Software as a medical device (SaMD) is a growing area 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 that perform these purposes without being part of a hardware medical device’.
Remote patient monitoring (RPM) allows patients to better manage chronic conditions such as diabetes, insomnia and asthma in the comfort of their own homes. RPM systems allow physicians to monitor their patient’s vitals and unique condition biomarkers through transmitting data collected to a monitoring system or to a physician’s office for further assessment. For example, Pear Therapeutics developed a mobile health app, Somryst, that is a prescription-only cognitive behavioural therapy for chronic insomnia (CBT-I). The digital therapeutic allows physicians to monitor patients’ progress such as their sleep efficiency and insomnia severity remotely through the clinician dashboard.
In addition, SaMD can support physicians in decision making and treatment options, as well as provide early diagnosis of some diseases. The Royal Philips Capsule Surveillance solution is a clinical surveillance system that can live-stream data from any connected medical device, aggregate patient data, analyse data to create actionable insights, and notify healthcare professionals to intervene if needed. The Capsule Surveillance system also reduces hospital infrastructure complexity due to its large capacity. Since regulations for SaMD are still evolving while technology progresses, regulations are likely to remain behind technological advancements. As such, the limiting factor to new product launches is the establishment of adapted regulations.
GlobalData reports the RPM market to be valued at $585.5m this year and growing to $760m in 2030. And as technology advances and hospitals integrate more software, we expect to see a growth in SaMDs in RPM and other healthcare sectors.