The Strategic Case for Offshoring Early Feasibility Studies in Medical Devices: Why Latin America Makes Sense for US Medtech Startups
Clinical trials are the lifeblood of medical device innovation, but for US Medtech startups, conducting early feasibility studies (EFS) domestically has become increasingly challenging. As the founder and CEO of bioaccess®, I've witnessed firsthand how offshoring these critical studies to Latin America can provide significant strategic advantages. This article examines why US Medtech startups should consider Latin America for their early feasibility studies and how this approach can accelerate their path to market.
The Growing Challenge of Early Feasibility Studies in the US
Early feasibility studies for medical devices are critical for startups. Before committing to larger, more expensive pivotal trials, these initial clinical investigations provide valuable insights into device functionality, procedural approaches, and preliminary safety data. However, conducting these studies in the United States presents several significant startup barriers.
Patient recruitment—arguably the most critical aspect of any clinical trial—has become increasingly difficult in the US. Research examining clinical trial challenges cites patient recruitment as one of the most challenging aspects of trial conduct, with inadequate patient retention adversely affecting the ability to produce conclusive results. Many US-based trials fail to meet enrollment targets, with some studies showing that approximately 50% of clinical trials do not achieve their required patient numbers.
Recruitment delays can be catastrophic for medical device startups with limited funding and tight timelines, extending development timelines and increasing costs beyond sustainable levels.
Why Latin America Has Emerged as an Attractive Alternative
Latin American countries, particularly Brazil, Mexico, and Colombia, have become increasingly attractive destinations for Medtech companies conducting early feasibility studies. This shift is not driven primarily by cost considerations but by several strategic advantages:
1. Treatment-Naïve Patient Populations
Latin America offers access to what researchers call "treatment-naïve" populations – patients who haven't been exposed to multiple treatment options that might confound study results. These populations are particularly valuable for medical device studies because they can provide more precise signals about device effectiveness and safety.
For Medtech startups, this means:
Faster enrollment rates
More homogeneous treatment responses
Potentially cleaner safety and efficacy signals
2. Patient Accessibility and Willingness to Participate
Unlike in the US, where recruitment challenges are pervasive, Latin American patients often view clinical trials as an opportunity to access advanced medical technologies more favorably. This perception difference dramatically impacts recruitment timelines and success rates.
In my experience working with numerous Medtech companies through bioaccess®, we've consistently seen enrollment rates 2-3 times faster than comparable US-based studies. This acceleration can literally save months in development timelines – a critical advantage for startups operating with limited runway.
3. Centralized Healthcare Systems
Many Latin American countries have centralized healthcare delivery systems with large public hospitals treating high volumes of patients with specific conditions. This centralization creates efficiency in patient identification and recruitment that doesn't exist in the fragmented US healthcare system.
For a medical device startup targeting specific cardiovascular conditions, a single hospital in Brazil or Colombia might see more eligible patients in one month than multiple US centers would see in a year.
Addressing Key Concerns About Offshoring Early Feasibility Studies
When discussing offshoring clinical trials, several legitimate concerns arise. Let's address them directly:
Ethical Considerations and Patient Protection
The ethical treatment of research participants is a significant concern when considering international clinical trials. However, contrary to outdated perceptions, Latin American countries have rapidly developed robust regulatory frameworks and ethical review processes.
Countries like Brazil, Mexico, and Colombia have established regulatory authorities that enforce ICH-GCP (International Conference on Harmonization - Good Clinical Practice) standards. Many sites in these countries have experience with FDA and European regulatory requirements, ensuring trials meet or exceed global ethical standards1.
Data Quality and Regulatory Acceptance
A critical question for any medtech startup is whether the FDA or other regulatory authorities will accept data generated in Latin America. The answer is unequivocally yes, provided the trials are conducted with proper oversight and adhere to international standards.
The FDA routinely accepts well-conducted international data, and many successful medical devices on the US market have included Latin American clinical data in their approval submissions. The key is ensuring trials are designed to meet the FDA's requirements and implemented with rigorous quality systems.
Cost Considerations: Important But Not the Primary Driver
While cost efficiencies exist when conducting trials in Latin America, with potential savings of 30-50% compared to US-based studies, this shouldn't be the primary motivation for offshoring. The fundamental value proposition comes from:
Faster recruitment (reducing overall development timeline)
Access to specialized patient populations
Potentially higher-quality data due to treatment naïvety and better follow-up rates
The ability to stretch investment dollars further, allowing for more comprehensive studies
Best Practices for Success in Latin American Early Feasibility Studies
Based on my experience helping dozens of Medtech companies successfully navigate Latin American clinical trials, here are several best practices for success:
1. Start with Strategic Site Selection
Not all sites are created equal. The most successful trials occur at sites with:
Experienced investigators familiar with novel medical devices
Robust infrastructure for patient follow-up
Previous experience with international regulatory requirements
High-volume patient flow for the condition of interest
2. Invest in Local Relationships
Building strong relationships with local investigators and site staff is crucial. These relationships drive recruitment success, ensure protocol adherence, and facilitate rapid problem-solving when challenges arise.
3. Implement Rigorous Quality Systems
Implement quality systems that meet or exceed FDA expectations to ensure data quality and regulatory acceptance. This includes:
Comprehensive investigator training
Regular on-site monitoring
Centralized data verification
Standardized documentation practices
4. Design for Global Acceptance
From the beginning, design your trial protocol with global regulatory requirements in mind. Work with partners experienced in Latin American regulations and FDA/CE Mark requirements to ensure your study design will satisfy all necessary regulatory bodies.
The bioaccess® Advantage: Why Experience Matters
Working with an experienced partner makes all the difference when offshoring early feasibility studies. At bioaccess®, we've built our reputation as Latin America's leading Medtech CRO by helping companies navigate the complexities of conducting trials in this region.
Our team brings expertise in medical device regulations, clinical operations, and local healthcare systems. We help Medtech startups:
Identify the optimal countries and sites for their specific device and indication
Navigate regulatory approval processes efficiently
Implement recruitment strategies that consistently outperform expectations
Ensure data quality that meets the highest international standards
Conclusion: A Strategic Imperative for Medtech Startups
For US Medtech startups facing the dual challenges of limited funding and tight timelines, offshoring early feasibility studies to Latin America represents more than a cost-saving measure—it's a strategic imperative that can dramatically improve the odds of success.
By accelerating recruitment, accessing treatment-naïve populations, and stretching research dollars further, startups can more efficiently generate the clinical evidence needed to secure additional funding, attract strategic partners, and progress toward FDA approval.
As the healthcare landscape continues to globalize, those companies that strategically leverage international clinical trial expertise will enjoy significant competitive advantages in bringing their innovations to patients worldwide.
Sources:
Petryna, A. (2007). Clinical Trials Offshored: On Private Sector Science and Public Health.
Kermanimojarad, M. (2020). What is the impact of patient recruitment on offshoring of clinical trials?
Yang, Y.T., Chen, B., & Bennett, C.L. (2018). Offshore Pharmaceutical Trials: Evidence, Economics, and Ethics.
