Is Mexico A Prime Location For Medical Device Clinical Trials?

By Julio G. Martinez-Clark, CEO, bioaccess

Mexico, one of Latin America's largest economies and most populous countries is emerging as a prime destination for medical device clinical trials and other advanced medical technologies. With its rich cultural heritage, diverse landscapes, and rapidly growing economy, Mexico actively promotes foreign direct investment (FDI) within a welcoming and secure business environment. Mexico is a middle-income nation of over 129 million people and one of the most significant democracies in Latin America. After recent government initiatives to promote clinical research, Mexico has emerged as an attractive destination for medtech companies looking to conduct clinical trials.(1-4) With its growing economy, favorable regulatory environment, and cost-effective landscape, Mexico offers significant advantages for medical device manufacturers seeking to bring new products to market. The country has emerged over the past decade as a bustling hub for the medtech and life sciences industries, generating remarkable growth and attracting significant investor attention globally. However, foreign companies must also navigate complex challenges when running trials in the country, from regulatory hurdles to cultural barriers. This article explores the critical aspects of conducting medical device clinical trials in Mexico.

The Healthcare System In Mexico

Mexico has a mixed healthcare system with public and private sectors. The public sector includes:

• IMSS (Mexican Social Security Institute) for private-sector employees

• ISSSTE (The Mexican Institute for Social Security and Services for State Workers or Civil Service Social Security and Services Institute) for government employees

• IMSS-Bienestar (formerly Seguro Popular/INSABI) for the unemployed and informal workers.

However, a significant portion of the population, especially in marginalized and vulnerable communities, faces challenges in accessing healthcare services through these public programs. These are some healthcare system challenges driving clinical trial participation in Mexico:

Mexico has a mixed healthcare system with public and private sectors. The public sector includes:

• IMSS (Mexican Social Security Institute) for private-sector employees

• ISSSTE (The Mexican Institute for Social Security and Services for State Workers or Civil Service Social Security and Services Institute) for government employees

• IMSS-Bienestar (formerly Seguro Popular/INSABI) for the unemployed and informal workers.

However, a significant portion of the population, especially in marginalized and vulnerable communities, faces challenges in accessing healthcare services through these public programs. These are some healthcare system challenges driving clinical trial participation in Mexico:

1. High out-of-pocket costs: Despite public healthcare programs, many Mexicans still must pay out-of-pocket for medical expenses, which can be prohibitively expensive, especially for chronic diseases and advanced treatments. Participating in clinical trials provides access to complimentary experimental therapies.(6)

2. Uneven distribution of healthcare resources: Public healthcare facilities and specialists are concentrated in major urban centers, leaving rural and remote areas underserved.(7) Clinical trials offer an opportunity to receive quality care that may be lacking locally.

3. Increasing incidence of diseases: Lifestyle changes have led to a rise in noncommunicable diseases like diabetes, cancer, and cardiovascular conditions in Mexico.6 With limited access to new treatments through public healthcare, clinical trials have become attractive for patients with these diseases.

4. Large treatment-naive population: Mexico has a sizable population that has yet to receive standard treatments, making them eligible for clinical trials evaluating new therapies against placebos or existing standards of care.(6)

By participating in clinical trials, Mexican patients can access potentially beneficial experimental treatments and high-quality care that may be otherwise unavailable or unaffordable through the public healthcare system, especially for those living in underserved areas or suffering from chronic diseases.(6,7)

Mexico’s Hospital Infrastructure

Mexico's robust hospital infrastructure makes it well-suited for clinical research trials. The country has a vast network of public and private hospitals, research institutions, and drug and medical device contract research organizations (CROs) with modern facilities and experienced investigators.

