bioaccess® Steps Up as Key Latin America CRO Amid MedTech Partner Shortage
The medical device industry has a serious shortage of trustworthy research partners in Latin America. Even though experts predict a $20 billion market value by 2025, this is happening.
bioaccess's extensive network covers Mexico, Panama, Colombia, the Dominican Republic, Chile, Argentina, Brazil, and other key markets in Latin America. The company manages complete medical device trials and regulatory processes across these regions. Medical device companies' unique challenges in Latin American markets range from complex regulatory requirements to patient recruitment strategies. The company's specialized contract research organization (CRO) services deliver flexible solutions that blend local expertise with international standards.
Latin America's MedTech Market Opportunity
Latin America's medical technology market shows remarkable growth, with revenue expected to hit USD 28.59 billion in 2024 [1]. The market should grow steadily at CAGR of 5.68% between 2024-2029 and reach USD 37.69 billion by 2029 [1].
Current market size and growth projections
Medical devices lead the market with USD 23.99 billion of total market volume [1]. Equipment categories of all types show impressive numbers. To cite an instance, critical medical equipment has grown substantially:
Panama saw hemodialysis machines grow by 104%
Costa Rica's X-ray machines jumped by 76%
Colombia's laparoscopic surgery equipment rose by 41% [2]
Regional healthcare needs and demands
Latin America faces unique healthcare challenges. Patients pay 24% of total healthcare costs out-of-pocket, while European Union patients pay only 14% [3]. 62% of patients put off medical care last year because they couldn't afford it or reach it easily [3].
Population changes tell a compelling story. The elderly population will grow by 130 million by 2055 [4]. This aging trend and more chronic diseases create an urgent need for medical technologies and services.
Competitive advantages of Latin American markets
Latin American markets offer several benefits to medical device companies:
Cost-Effective Operations: Companies spend less than in US and EU markets but maintain high quality [5]
Large Patient Pool: The region serves over 650 million people, and 80% live in cities, making patient recruitment easier [5]
Superior Patient Retention: Patients drop out one-third as often as in the US and EU [5]
Healthcare goes digital faster here, with 41% of patients choosing virtual care for simple cases [3]. Electronic medical records (EMRs) adoption grows 7.15% each year [2].
bioaccess's Strategic Position
We stand as Latin America's leading Medtech and medical device CRO, bringing over 15 years of specialized experience in medical device research [6]. Our expertise covers the complete spectrum of medical device trials, from early-feasibility studies to post-market follow-ups.
Company expertise and capabilities
Our detailed capabilities serve medical device companies through:
Pilot Studies and First-In-Human (FIH) trials
Early-Feasibility Studies (EFS)
Pivotal Studies
Post-Market Clinical Follow-Up Studies (PMCF) [7]
The combination of deep biomedical engineering expertise and extensive regional knowledge allows us to deliver faster clinical study results while upholding the highest quality standards [6]. Medical device companies face unique challenges during early-stage development, and we provide custom solutions to direct them through these complexities.
Regional presence and network
Our strong presence spans Latin America with +15-year-old networks in key markets. The strength of our regional expertise comes from:
Advanced Training Programs: Continuous development of research methodologies
Collaborative Ecosystem: Well-laid-out partnerships with leading institutions
Quality Control Systems: Rigorous adherence to international standards [8]
Medical device trials in the region have shown remarkable growth, with data revealing an impressive 249% increase from 2011 to 2017 compared to the previous decade [9]. Our local presence helps us utilize this growth effectively for our partners.
Track record in MedTech trials
Our team has supported over 100 Medtech companies in operationalizing clinical trials across Latin America since 2010 [10]. The success of our track record shows in our ability to:
Secure rapid regulatory approvals
Activate research sites quickly
Manage subject recruitment effectively
Deliver reliable clinical trial data [7]
Quality research within competitive timeframes often challenges development-stage companies struggling to find talented medical staff. We excel at working with prototype devices and managing early-stage trials in the region's expanding medical device research landscape while maintaining high ethical standards and cost-effectiveness [9].
Regulatory Navigation Excellence
Our regulatory expertise is the life-blood of our success in Latin America's complex medical device world. We know from experience that these frameworks need both deep local knowledge and international regulatory understanding.
