COVID-19 Ventilators: Why are they so difficult to produce?

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Around the world, manufacturers entering the medical devices field for the first time are racing to produce much-needed ventilators to address a global lack of supply.

These manufacturers are coming from a broad range of sectors, from aerospace to Formula One, to offer their services as part of the global COVID-19 relief effort. For these manufacturers, however, there are many bumps in the road, and some are struggling in the face of challenges that include regulatory frameworks and logistics.

What are ventilators?

Ventilators assist a patient’s breathing by helping the lungs inhale and exhale air. They are used on patients suffering from a variety of conditions including pneumonia and brain injury, and they have taken centre stage during the COVID-19 pandemic because there is simply not enough of them to go around.

The SARS-CoV-2 virus, which causes COVID-19, attacks the respiratory system. When a patient is infected with the virus, their ability to breath can be compromised. In the most severe cases, where a patient suffers acute respiratory distress, invasive respiratory support is required to keep them alive. This is provided via an artificial airway which is inserted down the patient’s windpipe and attached to a ventilator. This ventilator then breathes for the patient, keeping them alive.

There are a few different types of ventilator, including manual and the more modern mechanical—it is the latter type that manufacturers are racing to produce.

Manufacturing challenges

At the core of a mechanical ventilator is a computer which typically sits atop a trolley. They are highly complex pieces of equipment that feature a range of different screens, dials, cords, tubes, and cables. It is this level of sophistication and complexity that allows a superior level of care in contrast to their manual cousins.

While this is great news for doctors and patients, it means that considerable expertise in research, design, and manufacturing is required to produce a commercial mechanical ventilator which is reliable, serviceable, and adheres to strict regulatory standards. Since mechanical ventilators are typically used in scenarios where a patient would die without its use, all of this is of vital importance. There are also cost factors to account for—manufacturing ventilators is an expensive undertaking, and this can mean that a single unit can cost as much as US$50,000.

Regulatory headaches

The biggest problem by far is not design and manufacturing complexities, but regulatory challenges. Not just anyone can make a medical device. To use the UK as an example, all manufacturers that want to produce medical devices must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and abide by their stringent standards. And depending on how complex the device being manufactured is, other regulatory bodies may come into play.

Throughout Europe, ventilators are class IIb products. This is the second highest regulatory classification and as such, manufacturing them is not as simple as just making a machine that works. The ongoing production of ventilators in Europe must abide by strict rules, meet strict specifications, and pass high-level test protocols.

It takes a long time for medical device manufacturers to gain momentum. First, they must build their manufacturing knowledge and supply chains to ensure that their products are safe. They must also understand how their products interact with the human body and develop skills in risk management and quality assurance. This is all before regulatory considerations come into play. So, starting from scratch is a difficult thing to do—this is what manufacturers like the UK’s Dyson and America’s Tesla, are finding out.

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