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On September 30, we had a fascinating session by Dr. Jitendra Sharma, the Managing Director & Founder CEO of the Visakhapatnam based Andhra Pradesh MedTech Zone (AMTZ) Asia’s first medical devices manufacturing park.
The full recording of the session is available at:
About Dr Jitendra Sharma
Besides being the CEO of AMTZ, Dr Jitendra Sharma is also Founder Executive Director of Kalam Institute of Health Technology (KIHT) that serves as a medical technology policy think tank for various departments & ministries of the Government of India. Dr Sharma is Member Secretary of National Medical Devices Promotion Council, and founder Chairman of two med-tech incubators- Medi-Valley, and Bio-Valley. He is adjunct lecturer at University of Adelaide, Australia; Chairman of Indian Biomedical Skill Council and a Distinguished Senior Fellow at Niti Aayog.
Dr Sharma has won the European Union–India Young Leaders Award at EU Parliament, Brussels and AAMI-Laufman Greatbatch Award for his distinguished work in the medical technology sector. He is known in professional circles as the Med-Tech Man of India.
Dr Sharma’s story is truly fascinating. As a boy, right from the age of 9, he would move around on a bicycle and sell groceries to departmental stores to make a living (in West Bengal). Despite being a good student and qualifying for admission to top engineering and medical colleges, he did not have the resources to pursue higher education. That is how he joined Saya Sai institute of Higher Learning, where he received free education. He subsequently went to the All India Institute for Medical Sciences on a training fellowship. Dr Sharma went on to pursue 3 PhDs, 4 Masters and 7 fellowship programs, subsequently, even as he worked. He has been associated with a variety of organizations, including primary healthcare centres, government departments and the WHO. Dr Sharma is a hospital administrator, medical technologist and health economist rolled into one.
Dr Sharma’s mission is to work for the global good. He gave the example of how AMTZ has developed a linear accelerator for cancer treatment (which a few years back, cost Rs 16 crores and was made only by two companies, one in the US and the other in Sweden. A linear accelerator customizes high energy x-rays or electrons to conform to a tumour’s shape and destroy cancer cells while sparing the surrounding normal tissue.). 34 countries in the world do not have a single linear accelerator installed in their country. Thanks to AMTZ, this equipment, used for cancer treatment, is now available at half the price. For Dr Sharma, as the CEO of AMTZ, global good implies that India should be a source of good quality, high efficiency, high safety medical equipment supplier to the world.
I had the opportunity to meet Dr Sharma last year in Visakhapatnam, thanks to our Head of Innovation, Dr Sainath. Dr Sharma is a bundle of energy and can hold anyone spellbound with his visionary thinking and clear articulation. He is also a man of action. When it comes to speed of execution, few CEOs in India (across both the private and public sectors) will be able to match Dr Sharma.
Right at the start of the session, Dr Sharma expressed his gratitude to all his teachers who have helped in making him what he is today. He later urged all of us to be grateful to our teachers.
About AMTZ
The pandemic placed unparalleled demands but also provided opportunities to strengthen the healthcare industry through various innovations and cost efficiencies. AMTZ, built in a record 342 days, played its role in tiding over the crisis by a rapid escalation of the manufacturing capacity for essential and critical medical equipment. The story is documented in Dr Sharma’s book, “Made in Lock d0wn”.
In a day, AMTZ produces
- 100 ventilators (150 at the peak of the pandemic)
- 500 oxygen concentrators (1000 at the peak of the pandemic)
- 100,000 N-95 masks
- 5000 PPE kits
- 1 million RT PCR kits (11 lakhs per day at the peak of the pandemic)
- Superconducting Magnets for MRI
- Infrared Thermometers
- Pulse Oximeters
Other products manufactured at AMTZ include:
AMTZ has created a complete MedTech ecosystem with various centres and facilities like:
- Center for Electromagnetic Compatibility and Safety Testing
- Center for Biomaterial Testing
- Center for 3-D printing
- Center for Gamma Irradiation
- Center for Molding
- Centers for Lasers, MRI coils
- Many other Industrial Service Centers
AMTZ has several innovations to its credit. A few of them are listed below.
