Medical Device

Introduction

The healthcare and medical device sectors have grown significantly in the last decade. There is a huge gap in the current demand and supply of medical devices in India and this provides a significant opportunity for manufacturing devices in India. At present, many medical device manufacturers (domestic and international) are chasing this massive under penetration of medical devices in India as a significant growth opportunity.

What is considered a medical device?

“Medical device” is an extremely expansive term that can encompass a wide range of items intended for medical use — from syringes and scalpels to pulse oximeters and pacemakers.

Definitions

According to the World Health Organisation (WHO), a medical device is any instrument, apparatus, implement or machine intended by the manufacturer to be used (either alone or in combination) for a medical purpose for human beings. These purposes can include:

• • Diagnosing, monitoring, treating and alleviating disease
• • Supporting or sustaining life
• • Controlling contraception
• • Providing accurate patient data to help improve healthcare pathways

Often, it can be hard to distinguish between a medicine and a medical device. For companies to market a product as a medical device, they first need to gain approval from the relevant regulatory body.

Classification

Medical devices are classified by the regulatory authorities that oversee the marketing of such devices in different countries. Devices are often split into classes depending on the level of risk to the patient or user. Under US Food and Drink Administration (FDA) regulation, for example, there are three classes of medical devices. These are:

Class I medical devices. These are low-risk devices, such as bandages, handheld surgical instruments, enema kits, and non-electric wheelchairs.

Class II medical devices. These are intermediate-risk devices. Examples include electric wheelchairs, infusion pumps, and some pregnancy testing kits.

Class III medical devices. These are high-risk devices that are vital to health and/or sustaining life. 10% of medical devices regulated by the FDA are class III devices. Examples include implantable pacemakers, pulse generators, HIV diagnostic tests, and automated external defibrillators.

Strategies to capture Indian market

• • Understand dynamics of the market, local sentiments, challenges and opportunities better
• • Partner with domestic technology companies for an efficient market entry and market growth strategy
• • Revolutionize domestic sales force
• • Add more value to healthcare providers and patients alike, not just through products, but also services wrapped around the product.

Understanding the Indian market

Medical device industry is influenced heavily by factors such as the country’s GDP, overall healthcare expenditure, level of public spend on healthcare compared to private sector, population’s disease pattern-linked demand for treatment options, population’s awareness of treatment options and their reception to certain device-based therapy, healthcare providers, regulatory environment, taxation and reimbursement options.

Market

Medical device industry is influenced heavily by factors such as the country’s GDP, overall healthcare expenditure, level of public spend on healthcare compared to private sector, population’s disease pattern-linked demand for treatment options, population’s awareness of treatment options and their reception to certain device-based therapy, healthcare providers, regulatory environment, taxation and reimbursement options.

Market Size

In India is among the top 20 markets for medical devices worldwide. India’s medical devices market stood at US$ 11 billion in 2020 and is expected to reach US$ 65 billion in 2024. The medical devices sector in India comprises large multinationals and small and midsized companies The Government of India (GOI) has commenced various initiatives to strengthen the medical devices sector, with emphasis on research and development (R&D) and 100% FDI for medical devices to boost the market. From April 2000 to March 2021, FDI inflow in the medical and surgical appliances sector stood at US$ 2.19 billion.

Export Scenario

India has a 75-80% import dependency on medical devices, with exports at Rs. 14,802 crore (US$2.1 billion) in 2019 and is expected to increase at a CAGR of 29.7% to reach Rs. 70,490 crore (US$10 billion) in 2025. To increase export of medical devices in the country, the Indian Ministry of Health and Family Welfare (MOHFW) and Central Drugs Standard Control Organisation (CDSCO) implemented the following initiatives: re-examination and implementation of Schedule MIII (a draft guidance on good manufacturing practices and facility requirements), system for export labelling, clinical evaluation and adverse reporting clarification, state licensing authority to extend free sales certificate validity from 2 years to 5 years to allow exports, create a list of manufacturers with export licensing for easy access by regulatory authorities worldwide. The Medical Devices Virtual Expo 2021 will showcase Indian products and enable direct interaction between Indian suppliers and buyers/importers from participating countries. Also, 300 foreign buyers from the healthcare sector are expected to participate in this event.

