The human neck is really important because it holds up our head and lets us move it around. But sometimes, people hurt their necks, and it can cause a lot of problems like pain, numbness, and weakness. When this happens, doctors might need to do surgery to fix it. They use special cages called lordotic expandable corpectomy cages to help with the surgery. These cages are like little frames that go in the neck to support it and make it better. They’re great for fixing problems like when the neck gets too narrow, discs wear out, or bones break. These cages can be adjusted to fit each person’s neck perfectly, which has made a big difference in how well people recover from neck surgery.

In India, a lot of people are having problems with their spines, and over 200,000 spinal injuries happen every year. Many of these are in the neck. This is because people are getting older, having accidents, sitting too much, using screens too often, and being overweight. So, having these special cages is really important to help treat these neck problems and make people feel better.

Static vs expandable type cages

Fixed-height cages have become popular because they can help restore the height of the disks between the bones in the spine and improve the alignment of the spine. Lately, we’ve realized that having the spine aligned properly is really important for managing pain and getting back normal functions after surgery. Using these cages is recommended to make sure the spine is aligned well, which can be especially helpful when the bones are not in great condition. However, these cages can cause problems like sinking into the bones, injuring nerves, tearing the covering of the spine, or not fusing properly.On the other hand, expandable cages that can change shape offer a more flexible and less invasive option for neck surgery. They can be adjusted to fit each person’s spine perfectly, which helps reduce the chances of problems like the bones next to the surgery site getting sick. These cages are usually made of materials that the body can tolerate well, like titanium or a special plastic called PEEK. They’re meant to be put between the bones to make sure the spine curves the right way. These cages are good for surgeries where the goal is to do as little damage as possible and they often lead to better results for people who might not do well with traditional surgery.

Those who are considered for conventional fusion surgeries may also benefit from the customizable features of lordotic expandable cages, which are particularly suitable for the varied anatomies and conditions seen in the Indian population. This flexibility enables surgeons to personalize the treatment according to the specific requirements of each patient.

Indian market

The Indian market for lordotic expandable corpectomy cages is expected to grow at a Compound Annual Growth Rate (CAGR) of nearly 5% until 2030 due to the increasing incidence of spinal disorders and the growing demand for minimally invasive spinal surgeries. The Indian spine market is projected to reach nearly $1.0 billion (8,330 Cr.) by 2030. The key players in the Indian market for lordotic expandable corpectomy cages include major medical device companies such as Medtronic, Stryker, Zimmer Biomet, and DePuy Synthes. These companies are constantly striving to innovate and introduce new products to cater to the evolving needs of patients and healthcare professionals. Unfortunately, no Indian manufacturer is currently working on lordotic expandable cages; thus, they are imported to the country. For this reason, they are expensive and cost close to 1.5 lakhs per unit. These factors present a lucrative opportunity for domestic companies to capitalise on this growing market segment.

Despite the significant advantages of lordotic expandable cages for cervical spine surgery, the Indian market faces several challenges and that needs careful attention. One primary challenge is the cost, as these advanced implants are notably more expensive than traditional fusion procedures or non-expandable cages. Nonetheless, the potential for long-term benefits and the reduced risk of post-surgical complications associated with lordotic expandable cages may justify the initial investment. To reduce the device cost, there is a need to emphasize on innovation, quality, and increased participation from startups. The Medical Devices Policy, 2023 and rapid interest of startups in medical device startups provide optimism to see indigenous lordotic expandable cages in the Indian market soon. The development of an indigenous device will provide an essential implant to the Indian population at an affordable cost for a better quality of life. 

Authors biography

Er. Arvind Kumar Prajapati is a Scientist/Engineer.He has been closely working in design, development, testing and validation of Knee,Hip, and Spine implants and instruments.

Mr. Amijith A M is a Senior Project Engineer (short term staff)He has been closely working in design, development, testing and validation of Spineimplants and instruments.

