From Academia to the FDA: How SoundRocket Launched into Regulatory Research

Our Rocket’s Unexpected Trajectory

When we founded SoundRocket (then known as Survey Sciences Group, LLC) in 2004, we had no idea we’d one day be playing a critical role in regulatory health communications research. Our roots were firmly planted in academic social science survey research—working with universities, grant-funded studies, and large-scale data collection.

But, like any good research study, our journey took an unexpected turn.

Today, SoundRocket is a trusted partner in regulatory research, helping companies navigate the complexities of FDA submissions through user comprehension, label comprehension, self-selection, simulated use, and human factors studies. So how did we get here? Let’s take a trip back to where it all began.

The Early Days: Finding a Niche in Academic Research

In the early 2000s, academic survey research was still heavily reliant on telephone, in-person, and even paper surveys. At the same time, the commercial world was rapidly moving toward online data collection. We saw an opportunity: bridging the gap between rigorous academic research and the emerging technology of web-based surveys.

Universities and grant-funded researchers needed a partner who understood both the quality standards of academia and the efficiency of modern survey methods. That’s where we thrived. For years, we worked closely with institutions to refine online survey methodologies, ensuring high-quality, scientifically sound data collection.

But our first big shift didn’t come from within academia—it came from an unexpected source: the world of personal genomics.

A Pivotal Moment: The Study That Changed Everything

In 2008, a research team, working under the Genomes to People (G2P) research group, reached out to us. They were launching a groundbreaking study called the PGen Study (Impact of Personal Genomics), led by Dr. Robert C. Green at Harvard and Dr. Scott Roberts at the University of Michigan.

This study aimed to explore the social impacts of personal genetic testing, partnering with two commercial giants at the time: 23andMe and Pathway Genomics. It was a standard academic research project—right in our wheelhouse.

We helped design and implement surveys that examined participants’ expectations before genetic testing, their reactions after receiving their results, and how they interpreted their genomic information over time.

At the time, we had no idea that this work would become a stepping stone into the world of regulatory research.

Learning the Ropes: An Accidental Entry into Regulatory Research

Fast forward a few years. Following the pGen study—which examined how consumers interpreted personal genetic information—we were introduced to 23andMe. That connection led to a direct contract to help them design user comprehension studies for their genetic health reports. At the time, we saw this work as part of product development. What we didn’t realize was that it would later play a key role in regulatory history.

A couple of years later, while reviewing the FDA’s approval documentation for 23andMe’s genetic health risk tests, we discovered that they had internally replicated the comprehension studies we originally helped design—after revising their reports—using them to support their submission to the FDA.

Unintentionally, we had contributed to a foundational moment: the development of FDA’s user comprehension expectations for direct-to-consumer genetic tests. Our work helped shape the content that underpins the federal regulation on genetic health risk assessments (21 CFR 866.5950).

This realization was a turning point. We suddenly had a clear understanding of what the FDA looked for in regulatory submissions focused on consumer comprehension—and we were uniquely positioned to deliver it.

Becoming a Trusted Partner in FDA Regulatory Research

After 23andMe was granted authorization to market their genetic health risk tests, companies started seeking us out for similar studies. Ancestry.com, for example, approached us to help with their move into health-related genetic testing.

From there, our role expanded. We weren’t just supporting academic studies anymore—we were directly assisting companies in designing regulatory research that met the FDA’s rigorous standards.

Key Lessons We Learned Along the Way:

✅ Academic rigor is a strength. The meticulous approach we used in grant-funded research translated seamlessly into the demands of regulatory studies.
✅ FDA expectations require precision. Every study needed to be designed with clear methodologies that aligned with regulatory standards.
✅ Collaboration is critical. Our clients valued our partner-like approach, where we worked closely with them to develop custom research solutions rather than offering one-size-fits-all studies.

SoundRocket has played a role in nearly every direct-to-consumer genetic test that has received FDA clearance—including one such product just approved weeks ago—a testament to how much we’ve grown in this space.

Why Companies Choose SoundRocket for Regulatory Research

We’ve learned that regulatory studies aren’t just about checking a box for FDA clearance—they’re about understanding how real people interact with health-related information. That’s where we excel.

From a recent conversation with one of our regulatory research clients, a key theme emerged: not all research partners are created equal.

“We spoke with a few firms that specialized in regulatory research, but they felt rigid—like we had to fit into their existing process. SoundRocket was different. They worked with us to understand our exact needs, refine our study design, and make sure we were on the most efficient path to FDA authorization.”

Our clients choose SoundRocket because we bring a unique blend of:

🚀 Deep expertise in survey methodology. We don’t just conduct studies—we design them with a social science research mindset to ensure high-quality, actionable data.

🚀 A flexible, collaborative approach. Unlike some regulatory research firms that take a rigid approach, we work alongside our clients to create a study that best fits their specific product and audience.

🚀 Meticulous project planning. Our milestone-driven process ensures that every phase of research is on track—helping clients meet submission deadlines with confidence.

What’s Next & How to Work with Us

SoundRocket has come a long way from our academic research roots. Today, while we continue to engage in higher education and custom social science survey research, we also specialize in label comprehension, user comprehension, self-selection, simulated use, and human factors studies—all critical components of FDA regulatory submissions.

If you’re developing a product that requires regulatory approval—especially if it involves consumer-facing health information—we’d love to chat.