymakers is delivering optimum health & social care in a safe, cost-effective and efficient manner.

With the implementation of a series of progressive reforms in the Indian healthcare ecosystem by the Government of India in the light of ‘Digital India’ and ‘Make in India’ campaigns, HSCC, a profit-making public sector unit (PSU) and the world’s one of the leading consultancy organisations under the Ministry of Health & Family Welfare, Government of India, has been assisting the Government in concretising these goals by rendering a comprehensive range of professional services in healthcare and other sectors.

Overview Established in 1983, HSCC has come a long way. It has established a brand image through consistent diligence and emphasis on quality over quantity.

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“IT has emerged as game changer and strengthening of IT infrastructure has become a strategic imperative. In fact, it will be the key to how we innovate and expand our business along with retaining our competitive edge” Gyanesh Pandey Chairman & Managing Director HSCC (India) Ltd On the basis of the DPE’s MOU targets for the past 7 years, it has been consistently ranked ‘EXCELLENT’. As of today, HSCC boasts of 90 odd projects which are diverse and of varied capacity across the length and breadth of India.

HSCC

More importantly, it will be interesting to note how HSCC is spearheading the goal of both digitisation of healthcare services and capacity building. Interestingly, HSCC is those rarest PSUs that has learnt the lesson to keep pace with technological advancements and has emerged as the fastest growing PSUs in the last 3 years by continuing to be relevant.

Key Achievements Bhopal Memorial Trust Hospital & Research Centre (BMHRC), Bhopal: In 1999, HSCC became an IT enabler by adopting ICT in BMHRC, Bhopal in 1999. Post the apex court order, the 350-bed multi-speciality tertiary care centre BMHRC was established for the Bhopal Gas Tragedy (1984) victims and the public at large. Setting an example for others, BMHRC comprises various first-of-its-kind ICT facilities, including Hospital Management Information System (HMIS) and SAP. By introducing smart cards for the victims, BMHRC emerged as the first hospital to implement such an innovative measure that will facilitate easy record management. These IT infrastructure and innovations have been replicated across different hospitals designed and engineered by HSCC according to the client needs.

OPD Automation: The medical facilities as large as the All India

Understanding QMS

Special Article

Major System Components in Queue Management System (QMS) • Token Dispenser Unit It is used for printing tokens. Various services can be displayed on the panel (in touch screen dispenser).

QMS may have a single or multiple token dispenser units as per the requirement • Master Token Display The display unit is generally installed in the waiting area to enable the patients awaiting their turn to check the token number at the registration counter. It is available as LED/LCD TV • System Outputs Token: The system issues tokens which have serial number from 0001 to 9999. The token indicates the date, time & type of the registration etc Reports: The system can also generate various reports, facilitating manager/administrator optimise the resource allocation to improve patient care services; thus, providing real-time overview of all the ongoing activities Institute of Medical Sciences (AIIMS) with large patient flow are constantly in search of innovative technologies that can make the entire process patient-friendly, less chaotic and manual, and less time-consuming to increase throughput. Keeping these key takeaways in mind, HSCC which was entrusted with the responsibility of OPD automation of

Key Challenges • Implemented in a phase manner • Users’ resentment to accept the new system; adoption of new system made possible only after intervention by the higher authorities • Interfacing of QMS with HMIS of the AIIMS Rajkumari Amrita Kaur (RAK) OPD at AIIMS implemented a series of automation features, including queue management system (QMS), and established network infrastructure and hardware & system software, including desktops, printers, etc. As such, QMS has altogether changed the OPD practices ranging from registration to consultation with doctors of various departments.

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Special Article

HSCC

Therefore, those serpentine queues and hassles in getting consultations have become things of past.

Under the QMS, a number of devices, such as token dispensers and LED displays, have been installed along with the basic facilities like air conditioners and hygienic environment to ensure true customer care experience.

Though QMS has been operational in AIIMS since February 2011, AIIMS has moved ahead with the online appointment system to lower the load on the registration counters of the OPD.

Understanding Queue Management System (QMS) QMS essentially comprises a token dispenser unit with a touch screen, master display (LED TVs), computer desktops (each with a different client operator software) installed at the registration counter connected through LAN, counter display and a server with Manager Console server software.

