Medical device manufacturing in Mexico is carried out by some of the biggest names in the industry. These include well-known global powerhouses such as Medtronic, Kimberly Clark, Boston Scientific, Johnson & Johnson, GE, Tyco, Siemens and Cardinal Healthcare, Becton Dickinson, 3M, Stryker Incorporated and others. The medical device industry in Mexico is also populated by globally known major and mid-size EMS service providers that dedicate a significant portion of their production to medical device customers, as well as contract manufacturers of medical devices.
According to Mexico’s National Institute of Statistics and Geography (INEGI) the aggregate value of production derived from medical device manufacturing in Mexico in 2011 was an estimated US $8.6 billion. The same organization expects that the value of medical device production in Mexico will continue to rise throughout the decade and will total nearly US $15 billion by 2020.
A combination of factors that include a skilled workforce, proximity and access to one of the world’s largest consumers of medical devices and a globally competitive wage structure will propel continued growth in medical device manufacturing in Mexico. The internationally known and respected research firm, Global Insight, has expressed that these factors will contribute to Mexico’s achievement in the medical device production sector of 6.4% annually through the end of the present decade. This rate of expansion will outstrip other countries prolific in the production of items for the healthcare industry such as Japan, Germany, Switzerland and Canada. The value of production of medical device manufacturing in Mexico may also get a lift from U.S healthcare policy, as well. As of January 1, 2013, an exise on the gross sales of medical devices in the United States was imposed as a result of the initiation of provisions included in the Affordable Healthcare Act (ACA), also known as Obamacare. It is anticipated that, in some instances, rather than passing on additional cost to the customer, medical device manufacturers will opt to reduce their cost of production by establishing medical device manufacturing operations in Mexico under the maquiladora, or IMMEX, program.
According to the country’s Ministry of Economics, most medical device manufacturing for export in Mexico takes place in nine of Mexico’s thirty-one states. Approximately seven hundred and fifty manufacturers of products for the healthcare industry can be found distributed among the states of Baja California, Chihuahua, Coahuila, Jalisco, the State of Mexico and the Federal District, Jalisco, Nuevo Leon, Sonora and Tamaulipas. The Mexican state with the most medical device manufacturers in Mexico is Baja California, with the State of Chihuahua following in second position. Products exported by companies that are engaged in medical device manufacturing in Mexico produce items that include: disposables such as catheters and cannulae, medical gowns, surgical kits, respiratory therapy equipment, splints, orthopedic devices, surgical and dental instruments and equipment, medical drapes, custom fluid pouches, medical grade sewn products, thermoformed products and a wide range of other devices, instruments and products. According to FDI markets, between 2003 and 2011 twenty three projects involving medical device manufacturing in Mexico were came on-line. The orgin of the bulk of the capital used to make these investments had its source in the United States and Western Europe.
Over the years, medical device manufacturing in Mexico has progressed to include the production of sophisticated Class III devices. Class III devices have the most stringent controls and usually support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury to the patient. Products that are manufactured medical device facilities in Mexico undergo the same scrutiny and compliance as is required for Class III devices in the United States.