Medical Device Industry

Medical Device Industry

The medical device industry is a diverse, innovative, and dynamic industry with a huge potential to grow worldwide. Different countries have different regulatory norms and conditions for setting up a medical device industry. A medical device industry manufacturer needs to have clarity with their target market and thus comply with the stated regulations as per the market standard. In China, to enter into the medical device industry, a CFDA's approval is mandatory even if the world's most stringent approval has been issued, such as the USFDA for the medical device industry. In recent years, the medical device industry has witnessed remarkable growth and boom, with a huge difference in the availability of medical device products. With the advancement in technology, various medical devices have been introduced and thus become indispensable tools in modern medical practice. The increasing number of inpatient admissions and increasing procedures with surgical and diagnostic is fuelling the demand for medical devices. The increasing number of investments in R&D by big market players to meet the growing demand for innovative devices by developing technologically advanced equipment has also boosted the medical device industry in the forecast period.

What is a Medical Device?

Unlike the pharmaceutical industry medical device is an instrument, apparatus, machine, tool, etc that is used to diagnose and mitigate diseases and various other medical conditions through a physical, structural, or mechanical action and not through a chemical method injected into the body.

Indian Market Size of Medical Device Industry

As per the record, the medical device market size in India is estimated at $ 11 billion and is expected to reach $50 billion by the year 2025. This medical device industry sector has grown gradually at a 15% CAGR over the last 3 years. Moreover, in India, there are around 750-800 domestic in-house medical device industries manufacturing various medical devices, accounting for 65% of the market. This evolving medical device industry is versatile and diverse, accompanied by various innovations for addressing important health issues across the globe with the help of multiple organizations that are engaging in the findings of new medical devices.

Post Covid-19 the Indian medical device industry has boomed rapidly since India played a key role in fighting against the COVID-19 pandemic battle across the globe by contributing to the production of various medical devices and diagnostic kits such as ventilators, rapid antigen test kits, RT-PCR kits, IR thermometers, PPE kits, N-95 masks etc.

Various companies and industries have taken steps in the medical device industry along with multiple numbers of start-ups evolving across the Indian states, where various medical device parks are set up for manufacturing various types of medical devices at a very low price. Some of the major medical device industries are coming up in various states in India like Himachal Pradesh, Tamil Nadu, Madhya Pradesh, Uttar Pradesh, etc.

What are the types of Medical Devices?

The medical device industry has been segregated into five major types

• Consumables and disposable medical devices such as needles and syringes, etc.
• The diagnostic imaging medical device industry includes MRIs, X-rays, Ultrasounds, etc.
• Products related to dental clinics, such as dentures, braces, etc.
• Prosthetics and orthopaedics medical devices such as knee implants, artificial joints, etc.
• Various other patient aids, such as hearing aids, pacemakers, etc.

Advantages of Medical Device Industry in India

Here are the major advantages of the medical device Industry in India

• The increasing number of medical infrastructure and facilities will boost the demand for medical devices in the medical device industry.
• Various government initiatives and schemes, such as production-linked incentives (PLI) connected to the medical device industry, will increase the demand for medical devices.
• The medical device industry is expected to reach US$50 billion by 2030.
• The medical device Industry in India is driven by countries importing medical devices from the US, China, and Germany, which are 70-80%.
• With the bilateral trade between India and Russia, trade is expected to increase by an additional US$ 5 billion per annum, boosting opportunities in the medical device industry, minerals, steel, and chemicals.
• The government of India has also taken the initiative in July 2022 by issuing a draft on new drugs, medical devices, and cosmetics bills in 2022 to ensure that medical device items sold in India are reliable and efficient according to the required statutory standards.
• In the India Council of Medical Research, November 2021, collaborated with IITs to set up an ICMR at various IITs by setting up a centre for excellence for developing medical devices in India products and commercializing in the medical device industry sector.
• The medical device industry has also received a huge number of significant investors, which is boosting the industry rapidly.
• Between April 2000 to September 2023 FDI inflow in the medical and surgical appliances industry has stood at US$3.22 billion.

