Comprehension Testing & Optimization for
Direct-to-Consumer Health Content
“With the rising popularity of direct-to-consumer digital health products and services, people are making personally-guided health decisions everyday; ensuring your health content is clear, accessible and high quality, has never been more important than now.”
Jill Furnival, Genetic Counselor
SoundRocket Research Director, Genetics & Health Communications
SoundRocket collaborators include…
Consumer Genomics Companies
OTC Medical Device Manufacturers
OTC Medical Product Manufacturers
Health Information Companies
Key projects include..
- Genetic Health Risk User Comprehension Study (21 CFR 866.5950)
- Cancer Predisposition Test User Comprehension Study (21 CFR 862.3364)
- Pharmacogenomics User Comprehension Study (CFR 21 866.6090)
- Sample Collection Kit Consumer User Study
- Label Comprehension Study
- Self Selection Study
- Simulated Use Study
- Health Content Optimization Studies
- Comprehension Studies
Is this service for you?
If you are preparing an FDA 510(k) submission for a regulated OTC or DTC product
If you have submitted a 510(k) and received an additional information request for user testing
If you are bringing a medical product from another country to the US market
If you want to be FDA-ready for the future
If you simply want to optimize your health content so it is more meaningful to your user…
…let’s chat about SoundRocket’s suite of comprehension studies!
Regulatory Compliance Studies
FDA studies must meet specific and rigorous criteria to prove health content offers “accurate descriptive information that can be easily understood by a consumer without the involvement of a healthcare provider.” At SoundRocket, we know what the FDA is looking for in study design, sampling, data management, comprehension level, and reporting.
But the FDA only regulates some consumer-facing health content. For example, in order to obtain premarket FDA clearance, companies that manufacture over-the-counter (OTC) Class II medical devices must show that typical users can understand the product’s consumer-facing content–-like instructions for use, packaging, and test reports–through label comprehension studies or user comprehension studies.
There is a lot of health information widely available to the public which is not reviewed or regulated by a governing body. We believe, when you provide any type of health content directly to people, be it consumers or patients, it needs to be clear, accurate, and accessible to everyone across diverse populations. This promotes effective and responsible patient (or consumer) engagement and supports informed decision-making.
Health Content Optimization Studies
Based on our work in this area, SoundRocket has developed a protocol to evaluate and optimize any health content aimed directly at everyday people. The goal is to ensure typical users can access, understand, and apply health information in a way that meets their needs (e.g., to gain knowledge, to inform a decision, etc).
SoundRocket’s health content comprehension studies use a combination of expert recommendations and iterative, interview-based insights in the development and refinement of public-facing health information.
Our team is well-equipped to help you optimize your health content. We have two professional health and science writers on staff who can provide support and guidance for health communication projects.
Our studies go beyond comprehension testing; they also look at content readability, user experience, and how the user thinks about, engages with, reacts to, and acts on the health content provided. To make the most effective and reliable improvements to the content, a study design with user-centered feedback and repeat iterations of effort is suggested.
To learn more about our health content optimization services, schedule a consultation.