Accelerating Innovation: How US Medtech Companies Can Leverage Greenlight Guru EDC for Latin American Early Feasibility Studies
Early feasibility studies (EFS) are critical stepping stones in medical device development, providing essential insights into device functionality and safety before committing to larger, more expensive pivotal trials. However, for US Medtech startups, conducting these studies domestically has become increasingly challenging due to recruitment difficulties, regulatory hurdles, and rising costs. Latin America has emerged as a strategic alternative that offers significant advantages - and now, thanks to the partnership between Greenlight Guru and bioaccess®, these benefits can be maximized through advanced electronic data capture (EDC) technology.
Why Latin America is Becoming the Go-To Destination for Early Feasibility Studies
Clinical trials are facing a recruitment crisis in the United States. According to research examining clinical trial challenges, approximately 50% of clinical trials fail to meet their enrollment targets, with inadequate patient retention adversely affecting the ability to produce conclusive results.
Latin America offers compelling solutions to these challenges:
Faster Patient Recruitment
Latin American countries like Brazil, Colombia, and Mexico provide access to large, concentrated patient populations in centralized healthcare systems. These systems create remarkable efficiency in patient identification and enrollment that simply doesn't exist in the fragmented US healthcare system.
For Medtech startups, this translates to enrollment rates often 2-3 times faster than comparable US-based studies - potentially saving months in development timelines and extending the limited financial runway.
Treatment-Naïve Populations
Latin America offers valuable access to "treatment-naïve" populations - patients who haven't been exposed to multiple treatment options that might confound study results. This provides cleaner safety and efficacy signals, which are particularly valuable for medical device evaluation.
Cost Efficiency
While cost shouldn't be the primary motivation, clinical trials in Latin America typically cost 30-50% less than comparable studies in the US. For early-stage companies with limited funding, this efficiency allows for more comprehensive data collection within budget constraints.
The Technology Challenge: Managing Global Data with Precision
Despite these advantages, conducting trials across borders introduces complexity. Data collection, monitoring, and regulatory compliance become more challenging when managing studies in countries with varying standards and infrastructure.
This is where the right technology platform becomes essential.
Introducing Greenlight Guru's Clinical Data Manager: Purpose-Built for Medical Devices
Greenlight Guru's Clinical Data Manager is an electronic data capture (EDC) platform specifically designed for medical device clinical trials. Unlike generic EDC systems, Greenlight Guru's platform addresses the unique requirements of medical device studies, including:
Device-specific data models tailored to capture the unique endpoints and performance metrics relevant to medical devices
Configurable workflows that adapt to different study designs and regulatory requirements
Real-time monitoring capabilities allow study managers to identify issues promptly despite geographical distance
Regulatory alignment with both FDA and international standards, ensuring data acceptability across jurisdictions
Integration with quality management systems creates a seamless connection between clinical evidence and quality processes
The platform's intuitive interface reduces training time for clinical site staff, while its robust data validation features ensure high-quality data collection - critical factors when working with international research teams.
The Strategic Partnership: Greenlight Guru and bioaccess®
In a landmark collaboration announced in 2024, Greenlight Guru and bioaccess® have joined forces to create an integrated solution for US Medtech companies seeking to conduct early feasibility studies in Latin America.
This partnership combines:
Greenlight Guru's purpose-built medical device EDC platform
bioaccess®'s deep expertise in Latin American clinical trials and regulatory environments
Streamlined workflows tailored specifically to early feasibility studies
Local support and training for research sites across Latin America
The partnership enables US Medtech companies to leverage bioaccess®'s established network of high-performing research sites while maintaining rigorous data management standards through Greenlight Guru's platform.
Practical Implementation: How the Integration Works
For Medtech companies considering Latin American early feasibility studies, the Greenlight Guru and bioaccess® partnership offers a turnkey solution:
Study Design Optimization: bioaccess® experts help design protocols that maximize recruitment potential while ensuring data collected will satisfy FDA requirements.
Site Selection and Activation: leveraging bioaccess®'s established network of experienced research sites with Greenlight Guru's platform pre-configured for rapid deployment.
Streamlined Data Collection: Research staff use Greenlight Guru's intuitive EDC interface to capture clinical data, with built-in validation rules ensuring data quality from day one.
Remote Monitoring: US-based study managers can monitor study progress in real-time, identifying potential issues before they impact study integrity.
Regulatory Documentation: The system automatically generates compliant documentation for local regulatory bodies and the FDA.
Data Integration: Upon study completion, data seamlessly transfers to support subsequent development phases and regulatory submissions.
Real-World Benefits for Medical Device Companies
The combined solution addresses the key challenges that have historically made international clinical trials difficult to manage:
Enhanced Data Quality
The purpose-built EDC platform enforces consistent data collection across all sites, with automated validation rules flagging potential issues immediately. This is particularly valuable when working across different healthcare systems and languages.
Accelerated Timelines
By combining rapid recruitment capabilities with efficient data management, companies can complete early feasibility studies in a fraction of the time required in the US market.
Regulatory Confidence
The platform ensures that data collection meets local requirements and FDA standards, eliminating concerns about data acceptability for subsequent regulatory submissions.
Cost Control
Streamlined processes and reduced monitoring travel requirements further enhance the cost advantages of conducting trials in Latin America.
Making the Decision: Is This Approach Right for Your Company?
The Greenlight Guru and bioaccess® partnership is particularly valuable for:
Early-stage Medtech companies with limited funding seeking to maximize clinical evidence generation
Companies developing devices for conditions with challenging recruitment in the US market
Organizations looking to accelerate their path to pivotal trials and market approval
Startups needing to demonstrate clinical proof of concept to secure additional funding
Conclusion: A Strategic Imperative for Competitive Advantage
For US Medtech companies facing the dual challenges of limited funding and tight development timelines, the combination of Latin American early feasibility studies and advanced EDC technology represents more than a cost-saving measure—a strategic imperative that can dramatically improve the odds of success.
By accelerating recruitment, accessing treatment-naïve populations, and managing data with precision through Greenlight Guru's platform, startups can more efficiently generate the clinical evidence needed to secure additional funding, attract strategic partners, and progress toward FDA approval.
In the increasingly competitive medical device landscape, those companies that strategically leverage this powerful combination of regional advantages and purpose-built technology will enjoy significant competitive advantages in bringing their innovations to patients worldwide.
