Emerging Markets Are Pioneering Hybrid Clinical Trial Models For Medtech Products

By Julio G. Martinez-Clark, CEO, bioaccess

The global clinical research landscape is profoundly transforming toward decentralized clinical trials (DCTs), a market projected to grow from $9.39 billion in 2025 to $18.62 billion by 2030.¹ This shift, driven by the need for more patient-centric and efficient study designs, is having its most disruptive impact not in established hubs but in the emerging markets of Latin America, Southeast Asia, and Africa.

These regions present a compelling paradox: they are burdened by infrastructure deficits yet possess a unique capacity to innovate and leapfrog traditional site-centric trial models. The relative absence of entrenched legacy systems allows for the holistic implementation of new digital research frameworks from the ground up. This leapfrogging is a strategic imperative born of necessity. Vast geographies and a scarcity of specialist physicians make the traditional model nonviable, compelling these markets to innovate with hybrid and decentralized solutions to conduct meaningful research.

The scale of this opportunity for medtech market growth is immense. The APAC medtech market is projected to see healthcare spending in key Southeast Asian nations rise by 6% to 10% annually through 2032.^2,3 The Latin American medical device contract manufacturing market is expected to reach $7.37 billion by 2032.⁴ Yet this potential is set against a backdrop of profound research disparities. Africa, which bears 25% of the global disease burden, hosted as few as 4% of the world's clinical trials in 2023.^5,6 A similar gap exists in Latin America, where noncommunicable diseases constitute 48% of the disease burden but were the focus of only 14% of published randomized controlled trials (RCTs) in a landmark analysis.⁷ This article explores how this paradox is resolved through specific localized innovations forging a new, resilient paradigm for global medtech research.

Latin America: Leveraging Telemedicine And Regulatory Agility

Latin America is rapidly emerging as a leader in hybrid trials by combining its telecommunications infrastructure, diverse patient populations, and increasingly agile regulatory frameworks. Brazil, the region's largest market, offers a population of over 215 million, a high burden of chronic diseases, and a unified public health system that facilitates large-scale recruitment.² The region’s medical device CRO market is projected to reach $950 million by 2030, fueled by cost-effective solutions and proximity to North America.⁸

A landmark RCT in Brazil demonstrated the region's capacity for complex digital health studies. The trial tested a multicomponent telemedicine intervention for heart failure patients, involving nurse-led telephone support, remote monitoring of vital signs, and teleconsultations. The intervention led to a 44% relative reduction in heart failure-related rehospitalizations.⁹ Another Brazilian trial validated the accuracy of a remote physical examination device, finding over 90% concordance with in-person exams for key assessments like heart and skin examinations.¹⁰ Beyond advanced platforms, the region pragmatically leverages ubiquitous technologies like Short Message Service (SMS). A trial in Peru used a blood pressure monitor that automatically sent readings to providers via SMS, significantly reducing diastolic blood pressure.¹¹

Progressive digital health regulations enable this innovation. Brazil's Health Regulatory Agency (ANVISA) has established a sophisticated framework for Software as a Medical Device (SaMD) with its RDC 657/2022 regulation.^12,13 It provides a clear, four-tier risk classification system and mandates robust cybersecurity protections, creating a predictable developer environment.^12,14 Similarly, Colombia's National Food and Drug Surveillance Institute (INVIMA) is undergoing a major modernization to streamline regulatory processes and promote faster access to new technologies.¹⁵

Southeast Asia: A Hub For Wearables And Connected Devices

Southeast Asia (SEA) is a dynamic hub for trials leveraging wearable sensors and mobile health apps. The APAC wearable medical device market, valued at $7.5 billion in 2023, is forecast to grow at a staggering 28.4% CAGR to reach $42.8 billion by 2030, driven by a rising geriatric population and the prevalence of chronic diseases.¹⁶ The region’s total medical device market is already over $10 billion, with countries like Vietnam and Malaysia showing strong growth.¹⁷

A pioneering study in a Vietnamese intensive care unit highlights the region’s "stress-test" advantage. The trial evaluated low-cost wearable electrocardiogram and pulse oximeter devices on critically ill tetanus patients. Despite challenges like muscle spasms and profuse sweating, the study demonstrated it was feasible to collect high-quality physiological data comparable to expensive bedside monitors.¹⁸ A device that performs under such duress generates compelling evidence of its robustness, turning a resource-limited environment into a unique R&D opportunity.