Key Features of the Medical Device Industry

The medical device industry or a manufacturer after obtaining approval from the FDA (Food and Drug Administration) to sell medical devices starts selling such products to healthcare providers such as hospitals, doctors, and nursing homes rather than to individual consumers. There are usually two main types of medical devices in the market such as conventional devices and high-technology devices.

Conventional medical devices include basic surgical supplies and wound dressings. However, these devices are very easy to produce; thus, many companies enter the market competing on prices since such products are similar to each other. Companies entering into this conventional medical device industry often have to sell a huge number of products to make a lot of money since the margin of profit is very low compared to high-technology medical devices. Therefore, to achieve success, this business has to crack a deal with big buyers like hospital chains.

High-technology devices, on the other hand, are more complex as they require advanced technology and a huge amount of investment. Unlike conventional medical devices, it is hard for new companies to enter this market since it requires effective research, costs, patents, and various other regulatory frameworks. Competition in such a market is low, and companies can expect higher profits.

However big medical device industry usually sells both types of medical devices, and such diversity in business helps companies in many ways. Moreover, the big medical device industry or a company can use their high-tech products to increase the number of simple device sales in the market. Such an industry after receiving profits from conventional medical devices can use such profit in research and development of high-tech medical device tools.

Why choose India for the Medical Device Industry

With the changing global business environment, the medical device industry has taken huge steps favouring both big and small-sized medical device manufacturers. Here are the reasons why India should be the next hub for the medical device industry:

Strict policies for Intellectual property rights

In India, data is considered to be the new gold. With the advancement in technology, companies and industries understand the value of data privacy and their global presence in the manufacturing industries. In India, we provide multilayered protection and security to prevent data violations and various other cybersecurity attacks. Various intellectual agreements have also been signed by the government of India, such as TRIPS (Trade-Related Aspects of Intellectual Property Rights) and Patents Act 1970, a statutory law that grants patent rights to products related to medical devices and pharmaceuticals.

Skilled human resource and low operation cost

When it comes to skilled human resources India as a country is not lacking behind, we have several prestigious institutions where several talented and skilled professionals are produced every year contributing a huge number of resources to the R & D sector. Therefore, India is not only capable of producing skilled labor but also at a reasonable cost significantly benefitting the medical device industry.

PLI scheme

Recently the Government of India to attract larger investments from industrial sectors and to boost the domestic market, has proposed a scheme like Production Linked incentives. The major criteria under this scheme are that a company must have a net worth of more than 18 crores to be eligible to get the PLI scheme, moreover, there are no such restrictions for a company to enroll in other available schemes after enrolling in the same.

Make in India or Aatm Nirbhar Bharat Abhiyan

After the unprecedented COVID-19 pandemic, the government of India has taken initiatives intending to promote various industries, including the medical device industry, significantly.

Robust Ecosystem to Scale Production

With the advancement of technologies like IoT, the supply chain has reached to next level ensuring a simple and easy tracking method. Thus, by partnering with the Indian engineering company, a company will receive everything under one umbrella from skilled labor to cost-effective services.

Medical device Parks

Recently, the Government of India has taken the initiative to establish various schemes to set up medical device industry parks. These medical device parks include high standards world-class testing and infrastructure facilities. The main objective behind these medical device parks in India is to reduce and minimize the cost of medical device manufacturing thus promoting and enhancing the accessibility and overall affordability ratio in India.

