Clinical Trials for Medical Devices

A device designed for the real-world should be studied in the real-world.

It is essential to test medical devices to ensure patient safety and prove effectiveness. Before a device can ‘go-live,’ researchers must fully evaluate any risks and measure clinical efficacy for the intended population. This testing can be quite demanding.

Home-use medical devices must be assessed in the real-world. They need to consider variables that are not typically considered in a clinical setting, which can have implications for product development and approval. To successfully examine product interactions in the real-world, researchers can employ remote monitoring techniques that integrate multiple data streams into a single decentralized clinical trial platform, thus providing a more complete picture of the participant’s experience.

Our clients appreciate the ObvioHealth application because it allows patients to use medical devices from home or while on-the-go. Beyond fostering a better understanding of product performance in a real-world setting, the app’s device-integration capabilities enable patient vitals monitoring in real-time.  Our team has proven experience with remote monitoring and device integration in clinical research; see below for two examples of our capabilities.

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Assessing the efficacy of a medical device on pelvic floor dysfunction

A medical equipment manufacturer wanted to determine the effectiveness of an FDA approved Class II medical device compared to standard exercises to treat stress urinary incontinence (SUI) and stress-predominant mixed urinary incontinence (SMUI).

Participants are not be required to visit a lab or clinic during this study. Instead, a combination of validated digital questionnaires will be used to track health-related outcomes and flag potential AE/SAE in real-time.

Read Full Case Study
An graphic depicting device integration with the ObvioHealth App. Five devices shown.
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ObvioHealth Announces Next Generation Virtual Research Platform and Ecosystem

ObvioHealth, a global Virtual Research Organization (VRO), announces its next generation platform offering enhanced remote patient monitoring capabilities for the company’s end-to-end decentralized clinical trial solutions.

Read Press Release

The ObvioHealth App

Our proprietary application brings clinical research into people’s homes, making it easier for them to participate, and easier for researchers to collect robust data that reflect real behaviors.

"Cry detected" screen of the ObvioHealth app.
"Connecting to device" screen of the ObvioHealth app.

Want to learn more about how to go virtual with your medical device trial?

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How Do We Deliver Better Data for Your Medical Device Study?

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Recruitment & Onboarding

Recruitment is often a huge barrier to trial success. ObvioHealth uses digital targeting methods to find untapped populations. We identify the online behaviors that point to people with a positive pre-disposition for a specific trial and, because our studies are virtual, we are not geographically tied to a site location.  

Once recruited, we enroll participants through virtual prescreening/screening and e-consent. This eliminates the burdensome cost of site retention and staffing requirements, and often shortens the recruitment period.

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Outcome Measurement

The ObvioHealth platform and app incorporate multiple data capture technologies to adapt to the needs of any given trial.  These include simple survey-type completion of questionnaires and diaries, image, video and audio capture and use of wearables. Complementary data collection methods ensure more robust data real world outcomes.

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Logistics Management

Our platform makes it easy to trigger, track and manage products and payment of incentives. ObvioHealth can reimburse participants with the stipend program that is fully virtual. We ship any needed study supplies or devices directly to the participant’s home.

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Medication Adherence & Adverse Events

An important advantage of ObvioHealth’s app is the real time remote monitoring of medication adherence and potential adverse events. Our escalating system of reminders and immediate AE/SAE detection make our studies safer, while also improving medication adherence.

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Higher compliance, higher retention, more accurate data

Our easy-to-use, convenient app makes it easier for people to remain compliant. There is little to no time wasted travelling to clinical sites, so there are fewer dropouts. All of this means that studies end on time or ahead of schedule. And because participants are able to report more real world and real time experiences, the resulting data is more accurate and reliable.