The UK Health Secretary has called for British companies from the car and defence sectors to start making hospital ventilators, which provide lifesaving intervention to failing Covid-19 patients.
This seems like a creative way to meet the need for more than 14,000 ventilators in a short time, as major ventilator manufacturers have full order books and hold little in stock.
The respiratory ventilators market was a mature market with a stable competitive environment before the Covid-19 outbreak. Ventilators are standard equipment in intensive care units and emergency departments. The annual market growth primarily relies heavily on replacements.
According to GlobalData’s analysis, the Germany-based manufacturer Dragerwerk has a foothold in the market for ventilators in the UK. The other top players in the respiratory ventilators space include Maquet, Hamilton and Medtronic, all of which offer diverse product portfolios in the mechanical ventilation space. International players control approximately 80% of the ventilators market in the UK, with smaller manufacturers making up the remainder.
All major players are currently getting a surge of orders from China, Italy, Germany and other countries. GlobalData expects that local manufactures, such as SLE and Diamedica Limited, will grow their shares in the UK due to the increasing demand caused by the outbreak. SLE has already increased its maximum production capacity but still cannot meet the demand from its domestic and foreign customers.
It will be an obvious challenge for non-medical UK engineering companies to be able to help with the ventilator crisis. The first barrier is on the regulatory side. The ventilators business is subject to a large amount of government regulation in Europe. Ventilators are a class 2b device in the EU. Manufacturers of respiratory ventilators and resuscitators strictly follow the current regulations and guidelines concerning performance, accuracy and safety.
Generally, medical device developers must meet the requirements of International Organization for Standardization (ISO) 13485 certification for quality management systems and the International Electrotechnical Commission (IEC) 60601-1:2005 standards for product safety and effectiveness for electrical medical equipment.
Additionally, international standards specify requirements for the development, validation and routine control of different ventilators. For example, ISO 80601-2-12:2020 focuses on the basic safety and essential performance of critical care ventilators. The basic regulation within the EU is council directive 93 / 42 of the European Economic Community (EEC) from 1993, commonly known as the medical device directive. This directive defines essential requirements that are now used as the basis for Conformité Européenne (CE)-marking of medical devices within the EU.
Even if regulatory issues can be cleared more efficiently with government efforts, the manufacturing process of ventilators is complicated. A ventilator normally consists of gas supply, a flexible breathing circuit, a control system, monitors and alarms. Even if all ventilator blueprints are immediately shared, getting the required parts and tools to manufacture the product can take a few weeks, if not longer.
More importantly, product safety is the number one priority for ventilation equipment, as in many cases the patient depends entirely on the ventilator for breathing. Reported problems with ventilators range from software-based to hardware-based and are associated with the breathing circuits, control systems, monitors, alarms and other components. These malfunctions can lead to serious injuries or death for ventilator-dependent patients. Therefore, quality control and testing are strict.
According to GlobalData’s pipeline product timeline analyser, it takes a new respiratory device 4.7 years to enter the market on average. It is very difficult to imagine a car maker successfully assembling a functional and safe ventilator in a short enough period to successfully meet the current demand.
However, as the Covid-19 outbreak continues to worsen globally, GlobalData expects that more manufacturers will join the rush to meet the demand for ventilators in the UK and across the globe.