The Ventilator Project: IIT Kanpur Group's 90-Day Saga Shows The Way For Aatmanirbhar Startup Success

The Ventilator Project. Srikant Sastri & Amitabha Bandyopadhyay. Pan Macmillan India. 2021. Rs 599. Pages 248.

Ever since it arrived, the Covid-19 pandemic has flipped the switch on what is possible. Can people in large parts of the world be confined to their homes for the most part in public interest? Can professional work of various stripes continue daily without access to a physical workplace? Can behavioural change be implemented on a global level ‘asap’?

While responses to these questions would likely be soaked in varying degrees of pessimism pre-Covid, we are now forced to think differently because of the remarkable results achieved in many areas during the pandemic.

In the early months of 2020, it became clear that society was going to be challenged and, as that memorable line goes in Christopher Nolan’s science-fiction film Interstellar, there would be “no time for caution”.

Naturally, work on vaccines forged ahead at breakneck speed. The American biotechnology company Moderna, along with the National Institutes of Health, went from gene sequence selection to manufacturing of their vaccine candidate in just 25 days.

In comparison, 20 months was the time taken to develop a vaccine for the coronavirus that caused the Severe Acute Respiratory Syndrome (SARS) in 2002-03.

Surgical masks, personal protective equipment (PPE), and diagnostic kits were identified early for rapid production, but a particularly important device required was the ventilator.

The World Health Organization (WHO) had estimated that one in six persons would be seriously ill and likely to experience difficulty in breathing – after all, the virus was damaging the lungs. Ventilators would be necessary to assist people with breathing.

But the challenge was that there simply weren’t enough life-saving ventilator machines to go around. This was March when the cases were beginning to balloon.

In India, one early estimate suggested that there were less than half a lakh ventilators at a time when the projected requirement was two to four times more. Imports were going to be hard to come by as countries were shutting down.

A special effort was required then – and it came from the corridors of the Indian Institute of Technology (IIT) Kanpur.

The remarkable work that they accomplished is now the subject of an engaging, insightful, and inspiring book called The Ventilator Project. At the heart of it is an inspiring 90-day journey – traversing from having no idea to developing a fully functional, life-saving ICU ventilator – and the lessons accumulated from the hugely rewarding experience.

The authors are Srikant Sastri and Amitabha Bandyopadhyay – two key men who led the ambitious project all through the journey. Sastri is a seasoned entrepreneur and investor who is actively involved with several incubators, and Bandyopadhyay is associate professor at IIT Kanpur’s Department of Biological Sciences & Bioengineering.

They take us through the various stages of the project – answering the Prime Minister’s clarion call for Covid-19-specific solutions, forming a task force of experts, making the machines, navigating the regulatory maze, and deploying the machines in hospitals – and shine a torchlight on the path ahead for businesses that wish to flourish in the post-Covid-19 world.

Uncertain Beginnings

The seeds of the project were sown by two graduates of IIT Kanpur.

Nikhil Kurele and Harshit Rathore were running an IIT Kanpur-incubated company called Nocca Robotics. They had been making autonomous, waterless robots that cleaned solar panels for three years. Facing uncertain prospects in the pandemic, they contemplated how to keep the work going.

“It was 18th or 19th (March) when it was declared that only five people could come to the office. We were at a stage where we were doing a lot of demos (demonstrations) for clients and they were supposed to be converted into really good orders. We had worked hard for about four to five months, so that was the time when we were supposed to get the fruits (of our efforts), but then the lockdown happened,” Rathore tells Swarajya.

They learnt quickly that Covid-19 was here to stay and they had to prepare accordingly. “Our investors said you should plan for at least one year,” he says.

Watching the news, Kurele and Rathore found that medical necessities, such as masks, PPE kits, and ventilators, were in short supply. This got them thinking about how to use their existing resources to plug the gap.

Their initial ideas were humble, but Professor Bandyopadhyay asked them to consider developing a ventilator.

The founders were hesitant at first because they had neither seen a ventilator nor worked with medical devices before.

“But when we did the initial study, and we looked at how a ventilator works, we thought that, yes, a basic ventilator can be made with the kind of components that are available in India," Rathore says.

It would also mean that they could sustain their business during the pandemic if they were successful in developing the ventilator and commercialising it.

