Growing use of software medical devices in remote patient monitoring

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Software as a medical device (SaMD) is a growing field as technology evolves and becomes integrated into healthcare systems. In particular, the International Medical Device Regulators Forum defines SaMD as “software intended to be used for one or more medical purposes which performs those functions without being part of a physical medical device”.

Remote Patient Monitoring (RPM) allows patients to better manage chronic conditions such as diabetes, insomnia and asthma from the comfort of their own home. RPM systems allow physicians to monitor their patient’s unique vital signs and biomarkers by transmitting the collected data to a monitoring system or to a physician’s office for further evaluation. For example, Pear Therapeutics has developed a mobile health app, Somryst, which is a prescription-only cognitive behavioral therapy for chronic insomnia (CBT-I). Digital therapy allows physicians to remotely monitor patient progress, such as sleep efficiency and insomnia severity, through the Clinician Dashboard.

Additionally, SaMD can help physicians make decisions and select treatment options, as well as provide early diagnosis of certain diseases. The Royal Philips Capsule Surveillance Solution is a clinical monitoring system that can live stream data from any connected medical device, aggregate patient data, analyze data to create actionable insights, and ask healthcare professionals health to intervene if necessary. The Capsule Surveillance system also reduces the complexity of hospital infrastructure due to its large capacity. Since SaMD regulations are always changing as technology advances, regulations are likely to lag behind technological advancements. As such, the limiting factor for new product launches is the implementation of appropriate regulations.

GlobalData reports that the RPM market will be valued at $585.5 million this year and will reach $760 million in 2030. And as technology advances and hospitals integrate more software, we expect growth in SaMDs in RPM and other health sectors.

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