Public Hospital Infrastructure: Mexico has a massive public healthcare system called Instituto Mexicano del Seguro Social (IMSS), which provides medical care to over 50 million working Mexicans. IMSS comprises a nationwide network of hospitals, clinics, and full-time physicians, making it an attractive platform for conducting large-scale clinical trials with access to a diverse patient population.(8) Additionally, Mexico has several federal government-financed public hospitals catering to the medical needs of the underprivileged. These hospitals and the ten national health institutes dedicated to medical education, research, and healthcare excellence contribute to the country's robust public hospital infrastructure for clinical research.(8)

• Private Hospital Infrastructure: Mexico also has a well-developed private hospital sector, with prestigious teaching institutions and state-of-the-art facilities that meet international standards.(9) Major cities like Mexico City, Monterrey, and Guadalajara have many private hospitals and research centers equipped with advanced equipment and experienced investigators, enabling high-quality clinical trials.(9)

• Skilled Medical Workforce: Mexico has a sophisticated system of continuing medical education and board certification by specialty, resulting in a skilled medical workforce capable of conducting clinical trials.(8) The country's major public teaching institutions, such as the Universidad Nacional Autónoma de México (UNAM) and the Instituto Politécnico Nacional (IPN), have talented clinical scientists on their faculties, contributing to the advancement of medical research.(8)

These are some top-rated public and private hospitals across Mexico that are well-equipped to conduct high-quality clinical research trials:(10)

• Hospital Médica Sur (Mexico City): Hospital Médica Sur is consistently ranked as one of the top hospitals in Mexico and is part of Newsweek’s World’s Best Hospitals ranking.11,12 It is a prestigious private hospital known for its advanced medical services, specialties like cardiology, oncology, orthopedics, and neurology, and its association with the renowned Mayo Clinic in the U.S. Médica Sur has dedicated staff to support international patients. It is a popular choice for medical tourism and clinical trials.(13,14)

• Centro Médico ABC (Mexico City): Centro Médico ABC has two highly rated campuses in Mexico City. It is a nonprofit hospital associated with Houston Methodist Hospital and has one of Latin America's most advanced cancer centers.(14) ABC is JCI-accredited and known for investing in research, teaching, and specialized care for vulnerable communities.

• Instituto Nacional de Cardiología Ignacio Chávez (Mexico City): This is a leading center for cardiovascular care, offering advanced diagnostic tools and treatment procedures. Its expertise in interventional cardiology and electrophysiology makes it a standout for cardiac-related clinical research.(10)

• Instituto Nacional de Neurología y Neurocirugía (Mexico City): This specialized institution is dedicated to diagnosing and treating neurological disorders in children and adults. It is renowned for its expertise in areas like epilepsy, movement disorders, and neurorehabilitation, which could make it attractive for neurology-focused trials.(10)

• IMSS—Centro Médico Nacional Siglo XXI (CMN SXXI): CMN SXXI is one of Mexico's most prominent and highly regarded hospitals and is consistently recognized in various prestigious rankings. In 2021 and 2024, Newsweek listed it among the top hospitals in the world, showcasing its commitment to high-quality patient care and medical excellence.(12) In 2023, it also was highlighted as one of the best hospitals in Mexico, with a score of 92.97%.12 CMN SXXI is known for its high patient satisfaction, advanced medical facilities, significant contributions to medical research, and consistent recognition in national and international rankings.

• The National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ): INCMNSZ is a well-recognized hospital providing advanced adult care. It was established in 1946 as the Hospital for Nutrition Diseases and later renamed to National Institute for Nutrition Salvador Zubirán. In 2000, the name was updated to National Institute of Medical Sciences and Nutrition Salvador Zubirán to reflect its focus on medical expertise. The institute provides specialized medical attention for nutrition and internal medicine healthcare needs.

