The majority of existing and new companies in the medical device industry do not complete their own manufacturing, production, assembly, and packaging. Instead, these specific tasks are outsourced to contract manufacturers with the ability to meet specific industry standards for part production, clean room assembly, and other quality control standards that are required.
In the past, OEMs in the United States often outsourced production and assembly to companies outside of the USA, which may have offered lower production costs than contract manufacturers inside of the country. However, issues with supply chain management, constantly changing regulations and requirements, and even government and trade issues can make this a challenging proposition.
A solution to this problem is to work with a US-based contract manufacturing company offering medical device manufacturing in Mexico.
Factors to Consider
Using a US-based contract manufacturer with the capability to provide medical device manufacturing in Mexico allows the OEM to take advantage of lower production costs outside of the USA while still ensuring the processes and the facilities are ISO compliant.
The contract manufacturers offering medical device manufacturing in Mexico have established supply chain and logistics, ensuring on-time or Just-in-time deliveries can be provided. With many of the plants in Mexico located very close to the border, they provide easy access to US shipping and trucking routes, helping to reduce time and shipping costs for the OEM.
This is also a benefit for the OEM with the need to inspect or to view the production facility. When the plant is close to major American cities, including San Antonio, TX, it is a simple process to schedule a time and view the facility, getting a personal perspective on the production methods and quality control processes in place.
