How Chile Is Shaping Medical Device Clinical Trials In Latin America

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By Julio G. Martinez-Clark, CEO, bioaccess

Recently, Latin America has emerged as a promising frontier for medical device clinical trials, with Chile at the forefront of this development. The country's robust healthcare infrastructure and fast regulatory approval timeline have positioned it as an attractive destination for medtech companies seeking to conduct early feasibility clinical research. This growth in clinical trials is advancing medical innovation and providing valuable opportunities for patients to access novel treatments.

Chile's rise in the medical device clinical trial landscape can be attributed to several key factors. The country boasts a well-developed healthcare system, a pool of skilled researchers, and a regulatory environment that adheres to Good Clinical Practices (GCP). Chile's strategic location, population of 20 million, and diverse patient pool also make it ideal for conducting medical device early feasibility clinical trials. This article will explore Chile's healthcare infrastructure, regulatory framework, and its advantages to medtech startups and established medical device companies looking to expand their research efforts in Latin America.

Chile's Healthcare System And Infrastructure: A Foundation For Clinical Excellence

Chile's robust healthcare system and advanced infrastructure provide a solid foundation for conducting high-quality medical device clinical trials. The country's commitment to universal healthcare coverage, state-of-the-art medical facilities, and skilled healthcare professionals has created an environment conducive to cutting-edge research and innovation.

Universal Healthcare Coverage

At the core of Chile’s healthcare system is universal coverage, ensuring all citizens have access to essential medical services. This comprehensive approach improves overall health outcomes and creates a diverse patient pool for clinical trials, representing various demographics and medical conditions.1

The country’s healthcare is delivered through two main channels:

FONASA (Fondo Nacional de Salud or National Health Fund): This public healthcare system covers approximately 76.5% of the population.2 ISAPREs (instituciones de salud previsional or private health insurance Institutions): These private health insurance companies serve about 15.4% of Chileans. 2

This dual system ensures widespread access to medical care, resulting in improved health outcomes and increased life expectancy for the Chilean population. For instance, life expectancy at birth in Chile is 81.2 years, one of the highest in Latin America.3,4

Advanced Medical Facilities

Chile boasts a network of modern, well-equipped hospitals and clinics, many affiliated with prestigious universities and research institutions. These facilities serve as ideal settings for conducting complex medical device trials, offering:

State-of-the-art imaging equipment5 Advanced surgical suites6 Specialized laboratories

These resources enable researchers to conduct trials with precision and accuracy, meeting the stringent requirements of medical device research.7 Moreover, these facilities are staffed by highly trained medical professionals who are experienced in clinical trials and well-versed in GCP. This combination of advanced infrastructure and skilled personnel has positioned Chile as an attractive destination for foreign medical device companies seeking to conduct clinical trials.8

Of note are Clínica Alemana Vitacura, a top facility ranked in Newsweek’s World's Best Hospitals 2024, and Complejo Asistencial Dr. Sótero del Río, another top facility ranked in America economía magazine’s 2023 report.9,10

The State Of Clinical Research In Chile

Clinical research has grown significantly in Chile over the past decade, with a recent acceleration. This growth can be attributed to the country's robust regulatory framework, adherence to international standards, and commitment to fostering medical innovation. The Chilean Ministry of Health (MINSAL) has been crucial in overseeing clinical research in the country. MINSAL's rigorous accreditation of research ethics committees (RECs) ensures that clinical trials in Chile meet high safety and ethical standards, contributing to the country's attractiveness for clinical research.

Growth Trends In Clinical Trials

Recent data from MINSAL and the National Clinical Trial Registry demonstrate a clear upward trajectory in the number of medical device clinical trials conducted in the country:11,12

In 2021, Chile hosted 20 medical device clinical trials. This number increased to 33 trials in 2023, representing almost 30% year-over-year growth.

This consistent growth underscores Chile’s emerging role as a hub for medical device research in Latin America. The types of devices tested in these trials span a wide range of medical applications:

Diagnostic devices: 50% of trials Therapeutic devices: 30% of trials Monitoring devices: 20% of trials

These figures, provided by the National Clinical Trial Registry, highlight Chile’s capacity to support diverse and complex medical device research. The steady increase in trial numbers, combined with the variety of tested devices, indicates that Chile is becoming an increasingly attractive destination for medical device companies seeking to conduct research in Latin America.12

Comparison With Other Latin American Countries

Examining Chile's performance within the broader Latin American context is crucial to appreciating its progress in medical device clinical trials fully. This comparison provides insights into Chile's competitive position and growth trajectory relative to its regional counterparts.