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The medical devices segment is diverse, creative, and dynamic sector that includes a wide range of products such as implants, surgical instruments, medical equipment, In-vitro diagnostic reagents, and consumables. It is an essential part of the healthcare system for diagnosis, treatment, and prevention of health issues. The Indian medical devices market is currently estimated to be $11 bn, with global market share of nearly 1.5%. India is Asia’s 4^th biggest market and ranks in top 20 global medical devices markets. It is reported that the Indian medical devices sector is at its nascent stage and import centric, around 80% of medical devices are imported to meet the domestic requirements, majority of them come from the US, China, and Germany.

Despite high import dependency, the Indian medical devices sector is expected to grow at 7 % CAGR during 2021 to 2025 and is projected to observe the rapid growth in the Asia Pacific market. The accelerated growth is anticipated due to concurrent reasons such as rising demand of devices because of global pandemic, rising prevalence of chronic diseases, and elderly population which is expected to grow by 41% in 2031 compared to 2021. To reduce the import dependency and satisfy the rising demand of medical devices, a comprehensive, and carefully devised strategy is required, which shall assist in achieving the fundamental objectives such as accessibility, affordability, quality, in-house manufacturing and skilled manpower.

The need for contemporary healthcare infrastructure is essential, which may also attract the domestic manufactures to invest in medical devices sectors.

The various government initiatives

Although 100 percent FDI through automatic route in medical devices was allowed in 2014, tangible attention of policy makers and bureaucrats appeared only in the last two or three years during and post-pandemic. To strengthen the medical devices sector, the government provided financial support of 25 crore to Andhra Pradesh MedTech Zone (AMTZ) for a common facility centre. Subsequently, to improve manufacturing in cancer/radiotherapy, imaging devices, renal and cardio-respiratory devices and implants sectors, the production linked incentives scheme for medical devices was initiated in 2020, with an amount of 3,420 crore. Further, the medical devices parks were envisaged by allocating 400 crores for developing the medical devices, research facilities and skilled manpower. By introduction of the medical devices rule 2017, which categories the medical devices in four classes, the quality and efficacy was inducted in this sector.

Moreover, the national pharmaceutical pricing authority swung in action for price capping of knee implant, stents, oxygen concentrator and point of care devices (POC) to reduce the dealer’s margin. To address the rising price of drugs, the government opened 8604 affordable outlets (Jan Aushadhi Kendras) which offer 1451 drugs and 240 types of surgical supplies. Another step towards Universal Health Coverage (UHC), The initiative of the Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) was pioneered by providing the health insurance of ₹ 5 lakhs per family per year, which covers approximately 50 crore Indian poor and vulnerable families. The forenamed initiatives deserve the praise for notable work by the government, but there is still a necessity to advance medical devices sectors to achieve the vision of affordable and quality care to every stratum of the society.

The further boost in creating centres of excellence at reputed institutes would attract world class faculties to engage them in medical devices which are fit for India.

Areas of improvement and suggestions

Despite various schemes initiated by the government, there is a necessity for a comprehensive and clear roadmap for accelerated and continuous growth in the sector. The urge for improvements in the sector is further stressed by the diversity in the medical devices product segment which demands the wide range of interventions in different areas as underscored below. 

Medical devices regulation: The single window online portal for efficient management of information associated with medical devices is essential. The online portal should allow ease in medical device registration, obtaining import and manufacturing licensing, clearance for clinical investigation to all the stakeholders like Co-WIN portal used for vaccination drive.

Research and Development (R & D) funding: The allocation of dedicated funds to encourage joint research with industry, academic and start-ups is much entailed. The fund should be disbursed for building contemporary laboratories for various evaluations, implant and instruments testing, animal studies, equipment testing etc. for R & D activities. These well-equipped laboratories could lead to enhanced research-oriented collaboration, partnerships and innovation in the domestic medical devices sector. 

Price regulation of medical devices: The projected Indian annual per capita income in 2022 is ₹ 1,78,944 ($2,357.643) which translates to ₹14,912 per month. The per month income for quality health services to common people is surely less, thus price regulation of medical devices and hospital charges could play an important role in offering affordable medical devices to all. However, careful understanding of medical devices and well devised strategy for price regulation will be required to maintain stability in the medical devices segment.

