A Manufacturing Lifeline for Medical Devices
As COVID-19 increases its deadly grip on India and the surge in the number of cases that test positive, intensive care units (ICUs) of hospitals are constantly meeting challenges associated with the pandemic. Along with the shortage of protective gear and PPEs, hospitals are also facing a shortage of ventilators. To cope with the demand, manufacturing companies across the globe and in India, are ramping up production to deliver them on time.
According to a study by John Hopkins University in Baltimore, US, and the Washington and New Delhi-based Centre for Disease Dynamics, Economics and Policy (CDDEP), ventilator demand is soon to touch the 1 million mark. However, the study estimates that the current availability of ventilators in India is between 30,000 and 50,000 units, which points to the urgent need to manufacture ventilators.
Manufacturing Challenges
The target seems aspirational to say the least, looking at the current state of lockdown where the supply chains are severely affected. There are multiple challenges that exist, starting with the lack of components. As with any medical equipment, ventilators are comprised of some common, easily available components along with complex parts such as the pump system and the valves, which are hard to come by.
Processes like 3D printing work for some custom components or small batch items, but not for the kind of scale needed for producing complex products. When borders get shut down and supply chains get regionalized, the availability of parts becomes a big issue.
An added challenge is clinically testing the equipment once it is manufactured and then being able to rapidly scale the tests, so that the ventilators can go out to hospitals. For something like a ventilator, the testing device is an artificial-type lung that the ventilator has to be tested against; to make sure that it has the right flow rate and the right pressure control.
Manufacturing partners step up
Given the massive demand for ventilators and the quick turnaround times, manufacturers of ventilators are relying on their manufacturing partners who have to have the requisite expertise in medical device technologies, with a global industry footprint, as well as a global network of certified materials and component suppliers. They can also discover alternate supply chain sources to relieve bottlenecks.
Meeting this critical need for ventilators has also meant throwing the traditional rulebook for manufacturing timelines out of the window. What used to be a 12 to 24-month timeframe, is now being crunched to days and weeks in an unprecedented manner.
While ventilators are key, they are by no means the only equipment witnessing increased demand. Given the increased capacity that is being built in hotel rooms and dormitories to support increased patient numbers, IV infusion pumps, oxygen concentrators, or a basic portable system to generate oxygen for patients with compromised lung functions, are also being increasingly sought after.
Manufacturing companies such as Flex are taking an innovative route to address the acute shortage of ventilators by working with non-traditional companies like automakers who have substituted their production lines to meet the demand. While the automakers are not familiar with the highly regulated world of medical device manufacturing, they have the advantage of having a different set of supply networks, which helps them to access the skill sets of different people and their capabilities. It is a tremendous collaborative effort, which is working towards saving lives and getting the products out to market. These unprecedented times have also resulted in lateral thinking across the manufacturing process with elements of reverse engineering, as well as 3D printing and other advanced techniques taking center stage in the fight to make the necessary sub-components like valves and pumps, in the volumes required.
During this critical time when the World Health Organization has asked the private sector to join global efforts to tackle Covid-19, companies are making their assembly lines available and are helping to ramp up the supply of ventilators. In Brazil, the Flex team went from never having produced a medical product before – to getting regulatory registration and approval completed, building new infrastructure to install oxygen, setting up production lines, doing product assembly training by video conference, learning a new quality system and how to do validation, testing and regulatory documentation, and completely producing clinical units, all in a months’ time.
Examples of such innovation are coming from all industries – from fashion, food, auto, to hi-tech – where manufacturers are re-tooling themselves to make life saving medical supplies. With the world slowly easing lockdowns and trying to return to some semblance of normalcy, the need for ventilators and other related equipment will only go up. Governments all over the world are looking at manufacturing companies to come forward and save the day. It is obviously challenging for manufacturers who work with complex technologies to suddenly shift, but they are doing it. Most have started to successfully retool their production lines to fight the Covid-19 pandemic, to play their part in keeping the world safe.