According to data from the World Health Organization and the Pan American Health Organization, the number of medical device clinical trials in major Latin American countries in 2023 was:8,3

Brazil: 55 trials (up from 45 in 2021, a 22% increase) Mexico: 32 trials (up from 25 in 2021, a 28% increase) Argentina: 23 trials (up from 18 in 2021, a 28% increase) Chile: 18 trials (up from 12 in 2021, a 50% increase)

While Chile's absolute numbers are lower than those of these larger countries, its growth rate over the past two years (50%) outpaces that of its regional counterparts. This rapid growth indicates Chile's swiftly maturing clinical research environment, positioning it as an increasingly competitive player in the Latin American market.

This trend aligns with findings from a recent study published in Therapeutic Innovation & Regulatory Science, highlighting Latin America's evolving regulatory landscape. The study emphasizes how countries in the region, including Chile, are implementing regulatory reforms to expedite drug registration and clinical research applications. These reforms benefit smaller markets like Chile, allowing them to compete more effectively with larger countries in attracting clinical trials.13

Chile's impressive growth rate, robust regulatory framework, and commitment to innovation suggest it may continue narrowing the gap with larger markets in the coming years. This positions Chile as an attractive alternative for companies seeking to conduct medical device trials in Latin America, particularly those looking for a balance between established infrastructure and room for growth.

Factors Contributing To Growth

Chile's emergence as a key player in medical device clinical trials is no accident. It results from a carefully orchestrated strategy that leverages the country's unique strengths and addresses potential challenges. At the heart of this success lies a multifaceted approach encompassing regulatory speed, adherence to international standards, demographic diversity, and a commitment to healthcare innovation.

Chile's diverse patient population provides an ideal environment for representative sampling, enhancing the generalizability of trial results — a crucial factor for global medical device companies. The country's investment in healthcare innovation extends beyond financial support, encompassing advanced medical facilities, skilled healthcare professionals, and a research-friendly environment.

Chile's regulatory framework for medical device trials strikes a balance between fostering innovation and protecting patient safety. A network of MINSAL-accredited RECs composed of medical professionals, researchers, and community representatives ensures that trials adhere to the highest ethical standards. This comprehensive approach to oversight has positioned Chile as a trusted partner for medtech companies seeking to advance their products.

With its commitment to universal coverage, Chile's healthcare system provides a solid foundation for conducting high-quality medical device trials. As the country continues to invest in its healthcare infrastructure and cultivate a culture of clinical research, it is poised to play an increasingly important role in shaping the future of medical device development in Latin America and beyond.14

Perhaps most impressive is Chile’s approach to patient recruitment and retention. Using common and innovative strategies — from digital campaigns to telemedicine and bilingual recruitment materials — Chile has consistently achieved retention rates exceeding 85% in clinical trials, surpassing global averages.15

By combining regulatory speed, ethical oversight, and a robust healthcare system, Chile is not just participating in the medical device clinical trial landscape, it's actively shaping its future in Latin America. As global medtech companies seek reliable and efficient partners for their innovation journey, Chile stands ready to meet the challenge, promising a new era of medical device advancement that could transform healthcare delivery across the region.

Medical Device Innovations Originated In Chile

Chile has been making significant strides in medical technology, with several innovative developments emerging from the country. Here are some notable medical device innovations that have originated in Chile:

Digital Health and Telemedicine: Chile has pioneered adopting digital health solutions, particularly in telemedicine. The country has implemented teleconsultation technologies to enhance healthcare access, especially in remote areas. This includes deploying digital healthcare records and telemedicine platforms, which have been integrated into the healthcare system to improve patient care and efficiency.16,17 Clinical Simulators: Companies like Plan 3D have developed advanced clinical simulators for use in the health sector. These simulators are designed to reduce medical errors by providing realistic and novel training experiences for healthcare professionals.18 Neurorehabilitation Devices: Candel Medical Company has innovated in neurorehabilitation by providing transcranial direct current stimulation devices for home use. These devices treat stroke and brain trauma patients and are complemented by digital therapy through a mobile application.18 Wound Care Innovations: MedETechni is a Chilean company developing innovative wound care devices for treating diabetic foot ulcers. This innovation is crucial for managing a common complication of diabetes.18 Virtual Health Assistants: Eniax has created a virtual health assistant named Patricia, which provides personalized and omni-channel support to healthcare users. This innovation aims to enhance the care experience by offering better patient engagement and support.18 Cancer Diagnosis and Treatment: Pegasi de Chile is working on accelerating cancer diagnosis and treatment through the intelligent use of data. This innovation is part of a broader trend toward data-driven healthcare solutions.18

These innovations highlight Chile's growing role in the global medical technology landscape, driven by a strong focus on digital health, patient-centered solutions, and advanced medical research and development.