Understanding local regulatory frameworks
We have mastered the art of managing regulatory requirements in Latin America, where each country follows its own framework. Our experience shows that regulatory changes without proper advance notice can limit market access severely [11]. The region lacks complete harmonization. However, several countries have made important progress:
Colombia's INVIMA follows a predictable 30-day meeting schedule and leads as Latin America's most rigorous regulatory agency [12]
Mexico's COFEPRIS has cut review times from 90 to 45-60 days [12]
Paraguay completes approvals in three to four months with potential fast-track options [13]
Compliance success stories
Our track record of successful regulatory submissions speaks for itself. The team has secured more than 105 new marketing and clinical trial authorizations, including coverage in 10 countries throughout the region [14]
Strategic regulatory partnerships
Our advantage comes from our strong relationships with regulatory bodies in Latin America. We hold a unique position through:
Direct Agency Experience: Our regulatory affairs experts bring insider knowledge from their executive roles at Colombia's INVIMA [10]
Regional Expertise: We excel at navigating requirements of major regulatory bodies like COFEPRIS, INVIMA, and ANVISA [15]
Harmonization Initiatives: We help shape regional regulatory convergence by supporting the INTER-AMERICAN COALITION FOR REGULATORY CONVERGENCE launched in 2020 [11]
Poorly developed regulations create unnecessary trade barriers and raise costs for health systems [11]. We provide guidance that matches international standards with local requirements. This approach works especially when you have Latin American countries aligning their medical device regulations with international standards [12].
Cost-Effective Trial Solutions
Our team has transformed the cost structure of medical device trials in Latin America. We deliver exceptional value and uphold the highest quality standards. Research shows that clinical trials in emerging markets can reduce trial expenses by up to 60% [16].
Operating cost advantages
Our affordable approach brings substantial savings to medical device companies. Direct trial costs drop by 50% to 70% compared to U.S. or EU costs [16]. The simpler approval process cuts development time by 9 to 12 months [16].
These cost advantages come from:
Lower operational overhead costs
Quick patient recruitment strategies
Simpler regulatory pathways
Reduced administrative burden [17]
Resource optimization strategies
We use innovative approaches to maximize resource use. Our electronic data capture (EDC) systems allow up-to-the-minute data entry that reduces errors and speeds up analysis [18]. Sophisticated data analysis techniques, including machine learning and artificial intelligence, help researchers find meaningful insights quickly [18].
22% of Phase III Trials fail because they lack funding [19]. This reality led us to create a fixed-fee pricing model with transparent, upfront costs [19]. Sponsors can plan their finances and manage risks better than with traditional variable pricing models.
Value proposition for sponsors
Our benefits go beyond just saving money. Delayed development programs cost clinical trial sponsors about USD 37,000 in operational costs each day [13]. Our optimized processes cut study start-up times and speed up patient recruitment.
We use advanced statistical techniques and adaptive trial designs to modify studies based on incoming data [18]. This flexibility helps identify effective treatments quickly and stop ineffective ones early, which saves resources [18].
Our regional expertise combined with innovative technologies creates a complete approach to trial management. We balance cost efficiency with scientific rigor. Our decentralized clinical trials (DCTs) improve data quality while reducing site and patient burdens [20].
Clinical Trial Infrastructure
Our strong medical device clinical trial infrastructure extends to Latin America's premier healthcare facilities, making us a leading Medtech CRO in the region. Strategic collaborations with top-ranked hospitals include the Hospital Italiano de Buenos Aires and Hospital Universitario Austral. These facilities rank seventh and ninth among Latin America's best hospitals [21].
Site network capabilities
80% of our clinical research activity takes place in Latin American metropolitan areas [21]. Our infrastructure gives us several advantages:
Advanced digital health networks that enable secure patient data access
Standardized provider integration systems
Complete medical data sharing capabilities
State-of-the-art research facilities
Specialized medical device testing capabilities [21]
This infrastructure has accelerated our growth substantially. For instance, clinical trials in Argentina have seen a 61% increase from 2010 to 2021 [21]. Argentina receives about 200 new clinical trials annually, which places Argentina as the second-highest recipient of foreign-sponsored trials per million population in Latin America [21].
Patient recruitment strategies
Our pioneering community-based recruitment strategies have transformed patient enrollment in Latin America. These strategies work exceptionally well, with recruitment rates ten times higher than those in the United States and Western Europe [22].
Our region's socio-cultural dynamics understanding drives our success. Patient-centric strategies help us address language barriers, varying health literacy levels, and cultural sensitivities [23]. This approach leads to higher retention rates, and our community-based methods show notably lower dropout rates compared to traditional recruitment approaches [23].