Various types of token dispensers are coming up in the market

Despite many benefits, its adoption among both medical staff and patients needs to be accelerated at a rapid speed to realise the larger benefits. In order to ensure behavioural change and paradigm shift in the healthcare, regular workshops need to be conducted.

The diffusion of new systems and technologies is the true parameter

QMS - Salient Features • Supports multiple master LCD displays & multiple token dispensers • Can be operated as a standalone system • Flexibility in prioritising patients • Audio announcement of tokens • Services can be scheduled to stop issuing/ printing token after specified time in the day • Load distribution in each counter • Operator can defer a token & the patient can be recalled later Serpentine queues can become thing of past with QMS

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to determine economic growth, as it ensures increased productivity.

HSCC by introducing innovative technologies has been playing a crucial role in the economic growth.

Though such technologies initially bring discomfort, they ensure larger benefits to both hospitals and patients in the long run. Such innovative technologies can be implemented in other departments where heavy patient load is often witnessed.

HSCC can play a crucial role in increasing transparency and visibility by facilitating smarter technologies like smart cards and QMS discussed above in the medical facilities in its fold. It can also assist other healthcare stakeholders, such as health insurance companies and the Government of India, in uncomplicating the complicated procedures of application for any compensation, appeals and grievances by automating the entire process.

Automation of procedures will prove beneficial to both insurance and government bodies as their services largely involve data gathering from multiple sources and enable keeping a check on the deadlines and other requirements. QMS and smart cards can become the standard practice in the industry as they accomplish the entire objective of delivering productivity, quality care, less hassles and cost reduction.

AIMED

Medical Device Policy

Medical Device Regulatory Reforms – Ready to Boost Business & Quality Care via Improved Quality

With a focus on implementing best international practices & quality care as envisaged under the ‘Make in India’ campaign, the Government of India announced to create a separate rule book for medical devices post addressing the challenges & integrating the best practices. The medical device industry has welcomed the announcement and shared recommendations to accelerate the efforts in the progressive direction.

A

t a high-level meeting at the Prime Minister’s Office (PMO), industry representatives from AIMED - Association of Medical Device Industry, Confederation of Indian Industry (CII) and the Federation of Indian Chambers of Commerce and Industry (FICCI) shared their common visions and thoughts on ‘Medical Devices Regulatory Framework’ along with the officials from Ministry of

Health & Family Welfare (MOH&FW) to the PMO Secretariat, based on the following key principles: • Best international practice - Confidence in medical devices available in India whether manufactured in India or imported.

• Ease of doing business • Patient safety

What will change for medical device manufacturers?

A separate ‘Medical Devices Regulatory Framework’ will usher in change, which will hopefully be for the better. As such, there has been a long outstanding demand from AIMED for a separate rule book and separate law to regulate medical devices. The changes are being done in three to four phases.

• Step 1 - Schedule MIII under the Drugs and Cosmetics (D&C) Act that provided regulations for

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Medical Device Policy

AIMED

infrastructure and equipment requirements for three types of medical devices was inadequate to regulate the 15 medical devices notified as drugs. As the above Schedule did not have the provision of quality management system (QMS) or good manufacturing practices (GMP), the regulators used to arbitrarily apply Schedule MIII from pharmaceuticals to medical devices, which was inappropriate, incomplete and incorrect, leading to harassment. Now on the request of AIMED, Schedule MIII has been amended and notified on June 29 with the provision of QMS requirements and these are aligned to ISO / IS 13485 Standard.

• Step 2 - In addition to the Schedule MIII revision, the balance rules are being drafted to meet specific needs of the medical devices (and in vitro diagnostic device (IVD)) sector but under the current D&C Act, as the Government decided not to amend the existing Act as was being proposed by the MOH&FW by adding a chapter specific to medical devices. Hopefully, this will meet our requests of delegation of QMS inspections to third-party certification bodies.

Additional medical devices may be regulated on getting the specific notification. These draft rules have been discussed with the key stakeholders, and these have now been posted on the MOH&FW website in a week’s time to gather public comments.

• Step 3 - A separate Medical Devices Bill 2016 is under drafting too by the MOH&FW and will be on the lines of earlier proposed amendment to D&C Act, but hopefully would be better drafted with wider consultation. This is targeted to be issued for public comments

by September and tabled to the Parliament by the winter session.