Investments

To further incentivise investments in manufacturing medical devices, in May 2020, the government announced incentivisation plans of at least Rs. 3,420 crore (US$ 4.9 billion) over a period of five years, and these funds will be offered to manufacturers only if they invest in set-ups to manufacture key medical devices Some major investments and developments in medical devices are as follows:

• • To expand the primary healthcare Industry and clinical centers in the country, in July 2021, the government of Uttar Pradesh announced to introduce automatic medicine dispensing machine. The state health department has been initiated to design an action plan and install ‘Health ATMs’ walk-in medical kiosks with combined medical devices for fundamentals, basic laboratory testing, emergency offerings, cardiology, neurology, pulmonary testing, gynecology, etc., operated by a medical assistant in all 75 districts of Uttar Pradesh.
• • In July 2021, Abbott announced that it has launched pea-sized, life-saving device for babies with hole-in-the-heart malformations. The company has launched the device in India with emphasis on centres having an active neonatal intensive care unit (NICU).
• • In June 2021, AstraZeneca India signed a memorandum of understanding with Docon Technologies, a Bengaluru-based health start-up, to digitise 1,000 clinics across India by implementing customised Electronic Medical Record (EMR) systems in clinics to offer doctors access to complete patient history.
• • In July 2021, Blackfrog Technologies, a start-up backed by the Biotechnology Industry Research Assistance Council (BIRAC), developed Emvólio, a portable, battery-powered refrigeration device to provide efficient and safe transportation of vaccines.
• • In June 2021, the National Anti-profiteering Authority’s (NAA) directed tax officials to ensure rate cut on Goods and Services Tax (GST) for COVID-19-related medical supplies to offer consumers tax relief on supplies.
• • In June 2021, Skanray Technologies filed its draft red herring prospectus (DRHP) with SEBI for its initial public offering (IPO) worth Rs. 400 crore (US$ 53.70 million). The IPO is expected to include sale of secondary share, wherein its promoters and Ascent Capital (an existing private equity investor) are expected to sell a part of their stake.
• • By 2022, the Gautam Budh Nagar, Noida, is expected to have Northern India’s first medical tools and system manufacturing park. The park is likely to be developed in Sector 28 of the Yamuna Expressway Industrial Development Authority (YEIDA) Space by the Yamuna Expressway Authority. In March 2021, YEIDA is expected to introduce a mission scheme worth ~Rs. 5,000 crore (US$ 685.35 million), of which Rs. 100 crore (US$ 13.71 million) is likely to be funded by the central authorities.
• • In February 2021, Punjab’s Industry and Commerce Minister Mr. Sunder Sham Arora announced that a park for medical devices was proposed in Rajpura, Punjab, across an area of 210 acres, with an estimated project cost of ~ Rs. 180 crore (US$ 24.67 million).
• • In January 2021, Tamil Nadu government proposed to build a medical devices park (spanning 350 acres) near Oragadam in Kancheepuram district. The proposed cost for developing this project is Rs 430 crore (US$ 58.92 million).
• • In March 2021, Transasia Bio-Medical Ltd., a Mumbai-based in-vitro diagnostic company, announced plans to invest Rs. 150 crore (US$ 21 million) to set up a manufacturing unit at the Medical Devices Park in Sultanpur, Telangana. The company plans to manufacture state-of-the-art high-technology analysers in the unit to address biochemistry, immunology, hematology, molecular testing in addition to COVID-19, HIV, dengue, and TB testing for domestic and export markets.
• • Japan-headquartered Omron Healthcare, which established its Indian arm in 2010, is drawing growth plans for India that may include setting up a manufacturing unit in India and expanding its retail footprint. By the end of 2021, the company plans to have 10 retail outlets in India and plans to create a centre in Warangal as part of its expansion into Southern India, where it anticipates a potential contribution of 40% of its sales in FY 2020. The company expects a Rs. 220 crore (US$ 30 million) turnover in India during that period.
• • New Delhi-based SS Innovations, promoted by renowned robotic cardiothoracic surgeon Dr. Sudhir P Srivastava, will commercially launch India's first and cheapest robot surgical system in the next 4-6 months. The company plans to manufacture 100 units in 2021 of its new 'Mantra' multi-arm surgical robotics system, which was indigenously developed over the last three years, and sell >1,000 units in the next five years.
• • In April 2021, Medtronic inaugurated a Medtronic Engineering and Innovation Centre (MEIC) in Hyderabad to leverage India's large pool of diverse and qualified talent to accelerate its innovative work in the medical technology space in the country.
• • In April 2021, ResMed expanded ‘AirView for Ventilation’, a cloud-based remote monitoring and management platform in India, which allows healthcare professionals and physicians to leverage this digital respiratory monitoring solution to remotely track patients and provide better care.
• • In April 2021, Anthill Ventures announced a collaboration with Kanfit3D (an Israeli health tech company) to help the company (Kanfit3D) expand in India and produce custom-made medical implants and market access to healthcare providers in the country.

