ResMedx Secures FDA Emergency Use Authorization: Accelerating Global and Domestic Market Expansion with Innovative Respiratory Solutions

“There are too many chaotic phenomena in the domestic ventilator market,” said Yang Ning, founder of Rongxin Medical and a senior practitioner in China’s ventilator industry, in an interview with VCBeat.

In her view, the global outbreak of the epidemic has led to a shortage of ventilators. For domestic ventilator manufacturers, on one hand, professional Chinese ventilator manufacturers have enhanced the recognition of domestic brands in hospitals and their influence in overseas markets thanks to their contributions during the epidemic.

However, on the other hand, the application of ventilators is a highly specialized field. In critical care medicine, a ventilator is not merely a machine; different brands and types require professional personnel for installation, debugging, and calibration, each with its specific scope of application. During this pandemic, however, many emergency ventilators, even home-use ventilators and anesthesia machines modified into ventilators, were used for rescuing COVID-19 patients in ICUs. Many distributors unfamiliar with ventilators rushed to purchase them, driving up prices and leading to widespread chaos in the ventilator market.

Although the ventilator market is plagued by numerous irregularities, overall, the pandemic will accelerate industry development for professional ventilator manufacturers. As the surge in orders driven by the pandemic subsides, how can domestic ventilator brands sustain their momentum and achieve import substitution in the post-pandemic era? VCBeat interviewed Yang Ning, Chairman of Rongxin Medical.

Rongxin Medical was established in 2015, with its founding team comprising R&D and operational elites in the domestic ventilator field. Over the past five years, Rongxin Medical’s ventilator solutions have included the iBreeze series of home ventilators, ICU critical care solutions, and the ResAssist Respiratory Cloud Platform. The RS series of critical care ventilators from Rongxin Medical is the first domestically produced ICU ventilator to integrate both invasive and non-invasive ventilation, featuring multiple ventilatory modes.

As a leading domestic manufacturer of ventilators, Rongxin Medical has been providing professional support for epidemic prevention and control efforts both in China and abroad. Around February 10, upon learning of the rising number of severe COVID-19 cases in Wuhan, Rongxin Medical made early predictions regarding the pandemic and responded swiftly to the public health emergency. The company mobilized all its resources to deliver donated ventilators to Wuhan Tongji Hospital and other major hospitals across China.

During the outbreak, Rongxin Medical also donated its RS300 series ventilators to hospitals in Wuhan. This ventilator integrates high-flow oxygen therapy, non-invasive ventilation, and invasive ventilation modes. Notably, the single-limb circuit configuration in its non-invasive ventilation mode significantly enhances patient comfort, earning acclaim from physicians at renowned Grade A tertiary hospitals.

Yang Ning stated: "Everyone had assumed that we could breathe a sigh of relief after the peak of the domestic epidemic passed. However, the global outbreak of COVID-19 has prolonged the frontline of pandemic response, with China becoming a major supplier to alleviate the worldwide shortage of ventilators. As the number of confirmed COVID-19 cases continues to rise in countries such as the United States and Italy, ventilators have become critical strategic resources, drawing global attention to their production capacity and output."

Prior to the pandemic, Rongxin Medical’s products were sold in more than 60 countries and regions worldwide. Rongxin’s home ventilators are the only Chinese products included in the national health insurance systems of Germany and Spain, and the company maintains close collaborative relationships with health insurance service providers. In the realm of medical-grade ventilators, Rongxin Medical partners with top-three global medical device distributors to establish a presence in international markets. Currently, the company is also working with globally renowned enterprises such as Linde and Air Liquide to advance healthcare solutions for Obstructive Sleep Apnea (OSA) and Chronic Obstructive Pulmonary Disease (COPD).

This laid the foundation for Rongxin Medical’s overseas aid efforts during the pandemic. Since March, Rongxin Medical has received orders for tens of thousands of ventilators from countries around the world, including Germany, Italy, Russia, and the United States.Recently, Rongxin Medical obtained approval for Emergency Use Authorization (EUA) from the U.S. FDA, and will launch its products in the U.S. market.

“Across our entire company, we have spared no effort in providing ventilator supplies to the epicenter of the pandemic and delivering remote training on ventilator use to distributors and healthcare professionals. Since the beginning of this year, our marketing, supply chain, customer service, and R&D teams have worked in seamless coordination to deliver the most efficient support to our customers.”

Ventilator production has drawn global attention, bringing every link of the previously little-known ventilator industry chain into clear public view. Within China’s ventilator industry chain, shortages of upstream components and a lack of high-end products represent key weaknesses.

The founding team of Rongxin Medical has witnessed the development of China’s ventilator industry. In addressing the global shortage of ventilators, Yang Ning believes that, in addition to exposing problems in China’s upstream supply chain, the pandemic also revealed a shortage of respiratory therapists on the downstream end, particularly in China.

“Respiratory therapists play a crucial role on the front lines of epidemic treatment and prevention. While more than 23,000 medical personnel were deployed to Hubei Province to support the fight against the pandemic, only about 140 respiratory therapists were among those providing frontline assistance.”

