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.”

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

The rapid adoption of technology in healthcare also touched the area of diabetes care management; digitizing the available methods to provide more comfort and simplicity to the affected people. The sudden wave of smartphones had a great impact on the digital diabetes care as it brings forth several smart apps that help the consumers to track their blood glucose levels, diet and physical activities, sleep pattern, and so on at their fingertips. More innovations are being carried out to provide more compact and efficient solutions to diabetic people, especially the geriatric population in remote areas of the world.

The Global Digital Diabetes Management Market is is expected to cross around USD 20 billion by the end of 2024, registering a CAGR value of 24% during 2019 to 2025; as per the research report published by Research Cosmos.The growing adoption of technology and increasing acceptance of smart applications by consumers along with the extensive spread of diabetes in all the demographics, people are expected to drive the demand for digital diabetic solutions. The major benefit of these solutions is that they can be availed within the comfort of home, without any hospital visits or medical professional support. The portability offered by these digital solutions allows the patients to carry them anywhere without any hassle.

One of the most noteworthy trends in digital diabetes management is the introduction of wearable devices. These devices can be worn on the body with much ease and are capable to provide round the clock assistance to the consumer, along with the maintenance of style quotient. The advantage of these wearable could be continuous monitoring of the blood glucose levels of the person, providing required amounts of insulin to body without any external assistance, sharing patient condition to respective healthcare provider or doctor, providing regular alerts about health status, offering suggestions to improve health and so on and so forth.

The increasing acceptance for digital diabetes management has pushed many manufacturers in healthcare to concentrate more on the development of innovative solutions to grab the major chunk of the world profits. Several acquisitions, mergers, collaborations and new product launches have become the important strategy of many leading players to improve their market holdings. One such popular event in the recent years is the partnership of digital diabetes platform provider GlucoMe with the leading German pharmaceutical company Merck KGaA to offer the digital diabetes platform services to various hospitals in Vietnam, which has one of the fastest growing diabetic cases in the Asia-Pacific.

The major challenge these digital solutions face is to reach the rural population in many developing regions of the world. The lack of awareness about the availability of these features due to the improper publicity and initiatives from the government can be a stronghold for this market. Additionally, the high costs of smart devices and unstructured regularization of the products, which can lead to the availability of counterfeit products that are harmful to the body could act as limiting factors for the rapid adoption of the digital diabetes solutions among the global population.

However, the future looks more promising for the digital care in diabetes with the augmenting innovations in the technology such as data analytics and artificial intelligence (AI). These technologies will further intensify the services offered currently at more affordable prices. In particular, AI will play a prominent role in the increasing efficiency and care of these solutions. Similarly, the added style factor in wearable devices by several manufactures around the world will further create huge demand for digital diabetic solutions. Furthermore, the growing elderly population of the world, who prefer home healthcare will become the lucrative segment of end-users for these devices; pulling the market players to focus more on this section.

Globally, North America has been the demanding region with the significant market share in digital diabetes management market. The contribution from the developed nations of this region like the USA, Canada and Mexico has been tremendous in the recent years. The increasing cases of diabetes, rapid adoption of advanced technologies in medical care, sophisticated healthcare infrastructure, mounting number of geriatric populations, awareness about the benefits of these devices among the population and the favourable government reimbursements have been the driving factors for the growing demand of digital diabetes management in the North American nations.

Some of the prominent names in the global digital diabetes management market are Abbott Laboratories, Merck KGaA, Roche Diagnostics, AgaMatrix, Glooko Inc, Tandem Diabetes Care, Medtronic, Dexcom, Lifescan, DarioHealth, Tidepool, Insulet Corporation, B. Braun, Ascensia Diabetes Care, and others. All these players are investing in their R&D activities to implement and introduce more innovative solutions in the world digital diabetes management market.

About the author:

Kevin Stewart is currently working with Research Cosmos as Market Research Manager; a firm that does Global Market Intelligence.

The post Digital Diabetes Management Market appeared first on InnoHEALTH magazine.

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.

The post Cyber4Healthcare: An Issue of Today & Tomorrow appeared first on InnoHEALTH magazine.

The critical care environment has undergone significant alterations in the past several years. This has happened because our lifestyles in the fast-paced lives of modern India are ensuring that most people, in the age group of 30-50 years are falling prey to life-threatening cardiac diseases and strokes, in addition to diabetes, hypertension, cancers, liver, kidney and lung diseases – these diseases being called Non-Communicable Diseases or NCDs. They are now responsible for killing more than 65% of our population says Dr Arvind Lal, known for his diagnostic labs across the country.

Flagging concerns on such trends, these patients need high-cost intensive care, be it for complications of heart attacks, strokes, diabetes, hypertension, cancer or lung diseases. This is where the importance of Point-of-care testing (POCT) comes in. It helps in almost diagnosing the patient instantly and improves the physician’s ability to take immediate corrective action and decreases hospital stay. One such test is Troponin – that has revolutionized cardiac care by diagnosing heart attacks or myocardial infarction.

