Brazil's Competitive Edge: Infrastructure And Operational Advantages For Medical Device Trials

By Julio G. Martinez-Clark, CEO, bioaccess

Brazil has emerged as a powerhouse in Latin America's clinical research landscape, offering unique advantages that make it an attractive destination for medical device clinical trials. With a robust healthcare infrastructure, diverse patient population, and streamlined regulatory processes, Brazil provides sponsors with an optimal environment for conducting high-quality, cost-effective research. This article explores the practical advantages that position Brazil at the forefront of medical device clinical trials in the region.

Brazil's Healthcare Infrastructure And Research Capabilities

Brazil's expansive healthcare system is a solid foundation for clinical research, combining advanced medical facilities with experienced professionals. The backbone of this system is the Unified Health System (Sistema Único de Saúde, SUS), established in 1988 to provide universal healthcare access to all Brazilian citizens.¹ SUS is pivotal in supporting medical device research through evaluation, funding, and integration into the health system.^1,2

The country's healthcare infrastructure is impressive in scale and sophistication:

• approximately 6,500 hospitals and 29,300 operating rooms as of March 2024^1,3
• over 380,300 hospital beds nationwide^1,4
• a workforce of 546,000 physicians and 41,500 licensed general surgeons¹
• more than 52,000 intensive care unit (ICU) beds.³

Brazil boasts over 3,000 research centers, including public universities, private hospitals, and specialized clinics.² These centers are staffed by qualified professionals with extensive experience conducting clinical trials according to international standards.¹ World-class medical facilities like Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo and Hospital Israelita Albert Einstein in São Paulo are recognized for their advanced technology and research capabilities.^1,4

Integrating research activities within the public healthcare system has been crucial for Brazil's success in clinical trials.² Many SUS hospitals serve as research sites, enabling efficient patient recruitment and data collection.¹ This integration ensures that research outcomes can quickly translate into public health policies and practices, benefiting the broader population.³

Diverse Patient Population And Recruitment Advantages

Brazil's population of over 215 million provides researchers with access to a sizable and diverse pool of potential trial participants.^1,2 This diversity — encompassing ethnicity, genetics, and socioeconomic backgrounds — perfectly aligns with the growing emphasis on inclusive clinical trials, as highlighted by regulatory bodies such as the U.S. FDA.^2,5

One of Brazil's key strengths lies in its genetic diversity.² The population results from centuries of intermarriage between indigenous peoples, European colonizers, African slaves, and later waves of immigrants from Asia and the Middle East.⁵ This genetic melting pot provides an ideal setting for medical device studies, enabling researchers to recruit from a diverse pool of patients with a wide range of health conditions.^2,5

Brazil faces a high burden of both communicable and noncommunicable diseases, making it easier to find patients for trials targeting these conditions.² The high prevalence of cardiovascular diseases, diabetes, and cancer ensures a steady stream of eligible participants for relevant medical device clinical trials.^2,5

The country's patient recruitment strategies are multifaceted and leverage both traditional and innovative approaches:

• Public Health System Integration: SUS serves as a crucial recruitment channel, with its extensive network of hospitals and clinics identifying potential participants across various medical conditions.^2,5
• Digital Recruitment: With increasing internet access, Brazil has seen a rise in digital recruitment strategies using social media campaigns, online patient communities, and mobile health apps.²
• Community Engagement: Contract research organizations (CROs) and research institutions often engage with local communities through health fairs, educational programs, and partnerships with patient advocacy groups.²

The effectiveness of these strategies is evident in Brazil's high patient retention rates, which are 10%-15% above global averages.⁶ This success is attributed to solid patient-physician relationships and comprehensive follow-up procedures.^2,5

Cost-Effectiveness Compared To U.S., Europe, And Other Markets

Brazil offers a cost-effective solution for medical device clinical trials, providing high-quality data at a lower cost compared to the U.S. and Western Europe.^7,8 A 2023 report indicates that the average price per patient in Brazilian medical device trials is 25%-35% lower than in the U.S., primarily due to reduced operational expenses, including labor and site management fees.^7,2

Site fees and investigator payments in Brazil are typically 20%-30% lower than in the U.S., resulting in significant savings for sponsors.^7,2 While Brazil's costs are higher than those of emerging markets like India and China, the country aligns better with global regulatory standards, particularly ISO 14155 (Clinical investigation of medical devices for human subjects — Good clinical practice).^7,2

Brazil's cost of living — a manageable $754 per month — is a pivotal advantage, particularly compared to high-cost markets.² This lower cost of living helps control operational expenses such as:

• salaries for research professionals^7,2
• healthcare services costs²
• daily operational expenses, including transportation and researcher accommodations.²

