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Software as a Medical Device: 5 Things to Know

Technology has pushed the healthcare industry forward for years. From the invention of the X-ray to MRI and CT machines to the advancements in artificial intelligence and machine learning we are seeing in the healthcare industry today, technology has always played a key role in improving healthcare.


In 2020, one of the biggest technological advances that we are seeing in the industry is Software as a Medical Device (SaMD). This technology is making healthcare easier, more efficient, and more effective. Here we will look at what SaMD is, what it is not, and a few other things you need to know about this innovative healthcare technology.


1. The definition of SaMD

Software as a medical device refers to software that acts as a standalone medical device or product, not software that functions as part of another medical device. This software is capable of performing at least one (and sometimes several) medical functions on its own without the need for additional hardware. To be considered SaMD, the software must help patients prevent, cure, diagnose, or treat medical conditions.


While SaMD does not need another medical device to function as software, it does need a platform to operate on. SaMD is most often used in conjunction with smartphones, tablets, other handheld devices, or on normal laptops or desktop computers. You can often find SaMD as an app on a smartphone or other device.


>2. Not all medical software is SaMD

All medical software (or even all medical software apps) are SaMD. There is general medical software that is not a device on its own, software that acts as an accessory to a medical device, an–the type of software that is most often confused with SaMD–software in a medical device (SiMD).


Software in a medical device is software that is part of a larger medical device. Often, SiMD is literally in the device to help it run but even an app that is necessary for a hardware device to operate properly is considered SiMD, not SaMD.  


Orthogonal notes two key rules for determining whether or not your software qualifies as SaMD. Rule #1 is that it has to qualify as a medical device by the definition established by the International Medical Device Regulators Forum (IMDRF) and achieve one or more medical purposes. Rule #2 is that it must be able to be used as a standalone device. It cannot require another medical device in order to function or be a critical component in the functioning of another medical device.


3. The benefits of SaMD

There are several benefits that SaMD provides the healthcare industry which is why it is such an exciting new technology. One of the biggest benefits is that it makes medical data more portable. Medical professionals and patients can get real-time data about their health in the palm of their hand. These devices can collect more data than ever and process it in a way that other medical devices can’t. This gives medical professionals more data-driven insights than ever before. Having this real-time data and the insights that come from it helps improve data-driven treatment and prevention of medical issues, which in turn is leading to more effective practices that improve patient outcomes.


Another benefit of SaMD is that it speeds up the innovation cycle. When you are dealing with big, expensive, complicated medical device hardware, changing it, upgrading it, or improving it can take a long time and cost a lot of money. When the device is software, it is much quicker, easier, and less expensive to make these changes. This means that the device can improve all the time with a simple software update.


4. Questions surrounding SaMD

While the reception and overall perception around SaMD are very positive overall, like any new technology there are questions around how to continuously improve SaMD and how to overcome some of the challenges it faces. From an improvement standpoint, SaMD derives a lot of its value from how quickly the innovation loop functions. Developers of this software are always looking to make this loop faster without sacrificing quality. How to constantly improve the user interface (UI) and user experience (UX) is another question SaMD developers are always grappling with.


SaMD technology is part of a larger category of technology, the Internet of Things (IoT). This term refers to the network of internet-connected devices that can communicate with each other and larger systems. Securing these devices is a constant battle and one that developers are always fighting. With devices that collect and transmit incredibly sensitive medical data, security is a serious challenge and top priority.


5. Examples of SaMD

Software is currently being used in many ways as a medical device to help treat, diagnose, or prevent all types of health conditions. The best way to start to wrap your head around what these medical SaMD devices are, how they work, and what they have the potential to accomplish is by understanding how they are currently being used.


SaMD provides a handful of broad categories to draw examples from. One type of SaMD is software that calculates a drug dosage based on highly individualized information you enter. Another is software programs that take data from another medical device and analyze it. This analysis can be to determine risk factors or preventative measures to take. Some SaMD can even use artificial intelligence to scan huge amounts of data or pictures from x-rays, MRIs, or CT scans to help find warning signs the human eye or less advanced machinery may have missed.


Examples that the average person who is not a healthcare professional may be more familiar with involve SaMD on the smart devices we use every day. An app that accesses your smartphone’s microphone to detect abnormalities in breathing and alert the user is one example and a smartwatch that measures vital signs is another. This SaMD technology is putting more control of a person’s healthcare in their own hands.



Now that you know these five things about SaMD, you hopefully have a better understanding of what it is and how it works. It’s also important to know that SaMD technology is not only improving healthcare delivery for the medical industry, it’s also providing greater information and control for the average person as well. SaMD is something you’ll see more and more in the future as technology continues to impact and improve the healthcare industry.