Health Technology Validation: Strategic Opportunities in Brazil
10/04/2025
In a global landscape increasingly driven by technological innovation, the validation of new solutions in the healthcare sector is a crucial step to ensure effectiveness, safety, applicability, and regulatory viability.
In Brazil, this process has been consolidating as a strategic opportunity—not only due to its technical and regulatory robustness but also because of its infrastructure advantages, population diversity, and cost-effectiveness. Eretz.bio, the innovation hub of Hospital Israelita Albert Einstein, is part of this ecosystem, offering comprehensive support for companies and startups in the development and validation of health technologies.
Brazil as a Favorable Environment for Technology Validation
Brazil brings together a set of characteristics that position it strategically for conducting clinical trials, preclinical studies, and usability assessments:
- 10th largest global economy, with a broad consumer market and growing demand for health solutions
- Population of 212 million, with wide ethnic and genetic diversity
- World’s greatest biodiversity, offering potential for the development of bio-inputs and innovative solutions
- 42% of clinical trials in Latin America are conducted in Brazil
- A well-established ethical system, with CONEP and RECs operating under international standards
- Advanced infrastructure comparable to the best healthcare centers in the world
- Competitive costs, both for recruitment and operational resources
These factors are reinforced by a regulatory system that is constantly evolving. The collaboration between ANVISA and the FDA allows for data sharing and mutual recognition, which can accelerate approvals in different markets. With the implementation of Law 14.874/2024 and RDC 70/2024, a significant reduction in the time required for clinical trial approval is expected.
International Regulatory Comparison
When compared to other regulatory centers, Brazil offers a balance between technical quality, cost, and approval timelines.
In addition, the country has a high population adherence to studies, lower recruitment costs, and strong international acceptance of the data generated.
Einstein’s Infrastructure Advantages for Technology Validation
Hospital Israelita Albert Einstein, recognized for its excellence in care and research, provides unique conditions to support technology validation in real-world care settings. Key attributes include:
- Highly qualified professionals with national and international experience
- Strategic role in the Latin American innovation ecosystem
- Advanced infrastructure comparable to the best healthcare centers in the world
- Coverage across all levels of healthcare complexity, from primary to quaternary care
- Deep understanding of both public and private health sectors
- Centers of excellence in areas such as genomics, precision medicine, and advanced therapies
Eretz.bio’s Role in the Validation Process
Eretz.bio’s Health Technology Validation services include full technical and regulatory support, structured across five key areas:
- Clinical Studies
Conducted in compliance with Ethical and regulatory protocols. - Non-Clinical Studies
In vitro and in vivo laboratory tests for preliminary efficacy and safety assessment. - Usability Studies
Access to insights from Einstein professionals and patients, including analysis of applicability and integration into the care journey. - Market Intelligence Studies
Evaluation of value proposition, competitive landscape, distribution channels, market perception, and technological trends. - Regulatory Support
Comprehensive assistance in regulatory strategy definition and navigation of processes with ANVISA and its relationship with other international bodies, focusing on agility and risk reduction.
Conclusion
Choosing the right location and partner for health technology validation is a strategic decision that directly impacts regulatory outcomes, market acceptance, and scalability.
Brazil, with its regulatory, ethical, demographic, and structural assets, offers a solid foundation for this process. Eretz.bio provides a unique validation platform connected to clinical practice, science, and the market. Companies looking to validate with excellence, mitigate risks, and accelerate their entry into the healthcare sector will find in this ecosystem a safe, qualified, and internationally recognized environment.
Learn more about the Technology Validation Office and how Eretz.bio can support your company: www.eretz.bio/tvo