Based on feedback from experts, they decided to develop an invasive-type ICU ventilator – one where a tube goes down the airway to push air into the lungs, as opposed to the passage of air through an external face mask. This stepped up the magnitude of the challenge further.

“All we had at that time was theoretical knowledge on the internet. We read that and saw how we could achieve the end result using basic science,” Rathore tells me.

But despite the inexperience, they had a ventilator model going in three days – made out of ordinary components found in local hobby stores.

Two days later, they had the backing of Prof Bandyopadhyay, Sastri, and several other esteemed generals who came together to form a task force to drive the project – satisfyingly reminiscent of the fellowship of the ring in the J R R Tolkien classic The Lord of the Rings.

The task force, comprising 20 experts across relevant areas, was formed on 29 March. They developed a daily ritual of getting on a Zoom call to discuss the goings-on. This daily call would become the bread and butter of communication and collaboration within the team right until the end of the project.

Since the members of the task force all had their areas of expertise carved out clearly, the division of labour was easy. However, they had an operating model in place from day one.

“We decided that the ‘real engineers’ would only do product development, while the rest of us would take care of everything else, like fundraising, supply chain, pricing strategy, marketing strategy, and manufacturing strategy,” Prof Bandyopadhyay tells Swarajya.

This allowed the technical and non-technical experts to tackle their respective problems without having to stress out over other domains.

It facilitated rapid progress. In a little over a week after the formation of the task force, Nocca was ready with their first prototype, the V110, with plans for developing the next version.

They were simultaneously speaking with potential partners to tap into proven, enhanced manufacturing capabilities.

As the team made rapid progress, they entered the thicker regulatory medium. They quickly learnt that there was little by way of a regulatory framework for medical devices in India.

“The only organisation that can approve a medical device in this country is the CDSCO (Central Drugs Standard Control Organisation). And CDSCO has only 22 equipment on its list so far,” Prof Bandyopadhyay tells Swarajya. And, notably, CDSCO was formed to regulate drugs and cosmetics.

Who would certify Nocca’s ventilator? Virtually no agency in India is accredited to certify ventilators made in India.

Under the Indian Certification for Medical Devices scheme, agencies like UL and TÜV SÜD can conduct product testing and certification, but Prof Bandyopadhyay says they only certify that a medical equipment is safe and robust, not that it works as intended.

Globally, the European Union’s Conformité Européenne (CE) and the United States of America’s Food and Drugs Administration (FDA) give certifications that are widely recognised and respected. Organisations in India – including the government – often rely on these foreign certifications to make their purchase decisions.

Given the short time frame, the IIT Kanpur consortium was not in a position to pursue an international certification.

However, when it realised that there was a lack of standards for ventilator manufacturing, the government came up with a set of qualifications for manufacturers to bid in the government-owned company HLL Lifecare Limited's tender. This made some matters murkier while simplifying others.

After reports emerged of poor-quality made-in-India ventilators, Nocca learnt of a new directive as per which they had to give a demo of their machine to a team of the Directorate General of Health Services.

“That actually made our life easier,” says Prof Bandyopadhyay. The team was confident in their machine – which the founders called “bhagwan” (god in Hindi) – as it was designed to meet all the necessary specifications.

After a minor hiccup in the first attempt, the task force received the nod the second time around.

Setting the Standards

Looking back now, Prof Bandyopadhyay says he wished there was a “properly formulated regulatory regime from day one”.

Sastri explains that the lack of a regime especially hampers the prospects of a medical device manufacturer that wants to tap into the global market.

“In the absence of a clear regulatory framework, it is the customers’ discretion – whether they want to consider you or not,” he says. That is, a private hospital can choose to, if they do make that choice, validate a medical device and decide if they want to use it.

But the greater challenge lies in a manufacturer wanting to export the machine.

“The European market or the US market will never consider it (the ventilator) because you don’t have any certification. So there is a challenge in terms of product acceptability in the market as a result,” Sastri says.

This is an important point raised by four central members of the task force and an important source of learning for India as it walks the path of aatmanirbharta (self-reliance).

It is imperative that India establishes standards in areas like medical device manufacturing. Unless that happens, there will always be a trust deficit – and therefore reluctance – in choosing a domestic product comfortably over an internationally certified product.

