News Article

Harmonized Regulations Needed to Strengthen Medical Device Sector

By Sofía Garduño | Thu, 09/01/2022 - 09:49

Mexico’s medical device industry, one of the largest in the world, has been constrained by the perception of the country as a low-cost manufacturing destination. Investment on design and R&D, alongside efficient regulations, can help the country take the next step and become a technology developer, according to industry experts. 


In 2021, the global medical device industry was valued at US$500 billion. Thanks to its steady growth, the sector is expected to be valued at US$800 billion by 2030. Currently, Mexico is the eighth largest manufacturer of medical devices in the world, but its contribution consists mainly of manufacturing. However, the industry is also working on the development of new technologies. 


“Guadalajara has is one of the most important hubs for medical devices. Within Breakthrough IP Intelligence, we have realized that technology is gaining more importance in the country,” said Pablo Fuentes, Partner, Breakthrough IP Intelligence.


Manufacturing of medical devices is subject to compliance with rigorous quality standards and regulations. “There are two ways in which companies operate their quality systems. There are those that are only concerned with complying with regulations and those that are also motivated by productivity,” said Víctor Rivera, Vice President, Visional Technology. Companies that are only focused on regulatory compliance operate quality systems that comply with regulatory provisions but fail to develop significantly in the industry. But those that also prioritize productivity manage to implement robust quality systems. 


As the industry grows, its relevance increases, leading to the establishment of more strict quality standards. “As we move forward, it has been achieved to map every part of the process and identify where mistakes are being made which is the result of implementing quality systems,” said Martin Quintero, Regional Sales Manager and Medical Business Development, Zeiss. 


While regulations are necessary, excessive regulations can hamper the development and introduction of new products to the market. To face this problem, manufacturers must have flexible operations. “A strong manufacturing process, together with flexible implementation, would help to develop new technology at a low production cost with fast implementation and fast access to market,” said Quintero. 


Harmonizing regulations contributes to technology development, as it leads to uniform technical guidelines across participating authorities, according to the FDA. “Harmonization is the gateway to the markets and the expectation is good because the agreements between regulatory entities and certifying bodies are increasing,” said Sealtiel Vera, Business Development Director, ATRAMAT.


The disruption of supply chains caused by the COVID-19 pandemic forced countries to shift from a global to a regional perspective. Harmonization is helping companies to adapt more easily to the transformation of the global supply chain, as it is making it easier to enter new markets. “Companies need to be ready and informed about the regulations and key players in the chain in which they participate,” said Vera. “If we develop strategies based on regulatory intelligence, we can overcome some of the restrictions of a highly regulated environment.”


The pandemic also opened the door for new actors to enter the industry amid the shortage of supplies. “Before the pandemic, it was difficult to supply manufacturing industries, but now it is more viable. New suppliers can enter the market and existing ones have been able to expand,” said Rivera. 


While this scenario is bringing opportunities to manufacturers, it also poses challenges. Companies can make mistakes because “when resources suddenly arrive after shortages, the operation of a company turns into a race,” said Rivera. Additionally, manufacturers must find the balance between ensuring supply and quality through the correct development of suppliers, explained Vera. 


In these post-pandemic times, Mexico needs to build a resilient supply chain by understanding the market, its needs and trends. “The starting point is to understand the needs and determine which actors within Mexico can carry out this role,” said Rivera. Aside from a strong supply chain, the participation of the private sector is essential to boost the growth of the industry and to stop relying on the efforts of the government. 


Moreover, Mexico stands to gain relevance as a developer of medical devices and not just a manufacturer. “We have to show ourselves to the world as developers and stop thinking solely like manufacturers,” said Quintero.

Sofía Garduño Sofía Garduño Journalist & Industry Analyst