Quality control measures
Quality control is the life-blood of our clinical trial management system. Our complete quality control framework provides:
Continuous monitoring of data collection procedures
Regular review of data management practices
Implementation of standardized operating procedures (SOPs)
Effective GCP clinical trial training
Independent review of approved protocols [24]
Our quality control measures consistently deliver exceptional results. Our trials have received positive assessments in all FDA and EMA audits [21]. Rigorous documentation standards ensure that all quality systems have detailed work instructions, tolerances, and policies [24].
Our advanced in-process review system tracks data capture, recording, and protocol compliance with up-to-the-minute data analysis. This system helps us maintain 91.8% foreign manufacturer sponsorship of our clinical trials, which shows international companies' high confidence in our quality control systems [21].
Our strong infrastructure and quality-focused approach create a reliable framework for medical device trials in Latin America. Our steadfast dedication to high standards and regional advantages makes us the preferred partner for medical device companies seeking budget-friendly and reliable clinical trial solutions.
Conclusion
Latin America's MedTech market offers significant growth opportunities for medical device companies. Our analysis shows the market could reach $37.69 billion by 2029. We help companies succeed with our 15-year old presence in key markets, regulatory expertise, and economical trial solutions. Companies can save up to 70% compared to U.S. and EU alternatives.
Our achievements demonstrate real results. We have secured over 105 marketing authorizations and built strategic collaborations with premier healthcare facilities. Patient recruitment happens ten times faster than Western markets. These results come from our deep understanding of local regulations, extensive site networks, and resilient quality control measures. FDA and EMA audits consistently yield positive outcomes.
Companies working with us get the best of both worlds - deep regional knowledge and international standards. Let us help tap into your medical device trials' full potential in Latin America. Contact bioaccess® today to learn how our expert CRO services can accelerate your path to market!
The medical device market in Latin America creates unprecedented opportunities for expansion-ready companies. Our proven expertise, established infrastructure, and steadfast dedication help medical device companies achieve their research goals. Quality standards remain paramount across Latin America.
References
[1] - https://proxy.parisjc.edu:8293/outlook/hmo/medical-technology/south-america
[2] - https://www.linkedin.com/pulse/how-medical-device-companies-can-access-latin-market-martinez-clark
[3] - https://www.mckinsey.com/industries/healthcare/our-insights/healthcare-in-latin-america-what-are-consumers-looking-for
[4] - https://americasmi.com/practice-areas-healthcare-research-latin-america/
[5] - https://www.bioaccessla.com/blog/future-prospects-for-latin-america-contract-research-organizations-in-medical-device-development
[6] - https://www.bioaccessla.com/about
[7] - https://www.bioaccessla.com/
[8] - https://www.bioaccessla.com/general-2
[9] - https://www.bioaccessla.com/blog/should-you-conduct-your-medical-device-clinical-trial-in-latin-america
[10] - https://www.interventionalconcepts.net/
[11] - https://www.advamed.org/wp-content/uploads/2021/08/Brochure-AdvaMed-Latin-American-Priorities-2021.pdf
[12] - https://www.meddeviceonline.com/doc/latam-s-regulatory-framework-for-medtech-early-feasibility-studies-0001
[13] - https://www.clinicalleader.com/doc/latin-america-s-landscape-for-medtech-clinical-trials-0001
[14] - https://www.interventionalconcepts.net/about-bioaccess
[15] - https://www.linkedin.com/pulse/navigating-regulatory-landscape-medical-96ddf?trk=organization_guest_main-feed-card_feed-article-content
[16] - https://journalforclinicalstudies.com/conduct-medical-device-clinical-trial-latin-america/
[17] - https://www.clinicalleader.com/doc/latin-america-a-compelling-region-to-conduct-your-clinical-trials-0001
[18] - https://medtech.gatech.edu/optimizing-clinical-trials-enhancing-efficiency-and-efficacy-in-medical-research/
[19] - https://vial.com/blog/articles/the-role-of-fixed-fee-pricing-in-the-globalization-of-clinical-trials/
[20] - https://www.worldwide.com/capabilities/trial-optimization/
[21] - https://www.meddeviceonline.com/doc/will-argentina-be-the-next-medtech-clinical-trial-destination-in-latin-america-0001
[22] - https://www.languageconnections.com/patient-recruitment-in-clinical-trials/
[23] - https://hclinical.com/community-based-patient-recruitment-for-clinical-trials-in-latin-america/
[24] - https://www.biopharmaservices.com/blog/the-key-role-of-quality-control-in-clinical-trials/
