The largest concentration of manufacturing in the medical device industry in Chihuahua is in the Ciudad Juarez border region.
An Overview of the Medical Device Industry in Chihuahua and in Guanajuato
The medical device industry in Chihuahua has developed a notable presence on the border at Ciudad Juarez over the last several decades. Currently, the Mexican city is home to 34 companies that are engaged in the production of many types of Class I, II and III devices. Among the specific items that are manufactured in Ciudad Juarez medical device factories are:
- Catheter-based devices;
- Orthopedic supports;
- Aortic and thoracic stents;
- Imaging equipment;
- Surgery kits;
- Electronic PCBAs for medical devices;
- Ophthalmic devices;
- Electronic and mechanical infusion pumps.
Although Ciudad Juarez has historically been best known for industries such as electronics and automotive, the medical device industry in Chihuahua increasingly stands out for the quality and complexity of its manufactured products.
The Medical Device Industry in Chihuahua Requires a Stable and Trained Workforce
One of the principal factors that ensures the quality of the medical devices that are manufactured in Ciudad Juarez is workforce stability.
Much of the reason for the permanence of laborers in the medical device firms there is the fact that it is one of the better remunerated industries in the city. While other activities in Ciudad Juarez may experience a turnover rate that is somewhat higher, the rotation of personnel that takes place among medical device manufacturers is generally between 1% and 3% annually. Additionally, the training that workers must go through at many of the companies is very specific. This is due to the quality demands that are common in for manufactured medical devices.
Although firms in the medical device industry in Chihuahua that are located in Ciudad Juarez routinely invest considerable resources in-house for the training of local talent, these companies occasionally recruit workers with specific skills sets from cities such as Guadalajara and Monterrey. Ciudad Juarez is, however, becoming more prolific in its ability to train local workers to meet its firms’ needs.
In many instances, companies in the medical device industry in Chihuahua and in Guanajuato are required to obtain particular quality certifications in order to conduct business. Examples of the types of quality designations that have been achieved by Cuidad Juarez device manufacturers include:
- ISO-13485-2016 – This certification is characterized by requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO-13485-2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
- COFEPRIS Good Manufacturing Practices – COFEPRIS is Mexico’s Federal Committee for Protection from Sanitary Risks. It is a department within the country’s Ministry of Health that regulates the import and export of medical devices. Its “Good Manufacturing Practices” program ensures that products are consistently produced and controlled according to quality standards that have been set by Mexico’s federal government.
- FDA rules in the U.S. – Foreign firms that manufacture medical devices that are imported into the U.S. must comply with applicable U.S. regulations before, during, and after importing their products into the United States or its territories.
Research and Development and Supply Chain Growth
Increasingly companies in the medical device industry in Chihuahua and Ciudad Juarez are involved in research and development. It is not unusual for plants in the region to have R&D units within them to design products that will be marketed now and in the future. Much of the investment in this activity has been made over the course of the last ten years.
Additionally, Ciudad Juarez continues to expand its base of suppliers to the medical device manufacturing sector. Over the last several years, growth in the industry has been organic, as its expansion has been marked by increased local output, widening customer base, and local new product development. Both medical device sector manufacturers and their local suppliers have brought new production lines to their plants in order to promote their capabilities and to begin new and challenging projects.