Shifting dynamics in Latin America and beyond are redefining early-phase execution — where speed, structure, and smart planning make all the difference.
first-in-human · clinical trial · regulatory · ANVISA · medical device · MedTech
Shifting dynamics in Latin America and beyond are redefining early-phase execution — where speed, structure, and smart planning make all the difference.
• Structure trials correctly in Mexico to avoid setbacks.
• Watch innovation gain ground across Latin America.
• See how early-phase work leads to approval success.
• Track where investment is shaping future trials.
Stay ahead by aligning strategy with execution from day one.
Delays in pharmaceutical approvals in Brazil are pushing sponsors to rethink how they approach clinical development in the region.
Navigating the regulatory landscape requires more than submission — it demands a clear strategy around timelines, agency expectations, and local processes. Sponsors that proactively align with ANVISA requirements and anticipate potential bottlenecks are better positioned to keep studies on track and avoid costly slowdowns.
As Brazil continues to play a central role in Latin America’s clinical trial ecosystem, understanding how to work with the system — not against it — is becoming a key differentiator.
What to Focus On: Success in Brazil often comes down to preparation. Early engagement, well-structured submissions, and local regulatory expertise can significantly reduce delays and improve overall study timelines.
Successfully bringing a medical device into Mexico requires a clear understanding of how regulatory responsibilities are divided on the ground.
A key distinction lies between the registration holder and the distributor — two roles that can significantly impact how efficiently approvals are secured, products are imported, and clinical activities are supported.
Key considerations:
• The registration holder maintains regulatory control and is accountable to authorities
• The distributor manages commercialization, logistics, and local market access
• Misalignment between the two can delay approvals and complicate operations
Aligning regulatory strategy with operational structure early on can streamline both clinical trial execution and downstream commercialization.
Practical Insight: Getting the structure right from the beginning isn’t just administrative — it directly impacts speed. Clearly defined roles and experienced local partners can significantly reduce friction across both clinical and commercial phases.
Does your company need accelerated first-in-human clinical trial results?
Overcome the complex landscape of first-in-human clinical trials with confidence. Whether you’re advancing Medtech devices, Biopharma therapies, or Radiopharmaceutical innovations, bioaccess® delivers expert solutions to help you succeed.
• Leverage 20+ years of expertise across Medtech, Biopharma, and Radiopharma first-in-human trials
• Navigate Latin America’s regulatory environment and access high-quality research sites
• Get tailored support for study design, approvals, site selection, and patient recruitment
Bring your innovations to market faster with Latin America’s first-in-human trial experts.
Schedule your first-in-human trial consultation at bioaccessla.com
Cutting-edge cardiac innovations are increasingly finding their way into Latin America, signaling a shift in where new technologies are being introduced and adopted.
The expansion of pulsed field ablation (PFA) — a next-generation approach for treating cardiac arrhythmias — highlights growing confidence in the region as a destination for advanced medical technologies. With its ability to offer more precise and potentially safer tissue targeting, PFA represents a meaningful step forward in electrophysiology.
The introduction of these technologies into markets like Peru reflects a broader trend: innovation is no longer limited to traditional geographies.
As pressure builds to accelerate clinical timelines, the focus is shifting from speed alone to smarter execution.
Insights from Kristen Mittal emphasize the importance of aligning trial design, regulatory strategy, and operations early — reducing delays before they arise rather than reacting to them later.
What to Focus On:
• Align regulatory and operational strategies early
• Anticipate bottlenecks before study start
Why It Works: When execution is aligned from the outset, timelines compress naturally — without sacrificing quality.
Advancing a medical device from concept to approval requires more than innovation — it demands strong clinical validation at every stage.
The approval of a transcatheter heart valve system highlights how early-phase studies, including first-in-human and feasibility trials, lay the foundation for successful regulatory outcomes. Each phase builds the evidence needed to demonstrate safety and effectiveness, ultimately enabling market access.
It’s a reminder that breakthrough devices are not just engineered — they are clinically proven.
Why It Matters: Regulatory approval is the outcome of well-executed early-phase strategy. Strong study design and efficient execution early on can significantly impact the speed and success of the entire development pathway.
Capital is increasingly flowing into next-generation therapeutic modalities, accelerating development in high-impact areas like oncology and metabolic diseases.
These investments are not just expanding pipelines — they’re reshaping how therapies are designed, with a focus on more targeted, personalized, and effective treatments. As funding continues to concentrate in these areas, early-stage development activity is expected to follow.
The momentum behind these modalities signals a sustained push toward more complex — and potentially more transformative — therapies.
Why It Should Be a Priority: Where capital goes, clinical activity follows. Tracking investment trends offers an early view into which therapeutic areas are likely to drive future trial demand and innovation.
• Brazil’s approval delays are rewarding sponsors who prepare proactively
• Mexico’s device pathway depends on aligning registration holder and distributor roles
• Advanced cardiac technologies like PFA are gaining commercial traction in Latin America
• Trial acceleration starts with early alignment of design, strategy, and operations
• Early feasibility and first-in-human studies lay the foundation for regulatory success
• Investment trends in oncology and metabolic disease are signaling where future trials will land
← All Global Trial Accelerators editions · Contact bioaccess®