Brazilian manufacturer of lung ventilators wants to increase its presence in the U.S. market

The FAPESP-supported company already exports one model and has applied for certification of two new devices in the United States.

By Elton Alisson  |  Agência FAPESP – At the beginning of April, a team of inspectors from the FDA (the U.S. health surveillance agency) spent a week at Magnamed’s factory in Cotia, in Greater São Paulo (Brazil). The purpose of the visit was to inspect the manufacturing processes of a lung ventilator model called OxyMag in order to renew its certification. The Brazilian company already exports this model to the United States, a market considered strategic for its growth plans.

“The United States represents more than 30% of the global mechanical ventilation market. We have a well-established operation there, with a factory and sales office in Fort Lauderdale, Florida,” Sidney Medeiros, Magnamed’s chief operating officer, told Agência FAPESP.

The company entered the North American market in 2017 by commercializing OxyMag for the veterinary medicine sector. In 2023, the FDA approved the use of the transport and emergency pulmonary ventilator for human health in the country. The device was developed with support from FAPESP’s Innovative Research in Small Businesses Program (PIPE) between 2006 and 2012 (read more at: agencia.fapesp.br/41739).

After a four-year process requiring more than USD 1 million in investments for laboratories, consultants, prototypes, pilot lines, and travel, Magnamed received approval and became the first Brazilian manufacturer of lung ventilators with a captive presence in the United States.

“We’ll start manufacturing the OxyMag for the American market from the second half of 2025 with semi-assembled kits shipped from Brazil. We also have a customer service area to meet demands and supply spare parts and equipment maintenance,” explains Medeiros.

In addition to the OxyMag, the company plans to obtain certification and sell other lung ventilator models in the North American market in the coming years. One of them, called OxyMag Air, is due to be launched in Brazil in May. It has the same characteristics as the standard OxyMag but eliminates the need for oxygen gas cylinders or networks.

“This feature is very interesting, especially for transporting patients who need mechanical ventilation [such as by ambulance]. We’ve already started the certification process for this product in the United States, and we expect to receive certification in 2026,” says Medeiros.

Market opportunities

The executive sees growth opportunities in the North American market, especially in the patient transportation segment, where ventilation is still performed using simple manual ambu resuscitators.

The device is a type of pump attached to a mask on the patient’s face. The paramedic team controls its frequency to ensure respiratory control until the ambulance arrives at the hospital.

“The American market relies heavily on ambu and pneumatic products, which are still low-tech. We believe our equipment, such as the OxyMag, can meet the growing demand for more modern, lightweight, and versatile products there,” says Medeiros.

The specialist says that one of the features that sets the company’s ventilator models, such as the OxyMag Max 300 (which is also in the process of being certified by the FDA), apart is that they can be used when transporting patients to the hospital and during hospitalization in intensive care unit (ICU) beds.

“This product has all the necessary ventilator models to ensure the preservation of life during transportation to a hospital and during an ICU stay, without the need to make the transition from one mechanical ventilator model to another,” Medeiros compares.

As is customary in the North American medical and hospital products market, the company sells OxyMag in the United States through distributors.

New competitors

After the COVID-19 pandemic, more than 90 new brands of lung ventilators emerged, primarily from China, eager to capture a share of the market with annual sales estimated at over USD 6 billion. However, most of these brands have disappeared because they are unaware of the characteristics of this sector, says Medeiros.

“These new competitors, mainly Chinese, entered the market with a more aggressive pricing strategy and thought the barriers wouldn’t be so high. But some countries, like Brazil, have an extensive and very rigorous certification process for medical products. They also thought that the demand for these products would be exponential and last a long time, but that didn’t happen,” he says.

Until the COVID-19 pandemic, Magnamed produced 150 ventilators per month. When the SARS-CoV-2 virus emerged and serious cases of the disease increased, the Ministry of Health approached the company to supply more than 5,000 ventilators to be distributed to public hospitals across the country. Magnamed was only able to fulfill these orders through partnerships with companies such as Positivo, Embraer, and Flextronics (read more at agencia.fapesp.br/32996).

“If the company were to produce the way it did before, it’d take a few years to deliver the quantity of fans needed to meet demand during the pandemic. The partnership with these companies was fundamental,” says Gustavo Junqueira, a partner and operations director at KPTL, a venture capital investment manager who invested in Magnamed when the company started in 2008.

The executive says that another factor that has allowed the company to increase its production scale is the robust quality of its engineering. “The processes are so well controlled and documented that when it was necessary to scale up production, Magnamed had no difficulty,” he says.

Aging population

The market for lung ventilators has grown organically since the pandemic. According to Medeiros, one factor driving the demand for this type of equipment is the aging global population.

“We understand that there will be an increasing demand for life-supporting medical devices because people are living longer. We also see opportunities in home care, which is a huge trend worldwide, but needs to be better structured in Brazil,” he said.

According to the executive, 70% of the materials used to manufacture lung ventilators, including plastic resins, electronic boards, and machine parts, are sourced domestically. The remaining 30%, including two specific components such as valves, are produced by international partners.