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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.

Virology category label.

Evaluating the Safety/Efficacy of an Oral Investigational Drug from Home

To date, COVID-19 trials have been primarily managed in hospitals. However, most symptomatic patients are recovering at home.

ObvioHealth recently-launched a randomized, double-blind placebo-controlled decentralized study to test the safety/efficacy of a COVID-19 treatment using a combination of mobile app, devices, and assessments by in-home nurses.

Participants are trained to use a kit with five digital devices for remote monitoring of vitals including: temperature, respiratory rate, heart/pulse rates, blood pressure oxygen saturation, body weight, and cardiac rhythm and QT interval (ECG). In parallel, they record their symptoms via a daily digital diary on the app.

(More Info Coming Soon)
A mother kissing her fussing newborn.
Pediatrics category label.

Measuring Crying and Fussing Events in Babies via Digital Recording Device

The client wished to determine the effectiveness of a recording device in identifying the prevalence and duration of infant crying/fussing.  

Parents of infants were asked to record such events digitally through the ObvioHealth app; a recording device attached to each infant was tasked with the same.

 After a comparison, it was found that parents frequently reported the events inaccurately. This provided insight into device functionality and human error.

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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.