I Lab
I-Lab (Infectious disease diagnostic lab) with a biosafety facility is capable of RT PCR, ELISA (used to measure antibodies, antigens, proteins, and glycoproteins in biological samples) and 30 more tests. I-Lab ensures ease of testing in rural areas.
O2Home
An app available on Android and iOS platforms enables people to rent oxygen concentrators on a per-day basis at affordable rates.
Oxy Wheel
With a capacity of 250 Liters/min, this mobile oxygen generator ensures oxygen generation on demand at any required location.
Safe Zone
This Infectious disease containment and treatment zone can be moved anywhere when needed and make beds available during crucial times. Dr Sharma’s vision for AMTZ is 50-50-50. AMTZ should account for 50% of the medical devices made in India, at 50% of the current price and do all this in 50 months.
Introduction
Dr Sharma began the session on a note of reflection. He pointed out, using the example of the car industry, that any sector can improve in three ways:
- By expansion: adding more capacity, launching new products, and services. e.g., A new car model
- By removing inherent problems. e.g., A better seat belt
- By creating more value out of existing investments. e.g., Uberization
- Where is the problem?
- Why is there a problem?
- How can we create a bridge between the two? How can we restructure the value chain to solve the problem?
- Manmade: What we have ourselves created
- Unidentified: Those which we are not aware of.
Whenever we are trying to strengthen a sector, a careful and systematic analysis is important. Dr Sharma learnt this important lesson in 2012 during his days at the Ministry of Health when he launched various important national programs: Dialysis, CT scan, Pathology, Teleradiology, Medical mobile unit, etc.
Dr Sharma also pointed out that in any sector, there are two kinds of bottlenecks:
If we can distinguish between these bottlenecks, things can become much easier.
Later during the session, Dr Sharma added that we should be clear about our role: what we should be doing and what we should be getting done through others. There are things which we should be making ourselves. Then there are other things where we should be playing the role of a facilitator/ integrator. Thus, a car manufacturer should not be making windshields. Indeed, a car manufacturer is more of an integrator of parts sourced from hundreds of vendors. Facilitation could include developing prototypes, hand holding suppliers, etc. This is what AMTZ does for start-ups.
Healthcare
Healthcare refers to compassionate, science driven, good quality interventions to reduce suffering or to save life. It comes in various forms like medical technology, homeopathy, yoga, etc.
Modern healthcare has four constituents:
Land and Building: This is not a core part of healthcare.
Human resources: It is neither desirable nor feasible to cut costs here. Of course, there is scope for productivity increase or automation to reduce the number of people needed.
Pharmaceuticals: India is a global leader in pharmaceuticals. One out of five medicines consumed globally is sourced from India. We have a large global market share. Of course, we are dependent on imports for many of the APIs (active pharmaceutical ingredients). But this has not created any problems and India is globally recognized for the manufacture of affordable medicines.
Medical technology: Till recently 80% of our supplies were through imports (Rs 63,000 crores in 2021-22). Exports were about Rs 23,000 crores. While our imports were high value items like ECG machines and oxygen concentrators, our exports were high volume low value items like gloves and syringes. Thanks to AMTZ, we are becoming less dependent on imports and value-added exports are on the rise.
India’s Medtech sector
When Dr Sharma took charge, India’s local manufacturing base for medical devices was weak and the country was heavily dependent on imports for 4 reasons:
The sector was too heterogeneous. Products spanned a wide range: gloves (essentially textile products), RTPCR (biological reagent), X ray machines (radiation emitting device) Spectacles (polycarbonate product), ECG machines (electronic product). In contrast, pharma is far more homogeneous with just two segments: chemicals and biosimilars.
Scientific facilities were not available in India. These included: Gamma irradiation facility, electromagnetic interference lab, 3D printing, etc.
Standards did not exist in many cases. BIS covered only 100 products in 2014 There were 6000 products out of which 1500 made up 98%.