This article is based on the keynote address on the occasion of 2nd Annual International InnoHEALTH Conference 2017 – ‘Transforming Healthcare Through Innovation’ in New Delhi, said there are numerous promising diagnostic technologies. The key message is that in a country where 70% of the population lives in rural surroundings, ‘it is our duty to rapidly adopt disruptive innovative affordable technologies including telemedicine. Thus, our underserved population would be able to avail of the best treatment possible and bring in massive visible change’. He said the importance of bringing quality healthcare needs no reminder and the time has come for India to change the direction of healthcare for the masses.

Healthcare is a right – and access to good healthcare should not depend on where one lives and how much he or she earns. But sadly, that is exactly what plagues India’s healthcare today, he lamented. India faces a severe shortage of both hard infrastructure and talent. With about one doctor and one functional bed per 1000 population, healthcare is truly underserved in India. Add to this the regional imbalances and variations in healthcare delivery. The healthcare infrastructure is skewed towards urban over rural India.

Although rural India accounts for about 70% of the population, it has less than one-third of the nation’s hospitals, doctors and beds, resulting in large disparities in health outcomes across urban and rural India. British Medical Journal (BMJ) has observed that there is a remarkable saving of lives in India if good healthcare facilities consisting of operation theatres, surgeons, anaesthetists, blood banks are available within 50 kilometres of the patient providing quality medical services within the ‘golden hour’.

Though there has been a sea change in the last five decades, India now needs to reinvent the field of diagnostics as laboratory tests are responsible for 70% of all clinical or medical decisions.

In today’s life where internet rules the roost, the patients have become very knowledgeable, thanks to the globalisation of healthcare, and are demanding very high-quality healthcare for themselves. They are insisting on a very wholesome and satisfying experience rather than being told that the ‘treatment is over’.

Soon, a time will come when the tests shall be ordered by the patients based on clinical history and clinical findings that shall be answered by an Artificial Intelligence (AI) application. Artificial intelligence has already found several areas in healthcare from the design of treatment plans to assist in repetitive jobs to medication management and drug designing. The most obvious application of artificial intelligence in healthcare is data management. Collecting it, storing it, normalizing it, tracing its lineage – it may well be the first step in revolutionizing the existing healthcare systems.

Recently, the AI research branch of the search giant, Google, launched its Google Deepmind Health project, which is used to mine the data of medical records in order to provide better and faster health services. The project is in its initial phase, and at present, they are working with Moorfields Eye Hospital of NHS Foundation Trust, UK to improve eye treatment.

Just a few years ago the patient after giving the sample used to come back in the evening to the lab to collect a physical copy of the test report. This was replaced by making the report available on the internet that could be downloaded by the patient in the comfort of his home. These days this has been further replaced by making available an App on his mobile phone wherein he can book an appointment for the sample to be collected at home and the report being later available on the same mobile App.

‘IBM Watson, whose headquarters I had the privilege of visiting a few months back in the Silicon Valley, is an AI-based engine that has launched its special program for oncologists to provide clinicians evidence-based treatment options. The program has an advanced ability to analyze the meaning and context of structured and unstructured data in clinical notes and reports in its encyclopedic memory that may be critical to selecting a treatment pathway’. IBM launched another algorithm called Medical Sieve. It is an ambitious long-term exploratory project to build a next-generation ‘cognitive health assistant’ that is able to analyze radiology images to spot and detect abnormalities faster and more reliably. This shall help radiologists in the future to look at the most complicated cases where human supervision is essential.

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The lab-on-a-chip (LOC) is another device that integrates one or several laboratory functions on a single integrated circuit (commonly called a “chip”) of only a few square centimetres to achieve automation and high throughput screening. Imagine that a patient comes to one of our 2,100 collection centres in the remote tier three or tier four towns in India with the high fever. We take a drop of blood from his finger and inform the clinician almost immediately that the patient is suffering from Chikungunya and not from Malaria or Typhoid, or Dengue fever or Japanese Encephalitis – all in a matter of minutes! The driving notion behind POCT is to bring the test conveniently and immediately to the patient. Needless to add, the patient’s data by POCT shall be made available to update the patient’s electronic health records (EHR).

Talking about POCT Instruments: Currently, two broad type of POCT instruments are available: Small benchtop analyzers (for example, blood gas and electrolyte systems) and handheld, single-use devices (such as urine albumin, blood glucose, and coagulation tests). Now let us talk about if POCT is Boon or Bane? The strong point of POCT is speed and the rapidity with which it shall save lives in emergencies. As India marches towards quality healthcare delivery, in course of time regulatory compliances shall have to be adhered to in the interest of the patient’s health.

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