Challenges in the Medical Device Industry

Developing and manufacturing medical devices is indeed not an easy task. There are several challenges before a final product is eligible to operate in the market. Given below are some of the challenges faced by the medical device industry:

• With the rapid growth of advanced technology, this medical equipment has also become advanced and thus it becomes challenging for a medical device industry or companies to keep up-to-date with such latest technologies or innovations in this competitive market.
• Nowadays, there is a rapid increase in healthcare costs. Therefore, there is huge pressure on the medical device industry to innovate and develop devices that are cost-efficient without compromising quality and performance.
• The medical device industry has to comply with the stringent regulatory framework as it is connected to the well-being of a patient, thus mandatory to meet all the necessary compliance to market their medical devices.
• Intellectual property rights protection is another challenge, that the medical device industry faces due to the increasing number of competition in the market with similar products making it difficult to figure out the differences.
• The medical device industry is a global market; thus, the competition is across the globe with those in the emerging markets.
• There should be time-to-time innovations and developments to meet the evolving changes in the healthcare industry.
• Another major challenge that was highlighted during COVID-19 was the supply chain disruptions and manufacturers of medical devices prepared to deal with any unprecedented situation.
• A medical device industry must adopt a sustainable procedure in manufacturing such medical devices, as it has a potential impact on the environment.
• Healthcare reimbursement policies vary from country to country, which indirectly impacts the medical device demand and prices that a company may charge on medical devices.

Indian Investment Climate

With the increasing global medical device industry, foreign investors in India have now found more freedom than ever before to invest in India's medical device industry. The Indian medical device industry is one of the critical sectors that has the potential to become a global powerhouse in the field of medical devices. Such significant growth is influenced by various factors, such as a large and skilful workforce, government initiatives, and a growing domestic market. India imports 70 % of its medical devices. However, a PLI scheme has taken the initiative to set up 39 medical device manufacturing plants to cut down the import bill. However, in recent years, India has reduced its dependency on various medical products and devices and has emerged as a major exporter of various medical device products.

Unlike the pharmaceutical industry, the Indian medical device Industry is smaller yet experiencing rapid growth. Below are some of the major factors for such increasing demand

• The increasing middle-class population in India with its increasing disposable income has maximized the growth of health awareness thus leading to the medical device domestic demand.
• The government of India has also taken various initiatives to promote the expansion of the medical device industry, such as Make in India and Production Linked Incentive (PLI), thus encouraging and promoting a domestic medical device industry.
• Emerging Indian companies have also introduced an R&D department to promote and focus on innovations in developing various medical devices to meet the needs of the medical industry.
• India as a developing country, provides skillful employees and cost-effective manufacturing prices as compared to the other developed countries. Thus, attracting foreign investors and the medical device industry to set up their firms to avoid unnecessary cost production on medical devices.

Thus, the medical device industry is rapidly growing in India, leading to a journey to become one of the potential global leaders and manufacturers of medical devices. The initiatives taken by the government of India by introducing various schemes have made it easy to invest in the medical device industry, as R&D and industry-academia collaboration are the ways to uplift the medical device industry.

Relationships between Device Manufacturers and Physicians

There is a deeper and more extensive relationship between medical device manufacturers and physicians, and the medical device industry is highly notable compared to the relationship between physicians and drug makers. Some of the major relationship forms between medical device manufacturers and physicians are

• To ensure a royalty payment to those physicians who help to develop and invent a medical device.
• A fee will be charged to the consulting physician for issuing feedback on the medical devices designed by the companies.
• Research funding to various physicians.
• Funding is needed for various medical device education and activities to promote such devices for medical purposes.

Government Initiatives

In recent years, the medical device industry in India has dramatically expanded, producing various medical equipment, such as consumables and surgical implants. Moreover, the medical device industry is highly capital-demanding, and therefore, continuous healthcare training and awareness have to be conducted by companies to keep up with the latest technologies. However, there is a significant gap between the demand and supply of medical equipment in the Indian medical device industry, as the country is dependent on imports of 70-80% of medical device needs. The global medical device market is currently considering India's market as huge and affordable, setting up the medical equipment market to be an opportunity for big growth.

