We Design, Do, & Deliver Studies
Founded over twenty years ago, SoundRocket can meet your social science study needs in everything from design and data collection to analysis and reporting.
Your Research Partner in Precision & Execution
Expert project management, clear communication, and scientific rigor—SoundRocket integrates seamlessly with your team to keep studies on track. We specialize in two areas:
Regulatory Studies
SoundRocket specializes in regulatory studies that support successful 510(k) submissions with scientifically sound, defensible research. Call us when you need your next…
- Label Comprehension Study
- Self-Selection Study
- User Comprehension Study
- Human Factors Study
- Actual Use Study
- Simulated Used Study
- ACNU Study
- Consumer Study
- Provider Study
- Custom Study
Academic Studies
SoundRocket partners with researchers to design and execute high-quality social science studies using proven survey methodologies. Bring a Survey Methodologist and expert Survey Manager to your next…
AncestryDNA Factor V Leiden Genetic Health Risk Test
K192944
AncestryDNA Saliva Collection Kit
K192947
AlphaID At Home Genetic Health Risk Service
K221420
FERTI-LILY Conception Cup
K222969
GlutenID Celiac Genetic Health Risk Test
K241456
Select FDA Clearances
We design and implement science-guided, defensible studies that are targeted, rigorous, and led by experts.
We just got clearance from the FDA for the AlphaID At Home Service for OTC use!
USER COMPREHENSION STUDY Genetic Health Risk Test
SoundRocket Customers
SoundRocket has served over 400 institutions and organizations since 2004.
From the Launchpad
How Patient Preferences Shape Medical Device Development: Insights from FDA Draft Guidance
Explore how Patient Preference Information (PPI) impacts medical device development and regulatory submissions, with insights from the FDA’s draft guidance and key benefits for manufacturers.
Expanding Diversity: Beyond Clinical Trials to Human Factors and Label Comprehension
At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), marking a significant regulatory shift. Labs now face a phased compliance process over four years, adapting to stringent requirements. SoundRocket specializes in human factors and user comprehension studies, essential for FDA submissions. We provide comprehensive support through user and label comprehension studies, simulated use studies, and regulatory guidance. With proven expertise in FDA submission support, SoundRocket ensures your LDTs meet regulatory standards efficiently. Embrace the new regulatory landscape with confidence by partnering with SoundRocket. Visit our services page to learn more.
Insights on the FDA’s Virtual Public Meeting: Home as a Health Care Hub Initiative
At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), marking a significant regulatory shift. Labs now face a phased compliance process over four years, adapting to stringent requirements. SoundRocket specializes in human factors and user comprehension studies, essential for FDA submissions. We provide comprehensive support through user and label comprehension studies, simulated use studies, and regulatory guidance. With proven expertise in FDA submission support, SoundRocket ensures your LDTs meet regulatory standards efficiently. Embrace the new regulatory landscape with confidence by partnering with SoundRocket. Visit our services page to learn more.
Navigating the New FDA LDT FinalRule with SoundRocket’s Expertise
At the end of April 2024, the FDA finalized its rule on Laboratory Developed Tests (LDTs), marking a significant regulatory shift. Labs now face a phased compliance process over four years, adapting to stringent requirements. SoundRocket specializes in human factors and user comprehension studies, essential for FDA submissions. We provide comprehensive support through user and label comprehension studies, simulated use studies, and regulatory guidance. With proven expertise in FDA submission support, SoundRocket ensures your LDTs meet regulatory standards efficiently. Embrace the new regulatory landscape with confidence by partnering with SoundRocket. Visit our services page to learn more.
Empowering the Home as a Health Care Hub – The Role of User Comprehension Studies
To advance health equity, the FDA has launched the "Home as a Health Care Hub” initiative. This initiative aims to transform the traditional home into a primary setting for health care. This forward-thinking approach recognizes the evolving landscape of medical care,...
Expert advice on designing DTC genetic test reports
There is little published guidance on how to present genetic or genomic results in an understandable way and at an appropriate reading level for a typical consumer.1 Most of the literature on developing genetic test reports for non-experts (i.e., anyone without...