Healthcare Infrastructure: The highly infectious COVID-19 virus has created panic in the healthcare community and its deleterious episodes are continuing. On other hand it has emphasised the need for infrastructure requirements. The various media reports stressed the shortage of beds in health care centres, which left patients unattended for a long time. This insinuated the need for a good physical foundation for health services and healthcare research for better management and treatment of diseases. Thus, the need for contemporary healthcare infrastructure is essential, which may also attract the domestic manufactures to invest in medical devices sectors.

Promoting the collaboration: The idea of industrial cluster near to all academic Institutions, could provide the essential environment for industrial collaboration, The global giant in medical devices technology such as Medtronic, Stryker, GE Healthcare, Philips, and Medtronic shall be encircled in this type of collaboration, it can be easily done since most of them already have centres in India. The triple helix model, commonly used in western countries, shall be tried in this collaboration initiative, where government, industry and Institutes would interact for improvement in the domestic medical devices segment.

Innovation parks: The promotion of the ecosystem that houses the network of institutions, start-ups, clinical setting, funding agencies is much needed. This type of ecosystem is called innovation parks; the medical devices parks should be initiated to provide the impetus to scale up the production, encourage the research to market translation and quality medical devices. These parks shall further have strong association with the Ministry of Human Resource Development to make necessary corrections in National Education Policy 2022, by designing proper course work to meet the domestic medical device industry requirements.

Creating centres of excellence: The further boost in creating centres of excellence at reputed institutes would attract world class faculties to engage them in medical devices which are fit for India. These centres shall be further strengthened to drive the role in product development, validation, certification, promote the safety and efficacy and use of latest technology such as Internet of Things (IoT), Robotics, Telemedicine, Artificial Intelligence (AI) etc. in the medical devices sector.

Trained Human Resource: As pre survey from AMTZ the half of the workforce in the medical devices sector are unskilled, signaling the need for skill development programs in this sector. The National Institutes for medical devices like IITs, NITs and IISc could be envisaged. These institutes shall provide training, internship, and hands -on experience in medical devices. Further, association with private players shall be encouraged for research and training funding. The course curriculum in these Institutes shall be drafted such that it brings doctors, technicians, service engineering, scientists, and engineers together like Clinical Engineering, a joint initiative by three Institutions namely IIT Madras, SCTIMST and CMC Vellore to improve the skills in the domain.

IP (intellectual property): Patenting is the formal way to protect innovative ideas. Intellectual property right offers various advantages such as, competitive advantages against the established competitors, prevents ideas from theft, and signals to investors about the new technology. Patenting in the Indian medical devices sector shall be encouraged for continuous and stable growth in the sector.

Custom Duty: It is a long pending request from the Indian Medical devices industry to increase the custom duty on imported medical devices. The demand is to increase the custom duty from 0 to 7.5 % to 15% and reduce the GST from 18% to 12%. The call on the request shall be considered after proper evaluations, since on one side it will ease the entry of local medical device manufacturers in the market but on other side it will lead to deficiency of quality and innovative product in market. 

Acceptance of personalized treatment: Personalized care often called precision medicine is tailor-made treatment to patients based on their molecular profiling. It is an emerging and exciting treatment approach which envisages an important role in preventing, predicting diseases and educates patients to get the right treatment. There shall be a policy to promote such patient centric treatment initiatives within the country, which will contribute to the growth in the medical devices segment since personalized medicine has over-reliance on diagnostic devices.

The aforementioned suggestions are specific to build a strong foundation for the Indian medical devices sector. These are a few steps to reduce import dependency and realize a self-reliant India. If these areas are stressed for the next decade, India could become the global supplier in medical devices from the status of importer.

Composed by: “Arvind Kumar Prajapati is presently associated with Biomedical Technology Wing, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, India. He has worked on design, development and validation knee, hip, spine implants and instruments.”

The post Furthering the Medical Devices Sector in India appeared first on InnoHEALTH magazine.