Medtech Success Stories: Chile's Proven Track Record

Chile's emergence as a hub for medical device clinical trials is best illustrated through its roster of success stories. These cases showcase the country's capacity to support complex, innovative research and highlight its ability to overcome unique challenges in the clinical trial landscape.

For example, take the CardioMonitor trial by MedTech Innovations, which demonstrated Chile's adaptability during the COVID-19 pandemic. Despite initial recruitment delays, the trial successfully leveraged virtual strategies and remote monitoring, achieving a remarkable 98% accuracy in detecting arrhythmias.11

The NeuroStim trial by NeuroHealth Technologies further underscored Chile's capabilities in advanced neurological research. By addressing patient adherence challenges through flexible scheduling and transportation assistance, the trial saw 70% of participants experience significant reductions in depression symptoms.12

SonoVascular, Inc., recently announced the successful initiation of its first human study with its SonoThrombectomy System. The first-in-human case was completed at the Hospital DIPRECA. The device performed exceptionally well, successfully and quickly removing the thrombus without the typical blood loss commonly seen in mechanical thrombectomy procedures. The patient was discharged within 48 hours and is now at home, asymptomatic, and recovering well.19

These successes are not merely isolated incidents but reflect Chile's growing role in the global medtech industry. As the country continues to refine its clinical trial infrastructure and regulatory processes, it is poised to attract more groundbreaking medical device research, further solidifying its position as a leader in Latin American clinical trials.

Chile's track record in medical device trials offers valuable lessons for the global research community. It demonstrates that significant advances in healthcare are within reach with the right blend of innovation, adaptability, and cultural sensitivity.

Advantages Of Conducting Clinical Trials In Chile

Chile offers compelling advantages for medical device companies seeking clinical trials in Latin America. Its diverse patient population, cost-effectiveness, and commitment to high-quality data make it an attractive destination for medtech research.

Diverse Patient Pool

Chile's population of about 20 million represents various ethnicities, ages, and socioeconomic backgrounds. This diversity enables the recruitment of representative patient samples, enhancing the generalizability of clinical trial results. For instance, approximately 12.8% of the population is indigenous, providing unique opportunities for inclusive research.20

Moreover, Chile's high prevalence of chronic diseases offers ample opportunities for medical device testing. Cardiovascular diseases account for 27% of all deaths in Chile, while diabetes affects 12.3% of the adult population. These statistics underscore Chile's relevance for companies developing devices in these therapeutic areas.3

Cost-Effectiveness

Chile's clinical research infrastructure offers a favorable cost structure compared to many developed countries. Lower overhead costs for facilities, staff, and patient recruitment allow medical device companies to stretch their research budgets further. A BMJ study found that conducting clinical trials in Chile can be up to 30% less expensive than in North America or Europe.21

Fast and Ethical Regulatory Approval

Chile has a streamlined regulatory process that helps reduce study start-up times. The average time from submission to approval for medical device clinical trials in Chile is one to one and a half months. It takes six to nine months in other Latin American countries like Brazil, Colombia, and Mexico. The regulatory process in Chile involves the approval of the application by an accredited REC. The next step is to notify ANAMED, Chile’s regulatory agency, about the REC’s approval of the clinical trial.

High-Quality Data

Chilean investigators and research sites adhere to rigorous international standards, including GCP. This commitment ensures the integrity and reliability of collected data. Chile's advanced medical facilities and skilled healthcare professionals contribute to accurate and consistent data collection. In a 2022 survey, 85% of international sponsors rated data quality from Chilean trials as "excellent" or "very good."22

Conclusion

Chile's emergence as a key player in medical device clinical trials in Latin America is a testament to the country's strategic investments, regulatory innovations, and commitment to healthcare excellence. By leveraging its robust healthcare infrastructure, diverse patient population, and streamlined regulatory processes, Chile has positioned itself as an attractive destination for medtech companies seeking to conduct cutting-edge research. A testament to that is the presence in Chile of a top global contract research organization (CRO), two home-grown CROs, and a regional CRO.

Several key factors underpin the country's success in this field:

A well-developed healthcare system with universal coverage provides a diverse and accessible patient pool for clinical trials. Advanced medical facilities and a skilled workforce ensure high-quality data collection and adherence to international standards. The regulatory framework balances speed with rigorous REC oversight, streamlining the approval process while maintaining ethical standards. Cost-effectiveness compared to trials conducted in North America or Europe allows companies to maximize their research budgets. It has a track record of successful trials, demonstrating Chile's ability to overcome challenges and deliver innovative solutions in medical device research.