Recruitment in Brazil benefits from the extensive public healthcare system (SUS), allowing faster access to a diverse patient population.² Recruitment is typically 15%-20% quicker than in North America, a significant advantage for medical device trials where patient availability can be critical.^2,5 Moreover, Brazil's patient retention rates further cut costs by minimizing re-recruitment needs.²

While Brazil's regulatory processes may increase initial setup expenses, these are offset by lower operational costs and government tax incentives offering up to a 34% reduction in corporate income tax for R&D investments.^7,2

The Thriving CRO Network With Global And Local Expertise

Brazil's CRO ecosystem boasts a dynamic blend of well-established global leaders and nimble small to midsize enterprises (SMEs), providing sponsors with tailored solutions for medical device clinical trials.^2,1 The Latin American medical device CRO market is projected to reach $950 million by 2030, with a compound annual growth rate of 9% from 2024 to 2030.^1,5

Renowned international CROs like IQVIA and PAREXEL bring a wealth of global expertise and comprehensive service portfolios, ensuring robust operational frameworks and adherence to international standards.¹ Meanwhile, local SMEs distinguish themselves with their in-depth understanding of Brazil's regulatory and cultural landscape, offering tailored, region-specific insights, greater flexibility, and personalized client engagement.^1,2

This combination of global and local players positions Brazil as a strategic hub for clinical research.^5,1 Local CROs offer invaluable insights into:

• navigating Brazil's regulatory environment^2,5
• cultural nuances that impact patient recruitment and retention²
• regional healthcare practices and standards.¹

The presence of both global and local CROs ensures that sponsors can select partners that best align with their specific research needs, whether they require the extensive resources of a multinational organization or the specialized knowledge and flexibility of a local provider.^5,1

Geographic And Logistical Advantages

Brazil's geographical proximity to the United States provides significant logistical benefits for clinical trial sponsors.^2,9 There are 11 direct flights connecting major cities in Brazil, such as São Paulo and Rio de Janeiro, to U.S. cities like Miami, New York, and Houston.² The average duration of a direct flight between São Paulo and Miami is approximately 8 to 9 hours, facilitating swift travel for personnel involved in clinical trials.²

This proximity allows more frequent and efficient interactions between sponsors, CROs, and research sites.² It enables regular visits, effective oversight, and direct communication, all crucial for successful clinical trials.² Additionally, the similar time zones between Brazil and the United States contribute to more efficient coordination of activities and meetings.^2,9

The logistical advantages extend beyond mere proximity.⁹ Brazil's well-developed transportation infrastructure in major urban centers ensures efficient clinical trial materials and equipment movement.² The country's advanced telecommunications infrastructure facilitates real-time communication and data sharing between research sites and sponsors.⁹

Comparison With Other Latin American Countries' Capabilities

While other Latin American countries demonstrate potential for medical device clinical research growth, Brazil holds a competitive advantage.^2,10 Brazil offers a more extensive and diverse population, a more established network of research centers, and a more streamlined regulatory framework than Argentina, Colombia, and Mexico.^2,11

To provide a comprehensive comparison, specific metrics across these countries reveal:

• As of 2024, Brazil leads Latin America with 4,500 active clinical trials, surpassing Argentina (2,800), Mexico (2,300), Colombia (1,900), and Chile. (1,200)²
• Regulatory approval timelines in Brazil are notably efficient, taking between 60 and 90 days under Law 14.874/24, compared to Argentina's 90 to 120 days, Mexico's 180 to 240 days, Colombia's 180 to 270 days, and Chile's 120 to 150 days.^2,11
• Brazil's clinical research infrastructure includes over 3,000 accredited research sites, significantly more than Argentina's 1,500, Mexico's 1,200, Colombia's 800, and Chile's 600.²
• With a population of 215 million, Brazil offers the largest and most diverse patient pool in the region, compared to Mexico's 130 million, Colombia's 51 million, Argentina's 45 million, and Chile's 19 million.^2,10

Each country has unique strengths.^2,10 Argentina excels in oncology research, while Chile has made significant strides in telemedicine and digital health trials.² Mexico's proximity to the United States offers logistical advantages for particular studies.¹⁰

The collaborative nature of clinical research in Latin America should also be noted.^2,5 Many multicenter trials span multiple regional countries, leveraging each of their strengths.⁵ For instance, a trial might recruit rare disease patients from Brazil's diverse population, conduct specialized imaging in Argentina's advanced facilities, and utilize Chile's expertise in digital health for remote monitoring.^2,5

Key Success Metrics: Setting Brazil Apart

Brazil's performance in key clinical trial metrics further solidifies its position as a preferred destination for medical device research.² The country excels in several critical areas that directly impact the efficiency and quality of clinical trials:

