Aug 20

Ventilator Story: Ascendancy Accessibility Advancement

Everything you want to know about ventilator in India

A wave of innovation swept through India as the Coronavirus disease-19 (COVID-19) pandemic unfolded in the country. Ventilators took center stage and the wheels of medical device manufacturing started churning. Academic institutions, automobile manufacturers, Government PSUs and even engineering graduates started dreaming about ventilators. The domestic manufacturers were happy to help and others were trying to fix their logistical hurdles to be able to service the growing demand in India? It seemed like India was set for the ventilator shortage challenge and become the largest ventilator producer in the world in no time.

Covid-19 Pandemic

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What started as an epidemic from China in Dec 2019, spread across the globe quickly to become a pandemic by March, 2020. A new coronavirus, named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was wreaking havoc in the European countries; England, Spain and Italy were devastated. This new virus was causing a flu-like disease which was much more deadly, Covid-19 had arrived. Because of its highly contagion nature and death toll, governments across the world had to take drastic measures to avoid it. India went into total lockdown on March 24, 2020. Taking cue from Italy and England India ramped up its healthcare infrastructure. Covid isolation wards were earmarked at both government and private hospitals and Covid quarantine centres were set up on war footing. However, when the cases started to explode, the lack of co-ordination among government departments, healthcare providers and policy makers; shortage of medical equipment; unavailability of hospital beds and rising death toll overshadowed our gains.

Ascendancy: Why ventilator took centre stage during Covid-19

As clinicians around the world learned more about Covid-19 it was clear that patients with severe disease needed breathing support. “In severe cases of COVID-19, patients may contract pneumonia,” says Dr K K Aggarwal, Former President, Indian Medical Association. “The resulting fluid build-up in the lungs reduces the ability to take in oxygen and expel carbon dioxide,” he explains. Ventilators helps the patients breathe or in some cases breaths for the patient. A mechanical ventilator is a machine that works as an external lung, when patients are not able to breathe properly on their own. “The mechanical ventilator is used when oxygen levels are low or patients have severe shortness of breath from an infection such as pneumonia,” explains Dr Aggarwal. In March, 2020 industry body AiMed (Association of Indian Medical Device Industry) said that India will face shortage of ventilators by mid-May. AiMed said that the country might need anywhere between 110000 – 220000 ventilators by May 15 in the worst-case scenario and there were only 57000 ventilators available in India at that time. “There is a pressing need for ventilators in India and a huge disparity in their availability in various states. For instance, Mumbai alone has 800-1000 ventilators, while states such as Tamil Nadu and Madhya Pradesh have 1500 and 1800 respectively. The city of Bengaluru, has approximately 400 ventilators, whereas Kerala has 5000,” said Rajiv Nath, Forum Coordinator, AiMeD. Sensing an opportunity in the demand and supply gap in India’s healthcare space, many veterans from other industries took to collaboration and manufacturing medical devices. Large companies like Maruti, Mahindra & Mahindra, Kalyaani Group, Tata Motors, Hyundai etc., joined hands with domestic manufacturers to rapidly scale up production of ventilators. This brought ventilators to the limelight. Now, people even in remote villages started to innovate on breathing devices. Ventilator became a part of the national vocabulary and everyone had an opinion on what ventilator should be and how it should be used. Between March and April, many deals were signed to scale up production capacity of ventilator manufacturers. Mysuru based, Skanray Technology created a consortium with BEL, BHEL and Mahindra & Mahindra to ramp up production from standard 2000 pcs per month to currently 5000 pcs per month and 30,000 pcs per month by May. Similarly, AgVa has tied up with Maruti to scale up production from 400 pcs per month to 4000 pcs per month in April to 10,000 pcs per month by May.Large companies like Maruti, Mahindra & Mahindra, Kalyaani Group, Tata Motors, Hyundai etc., joined hands with domestic manufacturers to rapidly scale up production of ventilators.

At the same time, the PM CARES Fund Trust said that it would allocate two thousand crore rupees to equip government run COVID hospitals in all States and Union Territories with 50 thousand ‘Made-in-India’ ventilators.While the domestic manufacturers were busy ramping up production, traditional ventilator manufacturers around the world were also looking to enhance their production. Large medical device manufacturers like Hamilton Medical, Dräger, Mindray, Medtronic, Löwenstein, Vyaire Medical, Philips, GE Heathcare, and Fisher & Paykel Healthcare, among others were constantly trying to break the supplychain and logistic barriers. In fact, Medtronic made the full design specifications, produce manuals and design documents for its portable ventilator hardware public so that engineers around the world could benefit from it.