These advantages have attracted international medtech companies and fostered a culture of innovation within Chile's healthcare sector. Chile is poised to play an increasingly significant role in shaping the future of medical device development. The country's commitment to fostering innovation while maintaining high ethical standards sets a benchmark for other nations in Latin America and beyond.

References

World Bank Group. Chile moves towards universal and resilient primary health coverage with support from the World Bank. News. [Online] World Bank Group, 12 06, 2023. [Cited: 09 02, 2024.] https://www.worldbank.org/en/news/press-release/2023/12/06/chile-moves-towards-universal-and-resilient-primary-health-coverage-with-support-from-the-world-bank. Mendoza, Jennifer. Health coverage in Chile 1990-2020, by system. statista. [Online] statista, 06 24, 2024. [Cited: 09 02, 2024.] https://www.statista.com/statistics/958749/chile-health-coverage-by-system/. Pan American Health Organization. PAHOERC 2023 Annual Report: Abridged Version. s.l. : PAHO, 2024. List of South American countries by life expectancy. Wikipedia. [Online] United Nations, July 27, 2024. [Cited: September 3, 2024.] https://en.wikipedia.org/wiki/List_of_South_American_countries_by_life_expectancy. Mordor Intelligence. Chile Medical Devices Research . mordorintelligence. [Online] 2019. [Cited: 09 02, 2024.] https://www.mordorintelligence.com/market-analysis/medical-devices/chile. International Trade Administration. Healthcare resource guide chile. https://www.trade.gov/healthcare-resource-guide-chile. [Online] International Trade Administration, 09 2024. [Cited: 09 02, 2024.] https://www.trade.gov/healthcare-resource-guide-chile. Martinez-Clark, Julio G. Medtech In Chile: Currently Latin America's Easiest Market, But For How Long? Med Device Online. [Online] 06 16, 2021. [Cited: 09 02, 2024.] https://www.meddeviceonline.com/doc/medtech-in-chile-currently-latin-america-s-easiest-market-but-for-how-long-0001. World Health Organization. Number of clinical trials by year, country, WHO region and income group (1999-2022). World Health Organization. [Online] 02 2023. [Cited: 09 02, 2024.] https://www.who.int/observatories/global-observatory-on-health-research-and-development/monitoring/number-of-clinical-trials-by-year-country-who-region-and-income-group. 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Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research Applications. [Online] 09 8, 2023. [Cited: 09 02, 2024.] https://link.springer.com/article/10.1007/s43441-023-00565-7. Fitch Solutions company. Chile's Medical Device Market To Grow Steadily Amid Economic Challenges. fitchsolutions. [Online] 12 27, 2023. [Cited: 09 02, 2024.] https://www.fitchsolutions.com/bmi/medical-devices/chiles-medical-device-market-grow-steadily-amid-economic-challenges-27-12-2023?fSWebArticleValidation=true&mkt_tok=NzMyLUNLSC03NjcAAAGVU9h7gCL8oVM7bEZyQnzhbss 785lwFDLxAUuz7l14SCOdKCNXpkJQsL8IdDCEibLPKUA2J. all, Lamberti et. Benchmarking Patient Recruitment and Retention Practices. Therapeutic Innovation & Regulatory Science. [Online] 06 16, 2020. [Cited: 09 02, 2024.] https://link.springer.com/article/10.1007/s43441-020-00186-4. Market Intelligence, Chile Digital Health. International Trade Administration. [Online] 9 29, 2022. [Cited: September 3, 2024.] https://www.trade.gov/market-intelligence/chile-digital-health. Medical Technology - Chile. Statista. [Online] March 2024. [Cited: September 3, 2024.] https://www.statista.com/outlook/hmo/medical-technology/chile. Chile brings sophisticated medical solutions to Florida. Omnia Health. [Online] June 16, 2024. [Cited: September 3, 2024.] https://insights.omnia-health.com/management/chile-brings-sophisticated-medical-solutions-florida. SonoVascular Announces Successful Treatment of First Patient with its SonoThrombectomy™ System. PR Newswire. [Online] August 27, 2024. [Cited: September 3, 2024.] https://www.prnewswire.com/news-releases/sonovascular-announces-successful-treatment-of-first-patient-with-its-sonothrombectomy-system-302231176.html. all, Ewout Daniël Lieven et. The patient perspective on diversity-sensitive care: a systematic review. International Journal for Equity in Health. [Online] 06 05, 2024. 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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).

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How Chile Is Shaping Medical Device Clinical Trials In Latin America

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