- Medical Wearables
- Data Services
- Decentralized Clinical Trials
Selecting the right medical wearables for remote patient monitoring can be confusing. Beyond technical features, here is a list of practical questions to consider.
It can matter greatly. Patient adherence to protocols and instructions is one of the keys to ensuring successful remote monitoring.
If a device is not comfortable (size/weight), or is not easy to use by the patient themselves, it will not be used on a consistent basis.
Yes, if you want to access data remotely. If you just want to record data and access data retrospectively, then an offline recording device can work. But this also puts the burden on the patient to send or bring back the device to the clinic.
There are generally two ways you can access data from networked wearables: 1) directly from the device itself, 2) via a cloud service. Some medical wearables offer a development kit that allows you to directly take control of the data, commonly from mobile apps. While others provide you with cloud access to the data from the wearable, and it usually means you also need to use their mobile app and cloud service.
In RPM or ambulatory situations, it is common for there to be network (e.g. bluetooth, internet) disruptions.
During network disruptions, data will not be successfully transmitted from the wearable device to the mobile app or cloud.
In these situations, it is important to use wearables that have on-board memory so that you don't lose data.
This depends on your expectation of “realtime”. In general, with a good end-to-end network connection and well designed application, data can be transmitted from wearables to the cloud within seconds, followed by a continuous stream of data.
Consider the various paths that the data needs to travel:
From wearable to mobile app - assuming you have a reliable connection (e.g. BLE), the timing may be 1 to 5 seconds on the initial transmission, then a continuous stream of data depending on the data type and sampling rate.
From mobile app to cloud - assuming you have a reliable internet connection, this delay is mainly dependent on the way the mobile app is designed. With a fast internet connection, the delay should be minimal.
There are two things to consider for patients who are mobile: 1) data accuracy, 2) device adherence.
The most common impact is signal quality. This depends on how much movement there is, the modality or location of the wearable, and the type of data you’re trying to capture. For example, ECG signals can be noisy with high activity. But if you just want heart rate, there are many devices which can measure an accurate heart rate even with movement.
The other issue has to do with whether the device will stay securely on the body. You’ll want to choose devices that won’t shift easily (which affects signal quality), and won’t fall off with movement. Also consider nighttime readings since some people move quite a bit during sleep.
Note also that with adhesives based devices, heavy sweat or humidity can affect how well it adheres to the body.
This depends on the type of wearable device. Wrist style devices can be worn as a daily lifestyle with little impact to comfort.
Adhesives based devices are designed for multi-day use, but not necessarily for non-stop everyday use over a long period of time due to potential irritation.
There are different types of adhesives, so understanding the duration and frequency of application is important in order to find the right match.
In most clinical situations you’ll need the proper clearances such as FDA, CE Mark or NMPA. For research, you may be able to use investigational devices.
But even with regulated devices, you want to check that the use case is well matched to the function.
Unregulated devices can run a higher risk of data accuracy, or even potential harm.