• Hospital Universitario de Nuevo León: Its official name is the "Dr. José Eleuterio González" University Hospital. It is part of the Autonomous University of Nuevo León (UANL) in Monterrey. It is considered one of Mexico's ten most well-equipped hospitals. It offers services in various medical specialties and has been recognized for its commitment to continuing education and research.(15)

• Christus Muguerza: Christus Muguerza is a private hospital system founded by José A. Muguerza, a Mexican businessman and philanthropist, in 1934.16,17 The health system began operating in Monterrey and soon expanded in northern and southeast Mexico.(18) He is recognized for inaugurating the first maternity home in Latin America in 1885.(19) Over the years, it has adopted the conviction of serving the regional population efficiently, investing, for example, more than 1.3 billion pesos to build a 100% digital hospital.(20) It has 12 hospitals, two nursing schools, an ambulance system, and a network of primary care clinics in low-income populations.(21) Five hospitals in the Christus Muguerza system are ranked in the top 50 places of the “Best Private Hospitals in Mexico” annual ranking.(22) The Christus Muguerza Alta Especialidad Hospital in Monterrey has received accreditation from the Joint Commission International (JCI), a globally recognized standard for healthcare quality and patient safety.(23) Additionally, Christus Muguerza hospitals are certified by the General Health Council of Mexico and have received various other distinctions, such as the Distintivo M and Distintivo H, which are acknowledgments for excellence in clinical quality and pathology processes.(24)

FDA Acceptance Of Clinical Data From Mexico

The U.S. FDA can accept medical device clinical trial data from research sites in Mexico, provided specific requirements are met:

1. The study must follow good clinical practice (GCP), including review and approval by an independent ethics committee and obtaining informed consent from subjects.(25–29)

2. The FDA must be able to validate the study's data through an on-site inspection if necessary.(25,26,27,29) The FDA can inspect clinical trial sites outside the U.S. to verify compliance with applicable regulations.

3. The clinical investigators conducting the study must be of recognized competence.(25,26) The application should describe their qualifications and research facilities.

4. The study must be well-designed so that the data can provide valid evidence meeting U.S. statutory requirements for medical device approval.(25,26,29)

5. The application should provide information showing the data applies to the U.S. population and U.S. medical practice.(25,26)

Additionally, the FDA encourages sponsors to meet with the FDA review divisions in a presubmission meeting when seeking approval based solely on foreign clinical data.(26) This allows the FDA to provide feedback on the adequacy of the data.

The State Of Clinical Research In Mexico

Mexico has become an attractive destination for clinical trials, driven by its favorable regulatory environment, cost-competitive landscape, and access to a large patient population. Here are some key points about the current state of the clinical trial industry in Mexico:

Regulatory Environment and Approval Process

• The regulatory body COFEPRIS (Federal Commission for Protection Against Sanitary Risk) has recently streamlined the approval process for clinical trials.6,30 Mexico has become a member of the International Council for Harmonisation, aiming to strengthen the regulation of clinical research in line with international standards.(31)

• COFEPRIS has identified priority therapeutic areas for clinical investigation, including diabetes, cancer, cardiovascular disease, and arthritis.(6)

• The ethics and regulatory process to get a clinical trial approved in Mexico involves several key steps:

  • Site Selection: The sponsor selects the healthcare institution(s) where the trial will occur. The sites must have a valid Sanitary License from COFEPRIS.(32)

  • Ethics, Research, and Biosafety Committees: Each trial site must have approved committees registered with the National Bioethics Commission (CONBIOÉTICA) and COFEPRIS. The ethics and research committees’ decision usually happens within 30 business days from filing, although it could take up to 60 days or longer in public hospitals:

    • The ethics committee reviews informed consent, technical quality, and scientific merit.(33)

    • The research committee evaluates the protocol.(33)

    • The biosafety committee determines the use of radiation or genetic engineering techniques (if applicable).(33,34)

    • COFEPRIS Submission: The sponsor submits a dossier to COFEPRIS with approvals from ethics/research committees, the protocol, investigator manuals, preclinical/clinical data, resource descriptions, and investigator responsibilities. All materials must be in Spanish.(32–34)

    • Sequential Approval: COFEPRIS can only review the application once the ethics committee approves it. The approval process takes, on average, three to four months.(6)

    • Import Permit: If the medical device is foreign-made, an import permit must be obtained from COFEPRIS after protocol approval.(32)

    • Registration: Once approved, the trial is listed in the National Record for Clinical Trials database.(32)

The regulatory process in Mexico aims to ensure ethical standards, participant safety, and scientific validity while navigating regulatory requirements from COFEPRIS and trial site committees.