The various government initiatives

Although 100 percent FDI through automatic route in medical devices was allowed in 2014, tangible attention of policy makers and bureaucrats appeared only in the last two or three years during and post-pandemic. To strengthen the medical devices sector, the government provided the financial support of 25 crore to Andhra Pradesh MedTech Zone (AMTZ) for a common facility centre. Subsequently, to improve manufacturing in cancer/radiotherapy, imaging devices, renal and cardio-respiratory devices and implants sectors, the production linked incentives scheme for medical devices was initiated in 2020, with an amount of 3,420 crore. Further, the medical devices parks were envisaged by allocating 400 crores for developing the medical devices, research facilities and skilled manpower. By introduction of the medical devices rule 2017, which categories the medical devices in four classes, the quality and efficacy was inducted in this sector.

Moreover, the national pharmaceutical pricing authority swung in action for price capping of knee implant, stents, oxygen concentrator and point of care devices (POC) to reduce the dealer’s margin. To address the rising price of drugs, the government opened 8604 affordable outlets (Jan Aushadhi Kendras) which offer 1451 drugs and 240 types of surgical supplies. Another step towards Universal Health Coverage (UHC), The initiative of the Ayushman Bharat-Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) was pioneered by providing the health insurance of ₹ 5 lakhs per family per year, which covers approximately 50 crore Indian poor and vulnerable families. The forenamed initiatives deserve the praise for notable work by the government, but there is still a necessity to advance medical devices sectors to achieve the vision of affordable and quality care to every stratum of the society.

Areas of improvement and suggestions

Despite various schemes initiated by the government, there is a necessity for a comprehensive and clear roadmap for accelerated and continuous growth in the sector. The urge for improvements in the sector is further stressed by the diversity in the medical devices product segment which demands the wide range of interventions in different areas as underscored below. 

Medical devices regulation: The single window online portal for efficient management of information associated with medical devices is essential. The online portal should allow ease in medical device registration, obtaining import and manufacturing licensing, clearance for clinical investigation to all the stakeholders like Co-WIN portal used for vaccination drive.

Research and Development (R & D) funding: The allocation of dedicated funds to encourage joint research with industry, academic and start-ups is much entailed. The fund should be disbursed for building contemporary laboratories for various evaluations, implant and instruments testing, animal studies, equipment testing etc. for R & D activities. These well-equipped laboratories could lead to enhanced research-oriented collaboration, partnerships and innovation in the domestic medical devices sector. 

Price regulation of medical devices: The projected Indian annual per capita income in 2022 is ₹ 1,78,944 ($2,357.643) which translates ₹14,912 per month. The per month income for quality health services to common people is surely less, thus price regulation of medical devices and hospital charges could play an important role in offering affordable medical devices to all. However, careful understanding of medical devices and well devised strategy for price regulation will be required to maintain stability in the medical devices segment.

The various media reports stressed the shortage of beds in health care centres, which left patients unattended for a long time. This insinuated the need for a good physical foundation for health services and healthcare research for better management and treatment of diseases.

Healthcare Infrastructure: The highly infectious COVID-19 virus has created panic in the healthcare community and its deleterious episodes are continuing. On other hand it has emphasised the need for infrastructure requirements. The various media reports stressed the shortage of beds in health care centres, which left patients unattended for a long time. This insinuated the need for a good physical foundation for health services and healthcare research for better management and treatment of diseases. Thus, the need for contemporary healthcare infrastructure is essential, which may also attract the domestic manufactures to invest in medical devices sectors.

Promoting the collaboration: The idea of industrial cluster near to all academic Institutions, could provide the essential environment for industrial collaboration, The global giant in medical devices technology such as Medtronic, Stryker, GE Healthcare, Philips, and Medtronic shall be encircled in this type of collaboration, it can be easily done since most of them already have centres in India. The triple helix model, commonly used in western countries, shall be tried in this collaboration initiative, where government, industry and Institutes would interact for improvement in the domestic medical devices segment.

