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Compliance In Focus
Posted by John Lehmann on Tue, Sep 1, 2020

5 Wearable Medical Devices Transforming Clinical Research

Wearable medical devices are growing in popularity along with the rise of consumer-grade wearable technologies, such as fitness trackers and the Apple Watch.

wearable-medical-devices

Investigators are using wearable medical devices to collect data for clinical research, while physicians and other healthcare professionals are using them to help with treatment. These wearable sensors collect patient-generated data faster and more conveniently, making it easier for people to participate in clinical trials and allowing clinicians to monitor patients more closely.

These devices are part of a growing trend toward more personalized health and more precise treatment of chronic conditions.

Here are the five wearable medical devices that are transforming clinical research and patient care.

5 Innovative Wearable Medical Devices 

E4 Smartband

Company: Empatica

Use: Real-time physiological data collection, streaming and visualization

The E4 Smartband is a medical-grade, wearable device that allows researchers to collect and analyze patient data in real time.

The smartband collects data from the patient, including respiratory rate, temperature, heart rate, heart rate variability, activity and rest. It transmits this data using Bluetooth to the patient’s Care app on their smartphone.

The smartphone app streams the patient data in real-time to the secure Empatica Cloud, where it is displayed within Empatica’s HIPAA-compliant dashboard.

This has many benefits for clinical researchers, including the ability to see the impact of treatment in real time and conduct risk-based monitoring of adverse events.

CENTREPOINT Insight Watch

Company: ActiGraph

Use: Medical-grade monitoring of physical activity

The CentrePoint Insight Watch is a Class 2 medical device that captures continuous data on physical activity and sleep.

Data points include:

  • Raw acceleration (G's)
  • Energy expenditure
  • Physical activity intensity
  • Total sleep time
  • Wake after sleep onset
  • Sleep efficiency

Clinical investigators can access this data almost instantly, which can help them make faster, more informed decisions throughout a trial.

This has the potential to improve data accuracy and study outcomes.

VitalPatch

Company: VitalConnect

Use: Patient vital sign monitoring

The VitalPatch is a Class 2 health-monitoring device that provides data on vital signs to physicians and nurses. This biosensor monitors eight physiological measurements in real time, without the hassle of traditional monitoring equipment, wires and plugs.

VitalPatch monitors eight vital signs:

  • Single-lead ECG
  • Heart rate
  • Heart rate variability
  • Respiratory rate
  • Body temperature
  • Body posture
  • Fall detection
  • Activity

With third-party devices, it also monitors blood pressure, weight and oxygen saturation.

Researchers conducting clinical trials use the VitalPatch to gather the data they need more quickly, efficiently, and reliably. This helps them prove or disprove concepts more quickly, before they have invested more significant time and money.

AWAK Peritoneal Dialysis Device

Company: AWAK Technologies

Use: Portable dialysis for renal disease patients

The AWAK Peritoneal Dialysis Device allows patients to perform dialysis on the go.

More than 4 million people around the world need dialysis, including over 650,000 patients facing end-stage renal disease in the US alone, according to AWAK, and they have limited options. They can either spend several days a week receiving treatments at a center or perform peritoneal (at-home) dialysis using a manual process that must be done 3-4 times a day. This requires costly, bulky machines that limit their mobility.

The AWAK PD device combines a sorbent patch and a portable device. The sorbent patch removes uremic toxins from the spent dialysate and the portable device regenerates fresh solution in real-time. The portable device is designed to provide six to eight hours of treatment. The FDA designated it as a breakthrough device in 2019, a distinction granted to expedite the review of devices for which there are no FDA approved alternatives.

Considering one year of peritoneal dialysis costs about $53,000, according to US Renal Data System data cited by Modern Healthcare, this device has the potential to reduce a significant cost burden for patients, payers and providers.

G Medical Patch

Company: G Medical

Use: Remote patient monitoring

The G Medical Patch (VSMS/GMP) is a clinical-grade solution for monitoring patients at every stage of their healthcare journey.

The device uses wearable sensors that monitor vital signs, including:  

  • Heart rate
  • Blood pressure
  • Temperature
  • Electrocardiography
  • Body position
  • Location

The data is transmitted to a centralized database, allowing patients to easily share it with healthcare providers or clinical researchers. This allows patients to continue to receive consistent care no matter where they are, even if they move to a different provider. It also has the potential to improve patient care and reduce readmissions. 

6 emerging medical device trends

Should You Use Wearable Medical Devices In Your Clinical Trial?

Adding wearable devices to a clinical trial typically increases costs. The cost depends on a number of factors, including the type of wearable used, the kind of data you are gathering and the number of participants needed.

You also need to monitor patient adherence rates to ensure that you collect the data you expect to. Your chances of success partly depend on the technical specifications of your medical device. Device size, battery life and ease of use are all important considerations.

Despite these concerns, wearable medical devices have the potential to transform your clinical research and patient care.

As a global medical-device contract research organization with two decades of experience ensuring patient protection and regulatory compliance, IMARC can help you explore these options.

We have specific experience with trials involving wearable devices, as well as a strong working knowledge of clinical research regulations and best practices. We can also collaborate with your team in person or through video conferencing to help you navigate your next steps in this uncharted territory.

To learn more about the latest medical device trends, download our latest whitepaper.

 

Topics: medical device trends

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