“If we do that, you’ll see a sea change in the Indian manufacturing sector,” he says.

Nocca founder Kurele notes that it is also important that standards in India be at par with international standards, so that the world-class products being made in India get accepted both within the country as well in the global market.

Besides installing a regulatory and certification regime, the government can promote the excellent work of novice medical technology startups by virtue of its being the biggest buyer of healthcare equipment and services.

Sastri believes that the government can help young, innovative startups achieve production at scale – so they can, in turn, use that platform to compete globally – by increasing the investment in healthcare infrastructure, and to buy local and incentivise local manufacturing.

During their journey, the task force navigated the regulatory landscape, thanks to experience and competency in the task force. Marching forward, close to 50 days in, they got the third version of the ventilator, the V310, ready. This version would ultimately get deployed in hospitals.

Before it got there, it underwent testing in various settings.

It cleared a compliance test in Pune in May, then underwent a successful demo at DGHS in June, and cleared patient testing at Ruby Hall Clinic in Pune later that month. It was then declared fit to be used in the ICU.

On 29 June, the Medanta and Artemis hospitals in Gurugram tested and approved the V310. This was a landmark moment for the group.

The task force was disbanded two days later on 1 July.

Commercial dispatches of the ventilator started mid-July – rounding off an exceptional business adventure that began only in the third week of March. Under ordinary circumstances, the product development cycle for medical devices lasts between 18 and 24 months.

Today, Nocca has about 750 ICU ventilators in various hospitals across the country. A little over a year ago, they didn’t know how to make an ICU ventilator.

Model for Success

The ventilator project ended in just three months, but it has left behind lasting lessons for academia, industry, and government to succeed in the post-Covid world.

In the book, Sastri writes that the task force was able to work closely with the help of popular online tools like Zoom and WhatsApp. By doing that, they were able to cut into the advantages offered by the traditional setup of working in close proximity.

One shining example where close collaboration has created wonders for decades is the Silicon Valley. Here, the world’s top technology talent are working close by, and a path-breaking partnership, a lucky break, or the next big idea is never far away.

But with the way that the task force worked in the pandemic, they were able to subvert the importance of time and space in making things happen.

“Top universities; global talent, especially from the Indian diaspora; and capital were brought together in the virtual world. The ventilator project is thus a successful template to reinvent Silicon Valley in India and could very well be replicated for other ventures to create world-class companies,” Sastri and Bandyopadhyay write in the book.

The startup wave has already been washing over the smaller towns and cities in India for sometime now. The example of the task force can help non-metro India believe, rightly, that they don’t have to hold back because of limitations of time and space or weaker physical infrastructure.

The task force model also shows how favourable industry-academia collaboration can foster science-and-technology innovation.

But a congregation of academic and industry players for specific projects, like in the case of the IIT Kanpur consortium, can help bridge this gap.

“If you look at the fact that there’s a faculty entrepreneurship policy, there’s a student entrepreneurship policy, and there’s an incubator, these together provide the bridge between academia and industry,” Sastri says.

He believes that the incubator, in particular, can help connect academic research to real-world problem statements in the industry. “In the past, this bridge was missing,” he says.

Energised by their personal experiences, Sastri and Bandyopadhyay are already driving change in their environments.

In late 2020, Sastri initiated a programme at IIM Calcutta to replicate the task force model for promising startups in IIM Calcutta Innovation Park. The goal was to make these startups investor-ready. According to Sastri, the ‘Post-Covid Venture Experience’ is an experiment around reinventing Silicon Valley in India.

Similarly, Bandyopadhyay returned to IIT Kanpur to encourage graduating BTech students to participate in in-house entrepreneurship via the institute’s Startup Incubation and Innovation Centre (SIIC).

Other steps have involved transforming how the incubator works. Bandyopadhyay has forged partnerships to enable the SIIC to make an impact in the healthcare, technology-enabled education (ed-tech), and technology-enabled finance (fin-tech) sectors.

“Nothing succeeds like success,” says Prof Bandyopadhyay.

As India prepares to work better in the pandemic – with one eye on transitioning gradually into the post-Covid world – it stands to benefit from transformational models to lift business and entrepreneurship in the aatmanirbhar Bharat era. The Ventilator Project shows the way.

(Link to the book)

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