Innovation parks: The promotion of the ecosystem that houses the network of institutions, start-ups, clinical setting, funding agencies is much needed. This type of ecosystem is called innovation parks; the medical devices parks should be initiated to provide the impetus to scale up the production, encourage the research to market translation and quality medical devices. These parks shall further have strong association with the Ministry of Human Resource Development to make necessary corrections in National Education Policy 2022, by designing proper course work to meet the domestic medical device industry requirements.

Creating centres of excellence: The further boost in creating centres of excellence at reputed institutes would attract world class faculties to engage them in medical devices which are fit for India. These centres shall be further strengthened to drive the role in product development, validation, certification, promote the safety and efficacy and use of latest technology such as Internet of Things (IoT), Robotics, Telemedicine, Artificial Intelligence (AI) etc in the medical devices sector.

Trained Human Resource: As pre survey from AMTZ the half of the workforce in the medical devices sector are unskilled, signaling the need for skill development programs in this sector. The National Institutes for medical devices like IITs, NITs and IISc could be envisaged. These institutes shall provide training, internship, and hands -on experience in medical devices. Further, association with private players shall be encouraged for research and training funding. The course curriculum in these Institutes shall be drafted such that it brings doctors, technicians, service engineering, scientists, and engineers together like Clinical Engineering, a joint initiative by three Institutions namely IIT Madras, SCTIMST and CMC Vellore to improve the skills in the domain.

Patenting is the formal way to protect innovative ideas.

IP (intellectual property): Patenting is the formal way to protect innovative ideas. Intellectual property right offers various advantages such as, competitive advantages against the established competitors, prevents ideas from theft, and signals to investors about the new technology. Patenting in the Indian medical devices sector shall be encouraged for continuous and stable growth in the sector.

Custom Duty: It is a long pending request from the Indian Medical devices industry to increase the custom duty on imported medical devices. The demand is to increase the custom duty from 0 to 7.5 % to 15% and reduce the GST from 18% to 12%. The call on the request shall be considered after proper evaluations, since on one side it will ease the entry of local medical device manufacturers in the market but on other side it will lead to deficiency of quality and innovative product in market.

Acceptance of personalized treatment: Personalized care often called precision medicine is tailor-made treatment to patients based on their molecular profiling. It is an emerging and exciting treatment approach which envisages an important role in preventing and predicting diseases and educates patients to get the right treatment. There shall be a policy to promote such patient centric treatment initiatives within the country, which will contribute to the growth in the medical devices segment since personalized medicine has over-reliance on diagnostic devices.

The aforementioned suggestions are specific to build a strong foundation for the Indian medical devices sector. These are a few steps to reduce import dependency and realize the self-reliant India. If these areas are stressed for the next decade, India could become the global supplier in medical devices from the status of importer.

Composed by: “Er. Arvind Kumar Prajapati is a Scientist/Engineer at Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Department of Science and Technology, Government of India, Trivandrum, Kerala. He has been closely working in design, development, testing and validation of Knee, Hip, and Spine implants and instruments.”

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In a recent healthcare conference, the people were unaware when I spoke about how on October 21, 2013, the former US Vice President Dick Cheney’s doctors disabled his pacemaker’s wireless capabilities to thwart possible assassination attempts. To this, everyone had an issue on accountability. It remains unanswered that who would be liable, the doctor, hospital, company which provided pacemaker or the insurance company. Amidst all this, nobody was concerned about the patient as none present there questioned it. Maybe we are awaiting a major catastrophe to happen to put our minds to work. It is our endeavor to equip the healthcare community to this aspect of digital health.

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“We are moving into a bold era, defined by advanced medical technologies and artificial intelligence. But healthcare will always remain a human business”. For Dominic Asquith, British High Commissioner to India that is the crux of the current situation, but a razor-sharp competitive business in medical devices across the world has a different narrative because of market compulsions vis-a-vis human business.

India’s strong position on heart stents’ price regime triggered debate and the price war snowballed into tough positions and international players gaped with bewilderment. Many institutions and professional bodies flew into action and debated price structures while the country’s federal government unveiled its world’s largest health coverage scheme for millions, virtually creating a colossal potential in the health sector. If the government extends healthcare services to its 1.25 billion population as part of India’s Universal Health Coverage (UHC) agenda, it will be a challenge to devise ways to reduce catastrophic Out Of Pocket (OOP) expenditure on healthcare and ensure affordable access to essential healthcare for the entire population with the limited resource envelope.

