“We are trying to send this to the doctor now. Based on his feedback we’ll take a call."
“Probably we are the only team that hopes that we never have to use our creation."
This “creation", the splitter, allows one ventilator to treat four patients by splitting the oxygen flow. Ventilators are critical devices that assist people in breathing when lungs fail. Usually, one machine supports one patient. But then, these are unusual times.
Over the last many days, participants in the WhatsApp group—doctors, engineers, investors, product managers, policy makers and 3D printers—have been brainstorming to make an open-source splitter. The picture posted is version number five; different versions of the splitter have been tested in hospitals in Bengaluru, Mumbai, Jaipur and Srinagar.
“It could be the fastest and cost efficient way to save lives during the covid-19 pandemic," Pankaj Gupta, managing partner at EthAum Venture Partners, a technology accelerator, said. “We will do another round of testing in Vijaywada and freeze the design by the middle of next week," he added. He is one of the volunteers for the open-source project.
The Cv19 Ventilator Splitters group meets over a Zoom conference every day at 10pm to map their progress. The splitter project is part of a larger platform—the Covid India Initiative— with over 500 Good Samaritans to help source medical equipment and help open-source communities prototype and test their innovation.
Splitting a ventilator between patients is complicated because every lung is different. Not all doctors are comfortable with the idea. However, soon, there could be more patients needing ventilation in India than the number of ventilators available.
India currently has over 4,000 covid-19 infections and over 100 deaths. If positive cases rise exponentially in India, the demand-supply gap for ventilators could be as high as 160,000, Alvarez and Marsal, a professional services firm, projected. India currently has an installed base of 45,000 ventilators. Multinationals such as GE Healthcare import ventilators to sell. Imports are difficult because many countries are facing shortages and the global supply-chains are broken. There are around five domestic manufacturers in the country; ramping up production capacity quickly enough is a tough ask during a lockdown.
“We are way behind. We are woefully short," Amir Ullah Khan, policy analyst and a former adviser with the Bill and Melinda Gates Foundation, said. “We are now talking about 10,000 people testing positive in the next couple of weeks and deaths going up to a thousand. We have to arrest that. Even when covid-19 disappears, we would still need 100,000 ventilators because we have people dying of respiratory diseases every day," he said.
The open source movement fits in here.
Make it fast
The covid-19 outbreak has sparked over a dozen efforts to make ventilators. While the designs come in different shades, all of them have two goals—make it affordable, make it fast.
Ventilators from multinationals can cost upwards of ₹5 lakh. A sophisticated ventilator from AgVa Healthcare, a domestic manufacturer, is more economical at ₹1.5 lakh. Further stripped down versions that use only domestic components and local supply-chains can cut the bill to under ₹50,000. Open-source communities don’t charge for the intellectual property either, making products cheaper than proprietary ones.
Nevertheless, there are many questions. Can open-source ventilators be reliable? Medical devices are tested for months. In this case, people only have a few weeks to get the stuff up and running. Can these devices be safely used on patients suffering from acute respiratory distress syndrome (ARDS)? Are the devices safe for health workers to handle considering that covid-19 is contagious? And who takes the responsibility if bugs in the software code mess up with a running machine?
Many doctors this writer spoke to said that they would exercise caution because ventilators are mission critical.
The human lung is like a series of balloons connected to a large bush of tubes, Dr Prashant Jha, head of affordable medical technologies at the School of Biomedical Engineering and Imaging Sciences, King’s College, London, explained. “In ARDS, a patient has extreme difficulty in breathing and maintaining the levels of oxygen. One has to ensure that just enough air is pushed in. If you over inflate the lung, you will cause structural damage which could be lethal," he said. Controls in ventilators and how rigorously they are tested are, therefore, crucial.
As of now, scientists are collaborating with medical practitioners and hospitals of repute. The mutual endorsements, they hope, can make this work.
On the phone, Srinivasan Raghavan sounds composed. “Two months down the line you may not even need our solution. It might look like we were overreacting," he said. “Regardless, it is very satisfying to know that when the country is faced with a problem of this magnitude, people can stand up. It is up-lifting."
Raghavan, a scientist at IISc’s Centre for Nano Science and Engineering, mobilized 35 people and companies such as KAS Technologies (a factory-equipment maker) to develop an open-source ventilator with minimum electronics. “Our aim is to provide air or oxygen at a certain pressure, volume, flow rate and frequency. As engineers, we do it all the time in other realms. We decided to apply that knowledge to the covid-19 problem," he said.
Raghavan consulted with Manipal Hospitals. To begin with, he was advised to build a stripped down ventilator with just a “pressure mode", a common mode most ventilators work in. In this mode, air is forced into the patient at a certain pressure during inhalation and then withdrawn during exhalation. Sophisticated ventilators in intensive care units (ICUs) have many more modes, including a “volume mode" where a fixed volume of air is forced into the patient. More the modes, more the sensors and by extension, more imports.
“We have simplified the design significantly. It has very little electronics and automation at this point. Our second version will have a bit more (it would incorporate the volume mode) and still cost less than ₹50,000," he said.
