How various manufactures are ramping up ventilator production in a record-breaking time
Ventilators play a critical role in the management of patients with severe respiratory illness and without their support, some patients with severe respiratory disease might not survive. It is said that around 3 to 6% of all COVID-19 patients require ventilator support.
According to experts, India had 40,000 ventilators pre-COVID and around 14,000 ventilators have been allocated by the Government for COVID-19. However, it is predicted with the current surge in COVID-19 cases, India might need 1,00,000 ventilators by August, which can spike up to 500,000 by October- November. The Government of India (GOI) has pro-actively placed an order of around 70,000 ventilators- of which around 55,000 are from local companies and 15,000 are to be imported.
How is India going to scale up its ventilator production? The central government reached out to automobile manufacturers, urging them to re-purpose their facilities to produce ventilators. The Ministry of Health and Family Welfare (MoHFW) also urged Bharat Electronics (BEL), a public sector undertaking under the Ministry of Defence, to collaborate with local manufacturers to roll out ventilators. Encouraged and supported by the GOI, many leading as well as mid-sized manufacturers have stepped in to meet this acute need for ventilators.
The largest order of 30,000 ventilators has placed by the GoI to Mysuru-based Skanray Technologies, which has been manufacturing ventilators since 2013. Skanray is working round-the-clock on stretching its capacity to 5,000 units per month from 200 per month pre-COVID and then to 30,000 units per month. How did Skanray manage to ramp up so rapidly, amidst challenges of sourcing parts, several of which are imported? It already had built an additional capacity at Mysuru through EMS partners and had gone to 5,000 ventilators locally. However, to meet the requirement of 1,00,000 units that was projected by the GOI initially, it forged ties with BEL for a co-branded product under the BEL-Skanray partnership.
As per the agreement, Skanray is the sole design owner and BEL is the manufacturing partner and has volunteered to take care of installation, service and application support to leverage their large pool of engineers. The Defence Research and Development Organisation (DRDO) is assisting with the development of critical import substitute components like valves, solenoids and sensors and also helping the Skanray team to review the S/W codes and upgrades in features.
Says Vishwaprasad Alva, Founder and Managing Director, Skanray Technologies, “We transferred the manufacturing technology and the test set-up to BEL to be able to scale up from a stretched capacity of 5,000 per batch to a capacity of 30,000 units to be delivered in 8 to 12 weeks. All the 30,000 units ordered by the GOI to BEL-Skanray would be delivered before the middle of August.”
Under this partnership, only high-end ICU ventilators like skanrespiro and CV 200 are being produced. "Skanray has other anaesthesia ventilators and other simpler designs that are not in production now," adds Alva. While new entrants into ventilator production have to go through certification tests and clinicals, Skanray with its products being certified and exported requires just regular testing and demo for each batch prior to shipments.
Besides the 30,000 units, the BEL-Skanra partnership has in the pipeline an order to deliver another 1,000 units from state government and NGOs for government COVID-19 hospitals. “We are not taking private orders and exports until we deliver the GOI orders,” says Alva.
What were the roadblocks that Skanray faced for the massive production? First, as was expected, it was sourcing some critical parts like sensors, valves and solenoids. "But this turned out to be core R&D work and DRDO and their aerospace supply chain came in handy," says Alva. Second, training a large number of BEL and DRDO engineering and manufacturing teams appeared like a challenge but turned out to simpler than anticipated. “The speed at which DRDO and BEL responded will make PSU critics rethink on their views," says Alva.
The third, and an upcoming challenge, is installing the hundreds of ventilators and, training paramedics to use it and provide service. "This scale is not something anyone in the world has ever done, and we are yet to figure out the best way to do it and need to see how adequate our plan is,” says Alva.
Ashok Leyland, flagship company of the Hinduja Group and India’s leading commercial vehicle manufacturer, was approached by the Government of India and the Government of Tamil Nadu to work with and support ventilator makers and help them improve supply chain and output capacity. Ashok Leyland readied a simple yet intelligent ventilator, at low cost but with all the essential features to aid first mile ventilation including the necessary sensors and controllers for volume and pressure monitoring, and safeguards. The ventilator development is now complete, testing, certification and clinical trials will conclude soon, followed by mass manufacturing.