Amid ongoing trading tussle between US and China, many apprehend that ripple effect will also percolate down in India as the latter is going ahead with its price regimes and its moves to bring down stent and knee implant devices had raised many eyebrows.

A section of media has reported that AdvaMed (Advanced Medical Technology Association)in its briefing memo for US Commerce Secretary and US Trade Representative last year had conveyed that “Made in India” scheme has been used by parts of the Indian government to justify protectionist measures such as import tariff hike sand preferential market access policies.

The Economist newspaper recently carried a write-up which quoted China Digital times, a California based website, that Chinese media had been advised to play down China’s global dominance in various technological sectors, known as “Made in China 2025”.Such developments indicate that India should also dial down the hype on “Made in India”.

The 2014 World Bank Report estimated the OOP spending on healthcare in India to be as high as 89%. India is the only country, out of the major world economies, where out-of-pocket expenses are increasing, despite a concurrent increase in public spending. This effectively means that more people are availing private healthcare services due to rising incomes or are forced to spend due to inadequate public expenditure.

Official sources say big schemes can be ensured with the help of Health Technology Assessment (HTA), which is a widely used methodology internationally for optimization of resource allocation in health. HTA is a method of evidence synthesis that considers aspects pertaining to clinical effectiveness, cost-effectiveness, social, ethical and legal implications of the use of “health technology” for healthcare intervention.

The Indian healthcare industry was valued at over USD 100 billion in 2016 and is expected to reach more than USD175 billion by 2020, resulting in a CAGR (Compound Annual Growth Rate) of 20%. The medical device industry is valued at USD 6 billion. The medical device industry was accorded the status of an independent industry in 2014. The medical device sector today is clearly small and indicates low penetration in the country.

“The path to realizing healthcare goals is complex, and various fundamental issues and challenges need to be addressed and solved holistically. Long-term plans need periodic policy and regulatory interventions to ensure fair conduct within the industry while providing the support needed for profitable and sustainable growth. These activities will enable the medical device industry to accelerate rapidly and play a key role in making India healthier and stronger.” Mr. Guljit Singh, Executive Chairman of SKP Business and Abby Pratt, Vice President for Global Strategy and Analysis at AdvaMed said in their forward of the study. AdvaMed had partnered last year with SKP to publish the study entitled – Medical Device Industry in India –the evolving landscape, opportunities, and challenges.

The study also examined various policies and regulations impacting the industry and attempts to make recommendations on the way forward from the perspective of different stakeholders.

The study made a slew of recommendations like cap trade margins and not price to the dealers, should be capped after a detailed evaluation of each medical device segment and the role of trade. Trade margins should be fixed differentially for different categories of devices, based on service requirements and role of distributors.

It says allow the dealers to compete with each other and provide a fair price to the hospitals based on the terms and conditions of services and payments. There is a need to work towards bundled payment models as used in many other countries to better align incentives for hospitals and their business models. Increase government healthcare spending as a percentage of GDP; India lags behind the other BRICS in this regard.

Adequate utilization of government infrastructure to reduce the cost to private players – PPP model could be an attractive alternative to explore. Specify certain quantities/ proportions of supply of different stents at lower prices to specified government agencies for use with underprivileged sections. It advocated to empower the Medical Technology Assessment Board (MTAB) to evaluate the model of tiered pricing as observed in the French healthcare ecosystem, wherein the NPPA caps the generic products and leaves the latest generation products with incremental value out of the ‘essentiality purview’.

The incremental value could be on account of efficacy, material used, ease of delivery and shortened recovery time. Various combinations are possible here such as: an increase in the number of tiers, allowing new introductions to be free of price intervention for a certain number of years. Identify priority medical devices and procedures that demonstrate the greatest need stemming from disease burden. MTAB, alongwith other regulators for medical devices, should ensure that there are minimum quality parameters – in terms of safety, clinical efficacy, and cost-effectiveness – for medical devices that get used in the public and private health system, such that long-term costs are lowered over a patient’s lifespan, with need for fewer hospital readmissions, lowered need for medication, and overall better health outcomes.

