Production of the first respirator from Bosnia and Herzegovina (BiH) in Gradacac could start in the middle of this year, after a clinical examination of the device, which is planned at the University Clinical Center (UCC) in Tuzla.
A year ago, a team of experts from TMD Group from Gradacac, with the support of medical professionals from the UCC in Tuzla, created a prototype of the first BiH respirator.
To recall, the Prime Minister of the Federation of BiH, Fadil Novalic, is responsible for the establishment of the TMD Group. Although his name is not currently in the register of company’s founders, Novalic is connected with the founding of this company, according to his confession, back in April last year.
A few months after, more precisely at the end of last year, the device for artificial respiration of severe patients received a certificate from the Center for Testing and Evaluation of Medical Devices (MD-TEC) in the United Kingdom (U.K.), which confirms that the respirator achieves a high level of functionality in an intensive care department.
Tests in UCC Tuzla
This opened the door for its further development, with clinical testing and certification of components. The procedure for testing the functionality of this device will be performed at the UCC in Tuzla, and apart from the domestic experts, professionals from the U.K. will also participate in it.
“The UCC in Tuzla has already signed a contract with our company, and this will now happen with the British Clinical Center as well. The whole process will be carried out in BiH and we expect it to be completed by this summer,” said Adem Hanic, the director of TMD Group.
The company’s certification process is underway
For the needs of the production of the first BiH respirator, company TMD Group previously founded the company “TMD Medical Components and Devices” and it’s currently in the process of its certification.
“We have hired a consulting company that is currently working on the certification process in cooperation with authorized European centers. We hope that all this will be completed by the summer, after which we would start with the respirator production. Unfortunately, all procedures are extremely slow here, and so are these that we mentioned, ” added Hanic.
This idea about the creation of the first highly sophisticated device in BiH was made at the beginning of the coronavirus pandemic, which caused a great demand for respirators in the world market.
The prototype of the artificial respiration device in Gradacac was created based on one of the respirators, owned by the UCC in Tuzla, and shortly after that, it was redesigned and then sent to the U.K. for testing.
In its final form, BiH respirators will be intended for the European and world market, and the Gradacac company will also be engaged in the development and production of other medical devices and equipment, such as oxygenators, electromechanical beds, surgical knives, other devices, etc. In this way, a new branch of industry that has not been represented in BiH so far will come to life, Klix