COVID-19 and respiratory devices: A dynamic market and evolving regulations
The respiratory devices market is witnessing enormous demands across the globe, resulting from the increased need for ventilators due to rising COVID-19 cases.
As of now, the virus has infected more than a quarter of a million people globally. With the continued spread of this virus, which can cause pneumonia and difficulty breathing, hospitals are facing a limited supply of ventilators. For instance, in Italy, hospitals have been overwhelmed with patients in respiratory failure, and medical staff are having to make difficult life-or-death decisions about which patients receive ventilators.
As the shortage and prevalence of respiratory diseases increase, the global ventilators market is expected to grow from USD 1.05 billion in 2019 to USD 3.02 billion by 2027. Moreover, the global ventilator market is predicted to rise at a compound annual growth rate (CAGR) of 13.96 percent during the forecast period 2020-2027, according to a report published by Fior Markets in March 2020.
In addition to ventilators, the entire respiratory market will continue to rise as the global geriatric population grows and the incidence of chronic diseases, such as COPD and asthma, increases. In fact, a recent report projected the respiratory care devices market to reach USD 31.8 billion by 2024 from USD 20.6 billion in 2019, at a CAGR of 9.1 percent.
Government and regulatory implications during COVID-19
For now, the impact of the COVID-19 crisis is expected to further accelerate the growth of the respiratory devices market. In addition, the threat will have a lasting impact on governments and regulatory agencies in terms of future preparedness when it comes to the next pandemic. Today, governments worldwide are playing catch-up, swiftly intervening in an attempt to create alliances with manufacturers to handle the COVID-19 threat. And, international regulatory agencies are considering accelerated approval of certain respiratory devices.
In the United Kingdom (UK), for example, the government has asked automobile manufacturers — including Ford, Honda, and Rolls-Royce — to temporarily shift part of their assembly line focus from cars to developing respiratory equipment. Once an agreement has been reached, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) must then ensure that the automakers adhere to the same rules and regulations as the rest of the medical device industry.
And in late March, to help alleviate ventilator shortages, the U.S. Food and Drug Administration (FDA) granted emergency use approval to a device called Vesper — developed by Prisma Health — which can support up to four patients on one ventilator. Typically, using a ventilator for more than one patient is discouraged. Yet this often controversial usage is one of the exceptions regulatory bodies are making during a state of emergency.
In addition to expediting registration processes for needed goods, many regulatory agencies that govern medical devices are easing import restrictions, all in an effort to ensure that regulations do not block the development or supply of devices that could ultimately save lives. Case in point: To support the wider availability of devices for patients in need of ventilatory support, the FDA is encouraging foreign and domestic manufacturers of ventilatory support devices not currently legally marketed in the U.S. to pursue an emergency use authorization (EUA), which would allow them to distribute their devices in the states. Finally, the FDA is reaching out to manufacturers who have not previously been engaged in medical device manufacturing — similar to what was previously mentioned with regard to the UK.
Specific U.S. regulatory directives designed to ease the ventilator shortage
As the U.S. braces for shortages on ventilators — predicted to be in the thousands — the FDA issued a guidance to help expand the availability of ventilators, as well as other respiratory devices and their accessories. The devices listed within the guidance, which include ventilators, anesthesia gas machines, and other respiratory devices and their accessories, are needed to support patients who develop respiratory compromise from COVID-19 or other respiratory disorders.
The directive outlines that, if possible, healthcare facilities should use FDA-cleared standard ventilators or a device subject to an EUA. To further help ensure the availability of the greatest possible number of devices for this purpose, this policy aims to create more flexibility for manufacturers that make device modifications to address current manufacturing limitations or supply shortages. Examples may include:
- Changes to the ventilator motor to allow an alternate supplier to meet the required design specifications
- Changes to the material in the ventilator tubing to allow for more flexible material sourcing
In the guidance, the FDA outlines that this approach should help manufacturers that want to add production lines or manufacture at alternative sites that may have different manufacturing equipment in an effort to increase capacity and reduce manufacturing bottlenecks.
COVID-19 clinical operations
Keeping your clinical trial on track in an evolving environment.
New regulatory guidance for the UK and Europe and industry response
Drawn on the advice of anesthesia and intensive care medical professionals and medical device regulators, the UK’s MHRA published a new guidance that specifies the minimum clinically acceptable performance requirements for ventilators during the COVID-19 pandemic. The guidance defines the must have features needed for therapeutic use, and which features can be omitted to accelerate development and production.
Within the EU, several Member States, such as Germany and France, have reacted by requisitioning protective equipment or putting in place export bans. In response, MedTech Europe, the European trade association for the medical technology industry, voiced that measures such as these are counterproductive as they can create acute shortages in other parts of Europe, and undermine equal access to needed equipment across the Member States. MedTech Europe, further called on the European Commission and EU Member States to remove any barrier undermining the industry’s capacity to help manage the current public health emergency. In a press release, the association encouraged authorities to involve the industry, manufacturers and trade bodies to develop solutions jointly.
MedTech on the frontlines
Despite the efforts of various governments worldwide and by international regulatory bodies to manage the current crisis, there remains respiratory device shortages. A paper from the University of Pennsylvania estimated that even if social-distancing measures can reduce infection rates by 95 percent, 960,000 Americans will still need intensive care. Moreover, there are only about 180,000 ventilators in the U.S. and only enough respiratory therapists and critical-care staff to safely look after 100,000 ventilated patients.
Similar situations have been reported around the world, and device manufacturers are racing to meet the demand in ventilator production to potentially avoid the looming shortage and the possible need to ration respiratory devices. One such medtech company, Zoll Medical, said it is aiming to produce 10,000 ventilators per month, a 25-fold increase in its production volume, and is prepared to expand its supply base as necessary. Other efforts include: a collaboration between device maker Ventec Life Systems and GM to expand its ventilator production, and ResMed announcing its goal to double or triple ventilator output, in addition to scaling up ventilation mask production more than tenfold.
Moving forward beyond the COVID-19 crisis
As mentioned earlier, moving forward beyond the current healthcare crisis, the entire respiratory market will continue to rise as our global population ages and the incidence of chronic diseases increases exponentially. Further, the cost advantages of home care devices and services will be a key factor in the growth of respiratory devices. Another factor includes the improving standards and modernisation of medical centers in various developing regions of the globe.
Learn more about our range of services and how we are supporting medical device respiratory companies and others to meet the demands of this growing market. To speak with one of our experts, please contact us.