The biomedical sector is characterized as one of the most competitive, which means that companies have to implement highly efficient work models and complement them with quality review systems that provide total certainty that products comply with all standards and regulations.

For Jackie Buttler, CEO of Bio El Paso-Juárez, companies in the region oriented to the biomedical sector must implement highly efficient quality management systems and complement them with work models focused on the maximum use of resources, such as lean manufacturing.

Due to the large presence of the biomedical industry in the region, with more than 40 plants that employ 40,000 border residents, a perfect ecosystem has been created to encourage innovation.

Ricardo Gomez, explained to Mexico Industry, that several regions in the country, such as Juarez, are fertile ground to be referenced in innovation. However, to achieve this step it is necessary to extend the purposes of the industry in the areas beyond manufacturing.

One of the most important challenges faced by the different zones that host the industrial sector in the country is the lack of knowledge of the different sanitary regulations to which medical devices are subject. The position of some representatives, such as Jackie Buttler, is to maintain training for the workforce to help them adapt to the big picture and encourage innovation.

“Training the manufacturing workforce is critical to developing a strong medical device cluster that competes globally,” said Jackie Buttler, for Mexico Industry.

With the involvement of diverse members of the border region, the biomedical sector can address this issue from several fronts. Educational institutions are one of the main drivers since they offer engineering programs aligned to the interests of the industrial sector, and even programs fully integrated into the industry, such as biomedical engineering.

In addition to this panorama, the creation of links with governmental organizations such as the Secretaria de Innovación y Desarrollo Económico del Estado de Chihuahua and the AXIS Institute to continue improving quality by promoting innovation in the biotechnology industry must be added.

Should quality plans be established in the manufacture of medical equipment?

The biomedical industry is one of the strictest in its production processes; each step the product goes through is guaranteed to meet the high-quality standards required by the sector.

The need for a well-structured quality plan does not only lie in the search for competitiveness, as they are part of the strict rules required by the FDA or ISO 13485, which cannot be ignored. No one can afford to leave quality planning for “later”.

According to ISO 13485 “Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured.”

Each manufacturer can structure its quality plan according to the services and products they offer. This allows them to generate systems that let them adapt to changes in their processes or after the inclusion of new products.

The truth is that aside from giving companies a safe space in the industry, keeping them competitive, and an excellent platform to innovate, having a well-structured quality plan will give your team the necessary tools to know which guidelines to follow to achieve the highest quality standards in the manufacturing of medical equipment.

Aware of these benefits, in Bio EPJ we continue to form the necessary alliances to encourage companies to comply with the necessary certifications and know the regulations, to have the way ready for the development of new ideas that transform the industry.