Spare parts were being subjected to higher customs duty than the finished equipment. So, there was little incentive for local manufacturing.
Entrepreneurs were hesitant to invest because of the uncertain demand. Global players who had years of experience were dominant and it was not clear how new entrants from India could compete with them.
AMTZ has been set up to tackle all these problems. AMTZ’s focus has been on creating an ecosystem that enables the manufacture of a wide range of products in this heterogeneous sector. Today, APMTZ is the world’s largest Medtech cluster and makes a wide range of products from masks to MRI machines. AMTZ even makes its own PCBs. So it was not affected by the chip shortage during the pandemic. A country which was heavily dependent on imports is now exporting a range of products to other countries.
Kalam Institute was set up to develop standards which did not exist earlier. The Institute has developed 1480 standards (covering most of the 1500 main products sold in the country) over a period of 4 years. Kalam Institute is the only centre collaborating with WHO for healthcare innovations.
Customs duties on spare parts (earlier 10%) have been reduced to 2.5% while those on finished equipment (earlier 2.0%) have been raised to 7.5%.
Under a PPO (Public Procurement Order) issued in 2016-17, local vendors are preferred and given at least 50% of the order for medical devices if they can match the lowest price and guarantee significant local value addition.
Q&A
On the rise of Phygital in healthcare
Dr Sharma emphasised that we should be clear about the purpose of the data, how long it must be stored and how it will benefit the customer. Thus, we can measure blood pressure every day or temperature several times every day but there is no point in storing such patient data for 5 years. If we are not careful about what we are storing, we might end up accumulating garbage. Moreover, the data (Image, video, numbers, trends, etc) should be stored by different entities in such a format that they are harmonizable. For example, ECG trends plotted in different hospitals should be able to talk to each other.
When we use a technology, we must think of the end user. Consider AR/VR. It can be very meaningfully used for spinal cord injury/paraplegic patients. For such patients, it is difficult to travel. What if we could have the expert sitting at the paraplegic centre with the best machines and the patient lying at home. Using AR/VR glasses, we can make the patient feel as though he is in the paraplegic centre and the expert can guide him while doing exercises. In healthcare, the glamour of the technology is less relevant than how useful it is to the patient.
On privacy
The data ultimately belongs to the patient. It should be accessible only to people with whom the patients want to share their data. We should never forget this fundamental duty we have towards patients. When the patient is lying on the hospital bed, there is no privacy at all, and all the people around (nurses, doctors, ward boys, etc) have access to data. So, it is important not to misuse the data.
Data is relevant if it is used and respected. The ownership of the data lies with the patient and not a third party entity such a hospital. Dr Sharma had a simple question. When we get our ECG done, why does the graph not come straight to our cell phone?
On the safety of wearables
The safety of wearables depends on two factors:
- The safety of the biomaterials being used: Testing is done as per ASTM standards globally.
- Safety of the Electrostatic discharge/ electromagnetic interference coming from within the machine: The testing is done as per IETC standards.
On innovations in dental technology
When it comes to the dentist’s chair, X-ray, and the associated equipment and instrumentation, not much innovation has happened in the last 40 years or so. But in the case of dental implants, we have made a lot of progress in terms of safety, durability, weight, etc.
The dental fraternity must use their imagination to come up with innovations that truly matter. Can we provide a dental chair in a mobile van for older patients so that they do not have to leave their home? That is how we can connect science to society.
Is the private healthcare sector too commercially oriented?
The private sector, public sector, NGOs and charitable organizations are part of the same society. Doctors, medicines and machines all come from the same pool. So degradation cannot be happening only in one part of society. Before we jump to conclusions and attribute motives, we must try to understand what the problem is and why the problem is there. For example, we may have to revamp the medical education system.
On the use of AI in healthcare
AI must be a tool for doctors to make better decisions. AI must support the doctors and not substitute them. If AI is given discretionary, overriding powers, it can create havoc. In robotic surgery, robots do the surgery, but the doctor is still in charge. We should never view technology as a substitute for human beings. A teacher will always be relevant despite advances in learning technologies.