Elsewhere, governments are actively seeding innovation. In the Philippines, the Department of Science and Technology funds clinical trials for cutting-edge technologies, including an AI-powered handwriting analysis tool for neurological assessment and immersive gamification systems for rehabilitation.¹⁹ At the other end of the spectrum, Singapore’s fully decentralized PROMOTE study on maternal mental health, which had no in-person visits, achieved a 97% participant retention rate, proving the viability of a 100% remote model.²⁰

The regulatory landscape is a dual track of regional harmonization and national laws. The Association of Southeast Asian Nations’ Medical Device Directive (AMDD) aims to harmonize technical requirements across member states, but implementation remains inconsistent, and it lacks specific provisions for SaMD.²¹ Countries like Vietnam provide clear, albeit stringent, pathways at the national level. Vietnam's Decree 98/2021/ND-CP establishes a comprehensive risk-based classification system and detailed clinical trial requirements, offering manufacturers predictability.²²

Africa: Pioneering Offline-First And Community-Centric Models

Africa's contribution to hybrid trials is defined by resilience and ingenuity. With unreliable power and limited connectivity, innovators have developed a unique model built on sustainable energy, offline-first technology, and community-based health networks. This is critical in a continent that bears 25% of the global disease burden but hosts less than 3% of clinical trials.⁶

The most fundamental barrier is the lack of reliable electricity, with an estimated one in four health facilities in sub-Saharan Africa operating without any power.²³ Decentralized solar power is becoming the foundational solution. We Care Solar, a non-governmental organization, has deployed hundreds of portable "solar suitcases" to power lights and essential devices like fetal monitors in maternal health clinics across more than 25 African countries.²³

The second hurdle is inconsistent internet, which makes standard cloud-based data capture systems unusable. The African research community has pioneered offline-first mobile tools like the Open Data Kit (ODK). ODK allows researchers to capture data on standard Android devices without an internet connection and later upload it to a central server. This approach has been shown to dramatically improve data timeliness and quality compared to paper-based methods.^24,25

The final layer is the human infrastructure. Community health workers (CHWs) are the backbone of many African health systems, bridging the gap between remote communities and formal care. Initiatives are now empowering them with digital tools. Amref Health Africa's LEAP platform uses simple SMS and audio messages to provide continuous training to CHWs,²⁶ while organizations like PATH in Zambia co-design digital systems with CHWs to streamline their workflows.²⁷ This "innovation stack" — solar power, offline-first apps, and digitally-enabled CHWs — forms a cohesive, resilient system for conducting research in the world's most challenging environments.

Strategic Imperatives For Medtech Companies

Medtech companies must adopt a nuanced, strategic approach to succeed in this new landscape. A one-size-fits-all strategy is destined to fail.

First, master the regulatory process by engaging local experts who can navigate the specific requirements of bodies like Brazil's ANVISA or Colombia's INVIMA. Companies must also develop market-specific commercial models, such as leasing or pay-per-use options, to address the price sensitivity of many emerging markets.²⁸ A localized go-to-market strategy that is culturally tuned and leverages appropriate communication channels, from face-to-face meetings to WhatsApp, is also critical.²⁹

Second, select the right clinical research partner. A capable CRO must possess a trifecta of competencies: proven capability, extensive experience, and a robust local network of investigators and sites.³⁰ The CRO must also demonstrate specialized expertise in digital solutions and patient-facing technologies for hybrid trials.

Finally, recalibrate the cost-benefit analysis of hybrid trials. While some surveys suggest hybrid trials are currently more expensive, this view is shortsighted.³¹ A sophisticated analysis reveals a powerful value proposition. A well-designed hybrid trial in an emerging market is a strategic investment that can accelerate market access by generating required local data, de-risking commercial launch by building relationships with local champions, and generating market-specific evidence to support reimbursement and adoption.³² The clinical trial is no longer a siloed R&D expense; it is the spearhead of the market entry strategy.

Conclusion

The innovations unfolding in Latin America, Southeast Asia, and Africa are blueprints for a more efficient, resilient, and patient-centric future for clinical research. These regions have shown that a lack of legacy infrastructure can be a powerful catalyst for change, forcing the development of holistic digital ecosystems. Medtech companies that thrive will view these markets not as obstacles but as strategic opportunities to co-develop, stress test, and validate the next generation of medical technologies. The new frontier of medical device innovation is hybrid, decentralized, and genuinely global.

References

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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).