Understanding Medical Devices (DM) and Their Unique Challenges
Unlike medications that rely on a limited number of molecules, medical devices (DM) encompass an overwhelming diversity. This range includes simple wound care items like syringes to complex anti-infective dressings and diagnostic equipment with integrated software. Globally, the DM industry produces around 2 million distinct product models.
In Mexico, the DM industry holds significant manufacturing importance. Unlike pharmaceuticals, which dominate health policies, DM requires a tailored approach due to their rapid innovation and specific logistical needs. Joao Carapeto, the new president of the Mexican Association of Innovative Medical Device Industries (AMID), explains that DM face unique challenges, such as short shelf lives, specialized storage conditions (sometimes similar to biologics), and regulatory registrations lasting up to two years, compared to the five-year requirement for medications.
Regulatory Hurdles and Innovation Paradox
The complexity of DM logistics, combined with rapid innovation, sets the industry apart from pharmaceuticals. For instance, a device can be updated with new software, sparking regulatory debates on whether the change is minor or major. This process slows down their integration into healthcare systems.
Global DM Challenges and Mexican Progress
The global challenge for DM lies in their diversity and complexity, necessitating a paradigm shift in perception and management. While medications dominate health policies, DM’s rapid innovation and specific logistical needs require agile and differentiated regulatory frameworks.
In Mexico, Cofepris has made strides in understanding this, but the General Health Council (CSG) still needs to update the National Compendium to reflect DM innovation. AMID has initiated dialogue with President Claudia Sheinbaum and Health Secretary David Kershenobich, presenting a strategic framework based on “4 Is” — Innovation, Impact, Inclusion, and Integrity — aligning with Mexico’s Plan México, the “Healthy Republic” commitments, and sectoral programs.
AMID’s Proposals for Improved DM Sector
The DM industry aims to contribute to better planning for future public sector purchases in Mexico, avoiding the pitfalls of the 2025 procurement experience. AMID proposes improving purchase planning, optimizing regulatory processes at Cofepris (which has shown progress in distinguishing DM from medications), and strengthening logistics with distributors.
The DM industry in Mexico generates over $15 billion and 130,000 direct jobs with highly specialized personnel, positioning the sector as an economic and public health pillar.
Government Debt and Collaboration
Regarding supply issues, the industry advocates for collaboration with the government to plan more effective consolidated purchases. Authorities responsible for procurement are also open to dialogue with provider associations, including AMID. However, they remain entangled in the aftermath of canceling the 2025 consolidated purchase, which exposed planning failures.
The 165 problematic areas highlighted the difficulty in managing single-source, high-demand products requiring multiple suppliers. Additionally, the government’s debt to DM providers—1.6 billion pesos for AMID members and Canifarma providers—complicates matters, limiting companies’ ability to invest in manufacturing and logistics.
Despite these challenges, AMID aims to be a key solution actor by working with distributors to strengthen the supply chain and ensuring DM are better understood, distinct from pharmaceuticals.