Government Initiatives

The Government of India has recognised medical devices as a sunrise sector under the ‘Make in India’ campaign in 2014.

• • In July 2021, the government announced to build medical park in Uttar Pradesh, which is expected to generate an estimated Rs. 500 crore (US$ 67.13 million) business in the state.
• • In June 2021, the Quality Council of India (QCI) and the Association of Indian Manufacturers of Medical Devices (AiMeD) launched the Indian Certification of Medical Devices (ICMED) 13485 Plus scheme to undertake verification of the quality, safety and efficacy of medical devices
• • To boost domestic manufacturing of medical devices and attract huge investments in India, the department of pharmaceuticals launched a PLI scheme for domestic manufacturing of medical devices, with a total outlay of funds worth Rs.3,420 crore (US$ 468.78 million) for the period FY21-FY28.
• • On March 25, 2021, the Department of Pharmaceuticals (DoP) released a revised notice on the Public Procurement Order (PPO), incorporating 19 medical devices in the revised guidelines of the PPO, which is expected to improve domestic medical devices manufacturing (and strengthen ‘Make in India’) and reduce import bills by ~Rs. 4,000 crore (US$ 538.62 million).
• • In order to expedite the clearance of medical devices such as nebulisers, oxygen concentrators and oxygen cannisters in April 2021, the government made it easier to import critical medical devices by easing the requirements for clearance under the Legal Metrology Act (Packaging Rules 2011).
• • The government also approved applications for nine eligible projects that are expected to lead to a total committed investment of ~Rs. 729.63 crore (US$ 100.01 million) by the companies (e.g., Siemens Healthcare Private Limited, Allengers Medical Systems Limited (AMSL), Allengers OEM Private Limited (AOPL), Wipro GE Healthcare Private Limited, Nipro India Corporation Private Limited, Sahajanand Medical Technologies Private Limited, Innvolution Healthcare Private Limited, Integris Health Private Limited) and generate ~2,304 jobs.
• • In January 2020, the government set up a National Medical Devices Promotion Council to promote local manufacturing of high-end medical devices and attract investments in the sector.

Why must one choose the Medical Device Industry?

The Medical Device Industry is among one of the fastest growing industries in the world. India ranks fourth in terms of market size for medical devices in all of Asia. It has large multinational corporations and small and medium enterprises (SMEs) growing at an unprecedented rate. The market size of the medical device industry in India was estimated at Rs. 77,539 Cr (US$ 11 billion) in 2020. The market is expected to increase at a CAGR of 35.4% from 2020 to 2025, reaching Rs. 352,450 Cr (US$ 50 billion)

Top Career Opportunities within the Medical Device industry

As the medical device industry is a large and ever-expanding field, the functions of medical devices are divided into various sub-sectors. These areas of expertise include Quality Assurance (QA), Quality Control (QC), Manufacturing, Field Engineering, Research and Development (R&D) Design, Validation, Information technology, support functions, and Sales. The Medical Device industry welcomes Students from diverse backgrounds namely engineers, pharmacists, doctors, dentists, management students, and even students with a graduate degree in economics or environmental sciences. International organizations are beginning to recognize the potential value of India's experimental market due to the continued growth of medical tourism. The country has the level of technology and infrastructure that will enable it to maintain a strong position in the sector as other countries such as South Africa, Argentina and Malaysia are looking to enter the market. In addition, the Indian government has taken steps in the public health sector which focuses on improving medical infrastructure and rural health facilities, as well as promoting direct foreign investment in medical services.