Cost Advantages

• Mexico offers lower operating costs than the U.S., including lower labor costs, site expenses, and regulatory fees.(35)

• The favorable exchange rate further drives down clinical research budgets for U.S.-based companies.(35)

Patient Recruitment

• Mexico has a population of over 129 million, with a third concentrated in major metropolitan areas, facilitating patient recruitment.(6)

• Lifestyle changes have increased the incidence of diseases of commercial interest, such as diabetes, cancer, and cardiovascular diseases.(6)

Infrastructure and Expertise

• Mexico has well-qualified, U.S.-trained physicians who can lead clinical trials.(6)

• Training programs, such as those offered by the University of California San Diego (UCSD) and UNAM’s School of Medicine, are strengthening the skills of clinical trial personnel in areas like ethics, trial administration, and patient recruitment.(6)

• Most clinical trial sites in Mexico offer good infrastructure, although there is an uneven distribution of specialists and specialized infrastructure across the country.(36)

Challenges

• Bureaucratic approaches can hinder pharmacovigilance and interactions with regulatory agencies.(6)

• Finding the right local partner with proven experience in conducting clinical trials is crucial for success.(6)

• Cultural and logistical challenges need to be addressed through partnerships and training.(6)

• 70.9% of the Mexican population receives healthcare services, mainly through public, not-for-profit hospitals that are part of the public healthcare system. Most clinical research experts in Latin America agree that conducting clinical trials at public, not-for-profit hospitals is challenging due to bureaucracy, delays in institutional review board approvals, and contract negotiations and signing. This forces most CROs in Mexico to prefer private hospitals over public hospitals when selecting research sites for their studies.(37)

Overall, Mexico's regulatory improvements, cost advantages, patient access, and growing expertise make it an appealing destination for clinical trial outsourcing, particularly for U.S.-based medical device companies seeking cost savings and value creation during early-stage development.(6)

Medtech Success Cases In Mexico

According to Clinicaltrials.gov, 61 medical device clinical trials in Mexico have occurred in the past three years.38 The following are some notable examples based on recent press releases:

• FastWave Medical, a clinical-stage medical device company developing advanced intravascular lithotripsy (IVL) technology, announced on May 29, 2024, the successful 30-day results of its first-in-human (FIH) study using the company’s peripheral IVL technology with Dr. Antonio Muñoa at San Lucas Hospital, Chiapas, Mexico.(39)

• NuView's NV-VPAC1 liquid biopsy diagnostic test clinical trial is planned to commence in early 2024 in Guadalajara and Mexico City, with approval from COFEPRIS anticipated in early 2025. Following approval from COFEPRIS, NuView plans to immediately request FDA reciprocal recognition of NV-VPAC1 liquid biopsy diagnostic test for commercial use in the United States.(40)

• Rivermark Medical, a company dedicated to developing a novel therapeutic device for benign prostatic hyperplasia (BPH), announced on December 7, 2023, the entire enrollment of its RAPID-II clinical trial, a multi-center O.U.S. clinical trial with sites in Australia, New Zealand, and Mexico. (40)

• NeuroCytonix announced on Jan. 29, 2023, that its subsidiary NeuroCytonix Mexico has received a regulatory acknowledgment letter from COFEPRIS following the presentation of NeuroCytonix’s final report on its clinical trial on NCX-CP-01 for cerebral palsy.(40)