Back in India, innovative ventilators prototypes were making news every day. According to news reports, a first-year student of Industrial Design Centre at IIT Bombay developed Ruhdaar a low-cost ventilator using locally available materials. Then, Sree Chitra Tirunal Institute for Medical Sciences and Technology, jointly build a prototype of an emergency ventilator system based on artificial manual breathing unit with Wipro 3D. A group from IIT Roorkee collaborated with AIIMS, Rishikesh to create the low-cost, portable Prana-Vayu ventilator. Even the Indian start-ups jumped into the ventilator innovation bandwagon. A few 3D printing start-ups like Supercraft3D and Ethereal Machines came up with ventilator splitters to help administer breathing to two patients simultaneously. A start-up from Startup Incubation and Innovation Centre, IIT Kanpur, Nocca Robotics, designed and developed a fully functional invasive ventilator, the NOCCA V310 ICU ventilator. The Biodesign Innovation Labs, built an emergency and transport ventilator called RespirAID. In fact, government agencies were also not left behind in the race to develop a path-breaking low-cost product. Indian Railways, announced the development of a low-cost ventilator at its Kapurthala Rail Coach Factory, called Jeevan. Interestingly, Council of Scientific and Industrial Research (CSIR) and National Aerospace Laboratories came up with a non-invasive Bilevel Positive Airway Pressure (BiPAP) ventilator called SwasthVayu.

This overwhelming response to Covid-19 and ventilator requirement meant that India’s entrepreneurial zeal would soon turn it into a global exporter of ventilators. However, the ground reality painted a different picture.

Accessibility: Ventilator Shortage, Overuse and Spare Capacity

In the beginning of June 2020, the health ministry reported 336 deaths in one day with the total death toll climbing to 12,573. The total number of Covid-19 positive patients in India was rising to breach five lakh mark. The lockdown had been eased and patients were returning to hospitals for other pressing medical conditions. Consequently, ventilators became somewhat prized. So much so that people started to buy mechanical ventilators for personal use.

Sadly, reports of patients dying due to unavailability of healthcare interventions started making headlines. The Indian Express reported the death of a 68-year-old man who needed ventilation, but was not able to avail one. Similar reports emerged from Gujrat, Telangana and even Karnataka. Many patient groups and politicians started to raise the issue of shortage of ventilators in India.

“For a hundred bed hospital about 5-10 percent beds are demarcated for ICU and half of these beds have ventilators,” explains Ayanabh DebGupta, Co-founder & Group President, Medica Hospitals. At large teaching hospitals this could go up to 15 percent of total bed strength, he adds. The number of ICU beds at government tertiary care centers and medical colleges like AIIMS could go up to 20 percent of the available bed strength. According to a paper published by the Center For Disease Dynamics, Economics & Policy, India currently has 19 lakh hospital beds out of which 95 thousand beds are ICU beds and 48 thousand beds have ventilators. However, it was not clear if all available ventilators were in use or whether all ventilators were in working condition. “Ventilator shortage has not occurred in Delhi,” says Dr Kapil Kochhar, Additional Director, Department of Bariatric, Minimal Access & General Surgery, Fortis Hospital, Noida. “For some time in June when cases were increasing exponentially there could have been a shortage, but by mid-July things were under control. Today, most mechanical ventilators are easily available in India,” he adds. Dr Binila Chacko, Professor and intensivist, CMC Vellore says that even in developed countries, when there was a surge of cases, there was demand-supply mismatch in terms of ICU beds and ventilators. “It is likely that India is also facing similar challenges, especially in pockets where a large number of cases have been reported,” she says. Even as clinicians were worrying about ventilator shortage, a few critical care specialists flagged the overuse of ventilators. They argued that most of the patients could be treated with less invasive and simple respiratory support even though their oxygen levels were low. “About five percent of patients with COVID-19 infection develop severe lung injury that requires ventilatory support,” explains Dr Chacko. Though, some clinicians were baffled by the findings that Covid-19 patients with very low oxygen concentrations were still not exhibiting any signs of organ damage or brain inactivity. On the contrary, they were quite active. In a letter published in the American Journal of Respiratory and Critical Care Medicine, researchers from Germany and Italy wrote that their Covid-19 patients were unlike any others with acute respiratory distress. They said that these patients’ lungs were relatively compliant, a sign of healthy lung in sharp contrast to expectations for severe ARDS, even when they had low blood oxygen.For long, oxygen saturation rate below 93 per cent (normal range 95-100 per cent) is accepted as a sign of potential hypoxia and impending organ damage. Dr Kochhar says, “When the oxygen saturation in a patient goes below 95% and there are other clinical symptoms along with it then we start off with all the measures to improve oxygen saturation.”

