Software as a Medical Device

Technology in the medical field is an ever-growing area of human innovation. The combination of practical skills of health specialists with the precise analysis of electrical systems has improved life expectancy exponentially. Such medical equipment includes the likes of MRI scanners, life support equipment and surgical lasers. Any piece of advanced electrical hardware has an equivalent software that can control functionality. This ‘Medical Software’ is integral in the correct diagnosis of patients utilizing their hardware. In recent times, medical software has become abundant due to increased smartphone usage, wireless technology and health awareness. The designation for this technology is “Software as a Medical Device (SaMD)”, a new and trending market that has taken the world by storm.

A SaMD is defined as a piece of software that is used for one or more medical purposes, and can perform these purposes without belonging to a primary medical device. Modern smart devices usually come standard with wireless communication technologies, such as Bluetooth, Wifi and IrDA (Infrared Data Association), giving them the ability to connect to computers, tablets, smart phones or other medical devices to access and change medical data as necessary. This information exchange can be done either in real time or asynchronously. Applications can be made to operate across different platforms, making it possible to connect various medical devices together with one smart device. This advancement has made it possible for doctors to diagnose and treat patients remotely.

Remote Patient Monitoring (RPM) is a medical device that is used for remote treatment in the medical field. RPMs are wearable sensors that collect live health data. To send this data to a doctor over the internet an appropriate SaMD application can be installed on a patient’s smart device. This application must constantly check and update data accurately due to the importance of the information regarding the patient’s wellbeing.

An example could be a diabetes patient who relies on a glucometer to provide an accurate blood sugar level to their doctor. If the data is sent incorrectly the patient’s wellbeing could be in danger.

The software developed must therefore follow strict testing before it can be released to public. A SaMD manufacturer is expected to gather and evaluate test data as a method to assure their product’s safety, efficiency and effectiveness. The FDA released guidance on clinical evaluation of SaMDs in October 2016, a document explaining the procedures that must be followed if one wishes to develop such medical software. This evaluation ultimately wishes to determine three factors of the software: the scientific validity, analytical validity, and clinical performance.

SaMDs are now also becoming increasingly independent of the hardware it needs to operate. This means that one application installed on a single smart device can run several medical devices simultaneously. Around one million or so similar medical applications are estimated to be available for download. An example would be the software that syncs a user’s profile to various health and fitness devices they use to monitor their wellbeing.
The Ultrasound Virtual Medical Device is a portable handheld device that has its software installed on a computer or smartphone. Through this interface, the act of viewing, analyzing, storing and transferring of ultrasound data becomes simple. SaMDs are now appearing in all aspects of the biological world, where an interesting development in haptics (science of touch) is the ‘Kissenger’ device. A simple attachment linked to a smartphone application that provides: “eff ective communication of deep emotions and intimacy through a multisensory internet communication experience.” Whether this technology can actually be classified as a SaMD is up for debate…

Advancements in SaMD technology have made it easier for doctors to treat and diagnose their patients efficiently, as well as increased access to medical information for public use. Smart devices have the ability to inform instantaneously through the internet, and the medical world has taken this function to their advantage, ranging from monitoring life threatening diseases to simply showing the world your fitness levels. Technology using the human body will continue to evolve, in the weird and wonderful ways only people know how.
Written by : Fast Kung