In the mid-range and high-end ICU ventilator segments, Ashok Leyland is working with two Chennai-based ventilator manufacturers- Kriti Kare India Pvt Ltd, a manufacturer of the ACUvent ventilators since 2014, and Phoenix Medical Systems Pvt Ltd, a 30-year-old firm who are market leaders in infant, maternal care products, assistive devices.
To help the ventilator manufacturers to overcome the challenge of large-scale production in a short duration of time, Ashok Leyland is offering help with component sourcing, supply chain, logistics, manpower for production planning and in line-quality.
Said Vipin Sondhi, Managing Director & CEO, Ashok Leyland, “Our sourcing and engineering teams have been working 24X7 on these three projects. We are humbled that our efforts in developing these ventilators and support to ventilator makers, will help the Government to prepare themselves for the future needs of people needing ventilator care.”
Hyundai Motor India (HMI), the first smart mobility solutions provider, has entered into a partnership with Air Liquide Medical Systems Pvt. Ltd. (ALMS) a manufacturer of ICU ventilators, to augment the production and supply of ventilators in Tamil Nadu and other states. With this partnership, HMI and ALMS aim to achieve a target of 1,000 ventilators in the Phase 1 of production, and to scale up subsequently.
SS Kim, MD & CEO, Hyundai Motor India Ltd, said, “Ventilators and other respiratory aids are critical devices in the fight against COVID-19 and to this end, HMI and ALMS are working together to ensure a steady supply of ventilators in India.”
India's largest carmaker, Maruti Suzuki India Limited (MSIL), has tied up with Noida-based AgVA Healthcare, an existing approved manufacturer of ventilators, to deliver its first order of 10,000 ventilators to GOI by the end of May.
AgVa, which has developed a low cost, portable ventilator, used to source nearly 40% of the ventilator components from outside of India. For the unavailability of the imported parts, Maruti Suzuki stepped in with their expertise to scale up production. Within 10 days of joining hands, the first ventilator was ready, and now there is a daily output of about 300 ventilators. Now the partnership has received requests from Haryana and Gujarat governments as well for ventilators.
The GOI has been prompt to support the massive requirement of ventilators by also offering Rs 40 crore worth of support and facility space at the Andhra Pradesh MedTech Zone (AMTZ), a 270-acre facility built to fuel medical device manufacturing in India and reduce import dependencies. With the Centre placing an order of 3,500 ventilators to AMTZ, it is working with a capacity of making 3,000 ventilators and then scale up to 6,000 per month. Hindustan Lifecare (HLL) is assisting in the assembly of the ventilators. I
While an imported high-end ventilator costs around Rs 15 lakh and a standard one Rs 7 lakh, AMTZ promised to supply low-end ventilators for Rs 2 lakh a piece.
Trivitron Healthcare, a leading medical device company that did not have ventilators in its product portfolio, has also forayed into ventilator production. It has shared that its engineers are working 24x7 at its factories at AMTZ, Chennai and Mumbai, to roll out mechanical ventilators. The ventilator is built using up to 90% of locally made components. It is sourcing its components from auto companies as well as the local eco-system to assemble these ventilators.
Indian start-up Inali, which is into creating assistive healthcare products, has collaborated with Dassault Systèmes’ 3DEXPERIENCE Lab in the rapid development of a safe, affordable ‘smart ventilator’ that could be quickly manufactured and deployed for emergency use. Inali developed the smart ventilator, in less than eight days, using the 3DEXPERIENCE platform and a collaborative approach with designers and healthcare professionals from the lab’s OPEN COVID-19 online community, as well as with engineering mentors from the 3DEXPERIENCE Lab in India.
Using cloud-based digital applications, Inali engaged with this community of experts and innovators in real time – no matter their location – leveraging collective intelligence to rapidly design a 3D model of the smart ventilator, engineer it, simulate its function, and manufacture and validate a prototype. The smart ventilator was designed to identify performance metrics for parameters such as air velocity and air pressure that are needed to function, and adjust its operating parameters accordingly, as well as to identify the appropriate oxygen level for an individual patient and the safety metrics required for reliable and safe use.
esponding to the clarion call from the GOI, several ventilator manufacturers have shared their design specifications with others. For instance, Medtronic plc, a global leader in medical technology, has announced it is publicly sharing the design specifications for the Puritan Bennett 560 (PB 560) to enable participants across industries to evaluate options for rapid ventilator manufacturing. Introduced in 2010, the PB 560 is sold in 35 countries around the world.