The report said factors such as changing demographics, rising life expectancy, growing incomes and public awareness have contributed to a higher demand for medical care. A more focused approach from the government, with increased public expenditure on health, greater utilization of technology, vibrant private sector participation, and continued innovation can transform the sector and move India closer to its goal of providing quality universal healthcare.

Some of the key issues faced by the Indian healthcare industry are evident: with India’s disease burden shifting from acute to chronic diseases, large number of the population continue to not have access to basic healthcare services. Public health infrastructures are poorly equipped to deal with this shift towards NCDs.

While the government and value chain participants are undertaking several steps to address these issues, they have been executed in silos. Medical service providers are not only inadequate but are also not evenly distributed across rural and urban areas. This shortfall occurs despite an increase in the number of medical colleges from 23 in 1947 to 398 in 2014. The quality and availability of healthcare deteriorate as one moves away from large urban centers to lower-tier towns and rural areas. The Indian medical device industry, the report found, is highly fragmented. Currently, these sectors are dominated by MNCs with 70-75% of the demand being met through imports.

Approximately 30% of the domestically manufactured devices are exported, in which the consumables and disposables segment has the largest share.

On a mix of technologies such as engineering, electronics, material sciences and information technology – innovation, capital and technology drive the industry. However, India has not been able to bridge the gap between investments, skilled resources, and innovation to fully capitalize on these opportunities. Numerous factors underlie the prevalence of higher imports in the country.

Some of these are: no clear comparative cost advantage in view of other emerging markets; policy issues like inverted duty structured do not help in creating a positive environment; lack of favorable policy and regulatory framework, the report, compiled last year said.

On segments, the study said, hearing aids and pacemakers form major part of patient aid segment and constitute 70% of the segment collectively. Most of the products are sourced from Australia, China, Ireland, Singapore, South Korea and US.

The medical disposables and consumables sector consists of products such as plastic syringes, blood bags and many others. This segment is dominated by domestic players in India due to its low technology requirements. Needles and syringes constitute majority of the sales. However, wound management products and medical apparels are the fastest growing products in this segment. The Indian implants segment has witnessed an encouraging growth rate of CAGR 25%.

With a healthy mix of both domestic companies and MNCs, this segment has witnessed intense competition between players due to strong pricing pressure. The domestic players have realized the market potential which demands customization and differentiated product quality. The equipment and instruments section is the largest segment of the medical device industry constituting nearly 54% of the segment and is dependent on imports.

MRI machines, CT scanners, ultrasound machines, dental drills, dental chairs, dental x-ray machines are some of the key products of this segment. It is dominated by MNCs like GE Healthcare, Philips Healthcare, Schiller Healthcare, Danaher Corporation, and Roche.

Drug-eluting stents and bare metal stents form a major part of the stents segment and constitute more than 70% of the segment collectively. Most products are sourced from US and Europe. While domestic companies are manufacturing cost-competitive products, they still face competition from international players on account of quality. Diagnostics segment is growing due to advanced technology being increasingly applied in medical procedures.

The report had said government initiatives control regulation and the new Public Procurement Policy- the Preferential Market Access – do not fully reflect this and has alarmed many industry participants.

A clear long-term vision and roadmap for the industry and predictability of policy would excite the industry. The government needs to provide policy support for both the supply and demand side of the medical device industry to successfully accelerate growth. Industry and government need to work together to improve awareness, access has made rapid progress in the last decade, but significantly lags behind other nations in availability and quality of equitable medical care and services for citizens.

This, in turn, presents an enormous opportunity given the large population, growing economic prosperity, and the disease burden. Major issues such as availability of adequate infrastructure, trained human resources, geographic spread, rapidly changing disease burden, and high/often catastrophic out of pocket expenditures are challenges that the government is keen to address, the report said.

