MassVentil: A New Mass Ventilator Solution For Crisis Situations

The MassVentil mass ventilation system, currently under development by MEDICOR Zrt., may offer a new solution for mass ventilation required during crisis situations. The device will be capable of ventilating and monitoring numerous patients simultaneously, which is extremely important in the treatment of mass casualties. Its design takes into account the use in industrial, chemical, or wartime scenarios, enabling the military and disaster management authorities to utilize it as well. The first prototype is expected to be completed by the end of 2022, following which the system can be tested and refined, and eventually, mass-produced and widely applied.


According to Attila Vincze, the chief engineer of MEDICOR Zrt., the development of such a system poses several professional challenges. He mentions the original idea, which was based on the thought that patients could be ventilated in some way even if the necessary and vital tools are missing, just like they were during the first and second waves of the Covid-19 pandemic, when they disappeared from the world market. As Vincze explains, such a device that does not comply with the requirements for medical devices in peacetime (e.g., CE marking) cannot be released on the market. Therefore, the revised MassVentil system design has been made compliant with the CE marking requirements of the EU for medical devices, as well as for disaster management and military applications, either as a whole or in module units.

Progress and Pitfalls: Developing the Integrated MEDICOR MassVentil Device

Regarding possible technical pitfalls, Attila Vincze reports that during the development of the prototype, numerous requirements and often partially conflicting demands have to be met. Many tests cannot be conducted by the company’s experts in Hungary, and many external expert companies must be involved in the project.

He also states that the project is progressing well in terms of the main units, with the medical gas supply unit capable of producing gas of medical quality under extreme conditions in the process of assembly, and the necessary certification process has also started. The design of the “ward section” is also in progress, and the final ventilation units are being integrated.

Regarding the future application of the mass ventilation system, the specialist states that the MEDICOR MassVentil is a highly integrated device, in contrast to a heterogeneous system made up of many different devices found in a general intensive care unit (ICU), whose components users must learn and interpret separately.

The plan is to present an integrated monitoring system that provides more accurate monitoring, including the data from the devices connected to the patient, with less administrative time and a more user-friendly system. According to the development plan, a unified digital dashboard with complete therapy tracking will also become available. The chief engineer predicts that in their future plans, they would like to develop an AI-assisted decision support system that enables fast, high-quality care even in the absence of an experienced medical team during crises.

Compliance with MDR and ISO 13485: Ensuring Safe Operation of the MassVentil

Regarding the details of implementation, he says that a long road leads to the creation of a product from an invention. A medical device must be designed for a lifetime, comply with all relevant standards, and based on these, a risk management plan and analysis must be prepared. This is followed by a detailed product description. Attila Vincze mentions among the further tasks that the clinical relevance and biocompatibility must be analyzed, and a plan must be prepared for the device’s conformity certification. This will be followed by the examination of operational/safety parameters in accredited laboratories, evaluation, and approval procedures. After a successful certification process, the product can be launched in the European Union.

The technical leader of the MassVentil project emphasizes that compliance with MDR (Medical Device Regulation) also requires tracking the product’s life and problems after its launch, constantly evaluating it, and taking necessary measures (recording, warning, etc., which also serve as the basis for further development). The expert emphasizes that the ISO 13485 system and the MDR compliance process ensure the product’s safe operation in the future. Currently, the experts of Medicor Zrt are working on compiling the documentation. The goal of Medicor Zrt is to have devices by the end of 2022 that are suitable for clinical evaluation and to realize a mass-produced medical ventilator that can be used in crises (even for the treatment of up to 24 patients simultaneously in the absence of hospital infrastructure), and that can be used in its entirety or in its components in public healthcare or in disasters, war conditions, refugee camps.

With these goals in mind, we are designing our system to be NATO and UNICEF and WHO compliant,” adds Attila Vincze.