“Medtronic recognises the acute need for ventilators as life-saving devices in the management of COVID-19 infections. We know this global crisis needs a global response. Over the past few weeks, we have ramped up production of our Puritan Bennett 980 ventilators. But we also know we can do more, and we are,” said Bob White, Executive Vice President and President of the Minimally Invasive Therapies Group at Medtronic.
Tele-ventilator technology, which helps healthcare professionals monitor and programme the ventilator from anywhere in the world, in real time, is also being explored. ABM Respiratory Care, a medical device company focused on the development and commercialisation of airway clearance and ventilation solutions, is preparing for fast-track approval of its tele-ventilator with regulatory agencies in several countries, including India.
ABM’s Tele-Ventilator enables healthcare professionals to securely monitor and adjust ventilator settings through their online portal from any location. “AI-enabled infrastructure will see a lot of value in the present scenario where healthcare infrastructure has been overburdened because of an unprecedented demand,” said Vinay Joshi, CEO, ABM.
ABM’s Tele-Ventilator leverages new technology which is 25 times faster and creates 50 times less data traffic than traditional web technologies. This enables time-valuable, responsive, consistent telemetry and large-scale secure access to ventilators without a complex configuration which is usually needed in traditional connectivity systems.
Leading research institutes have also chipped in. The Indian Institute of Technology Mandi has developed two low-cost portable ventilators. The developed prototypes are easy to use and can be taken to remote locations in case of a medical emergency. Priced at around Rs 4,000, the smart ventilator prototype is a mechanised Artificial Manual Breathing Unit (AMBU) bag with options to control breath rate and volume of air going into the patient’s lungs.
The unique feature of the developed product is, apart from manual operation, it can be controlled by a mobile application over Wi-Fi as well. The designed prototype uses a slider-crank mechanism to pump air and is easy to manufacture, assemble and operate.
“Designed especially for COVID-19 pandemic, this low-cost ventilator can be operated manually as well as using a smartphone app connected over Wifi,” said Dr Apran Gupta, Associate Professor, School of Engineering, IIT Mandi.
While it’s encouraging to witness indigenous manufacturing of ventilators getting a fillip, the public and private sectors collaborate and various industries engage in knowledge sharing to rise up to a crisis, the quality of the ventilators that are being rolled out can not be overlooked. Questions were raised after doctors working at Ahmedabad Civil Hospital pointed out that ventilators installed at the hospital by a Gujarat-based manufacturer were not up to the mark.
In another incident, Visakhapatnam's King George Hospital refused to conduct clinical trials on the ventilator assembled at AMTZ, on the grounds that the testing lacked proper sensors and did not meet specifications set by the GOI.
According to Alva, “I strongly feel that we cannot put prototypes to clinical use under any circumstances. Ventilator is a life-critical and intrusive device. Not just malfunction, even a wrong button pressed, wrong mode chosen, wrong patient profile fed to the S/W can cause fatalities and prove more risky than not using a ventilator. This is not the time to invent new technologies. However, it is a good idea to support new ideas that stems from teaming with established players, IITs, scientists of other labs and shorten the evaluation and clinicals and encourage breakthroughs. Even if one company succeeds commercially from the 100s which tried, it is worth the efforts for indigenisation and self-reliance.”
Along with quality, experts are also looking at how IT can be leveraged to expedite and augment the production? Can Augmented Reality (AR) play a key role to help the manufacture of these ventilators? Says Kayan Sridhar, SVP & Country Manager- India, PTC, “Several non medical companies are willing to support the manufacturing of the high-quality medical equipment for the healthcare industry, since they have the industrial equipment but lack the skill set. In such a scenario, AR helps such companies to commence the knowledge transfer from the medical companies by implementing the technology to non-medical companies.
AR technology has proven itself to be valuable as a training aid and also by mitigating the need of an expert in each partner factory, reducing the risk of virus contamination in the process. At present, some UK-based manufacturing and technology companies have been working with ventilator manufacturers to increase the ventilator production to meet NHS's requirement of 20,000 units. “Similar collaboration can be worked out in India, with various ventilator manufacturers to design, operate and help manufacture complex products through AR,” says Sridhar.