Streamlining FDA Clearance for an Over-the-Counter Consumer Fertility Device

FERTI-LILY, a consumer-friendly at-home fertility aid designed to increase the chances of conception, was developed by an Amsterdam-based medical device company called Rosesta Medical BV. Initially launched in Europe in 2018, the product quickly gained traction, and Robert Stal, the company’s founder, set his sights on bringing FERTI-LILY to the U.S. However, when the company looked into FDA clearance to enter the U.S. market, they encountered a more complex and unfamiliar regulatory landscape.

For FERTI-LILY, the 510(k) submission process required rigorous usability and label comprehension studies to meet the FDA’s expectations for safe and effective over-the-counter (OTC) use. With no previous experience with FDA submissions, Robert and his team needed U.S.-based regulatory partners. 

To design and conduct their FDA-grade human factors studies, Rosesta Medical needed a research partner with deep knowledge in regulatory compliance, expert study implementation, and a strong FDA clearance track record to avoid costly delays. That’s where SoundRocket came in.

Complex FDA Requirements: Unlike the European market, where regulatory approval was relatively straightforward, the U.S. required FERTI-LILY to conduct three consumer comprehension studies: a self-selection study, a label comprehension study, and a simulated use study. These studies evaluate whether typical users can correctly self-select the product and then safely and effectively know how to use it based on product labeling and instructions for use (IFU).

Unclear Study Design: While there are FDA guidance documents which can be adapted to help with the design of self-selection studies, label comprehension studies, and simulated use testing, there was no roadmap for FERTI-LILY to perform all three studies together in a virtual setting (due to the COVID-19 pandemic) that would meet the FDA’s stringent requirements. Experience with previous FDA studies was critical.   

Resource Constraints: As a lean startup, Rosesta Medical needed to strategically allocate resources while ensuring a high-quality, FDA-compliant submission.

SoundRocket’s approach combined scientific precision, iterative testing, and deep regulatory expertise to streamline the approval process.

Expert Research Design: SoundRocket developed a virtual self-selection study, label comprehension study, and simulated use study aligned with FDA guidelines. The study tested consumers’ understanding of critical instructions, warnings, and intended use.

Data-Driven Refinements: The SoundRocket health communications team improved the product labelling and IFU based on prior experience developing user-friendly, FDA-compliant labeling. They conducted readability testing and open-ended interviews with typical users to identify comprehension barriers, such as complex medical terminology, unclear phrasing, or low-information retention areas. These insights were used to optimize product instructions before testing, reducing the likelihood of rework.

Instead of a one-size-fits-all solution, SoundRocket structured the project in phases, allowing Rosesta Medical to pause, refine, or accelerate based on regulatory feedback and business needs.

This approach reduced risk, prevented unnecessary costs, and ensured the study results met the FDA’s high and specific expectations.

SoundRocket worked as an integrated extension of Rosesta Medical, engaging in frequent strategy sessions to adapt study methodologies in real-time.

Detailed Gantt charts and structured project planning ensured Robert and his team were aware and aligned every step of the way.

As a result, project milestones were met on schedule and as expected, which is a true accomplishment with a project of this scale. 

With FDA clearance, Rosesta Medical scaled its U.S. commercialization strategy by securing an American distribution partner. SoundRocket’s proven research methodology also positioned them as Rosesta’s trusted regulatory partner for future projects.

Regulatory Success: The FDA granted Rosesta Medical 510(k) pre-market authorization for FERTI-LILY with SoundRocket’s FDA-compliant study methodology and results reporting as a key part of the submission. 

Collaborative, Integrated Approach: SoundRocket worked as an extension of Rosesta Medical’s team, ensuring seamless execution.

Beyond Compliance—Market-Ready Insights: By refining product instructions for clarity and usability, SoundRocket’s research not only satisfied FDA standards, but also enhanced the consumer experience, improving adoption potential.

Cost-Effective & Flexible: Compared to competitors’ rigid, high-cost models, SoundRocket delivered high-quality research at a fraction of the cost, with an adaptive, milestone-based approach that reduced financial risk.