Medical Device Innovation In Brazil: Success Stories And Future Opportunities

By Julio G. Martinez-Clark, CEO, bioaccess

Brazil is rapidly establishing itself as a powerhouse in medical device innovation, driven by recent regulatory reforms, a diverse patient population, and an expanding healthcare infrastructure. With the enactment of Law 14.874/24 and regulation RDC 837/2023, Brazil has created a more streamlined environment for medical device clinical trials, positioning the country as a leading destination for medical innovation in Latin America.¹ This transformation opens unprecedented opportunities for manufacturers to test and develop groundbreaking medical technologies more efficiently while maintaining robust patient protection standards.² From neurotechnology advancements to cardiovascular innovations, Brazil's research landscape is evolving into a vibrant ecosystem that rivals established markets in Europe and North America.³

Real-World Success Stories Of Medical Device Clinical Trials in Brazil

Brazil's research capabilities are exemplified by several high-profile clinical studies that have achieved significant breakthroughs in medical device technology. The BrainGate-Brazil study at the Federal University of São Paulo (UNIFESP) marked a notable milestone in neurotechnology research, evaluating an advanced brain-computer interface in patients with severe motor disabilities.² This groundbreaking trial demonstrated successful neural signal decoding, enabling participants to control digital devices through thought alone and positioning Brazil as a key player in neurotechnology research and development.³

Another success story comes from Hospital Sírio-Libanês in São Paulo, where researchers led a multicenter trial evaluating a novel spinal cord stimulation device for chronic pain management.² This study, involving multiple research centers across Brazil, demonstrated significant pain reduction and improved quality of life in patients with failed back surgery syndrome, leading to ANVISA approval and establishing a new standard for pain management in Latin America.^3,4

The RESTORE trial, led by REVA Medical, showcases Brazil's capabilities in cardiovascular research.⁵ This clinical study evaluated the ReZolve bioresorbable sirolimus-eluting coronary scaffold in patients at Instituto Dante Pazzanese de Cardiologia in São Paulo.⁵ The first implant was performed by Dr. Alexandre Abizaid, demonstrating the potential of fully bioresorbable scaffolds to revolutionize the treatment of coronary artery disease by restoring normal vessel function after addressing blood flow restrictions.⁵

Elixir Medical's BIOADAPTOR randomized controlled trial at Instituto Dante Pazzanese de Cardiologia (IDPC) represents another significant achievement.⁴ The trial evaluated the DynamX coronary bioadaptor system, demonstrating sustained durability with significantly lower target lesion failure rates than standard drug-eluting stents, particularly in left anterior descending (LAD) artery lesions.^4,2

Overview Of Market Opportunities In Key Medical Device Sectors

Brazil's medical device market is projected to grow at a compound annual growth rate (CAGR) of 7.4% from 2023 to 2028, reaching BRL42.2 billion by 2028.⁶ This growth is supported by improving economic conditions and increased healthcare budget allocations, creating substantial opportunities across various medical device sectors.⁶

In vitro diagnostics (IVDs) lead the market, driven by growing demand for advanced diagnostic tools.⁷ With projected market growth of 3.68% from 2024 to 2029, molecular diagnostics and point-of-care testing are experiencing surging demand, fueled by an aging population and increasing chronic disease prevalence.⁷ This expanding market presents fertile ground for manufacturers to validate cutting-edge IVD solutions while contributing to critical healthcare advancements.⁸

The medical equipment sector is rapidly evolving, with a notable shift toward wearable medical devices in clinical trials.⁹ Brazil has the highest density of CT scanners and MRI systems in Latin America, with approximately 28 CT scanners and 14.5 MRI units per million inhabitants as of 2022.⁸ These infrastructure and regulatory updates that simplify the clinical investigation process offer a streamlined pathway for testing devices that improve diagnosis, monitoring, and treatment outcomes.^8,10

The orthopedic implant market in Brazil is experiencing substantial growth, projected at 5.76% over the next five years.⁷ As the elderly population expands and demand for advanced medical technology rises, orthopedic device manufacturers can leverage clinical trials in Brazil to meet market needs and refine their offerings.^7,8

