How to Tell if a Medical Device is SaMD by Experts

In the ever-changing world of healthcare technology, new devices and technology (samd) are revolutionizing the way healthcare works. Two hundred years ago, the stethoscope was invented and doctors no longer had to put their ears to a patient’s chest. In many of our lifetimes, we have seen all kinds of advancements, from artificial hearts to artificial intelligence.

Software development (SD) has played a key role in healthcare innovation throughout the years. Software has allowed medical equipment and devices are more effective and efficient thanks to new and more powerful software. Thanks to software, data can be used in ways that were unimaginable just a decade ago.

Now, software in the healthcare industry has gone beyond simply making medical devices to operate better. It is now a healthcare device unto itself. Software as a medical device (SaMD) is an innovation that is changing the way healthcare is performed and also improving it. Here we will discuss what SaMD is and how to tell if a medical device is SaMD.

What is SaMd?

SaMD (Software as a medical device) is defined as any software that functions as a medical device independent of any other type of medical device. The device can provide a single medical function or multiple ones. To be classified as SaMD It must, on its own, help medical professionals or individuals diagnose, prevent, mitigate, or treat some kind of medical condition.

This is often confused or lumped into software in a medical device (SiMD). These are two different software categories, even though they sometimes seem similar. For example, an app on a smartphone that shows you the results from a medical device could go either way. If it is simply the way you get the results from the machine it is SiMD. If the app takes the raw results and analyzes or translates them in some way, it Is most likely SaMD.

How to tell if a device is SaMD

Figuring out if a device is SaMD, SiMD, a software accessory, or some type of general healthcare software can be challenging. According to Orthogonal, there are two major rules that qualify a device as SaMD.

Rule #1 is to figure out if the software qualifies as a medical device. The International Medical Device Regulators Forum (IMDRF) defines a medical device as any type of medical equipment that can be used for medical purposes. Rule #2 is that SaMD must be able to be used as a standalone device. Meaning, it can function as a medical device (as defined in Rule #1) on its own, without needing another medical device in order to use it. If the software in question meets these two criteria, then you are dealing with SaMD.

Examples of SaMD

With so many medical devices and so much medical software in the marketplace, it can still be hard to determine exactly what SaMD is, especially versus similar seeming SiMD. To help paint a clearer picture, we will give some popular examples of SaMD being used in the healthcare industry today.

Monitoring Sleep Conditions

Sleep apnea is a condition affecting millions of people that can lead to very serious health problems down the line such as heart disease, high blood pressure, or even Type 2 diabetes. SaMD can help people who suffer from this condition by monitoring their breathing and alerting them to irregularities as they sleep. To do this, an app on a person’s phone that is a SaMD device can access the phone’s mic and send an alert when breathing becomes irregular.

Fertility Apps

Using fertility drugs or other fertility treatments employed in order to become pregnant are more popular in the 21st century than ever. SaMD can put control of your fertility treatments in the palm of your hand. With a SaMD fertility app, users can input information about their bodies, their cycles, and their treatments; the app will help alert you to such things as how much of a certain drug to take or when to take it.

Examining MRIs

MRIs are used to detect all sorts of conditions hidden deep inside your body, from torn ligaments to tumors. Medical professionals are very skilled at looking at these images and diagnosing conditions but they are only human. SaMD offers software that uses machine learning and powerful analytics to analyze the results of an MRI and see incredibly minute things a human might miss. Using this technology allows medical professionals to diagnose conditions more accurately and earlier to help produce better outcomes.

Standard Product to Medical Device

Another example of SaMD is software applications that can be used to turn devices that do not have a medical purpose into a medical device.  This ability helps with the portability, expense, and versatility of healthcare products. A specific example of this type of SaMD would be software installed on a standard, general-use digital camera that allows the camera to operate a tri-axial accelerometer which can help with diagnosis.

Predicting Risk

Some SaMD devices can help calculate risk factors and share that information with a patient’s healthcare provider to suggest certain screenings or diagnosis. When a patient enters a selection of health information and vitals, software can use an advanced algorithm to determine how high-risk a person is for a disease like diabetes which will save time and money in the healthcare process.

Wearable SaMD

A whole classification of SaMD is paired with smart devices you wear on your body. This type of Software as a medical device is most often found in devices such as smartwatches. Using SaMD, these smartwatches become medical devices that transmit health data in real-time to medical professionals to aid in the treatment, prevention, or monitoring of a health condition.

Determining Treatment Plans

After a health condition is diagnosed, doctors use all kinds of information to determine the correct treatment plan. This information includes such factors as height and weight, age, blood pressure, and more. A SaMD device on a doctor’s phone or tablet can take this information and use analytics and algorithms to quickly and accurately come up with the best treatment plan so that doctors don’t have to perform much additional research or calculations.

Conclusion

Now that you know what SaMD is, the rules that determine it, and some real-world examples of it in action, you should be able to spot SaMD when you see it and know the difference between it and SiMD. This will be helpful now and in the future as SaMD becomes more popular and widely used.