The Indian government is committed to raise public expenditure on health to 2.5% of the GDP. Public and private sectors need to play equally important but different roles in bringing rapid change to the healthcare scenario in the coming decade.

Around opening up, FDI and infrastructure development are welcome initiatives that will enhance the ecosystem for investment. The Indian medical device industry appreciates government’s efforts to remove bureaucratic hurdles and improve the ease of doing business, but believes that additional steps can be taken to strengthen its approach.

The study identified challenges and said growth in the healthcare industry has been attractive. However, much more needs to be done. Despite the advent of private players and better government spending, most Indians can only afford and/or have access to basic healthcare. Hence, the path to universal healthcare coverage is challenging.

Some of the obstacles faced are – real estate prices and high capital costs limit the growth of delivery infrastructure; insufficient attention by policymakers and a complex tax regime are also responsible for the sector’s underdevelopment; the lack of a comprehensive policy and focus to develop the healthcare ecosystem; low penetration: the per capital medical device spending of USD 3 compared to USD 7 in China and USD 42 in Russia is significantly low.

Another study early this year – “Medical devices in India – an agenda to effective healthcare delivery” said to attract world’s top med-tech players to establish their research and development (R&D) operations in the country and to establish a firm footing in the global market, the Government needs to adopt a robust policy and regulatory framework. India can replicate some of the models being adopted by other nations that have succeeded in attracting leading medical players. The contents of this report are based on a study commissioned by AdvaMed and conducted by IQVIA on behalf of AdvaMed.

It said that the government can provide financial incentives in form of extended tax holidays or weighted tax reduction for R&D investments; boost local demand for medical devices by stepping up public healthcare spending which in-turn could catalyze investments in this sector. Further, the government should focus on creating an enabling regulatory landscape by creating a separate legislation system for medical devices.

The report said while, Medical Devices Rules 2017 is a welcome step towards regulating the medical devices sector, the setting up separate notified body and distinct legislation system for devices with a focus on the following could further boost growth of the industry like Grant product approvals; Instituting quality standards; Setting up monitoring mechanisms for devices; Expedite patent approval process for medical devices.

Medical devices form more than USD 200-billion global industry, which develops and manufactures essential healthcare equipment. The Indian industry is currently valued at USD 4.4 billion with about 700 medical device makers, India’s medical device market is currently the fourth-largest in Asia (after Japan, China and South Korea) and ranks among the world’s top 20.

Imports constitute a substantial part of the medical device market in India. An estimated 80% of India’s demand for medical devices is currently met by imports, nearly 30% of which are supplied by the US. Imported medical devices are often those that are critical, innovative and high-risk in nature – either life-saving or life-enabling, and therefore undergo rigorous testing. These complex, innovative devices are designed to address the growing expectations of India’s population in the country’s rapidly evolving healthcare system, this report said.

The medical device industry has been very encouraged by the Prime Minister’s recognition of the critical role of medical devices in addressing India’s healthcare challenges. The Adva Medwebsite says in general, we have a received a strong message from the government that they are interested in promoting the medical devices sector and creating an environment that fosters innovation. This is great news not only for manufacturers of medical devices but more importantly for patients who desperately need access to high quality yet affordable lifesaving and life-enhancing medical technologies.

The PM’s call to medical device manufacturers is a welcome recognition of this separate and important part of the healthcare system. Several of AdvaMed’s member companies have already established manufacturing units in India, and India is being increasingly viewed as an R&D base.

The website says, the medical device industry in India has grappled with challenges for several years around recognition and regulation. While the Global Medical Device Nomenclature (GMDN) lists more than 14,000 different product types, the current regime only regulates a relatively modest portion of these products.

Moreover, these devices/products are regulated as “drugs” under the Drugs and Cosmetics Act of 1940. This is problematic because medical devices are very different from drugs in terms of diversity, product development, patent structures, types of failures, scientific disciplines involved in assessing performance/efficacy.

In addition to the arbitrary application of the rules for drugs to medical devices, which hinders the development, quality of and access to medical devices, there is also a lack of predictability in the regulatory system. The industry is also concerned about the lack of standardization in line with global best practices.

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