Respiratory therapies encompass a wide variety of types, brands, and models, including conventional oxygen therapy, high-flow nasal cannula (HFNC) oxygen therapy, non-invasive ventilation (NIV), and invasive mechanical ventilation. For non-specialist healthcare personnel, achieving proficiency in the operation of diverse respiratory therapy equipment within a short timeframe presents considerable challenges. In contrast, respiratory therapists leverage their specialized expertise to rapidly set up and operate various respiratory devices, promptly monitor pulmonary function in critically ill patients, and provide physicians with robust clinical assessments.

In addition to the rapid setup of ventilators, once a patient is placed on mechanical ventilation, the scope of practice for respiratory therapists extends to monitoring and delivering respiratory support, airway management, cardiopulmonary rehabilitation, routine management and maintenance of ventilators, as well as the formulation and implementation of respiratory care plans. Beyond mastering specialized medical knowledge, respiratory therapists must also possess proficient clinical operational skills.

Even in normal times, without public health emergencies, China faces a severe shortage of healthcare professionals engaged in respiratory therapy.

Respiratory therapy has a history of more than 50 years in the United States, whereas respiratory therapists represent an emerging profession in China. On March 3, 2020, the Ministry of Human Resources and Social Security, jointly with the State Administration for Market Regulation and the National Bureau of Statistics, announced 16 new professions. This marks the second batch of new professions released since the promulgation of the 2015 edition of the Occupational Classification System of the People’s Republic of China, and includes “respiratory therapist.”

The outbreak of this epidemic underscores the need to strengthen public health infrastructure. Empowering primary healthcare institutions to implement respiratory health management will be one of the key approaches to addressing residents’ difficulties in accessing medical care and their limited health awareness.

“By strengthening primary healthcare, improving training and assessment mechanisms for standardized respiratory care, and implementing screening, evaluation, treatment, management, and follow-up at the grassroots level, comprehensively enhance the level of respiratory health management in China. Establish medical consortia across cities, form medical alliances at the primary care level, create specialized respiratory care alliances, learn from this epidemic, summarize experiences, and prioritize these efforts.”

This is also the original intention behind Rongxin Medical’s launch of its intelligent cloud information system. By leveraging intelligence and digitalization, the system aims to enhance the service quality and efficiency of healthcare institutions, enabling patients to receive professional diagnosis and treatment services from home. Meanwhile, it facilitates the decentralization of high-quality medical resources, narrows the gap in tiered diagnosis and treatment, establishes a collaborative respiratory specialty alliance, and enables two-way referral and treatment within the field of respiratory health.

The ongoing pandemic has introduced greater uncertainty across all industries. For domestic ventilator manufacturers in China, the fact that the epidemic is generally under control within the country has positioned Chinese manufacturers as the primary global suppliers of ventilators. This presents both challenges and opportunities for these domestic manufacturers, with the pandemic serving as a catalyst driving changes in the landscape of China’s ventilator industry.

At the time of Rongxin Medical’s establishment, there were very few domestic manufacturers independently developing ventilators in China, and the Chinese ventilator market was long dominated by European and American brands. To date, a number of Chinese ventilator brands have emerged. These domestic manufacturers have also played a significant role in addressing the shortage of ventilators overseas.

According to data released by the Ministry of Industry and Information Technology on April 8, Chinese ventilator manufacturers have cumulatively supplied nearly 29,000 ventilators nationwide, including nearly 18,000 to Hubei Province (of which 3,000 were invasive ventilators). Additionally, nearly 18,000 ventilators of various types have been supplied to foreign countries, including more than 4,000 invasive ventilators.

The surging epidemic, like a tidal wave, has drawn attention to domestic ventilator manufacturers. The impact of the COVID-19 pandemic on these manufacturers extends far beyond a short-term surge in orders; it is quietly reshaping the landscape of China’s ventilator industry.

“I believe Chinese enterprises played a very important role during this epidemic. Many companies strengthened the influence of their national brands by quickly responding to domestic and international demands, laying the foundation for subsequent import substitution and global expansion.”

For enterprises like Rongxin Medical that have established a presence in overseas markets, the current pandemic has helped build brand influence.

Next, Rongxin Medical will continue to expand its overseas presence. Aligning with national development strategies and following the Belt and Road Initiative, the company will establish distributor networks in relevant markets. Meanwhile, it will pursue international collaborations to enter European and American markets.

From the perspective of internal industrial upgrading, Yang Ning believes that as the pandemic subsides, domestic enterprises are expected to strengthen R&D in weak links and restructure their supply chains. During the pandemic, domestic ventilator production capacity was primarily constrained by upstream raw material supply chains, with a significant impact stemming from the supply of core components. In the post-pandemic era, Chinese brands will be incentivized to restructure their supply chains by identifying alternative suppliers for key components within the domestic market. This shift is likely to drive a comprehensive upgrade of China’s ventilator industry chain, increase R&D investment, address shortages in the supply of core components, and enhance market competitiveness. Meanwhile, demand for ventilators will persist, with the industry size poised for rapid growth and gradual import substitution.