In an effort to increase the resilience, safety, and diversity of the U.S. infant formula supply, the Department of Health and Human Services (HHS) and the Food and Administration (FDA) have launched Operation StorkSpeed—a government-wide initiative designed to streamline approval processes, enhance manufacturing readiness, and modernize regulatory oversight. This review reflects a growing recognition that the industry must evolve to keep up with both innovation and public health demands.

At ObvioHealth, we’ve already helped pave the way forward. For years, our decentralized clinical trial (DCT) platform has supported pioneering research in infant nutrition, using virtual tools to accelerate development timelines while reducing the burden on caregivers and ensuring high-quality data for regulatory decision-making.

Aligning with Operation Stork Speed: The ObvioHealth Approach

The FDA’s goals—speeding approval timelines, encouraging innovation, and improving access—mirror many of the outcomes we've achieved through our work in infant formula trials. By moving the clinical experience into the home, we enable:

• Rapid participant recruitment and onboarding

• Real-time, remote monitoring of infant health and safety

• Data capture through digital tools that empower caregivers

• Robust trial designs that align with FDA  regulatory requirements

Instead of requiring frequent site visits, our trials leverage caregiver-reported data, smart medical devices, and clinical oversight by remote pediatric experts. This not only improves study accessibility and inclusivity but also ensures the collection of real-world, reliable data for infant growth, feeding tolerance, gastrointestinal health, and more.

Transforming How Infant Nutrition Studies Are Run

Traditional trials in the infant formula space often face logistical, emotional, and regulatory hurdles. Engaging new parents, managing variable infant behaviors, and collecting consistent data can be especially complex. Our decentralized trial model addresses these challenges directly:

• Home-Based Measurements: Parents are trained and equipped to conduct and report infant measurements (such as weight and stool quality) using guided instructions through our mobile app.
• Smart Data Capture: Digital diaries, image uploads, and AI-enabled tools allow for objective and efficient data collection, such as stool consistency assessments and cry duration analysis.
• Clinical Oversight from Afar: A dedicated virtual team of nurses and coordinators monitors safety signals in real time and provides support to caregivers as needed.
• Regulatory Alignment: Our protocols are designed with input from regulatory and clinical experts, ensuring the data generated is fit for submission to health authorities.

A Future-Focused Model for Infant Nutrition

With the federal government actively pursuing faster and safer ways to evaluate and approve infant formula products, the need for flexible, scalable, and scientifically rigorous research methods has never been greater. ObvioHealth’s approach has consistently delivered:

• Reduced trial timelines

• Lower operational costs

• Improved caregiver engagement

• High-quality data for regulatory decision-making

By reducing site dependency and embracing virtual tools, we’re helping sponsors navigate complex pediatric trials with greater speed and confidence—an essential advantage in today’s rapidly evolving regulatory landscape.

Conclusion: A Proven Path for the Future

Operation StorkSpeed signals a turning point in how infant nutrition innovation will be regulated and supported. At ObvioHealth, we’re proud to contribute a proven, people-centered model that meets the FDA’s call for faster, smarter clinical trials. As the industry moves toward a more agile and responsive framework, decentralized research isn’t just a solution—it’s a catalyst for progress.

To learn how ObvioHealth can support your infant nutrition research goals, connect with us.