In Karnataka, 8,281 patients have been put on ventilator since the time the first case was diagnosed, The Hindu reported. “The proportion of patients coming to CMC with COVID-19 infection and requiring some form of ventilatory assistance is about 6-8 per cent. The higher proportion probably reflects referral bias given that there is very limited ICU facility in a 100-km radius around Vellore,” shared Dr Chacko. “We are using simpler, noninvasive strategies first,” including the oxygen concentrators, oxygen helmets and even nasal cannulas said Dr Kochher. Yet some, ICU doctors are moving patients to mechanical ventilators too quickly. “Covid protocols are reviewed frequently and the decision is driven by oxygen saturation levels, but there could be some centers which do not have multi-parameter ventilators or simpler breathing devices and hence put the patient on the available resource,” said Dr Kochher.Clinicians have said that for many Covid-19 patients ventilators could be of little benefit and may even be harmful to some. An emergency medicine consultant said, “We have to be more careful about the risk of long-term cognitive and physical effects of sedation and intubation from ventilator.” The consultant did not want to be named so as not to appear to be criticizing colleagues said that there have been reports and small observations from China, Italy and Germany where 90 per cent of the patients on ventilator died. However, he cautions that these studies have mentioned that the patients who died were above 70 years and some had co-morbidities. He went on to say that some patients with very low oxygen concentrations have also benefited from continuous oxygen support and not needed mechanical ventilation.
Advancement: How ventilators can be improved
While, clinicians are still battling one of the most unprecedented pandemic of our time, Indian medical device manufacturers are more determined than ever to benefit patients and the economy. Making ventilators is not easy because they are complex machines. From the simplest to the most complex of ventilators need more than 1,500 parts. Before Covid, these parts were sourced from suppliers across 15 or 20 countries. As Covid-19 started to spread countries began closing borders and restricted imports and exports. The global supply chain and logistics industry was confronted with an unprecedented challenge. Like everything else, ventilator production also saw a downward growth. In India, manufacturers were facing additional challenges. The companies that received large orders from government were facing dual challenge; of availability of components and finding components to fit government specifications. “HLL Ltd, the procurement agency under MoHFW provided specifications of ventilators in March which were similar to multinational brands,” explains Nath from AiMed. “Upon representation by Indian medical device industry, and subsequent intervention by Union Minister (Commerce), a committee was formulated by DRDO which revised the specifications,” Nath added. However, HLL ignored those specifications and released purchase orders with a rider that ventilators with higher specifications should be provided. Thereafter it issued a permitted deviation in its RFP which confused manufacturers with a third version of specifications. While the price fixed by HLL was Rs.1.48 lakhs, the specifications were equivalent to a ventilator costing 12-15 Lakhs. Awaiting clarification from the government manufacturers with unsold inventory were facing falling demand. The only way they could salvage their investments was to export but the government had banned the export of ventilators.
During this time a few manufacturers opted out of the government tender to be able to focus on innovation. One such company was Innvolution Healthcare. The Noida based company has recently launched Vi Swaas Pro, developed in collaboration with IIT, Bombay. Vi Swaas Pro is a pressure and volume controlled ICU grade ventilator available in the market currently. Gaurav Agarwal, Managing Director, Innvolution said, “On 2nd April we partnered with IIT Bombay to design and develop a high end ICU ventilator, which is both pressure and volume controlled. I’m happy that in 28 days we were able to build this prototype. We were able to test and validate it at one of the most advanced lung simulation labs in the country at DY Patil Hospital Mumbai. Leveraging Betic’s strong capabilities in rapid prototyping of medical technologies and building upon Innvolution’s strength in medical electronics, we aim to get this prototype CE certified by the German body TUV soon.” This and similar innovative ventilators are awaiting clinical deployment. These companies will be able to make a mark on the ventilator and respiratory device market as the exports open. According to BIS Research, the global ventilator market was estimated to be around $1,142.0 million in 2019. However, COVID-19 outbreak changed the expectations and the market is now expected to grow at a CAGR of 15 per cent during the forecast period from 2021-2030. “There are certainly innovations that are required in the field of ventilation, not only in India, but also globally. The challenge of such innovation is that critically ill patients who require high ventilatory support need to be managed with high end ventilators that are able to synchronize with the patient’s breathing appropriately and able to match the ventilatory requirements of the patient. Current ventilators that have been created in our country appear to be able to match the demands of less sicker patients but not the very sick patients. Thus more resource and inputs are required to create high end ventilators that could cater to the entire spectrum of needs of critically ill patients who require ventilatory support,” concludes Dr Chacko.

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