translated from Spanish: They create low-cost fan, but gets their approval in Conacyt

Mexican company Med Evolution developed a prototype invasive mechanical fan to care for critical COVID-19 patients that would cost about 20 or 30 thousand pesos and be distributed non-profit, according to its director, Kurt Nyssen.
But the process to materialize its creation is stuck in the National Council of Science and Technology (Conacyt), which for two and a half months received the prototype for evaluation and has not given an answer, neither favorable nor adverse.
Conacyt’s validation is just the first of three needed, according to the «Flowchart for approval of invasive fans in Mexico during the COVID-19 contingency», although the same document clarifies that flows can run in parallel to accelerate the outcome in the face of the health emergency.
The second agency involved is the Salvador Zubirán National Institute of Medical Sciences and Nutrition, where function tests must be done on an artificial lung and pigs.
Read: Mechanical Fans: What Must You Have to Keep a Patient Alive?
Although since June 22 Med Evolution did these tests with satisfactory results and support from the Institute and insisted on Conacyt, the response of the Directorate of Technological Development was that it «takes a little time to consider the workload», according to an email to which Political Animal had access. According to Nyssen, the first month and a half had not even answered their emails, until they began to press directly at the agency’s offices.
Without this prototype assessment, it cannot reach the final step, which is the temporary permit for its production and marketing, of the Federal Commission for the Protection of Health Risks (Cofepris).
Conacyt was asked why this delay and the first response was that the authorization depended on Cofepris but the subject would be revised, although there were no further comments afterwards.
Two weeks ago, Conacyt introduced two fans, with the names Ehécatl 4T and Gotsi, whose development coordinated and presented as «the first 100% Mexican fans», although they arrived two months late from the goal of having them ready on May 15, as announced a month earlier at the evening conference on the coronavirus pandemic.
At the launch, director María Elena Alvarez-Buylla delinfied the Conacyt from being the one who authorizes the prototypes and said that it is absolute attribution of Cofepris, despite this participation in the first stage of evaluation that is marked in official government documents.
Valve fan at 20 thousand pesos
Fans to address the coVID-19 sick emergency have been purchased in up to 1.5 million pesos from The company of León Manuel Bartlett Alvarez, son of the director of the Federal Electricity Commission (CFE), Manuel Bartlett Díaz, and in other cases cost about 800 thousand pesos.
Nyssen says in interview that real prices are even lower, but the industry has taken advantage of the urgency, and the model your company develops would be much cheaper and could be manufactured up to 300 in a week.
«More or less a fan with the same functions as this fan is around between 600 and 400 thousand pesos. We plan to make it a non-profit project. All the technology, the engineering put flex, which is an American company, we have invested a lot in the development, administrative issues, we have a complete team that is working, and our fan is going to cost 20 times cheaper than those of commercial firms, say. And said by the Institute of Nutrition, this fan has a lot more capabilities than others,» he says.
Read: Treasury and Conacyt agree not to apply cuts to research center budget
Manufacturing would be done at a Flex company plant in Aguascalientes, although all the work to develop it was done in Jalisco. That’s where nyssen explains the idea, in the meetings of the committee formed by the local government to deal with the pandemic, in which both the public, private and academic sectors participate.
«One of the company’s plants that helped with the development is there, and Jalisco wants a thousand fans and we’re going to give them the cost. So it’s an abyss to what they’d sell. We do have other contracts with government, but we’re putting up a grain of sand,» he said.
It is an invasive valve fan (others may be pistons, such as one presented by Conacyt, turbine, or a model called Ambu), which has yielded better results for use in adults or children.
They’re about to get the F certificate tooDA that gives the United States and would allow its commercialization in several countries of the world, while in Mexico they are still waiting for the evaluation of the Conacyt.
 
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Original source in Spanish

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