• Step 4 - The current rules are being drafted keeping in mind

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Medical Device Reforms in Regulations - Key Takeaways • Schedule MIII amended & notified on June 29 to include the provision of QMS requirements & aligned to ISO / IS 13485 Standard • Drafting of balance rules is under process to meet specific needs of medical devices.

• Drafting of a separate Medical Devices Bill 2016 is under process • Has recommended delegation of QMS inspections to third-party certification bodies.

• Has recommended manufacturers to be voluntarily self-compliant to ICMED or CE certifications • Need to tweaked to meet the challenges of patient safety and ease of doing business to enable Make in India

A separate ‘Medical Devices Regulatory Framework’ will enable regulation of all devices in one go

the regulatory framework being proposed in the new revised Bill, so that they would need minimal tweaking or change once the Act is done. The main impact of the Bill when enacted would be that all devices would get regulated at one go within a definite transition period instead of item by item notifications that lead to confusion of terminology and applicability.

What should manufacturers plan to do differently?

Manufacturers should aim to be voluntarily self-compliant to the Indian Certification for Medical Devices (ICMED) voluntary certification or CE certification. This will ensure they have to do minimal changes to documentation and processes to be compliant to these rules.

What are the proposed legislations? Any comments?

The forthcoming Bill will cover the legislation part of regulations for which the Government needs

AIMED

backing of Parliament. In case of rules, the Government of India can amend rules without pre-approval from Parliament. The major strategic elements are common in rules under drafting, e.g. it permitted Government of India to have powers to define rules to regulate through third-party certification bodies and consider a four-tiered risk-based proportionate regulatory control.

In essence, we welcome this separate set of rules as this has been a long outstanding request. However, there are some challenges, as these rules need to be tweaked to enable the dual needs of patient safety and ease of doing business to enable Make in India.

In terms of key elements, they are getting aligned to regulations of some or all the major economies.

In terms of who will regulate, we had proposed the Government of India through third-party certification bodies as done in the European Union (EU). However, we found that the Government of India is willing to consider this only for Class A & Class B Devices. The Government still wishes to use medical officers for inspection of Class C and D Devices and possibly B too. We need to negotiate with the Government of India to consider voluntary thirdparty certification for QMS-compliant high-risk devices as well.

Will there be risk proportionate regulations and controls?

Yes, a four-tiered proposed.

structure

Healthcare stakeholders are happy that medical device is now the national agenda

Third-Party Certification Bodies for Regulation • The GOI is willing to consider this only for Class A devices • The GOI still wishes to use medical officers for inspection of Class C & D Devices, and possibly B too • The Industry wants to negotiate with the GOI to consider voluntary third-party certification for highrisk devices as well

is

Who will regulate the Indian national medical devices regulator?

We have recommended that the currently proposed rules propose a Central Regulatory Authority to regulate the manufacturers and importers, as well as delegates the Regulation of Trading Company to the State Licensing Authority. This

Medical Device Policy

has to be seen in terms of challenges provided in the current law whereby the state is the licensing authority, but does not have the skill set, manpower and competency to regulate this case and complex field without handholding

by Government of India. The National Regulatory Authority and the National Accreditation Board of Certifying Bodies (NABCB) will jointly supervise the certifying bodies and their auditors.

What else was discussed at the meeting?

AIMED, CII and FICCI made a joint pitch for making India one of the top 5 manufacturing hubs in the world by implementing the following actions: • Department for Medical Devices or renaming the Department of Pharmaceutical as Department of Pharmaceutical and Medical Devices • Creation of a special purpose vehicle (SPV) for a coordinated approach for facilitating Make in India of medical devices • Incentives to attract overseas and domestic investors to build factories for not only importing substitution but for also targeting the global market and what it would take to compete with Ireland, China, Malaysia and Costa Rica as manufacturing destination and hub.

Overall, we were enthused by the importance being given to medical devices sector and the fact that it’s a national agenda now. We hope that the Government of India releases a comprehensive medical devices policy to realise not only the potential of import substitution of 23,000 crores, but also to unleash the huge export potential in the global market.

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