Meanwhile, a second team from IISc have come together to prototype an electro-mechanical ventilator using made-in-India components. For instance, to store and mix air and oxygen, the team reused sedimentation tanks found in household reverse osmosis (RO) water purifiers. To check pressure levels, sensors similar to those used to detect air pressure in car tyres are used.
Yet another ventilator effort is led by IIT Kanpur. This project uses a bit more electronics than the IISc teams. The ventilators, when ready, might be Internet-of- Things-enabled—meaning, they can be controlled remotely by the doctors.
Nocca Robotics, a company that makes waterless solar plant cleaning robots, was co-founded by IIT Kanpur graduates in 2017. When the covid-19 pandemic hit, Nocca came forth with an Ambu bag-based ventilator design. “Doctors told us that Ambu bags wouldn’t save any covid-19 patients. In a day, the Nocca team came up with a second design, for an invasive ventilator," Amitabha Bandyopadhyay, a professor at the IIT’s department of biological sciences and bioengineering, said. He also runs the business incubator at IIT Kanpur.
At its most basic, Ambu bags are made up of polymer and are a manual resuscitator device. Some open-source communities have now automated the manual functioning. Many doctors, nevertheless, said they would prefer a well tested and sophisticated invasive ventilator for conditions such as ADRS where patients may need to be in an ICU for over a week. In an invasive machine, positive pressure is applied through an endotracheal or tracheotomy tube to keep the lungs from collapsing.
“We have received 12 different interests for manufacturing. After beta testing, we would licence the design to manufacturers," Bandyopadhyay said. About 30,000 machines can be manufactured by May if everything goes well, he hoped. The IIT Kanpur ventilator project has advisers that include Ajai Chowdhry, one of founders of HCL, as well as Saurabh Srivastava, the co-founder of IT industry body Nasscom and the Indian Angel Network.
Rustom K. Bharucha is an octogenarian. He runs Bharucha Instrumentation and Control, a company that makes mechanical ventilators. Local doctors have used the ventilators to treat patients with snake bites, for instance. Why couldn’t it be retrofitted for the covid-19 scenario? Reinventing the wheel is sexy although time consuming.
Nick Booker, the co-founder of IndoGenius, a company that helps universities and government agencies across the world network with Indian institutions, teamed up with Dr Jha of King’s College, London, to start OpenBreath.Tech, a network of doctors and engineers. The duo engaged the Indian Institute of Science Education and Research and the Inter-University Centre of Astronomy and Astrophysics in Pune in their open-source efforts.
“We liked the Bharucha Ventilator because it was super sturdy, had no electronics in it. This means that even in the remotest parts of the world, this machine can be made using a simple lathe machine, a welding tool and screw drivers. It is easier to replicate than a machine that requires a printed circuit board," Dr Jha said.
The group, with Bharucha’s blessings, digitized the ventilator drawings (Bharucha only had paper sketches); it would be available as an open-source licence for anyone to use and tweak. OpenBreath.Tech, meanwhile, is also working on a version that would make the Bharucha Ventilator useful in ARDS cases. That includes adding mechanisms to control and adjust how pressure is generated and the volume moderated.
“This is an attempt to make a contrarian design, which is purely mechanical. We want to explore distributed manufacturing—in Asia, Latin America, Africa," Dr Jha said.
Back to the question around the reliability of open-source devices. A technical committee of Defence Research and Development Organisation (DRDO) has mandated six essential technical features in ventilators being used for covid-19 cases. The machine should be turbine/compressor-based because the installation sites might not have central oxygen lines; the machine should have invasive, non-invasive features; finally, pressure and volume control among others.
Currently, few open-source ventilator projects meet all the specifications.
A scientist who did not want to be quoted fretted that volume control needs flow sensors. “If you integrate flow sensors, the pricing could go up by ₹20,000—just in the material cost. There is less supply since the whole world needs sensors," he said. India, he argued, therefore needs a much more knocked-down version of the specifications. “Government officials, verbally, are saying they would take whatever is made in a crisis situation. However, it’s not written. You cannot have it both ways," he added.
Medical practitioners, for now, feel open-source projects need validation and endorsement from larger organizations.
Dr Sudarshan Ballal, chairman of Manipal Hospitals, said that for reliability, hospitals would prefer trusted manufacturers getting involved. “Much of the diagnostic kits from China were rejected by European countries. There is no point in adopting something that has come in a hurry because it might cause more damage than help," he said. “The source is important. If the devices come from a Maruti, a Mahindra, a Tata, they would be more trusted."
Fact is, India wouldn’t want to lose this war to covid-19. Doctors could prefer sophisticated and time-tested machines, but it is better to be prepared with every resource, keeping every device in the armoury. Because when push comes to the shove, they could save lives.
“In a crisis, nothing is perfect and nothing ideal. As clinicians, we will use every possible machine or resource at our disposal to save as many as possible," Dr Shalini Nalwad, founding partner of ICATT air ambulance service in Bengaluru, said.
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