Various initiatives have been taken by the government of India to make it a global hub for medical device technology and various other products. According to the report, Omron's Healthcare India Pvt.Ltd, a Japanese subsidiary business, has a plan to multiply its income in 3 to 5 years. In August 2023, Omron Healthcare India signed into a partnership with an Indian celebrity, Milind Soman, to increase awareness of the necessity of home monitoring as a part of wellness regimen monitoring. In 2023, Medtronic also invested around Rs 3,000 crore to expand the Medtronic Engineering & Innovation Centre in Hyderabad.

Another great initiative was taken by Hindustan Syringes & Medical Devices Ltd by supplying 1.75 billion syringes of about 13.3 billion during the COVID-19 pandemic across the globe. However, the government of India has taken the initiative to provide financial incentives to promote and boost the growth and innovations in the medical device industry. The objectives behind the financial incentives given by the government of India are to increase the acquisition of R&D technology and to build an infrastructure for medical device facilities. In addition to this, various tax breaks, subsidies, and grants have been launched by the government of India to promote and encourage the establishment of the medical device industry.

To increase India's participation in this global competitiveness, the government has collaborated with various international entities and organizations. Such collaboration has increased the exchange of knowledge, technology transfer, etc., giving access to the global medical device industry.

WHO Response to the Medical Device Industry

According to WHO every country in their national health plan must incorporate various policies, strategies, and action plans for medical devices. Such medical devices are important to smooth the healthcare system and to ensure safety and secure high-quality medical devices to prevent diagnosed diseases and assist patients in their rehabilitation.

To ensure medical device manufacturing industry standards, safety, quality, and effectiveness, the WHO (World Health Organization) offers guidance to countries through its global model regulatory framework for medical devices. Moreover, WHO also works closely with the member states to cooperate in developing various guidelines and regulatory frameworks for establishing a medical device industry.

In addition to that, the WHO also helps countries with limited medical device resources by identifying their medical device requirements and ensuring that they are equipped with such medical devices and use them in the right manner. The guidance through WHO is accompanied by a web-based database that helps countries select and identify the right medical devices based on various factors like level of care requirement, healthcare setting, environment, and various other specific health requirements, depending on country to country.

Legal and Regulatory Regime

With the evolving medical device industry, the Indian legal and regulatory framework governing the medical device industry has undergone a major change and modifications to meet the medical device industry's international standards. The government of India implemented Medical Devices Rules in 2017 with a significant impact and move towards complete transparency in the working or operations of the medical device industry regulatory frameworks. These Medical Devices Rules cover various medical devices' lifespans from production to post-market surveillance, with an assurance of the safety and efficacy of medical device products in the marketplace.

Indian Council of Medical Research- The Department of Health Research Policy was introduced by the government of India under the Ministry of Health and Family Welfare before various medical institutions on biomedical entrepreneurship and innovations. The objectives behind such policy are to set up holistic innovation and to spread multi-disciplinary collaborations among colleges and support each other in promoting Make-In-India, Atmanisrbhar Bharat, and various other start-up initiatives taken by the government of India. This guideline under the said policy will help the institutes collect the revenue portion incurred from the commercialization of the medical device innovations in the market, promoting a self-sustaining business.

CDSCO, or Central Drugs Standard Control Organisation, is the primary regulatory body that regulates medical device import sales and manufacturing by stating the standards of drugs, cosmetics, and various other medical devices. Licenses are also issued to businesses engaged in the import and manufacturing of drugs.

Conclusion

The medical device industry is a dynamic, indeed emerging industry; thus, to ensure safety measures for the users and patients, these devices must be tested. There are several compliance and regulations for establishing a medical device manufacturing company or industry. Without the medical device industry, it would have been impossible for common medical procedures such as bandaging a sprained ankle, diagnosing HIV/aids, surgical intervention, etc. Today, there are around 2 million types of medical devices across the globe, and they are categorized into more than 7000 generic groups of devices. Medical devices are considered one of the fundamental key components of the health care system. The steps involved in setting up the medical device industry, regulation, and planning are indeed complex and critical yet necessary to guarantee their quality, safety, and compatibility with medical needs.