Brazil's Growing AI And Digital Health Landscape

Brazil's artificial intelligence in healthcare market is experiencing explosive growth, projected to expand from $0.17 billion in 2022 to $3.60 billion by 2030, registering a remarkable CAGR of 46.22%.¹¹ This rapid expansion is positioning Brazil as a key player in the global AI-enabled medical device market. ⁽¹¹⁾ Regulatory advancements, such as ANVISA's Resolutions No. 657/2022 and No. 751/2022, have established clear guidelines for AI-based medical software (SaMD), ensuring compliance with international standards.¹¹

The Brazilian health technology industry has seen progressive integration of artificial intelligence, specifically generative AI, to enhance productivity and service delivery.⁹ This integration is pivotal in app development, improving software quality, and delivering personalized health services.⁹ AI-driven diagnostics and patient management systems have become increasingly prevalent, reshaping the competitive landscape and pushing traditional firms toward rapid innovation.^9,11

Telemedicine and virtual care have experienced significant growth in Brazil, driven by governmental efforts to improve healthcare accessibility, especially in remote regions.⁹ These advancements have been supported by the integration of AI tools, which optimize patient data management and enable personalized care solutions.¹¹ The continued expansion of telehealth services is expected as technological advancements and policy support further integrate these solutions into the mainstream healthcare framework.¹²

The Brazilian market for wearable health devices has seen substantial growth, driven by consumer demand for proactive health management solutions.⁹ These devices, enhanced by AI and IoT, offer advanced health insights and personalized recommendations.¹⁰ The government's investment in digital infrastructure has facilitated the accessibility of these technologies, paving the way for continued market expansion.¹¹

Notable Medical Device Innovations From Brazil

Brazil has a rich history of medical device innovation, with several groundbreaking contributions to global healthcare. Perhaps the most internationally recognized is the Jatene procedure, developed by Dr. Adib Jatene for correcting transposed arteries in neonates.¹³ This surgical technique became known worldwide as "Jatene's surgery" and established Brazil as a pioneer in cardiovascular medicine.¹³ Dr. Jatene also was responsible for creating the first artificial lung-heart machine at Hospital das Clínicas in the 1950s and performed Brazil's first bypass surgery in 1968.¹³

Another significant Brazilian innovation is the Cone procedure for tricuspid valve repair in Ebstein anomaly, developed by Jose Pedro Da Silva in 1993.¹⁴ This technique has gained worldwide recognition and demonstrates Brazil's contributions to congenital heart surgery.¹⁴

Brazil also has made notable advancements in diagnostic devices, including chest photofluorography for tuberculosis screening invented by Manuel Dias de Abreu and, more recently, portable retinal diagnosis equipment developed by the SENAI Innovation Institute in Pernambuco.¹⁵ The country also has developed low-cost isothermal reaction devices for diagnosing infections like tuberculosis and malaria, which are essential to accessible healthcare technology.¹⁰

Historical Growth Trends In Clinical Trials

The growth of clinical trials in Brazil over the past decade reflects the country's increasing prominence in global medical research.¹⁶ As of January 2025, Brazil had 10,380 clinical studies, with the majority (5,891) being completed studies.¹⁶ Among active trials, 1,029 were in the recruitment phase, demonstrating ongoing research momentum.¹⁶

The number of medical device trials has shown consistent growth, with a 25.42% increase from 59 trials in 2021 to 65 trials in 2024.² The Brazilian medical device clinical trials market generated revenue of $184.6 million in 2024 and is expected to reach $253.0 million by 2030, growing at a CAGR of 5.7%.¹⁷

Looking at historical trends, Brazil hosted approximately 1,500 active clinical trials in 2010, growing to around 2,700 by 2015.¹⁸ Following the implementation of Law 14.874/24, this number has surpassed 4,500, demonstrating the positive impact of regulatory improvements.^17,18 Phase 3 trials dominate the landscape, with 3,086 clinical studies, indicating Brazil's strength in late-stage clinical development.¹⁶

Companies That Have Successfully Conducted Trials In Brazil

Several international medical device companies have successfully conducted clinical trials in Brazil, leveraging the country's diverse patient population and advanced healthcare infrastructure.³ Elixir Medical conducted the BIOADAPTOR randomized controlled trial at IDPC, evaluating its DynamX coronary bioadaptor system, with positive three-year results demonstrating sustained durability compared to standard drug-eluting stents.⁴