• Patient Recruitment Speed: Recruitment in Brazil is typically 15%-20% faster than in North America, attributed to the extensive reach of the SUSU.S. healthcare system and effective recruitment strategies.^2,5
• Retention Rates: Brazil boasts retention rates 10%-15% higher than global averages, significantly reducing the need for additional recruitment efforts and ensuring continuity in data collection.²
• Data Quality: The quality of data generated in Brazilian clinical trials meets international standards, supported by the country's adherence to good clinical practice (GCP guidelines and the expertise of its research professionals.^2,12
• Regulatory Efficiency: With the implementation of Law 14.874/24, Brazil has dramatically improved its regulatory approval timelines, now ranging from 60 to 90 days, enhancing the country's competitiveness in the global research landscape.^2,11

The effectiveness of these metrics is evidenced by the growing number of medical device companies choosing Brazil for their clinical trials.² These success stories demonstrate Brazil's capability to deliver high-quality research outcomes while maintaining cost-effectiveness and operational efficiency.^2,5

Conclusion

Brazil's unique combination of a robust healthcare infrastructure, diverse patient population, cost-effectiveness, thriving CRO network, and strategic geographical position establishes it as a premier destination for medical device clinical trials.^5,2,1 As the country continues to enhance its regulatory framework and research capabilities, its competitive advantages will likely strengthen further, attracting more international sponsors and advancing its position in the global clinical research landscape.²

For medical device manufacturers seeking efficient, high-quality clinical trials with diverse patient representation, Brazil offers an unparalleled environment that balances cost-effectiveness with research excellence.^5,2,1 By leveraging Brazil's comprehensive advantages, sponsors can accelerate their path to market while generating valuable data that meets global regulatory standards.^5,2

References

1. Martin Hernandez-Torre, MD. Clinical Research in Latin America – The New Frontier. s.l. : Journal for Clinical Studies.
2. LATAM: A Model for FSP Success . Parexel. [Online] [Cited: June 17, 2025.] https://www.parexel.com/insights/article/latam-a-model-for-fsp-success.
3. Why Latin America Leads in Clinical Trials: Exploring the Key Factors. bioaccess®: Fast-Tracking First-in-Human Trials, Anywhere. [Online] [Cited: June 17, 2025.] https://www.bioaccessla.com/blog/why-latin-america-leads-in-clinical-trials-exploring-the-key-factors.
4. Why Latin America is the Ideal Location for Medical Trials: Key Advantages Explained. bioaccess®: Fast-Tracking First-in-Human Trials, Anywhere. [Online] [Cited: June 17, 2025.] https://www.bioaccessla.com/blog/why-latin-america-is-the-ideal-location-for-medical-trials-key-advantages-explained.
5. A Closer Look Into Brazil's Healthcare System: What Can We Learn? A., Roman. 5, s.l. : Cureus, May 1, 2023, Vol. 15.
6. Santos, Paulo Ricardo. Latin America and cancer clinical trials: Underrepresented region with significant growth potential. American Society of Clinical Oncology. [Online] 2025. [Cited: June 17, 2025.] https://www.asco.org/abstracts-presentations/ABSTRACT464260.
7. Lessons From Implementing a Clinical Research Network in Brazil. al., Jorge Alexandre Canedo et. s.l. : Am Soc Clin Oncol Educ, Vol. 42, pp. 447-456.
8. Clinical Trials in Latin America A Region of Diversity, A World of Opportunity. Pharm-Olam. [Online] [Cited: June 17, 2025.] https://cdn2.hubspot.net/hubfs/4238150/PharmOlam_March2018/PDF/poi-clinical-trials_whitepaper-latin-america.pdf?t=1526034567095.
9. Top Latin American Countries for Clinical Research You Should Consider. bioaccess®: Fast-Tracking First-in-Human Trials, Anywhere. [Online] [Cited: June 17, 2025.] https://www.bioaccessla.com/br/blog/top-latin-american-countries-for-clinical-research-you-should-consider.
10. Los procedimientos quirúrgicos más populares en Brasil. Global Health Intelligence. [Online] February 15, 2023. [Cited: June 17, 2025.] https://globalhealthintelligence.com/ghi-analysis/brazils-most-popular-surgical-procedures/.
11. Roosa Tikkanen, Robin Osborn, Elias Mossialos, Ana Djordjevic, George A. Wharton. International Health Care System Profiles: Brazil. The Commonwealth Fund. [Online] June 5, 2020. [Cited: June 17, 2025.] https://www.commonwealthfund.org/international-health-policy-center/countries/brazil.
12. Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications. Argotti U, Leyens L, Lisbona C, et al. 6, s.l. : Ther Innov Regul Sci., 2023, Vol. 57, pp. 1287-1297

 

Editor's Note: See this related article from the same author on medical device clinical trials in Brazil.

About The Author:

Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the LATAM Medtech Leaders podcast: A weekly conversation with Medtech leaders who have succeeded in Latin America. He has a bachelor's degree in electronics engineering (BSEE) and a master's degree in business administration (MBA).