USMCA, Other Advantages Propel Medical Devices Sector: AMID

Q: What is your reaction to US President-elect Joe Biden’s promise to “return” jobs in the medical devices sector and reduce US dependence on foreign countries in this area?

A: Mexico has more than one medical devices cluster. The two most important are in Chihuahua and Tijuana, with the latter hosting around 70-80 companies. These two clusters focus on manufacturing for foreign and national consumption. In this regard, AMID remains confident in the USMCA, as we worked alongside the Ministry of Economy on the development of the medical devices chapters within the agreement. The country complies with the best regulatory practices and conformity certificates, meaning that Mexico has been a convenient destination for mass manufacturing of complex and specialized devices for more than 20 years.

Joe Biden’s promise is understandable but the agreements we have with the US are backed up by the USMCA. Mexico exports 80 percent of the medical devices it manufactures to the US. Many commercial rules allow companies to manufacture in Mexico under the same terms that are applied in the US, which facilitates trade of such devices, considering rules of origin and other matters. Mexico’s highly qualified workforce is another great advantage for the country. We have experts on quality, regulation and conformity certificates and we are confident of remaining a competitive hub for medical devices for export to the US. I am looking forward to working alongside the government to attract new investment from the US.

Mexico also is looking forward to obtaining significant raw materials to build components required by medical devices to strengthen our production capabilities, including the production of disposables, metal devices and plastic components.

Q: How far along is AMID’s proposal to introduce better regulatory standards for medical devices?

A: AMID is part of the Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector and just as we have been pushing regulation in Mexico, we are also doing it in the Americas. Regulation can generate better quality products and significant savings on supply manufacturing through standardization but, importantly, it provides a feeling of safety on the part of the patient because they know that the same device that is being used on them is being used in other countries in Latin America.

One challenge we have faced is the presidential and Ministry of Health mandates regarding equivalence agreements. This has changed supply paradigm, with UNOPS now joining the party. But we are confident of a positive outcome once doubts have been cleared away.

Q: How have the changes to public tenders impacted the medical devices industry?

A: We understand the need for the government to provide medicines and medical supplies to everyone in the country and we are certain we can be a primary ally for the government, rather than relying on foreign manufacturers. This measure goes against promoting local manufacturing and, therefore, is not beneficial to the sector and its future.

Q: What is required for Mexico to achieve more final production of medical devices in the country?

A: We will begin to manufacture final products in the country when the Mexican government recognizes how important this sector is as a generator of health and starts to support the industry, alongside prioritizing local consumption over foreign consumption. This implies additional responsibility in terms of security, so the industry can reduce the risk of black-market sales. It also implies a commitment to device and technology adoption within the public sector. Furthermore, Mexico would have to create protocols that standardize the use of medical devices, which would ensure the availability of and access to homogeneous equipment and technology regardless of location. The idea is to build an affordable and accessible system that responds to the diverse needs of the population, considering demographic differences.

Q: How did the sector respond to the needs of the COVID-19 pandemic?

A: We were very attentive on how the pandemic was progressing since the outbreak was first detected. In February, AMID sent out a letter directed to the Minister and Deputy Minister of Health as well as to COFEPRIS and the Ministry of Economy mentioning all the medical technologies at AMID’s disposal. The list included many supplies, from face mask to ventilators. We also offered to work alongside them to start building a comprehensive approach to the needs in Mexico and create a response strategy. Due to the crisis, we did not receive an answer; however, the association’s company members did receive individual requests that where fulfilled. Later on, we met with the Ministry of Economy because, as a world class economy, we needed to build a plan to prepare the availability of medical devices for the crisis. While Mexico is the main exporter of medical devices in Latin America, and the eighth-ranked producer worldwide, the country does not consume those devices. We are large producers but the complexity of each device and their calibration makes it necessary to export them for assembly.

During the pandemic, AMID and all its company members committed to continue working because we are an essential sector and this drove companies to ensure their plants were safe and to develop strategies to protect their collaborators and continue offering their services.

The manufacturing of all devices used during COVID-19, from personal protection supplies to ventilators, multiplied by 10. This has been the largest growth we have experienced; however, we remain committed to non-COVID-19 patients who are experiencing other ailments. To this end, AMID and the pharmaceutical industry generated a care protocol within hospitals to ensure doctors could continue practicing safely.

Q: What has been your experience as a female leader in the healthcare industry?

A: Since I entered this industry, the environment has changed drastically. In the past, when I entered a meeting, I would be the only women in the room. But the medical devices sector is highly innovative and dynamic and this has helped open the doors to women. AMID has five committees and women make up around 60 percent of the members. Our leadership in the industry is still limited but I am happy to see that each day there are more women heading important companies and being properly recognized.

The Mexican Association of Innovative Medical Devices Industries (AMID) gathers global leaders in innovation of medical devices and diagnostic systems to work toward the advancement of health services in Mexico.