Articles by Julio G. Martinez-Clark

  1. The Cybersecurity Void In Mexico: Why Your FDA-Compliant Device Might Still Fail 2/20/2026

    While Mexico's health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has emerged with ad hoc stringent cybersecurity requirements.

  2. Navigating Brazil's Medical Device Clinical Trial Import Process 1/27/2026

    When medtech sponsors plan clinical trials in Brazil, many overlook a critical bottleneck that can delay trial launches by months: the process of importing clinical trial materials.

  3. The Synthetic Control Mirage: Why Your Medtech RWD Strategy Will Fail In Latin America 1/13/2026

    Regulators are actively encouraging medtech companies to use real-world data and synthetic control arms. Here's why this is currently incompatible with Latin America's fragmented RWD infrastructure, though this will change in the years ahead.

  4. Beyond Recruitment: A Practical ROI Model For Integrating Community Health Workers Into Medtech Trials 10/22/2025

    The medtech industry desperately needs — and currently lacks — a practical trial-specific financial framework to build a compelling business case for community health workers.

  5. The Balkan Puzzle: Using Non-EU States As A "Pre-MDR" Proving Ground For Your Device 10/3/2025

    The EU's Medical Devices Regulation (MDR) has introduced a new level of rigor. A sophisticated, yet practical, strategy is emerging: leveraging non-EU Balkan countries as a "pre-MDR" proving ground. 

  6. Emerging Markets Are Pioneering Hybrid Clinical Trial Models For Medtech Products 8/25/2025

    This article shares insights into how Latin America, southeast Asia, and Africa are pioneering hybrid clinical trial models for medtech products.

  7. Latin America Is Becoming The Testing Ground For AI-Enabled Medical Device Clinical Trials 8/7/2025

    This article explains why Latin America's demographic diversity, cost profile, and accelerating digital health infrastructure make it an ideal region for AI-enabled medical device clinical trials. 

  8. Medical Device Innovation In Brazil: Success Stories And Future Opportunities 7/28/2025

    Brazil is rapidly establishing itself as a powerhouse in medical device innovation. This article shares market opportunities, success stories, and strategic recommendations for medical device manufacturers.

  9. Brazil's Competitive Edge: Infrastructure And Operational Advantages For Medical Device Trials 7/10/2025

    Explore the practical advantages that position Brazil at the forefront of medical device clinical trials in the region.

  10. Brazil's Regulatory Revolution: How New Laws Are Transforming Medical Device Clinical Trials 7/3/2025

    Brazil is experiencing a regulatory revolution that is fundamentally transforming its medical device clinical trial landscape.