The hospital industry is the prime consumer of medical devices, it is also rapidly growing and is widely believed to be the next big thing in the Indian market by most healthcare investors. Some of the growth factors include the increase in medical tourism, improving medical insurance schemes, increased lifestyle-related health problems, increasing discretionary income, and government programs. In addition to this, there are plenty of new advances that are emerging namely Augmented/virtual reality operation planners for the success of surgical interventions, robotic surgeries, digital twins, etc. The following image shows the logos of a few recruiters.

Different types of medical device jobs

Because the medical device industry is such a broad field that is constantly expanding, medical device jobs are split into various sub-sectors. These areas of specialism include:

• • Quality Assurance (QA)
• • Quality Control (QC)
• • Manufacturing
• • Field Engineering
• • Research and Development (R&D) Design
• • Validation
• • Sales

Impact of Covid-19

Covid-19 has taken a heavy toll on the medical device industry, and while it has been boosted by revenue, it has shown resilience to work tirelessly to ensure product availability for both Covid-19 and non-Covid-19 emergencies across the country. The industry has shown great resilience in the face of difficulties to ensure a continued supply of critical medical devices and services, despite being plagued by numerous operational problems like scarcity of manpower, restrictive movement of service personnel and goods in several areas, etc. The industry is also reeling under taxing financial challenges like an escalation in costs due to the hike in charges, at the same time it has been hit by a significant fall in revenue as a result of -the postponement and cancellation of selection processes that drive a large part of the need for medical devices.

Key Challenges and the Way Forward

The Biggest Challenges in the Medical Device Industry are High Costs of Product Design & Development, Stringent Regulations, Security, Product Quality and High Recall Rates. The future of healthcare is shaping up in front of our very eyes with advances in digital healthcare technologies, such as artificial intelligence, 3D printing, VR/AR, nanotechnology, or robotics. The future of medical devices is influenced by technological trends and opportunities that promise to transform the work of health care providers and medical technology companies.

The medical device market space is driven by innovation, and the development of medical devices and technologies has shown unparalleled growth and advancement in the healthcare services industry. Currently, the medical equipment industry is in its early stages, which can be accelerated by building an efficient environmental system, developing skills, and supporting entrepreneurship and empowerment. These goals can be achieved by introducing legal and policy reforms, promoting research and innovation, providing funding opportunities, and facilitating testing and validation to increase manufacturing. To sustain innovation and develop the medical device industry in the post COVID era, the government must continue to work with investors, the private sector, and academics and check for the need for incentives and supportive action. Experts suggest that India will emerge as a trusted global partner in the medical devices sector and is ready for significant growth through a futuristic and collaborative approach.

Policy makers in India will need to set out an action plan to reduce the country’s dependency on medical devices/technology imports. At present, NITI Aayog is reportedly drawing up a strategic road map for medical devices similar to the incentive package that gives sizable capital subsidies for the electronics business, which helps boost local production of cell phones in the country. Medical device companies should develop India as a manufacturing hub for domestic and international markets, undertake India-based innovation in combination with indigenous manufacturing, collaborate across the Make in India and Innovate in India schemes, and produce Low to Medium technology products to cater to the underpenetrated domestic markets.

Achievements in the Sector

In India, medical device manufacturing is costly because it requires high investments in scientific facilities. To combat this cost, the Government of Andhra Pradesh is establishing the Andhra Pradesh MedTech Zone (APMTZ), which will house all capital-intensive scientific facilities, laboratories, etc., and will be leased to manufacturers in Vishakhapatnam. This initiative will help decrease the cost of good-quality products.

References: https://www.linkedin.com/pulse/career-opportunities-medical-device-industry-miss-santosh-chintakindi?trk=public_profile_article_view https://www.ibef.org/industry/medical-devices.aspx https://www.infosys.com/consulting/insights/documents/indian-medical-device-industry.pdf