REVA Medical performed first-in-human implants of its ReZolve bioresorbable scaffold at IDPC, initiating the RESTORE trial to evaluate the safety and performance of this innovative coronary scaffold.⁵ This pilot study involved 50 patients across multiple leading heart centers in Brazil and Europe.⁵

Akura Medical conducted a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the ATC system in subjects with acute pulmonary embolism (PE) at IDPC and Instituto do Coracao de São Paulo (InCor).¹⁹ Initial results indicated that the system is safe and demonstrated a significant reduction in right ventricular/left ventricular (RV/LV) ratio.¹⁹

Supira Medical conducted a first-in-human study to assess the feasibility and safety of the Supira system in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI) at IDPC and InCor.²⁰ The study achieved 100% procedural success with no device-related adverse events, demonstrating the potential of this low-profile, high continuous flow system.²⁰

Strategic Recommendations For Manufacturers Considering Brazil

Several strategic approaches can enhance success for medical device manufacturers looking to conduct clinical trials in Brazil.²¹ First, thoroughly understand ANVISA's regulatory framework, particularly recent updates like Law 14.874/24 and RDC 837/2023, which have streamlined approval processes and reduced timelines.² The most significant advantage is that manufacturers do not need ANVISA approval to start recruiting patients for first-in-human clinical trials with investigational high-risk devices if the results will not support future device registration in Brazil.²

Form strategic alliances with local research organizations, universities, and healthcare institutions to leverage local expertise and access established patient networks.^22,21 The Instituto Dante Pazzanese de Cardiologia and Instituto do Coracao de São Paulo (InCor) have proven track records in conducting successful device trials and can be valuable partners.^22,21

Take advantage of Brazil's cost-effectiveness compared to U.S. and Western European markets.⁶ Clinical trials in Brazil typically cost 25%-35% less than in the U.S. due to reduced operational expenses, including labor and site management fees.⁶ Recruitment generally is 15%-20% quicker than in North America, and patient retention rates are 10%-15% above global averages, further enhancing cost efficiency.²¹

Consider Brazil's diverse patient population when designing trials.² With over 215 million people and significant genetic diversity, Brazil offers an ideal setting for generating globally relevant data that meets inclusive trial requirements from regulatory bodies like the FDA.²¹ This diversity is particularly valuable for devices targeting cardiovascular diseases, diabetes, and cancer, which have high prevalence in Brazil.²¹

Finally, stay informed about emerging opportunities in AI and digital health, as Brazil's rapid growth in these sectors creates unique possibilities for innovative device trials.¹¹ The country's expanding telemedicine infrastructure and growing adoption of wearable health technologies provide fertile ground for testing connected medical devices and AI-enabled health solutions.^12,9

By leveraging these strategic advantages, medical device manufacturers can accelerate their path to market while generating valuable, diverse clinical data that meets global regulatory standards.² Brazil's evolution from a predominantly late-phase trial destination to a comprehensive research hub supporting all phases of clinical development makes it an increasingly attractive option for medical device innovation.¹⁷

References

1. Martinez-Clark, Julio G. LinkedIn. [Online] February 2025. [Cited: June 21, 2025.] https://www.linkedin.com/posts/juliomartinezclark_brazils-clinical-trial-game-changer-a-new-activity-7283950991580753920-SNDl?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAANE8MBRcTFSYWJy3xBBy
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4. Elixir Medical reports sustained durability with bioadaptor compared to Medtronic stent. Drug Delivery Business News. [Online] May 23, 2025. [Cited: June 21, 2025.] https://www.drugdeliverybusiness.com/elixir-medical-sustained-durability-bioadaptor/.
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12. The Impact of AI on Brazil's MedTech Sector. Pure Global. [Online] August 15, 2024. [Cited: June 21, 2025.] https://www.pureglobal.com/blog-posts/the-impact-of-ai-in-the-medtech-sector.
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14. Jatene Lecture on Surgical Innovation: Innovation in Congenital Heart Surgery: Contributions From South America. Juaneda I, Kreutzer C, Jatene MB. Fifth. 3, s.l. : World Journal for Pediatric and Congenital Heart Surgery, 2024, Vol. 15.
15. Healthcare: Medical Devices 2024. Chambers AND PARTNERS. [Online] August 29, 2024. [Cited: June 21, 2025.] https://practiceguides.chambers.com/practice-guides/healthcare-medical-devices-2024/brazil/trends-and-developments.
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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).