Ventilators, Much More Than an Entrepreneur Initiative

CONACYT is Mexico’s reference for scientific development. This council is a supporter of research and development in the country, which is why it was expected to collaborate in research efforts as soon as COVID-19 reached Mexico. It was on April 3 that CONACYT announced a series of actions to collaborate with the projects and efforts that the Ministry of Health was conducting. Among its actions, the council highlighted the development of AI tools, design and manufacturing of ventilators and respirators and a collaboration on clinical trials for existing medicines.

On the designing and manufacturing of ventilators, CONACYT said that its Industrial Engineering and Development Center had the manufacturing capacity to produce those medical devices and that scholars where already developing a prototype which would be submitted for approval to the Ministry of Health and would soon go to COFEPRIS for certification. The council also intends to ask CANACINTRA to join efforts, alongside the manufacture industry, to build a supplier network for mass production of ventilators and respirators.

Yesterday, April 23, the Head of CONACYT, María Elena Álvarez-Buylla, announced that the assembly of the ventilators will be ready by May 15 and productions will be destined to hospitals treating COVID-19 cases. She highlighted these products would comply with quality and biomedical safety requirements and would be much more affordable than foreign equipment. Álvarez-Buylla said that the prototype was based on an open model that MIT released in response to the COVID-19 crisis and that electronic parts will be donated by companies.

In an interview for Mexico Business News, Biomedical Engineer and founder of TINC CMMS, Luis Fernández exposed the importance of proper development and manufacturing of ventilators or any other medical device. “In the medical devices industry, there are companies fully dedicated to testing the electrical safety of a device. While some products are still prototypes, their purpose is to be used by medical staff, which pushes them to comply with basic standards for medical devices, such as the IEC 60601,” he stated.

Based on the announcement from CONACYT, ventilators will address two of the main concerns in the medical device industry, which are COFEPRIS approvals, that basically guarantees a safe use and right production, and also a plan-based development of the product.

While Mexico is a hub for medical devices manufacturing, technology is hardly developed here. Fernández explains that the national industry has the potential to grow but there two things stopping it, the first being technology. “We have now come to realize our dependence on technology. We might be a hub for medical devices manufacturing but our industry is not well-enough established to create the technology of the medical device.” CONACYT has said that it developed two ventilators and that one of them came from Mexican company Dydetec. The ventilator has been on trials with living beings and artificial lungs, gaining COFEPRIS approval.

Entrepreneurship has been a very strong and helpful actor on developing ventilators for the crisis, although some efforts have been more successful than others as there are many norms to comply with given the importance of these devices. On the subject, Luis Fernández says that Mexico has demonstrated its unity as a country. “Just look back at the earthquake in 2017 when the support shown by society was overwhelming. But this situation is far more delicate; while the motivation and good will of people might be pure hearted, it is not that simple. By itself, the equipment implies a risk to the person that will use it, whether it is a mechanical, electrical or biological risk.”

Nevertheless, the Ministry of Health, being aware of the crisis that might ensue due to the lack of ventilators, has said that production and imports of ventilators will no longer need a sanitary registry and that complying with a series of requirements will be enough to guarantee the safety of the devices. This with the objective of having enough ventilators for critical COVID-19 cases.