In a landscape increasingly shaped by digital transformation, real-time data, and demands for operational efficiency, leaders of major healthcare corporations and industries face a paradox: how to innovate swiftly without compromising regulatory rigor?
For organizations operating in sectors subject to health validations, lengthy approval cycles, and ongoing surveillance – such as those regulated by Anvisa, the FDA, or the EMA – innovation must be carried out with responsibility, methodology, and traceability.
Several market analyses (such as those conducted by McKinsey & Company) indicate that although healthcare companies recognize the importance of innovation, many still lack integrated processes that combine agile development with robust regulatory management. In highly regulated markets, this gap can be the main limiting factor for adopting innovative solutions.
Innovation Culture: A Prerequisite for Safe Innovation
Companies that invest in internal capabilities, validation methodologies, and an intrapreneurial mindset create safe environments where teams can propose, test, and adjust ideas quickly—but responsibly.
The Global Innovation Index 2024, published by WIPO, reinforces that countries and organizations with mature innovation ecosystems are those that integrate applied science, incentive policies, and governance structures from the early stages of project development.
Intrapreneurship and Innovation
Intrapreneurship is not about breaking the rules: it’s about solving the company’s most critical challenges from within. In regulated markets, this means identifying operational bottlenecks, suboptimal workflows, or emerging market demands that can be addressed through incremental – but technically validated—innovation.
An article by the Harvard Business Review highlights that companies adopting formal intrapreneurship programs in regulated industries are able to reduce internal approval cycles, align R&D with operational realities, and increase the speed of incremental innovation.
The Main Barriers to Innovation in Regulated Sectors Include:
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Fear of non-compliance with Anvisa/FDA/EMA regulations;
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Lack of formal clinical validation pathways;
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Absence of internal culture around documentation, version control, and technical recordkeeping;
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Leadership associating innovation with reputational risk.
The response to these challenges is not to avoid innovation – but to structure it.
How Eretz.bio Can Help Your Company Innovate Safely
Eretz.bio offers several exclusive corporate programs, tailored to the specific needs of each company. One of them focuses on Innovation Culture and Intrapreneurship, supporting the implementation of innovation methodologies aligned with regulatory constraints and operational priorities.
This solution has already trained over 9,000 professionals with a safe, practical, and healthcare-applied approach.
Biogen—a global biotechnology leader—is one of Eretz.bio’s partners that launched its first intercontinental innovation program through this initiative. Entitled the LEAP Innovation Program, it aimed to identify innovative projects from the BIR intercontinental region (Latin America, Australia, Asia, Japan, Middle East, Africa, Turkey, and Russia), directly engaging 15% of all employees in the region.
With Eretz.bio’s Solutions, Your Company Will Be Able To:
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Train teams with business vision and regulatory understanding;
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Develop internal solutions with evidence-driven prototyping;
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Apply structured innovation methodologies in a regulated environment;
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Identify and structure priority challenges using innovation tools;
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Engage technical, regulatory, and R&D teams in high-impact strategic projects.
➡ Learn more about our solutions: https://www.eretz.bio/en/corporate-solutions/