• Todos Medical announced on Oct. 11, 2022, that it had collected the first 40 blood samples from up to 750 patient study participants enrolled in a clinical trial in Mexico. These samples should allow the company to complete the analytical and clinical validation for Videssa as a laboratory-development test (LDT) and launch at Provista. The blood work also will allow for ex-U.S. regulatory authorization and set the stage for a pivotal study to achieve clinical utility data in the United States for Videssa in breast cancer.(40)

• AEGEA Medical announced on April 22, 2019, that it had completed enrollment in the Post-Ablation Cavity Evaluation Mexico (PACE MX) clinical study of women who previously underwent endometrial ablation as part of a pivotal trial of AEGEA's Mara water vapor ablation treatment.(40)

Tradition Of Mexican Medical Innovations

Medical innovations originating in Mexico or from Mexican inventors span various fields, from ancient practices to modern technological advancements. Here are some notable examples:

• Modern Medical Devices and Technologies

  1. Gätsi Ventilator: Developed by Dydetec in 2020 to address the COVID-19 pandemic, this mechanical ventilation device has been crucial in providing respiratory support to patients.(42)

  2. EVA Bra: Created in 2017 by Julian Rios Cantu, this device is designed for early breast cancer detection by monitoring temperature changes in the breast tissue.(42)

  3. VITACOR UVAD Artificial Heart: Developed by Dr. Emilio Sacristan Rock, this artificial heart significantly advances cardiac care.(42,43)

  4. Probionics Prosthetic Limbs: Founded by Luis Armando Bravo Castillo in 2008, Probionics produces prosthetic limbs at a significantly lower cost than other companies. (42)

• Research and Development Hubs

  1. Medtech and Life Sciences Hub in Baja California: The region, particularly Tijuana, has become a significant center for medtech manufacturing and life sciences research, attracting global companies and fostering innovation in medical devices and therapies.(5)

Conclusion

Mexico has emerged as an attractive destination for conducting clinical trials for medical devices due to several key factors:

1. Favorable regulatory environment: COFEPRIS has recently streamlined the approval process for clinical trials, with a typical approval timeline of three to four months. COFEPRIS also has identified priority therapeutic areas like diabetes, cancer, and cardiovascular diseases for clinical investigation.

2. Cost advantages: Mexico offers lower operating costs than the U.S., including lower labor costs, site expenses, and regulatory fees. The favorable exchange rate further drives down clinical research budgets for U.S.-based companies.

3. Large patient population: With over 129 million people and an increasing incidence of diseases like diabetes and cancer, Mexico provides access to a large and diverse patient pool for recruitment.

4. Robust hospital infrastructure: Mexico has a vast network of public hospitals (IMSS), private hospitals, research institutions, and experienced investigators capable of conducting high-quality clinical trials.

5. Skilled medical workforce: Mexico has a sophisticated medical education system, producing skilled clinical researchers and investigators.

Several medtech companies like FastWave Medical, NuView, Rivermark Medical, NeuroCytonix, Todos Medical, and AEGEA Medical have successfully conducted clinical trials in Mexico, leveraging these advantages. Mexico's geographical location and time zone alignment with the U.S. facilitates administrative and operational oversight of outsourced trials, making it a convenient and strategic choice for U.S.-based companies. While the FDA accepts foreign clinical trial data for medical devices, including from sites in Mexico, the studies must follow GCP, use competent investigators, and have a design allowing data to meet U.S. requirements; also, the FDA must be able to inspect the sites if needed. Meeting FDA's expectations increases the likelihood of the foreign data being accepted.

While challenges like bureaucracy, finding the right local partners, and addressing cultural barriers exist, Mexico's favorable landscape has made it an appealing destination for clinical trial outsourcing for U.S.-based medtech companies seeking cost savings and value creation during early-stage development.

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About The Author:

Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a contract research organization (CRO) that works with medical device companies to help them do early-feasibility clinical trials 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 holds a bachelor's degree in electronics engineering (BSEE) and a master's in business administration (MBA).