Understanding SaMD: A Quick Software as Medical Device Primer

Technology has long driven innovation and progress in the medical world. The latest advancements in this space are making the work of doctors, nurses, and other medical professionals easier. Tech also helps make healthcare better, cheaper, and more accessible for patients.

In 2021, many new technologies are helping to drive medicine. Advancements such as telehealth, electronic health records (EHRs), blockchain, artificial intelligence, and virtual and augmented reality are all disrupting and transforming healthcare in many different ways. Another technology that is growing rapidly within the healthcare field is Software as a Medical Device (SaMD).

Whether you are a patient, a healthcare professional, an investor, or someone who just likes to follow the latest trends, learning more about SaMD can be beneficial. To help you better understand this emerging technology and how it may affect your life now or in the future, here is a quick Software as a Medical Device primer to help you better understand it.

What is SaMD? 

Two major defining factors make software be SAMD. The first is: Does the software provide a medical benefit to patients and, if it is miscued or if it malfunctions, can it cause harm to the patient? The second factor is:  Can the software work independently from any other medical device? SaMD is software, so it does need to be run by something but it can’t be a medical device. It has to be something like a normal computer, tablet, smartphone, smartwatch, or other types of electronic devices.

SaMD is often confused with software that is used in conjunction with a medical device. This type of software is known as Software in a Medical Device (SiMD). If software helps you control an x-ray or MRI machine remotely, helps a medical device run, or is the primary way you see the output from a medical device, all of those qualify as SiMD, not SaMD. If you want to dig deeper into what SaMD is and what it isn’t, Orthogonal has a thorough guide to SaMD.

Examples of SaMD

We know what SaMD doesn’t do – need other medical devices to function properly – but what does it do? The short answer is: a lot. In 2021, there are all kinds of SaMD products. Some of these products are used by healthcare professionals in hospitals and other medical facilities. Others are available to the public and can be used on the patient side. To help give you a better idea of what SaMD is and what it can do, here are a few examples of SaMD in action.


SaMD products can take data provided by another medical device or entered by a medical professional or patient to help diagnose a health issue. SaMD is capable of running complex algorithms that can cross-reference images or symptoms with known diseases and present the most likely cause of the problem. This saves medical professionals time when going through the step-by-step diagnostic process and also helps with diagnosis of rarer diseases.

Computer-Aided Detection (CAD)

CAD is most often associated with cancer screenings. SaMD products can scan a mammogram or a chest x-ray looking for signs of breast or lung cancer. The computing power of this software is more powerful than the human eye so it can help detect signs of these diseases before a doctor may be able to do so. It helps reduce the occurrences of false negatives when identifying cancer and helps patients get appropriate treatment sooner, which improves outcomes.


SaMD is helping patients get more effective medication from both the patient and provider side. For doctors, SaMD can analyze a patient’s vitals and demographics as well as their diagnosis and recommend the best medication course for them. For patients at home, SaMD can provide an app to analyze a diabetic’s blood sugar levels and recommend the right insulin dose.

Creating a new medical device

SaMD is frequently being used to turn common consumer products into medical devices. Examples of this include software that helps consumer digital cameras to take medical images, software that uses your phone’s microphone to listen for interrupted breathing patterns while you sleep and alert you, or software that monitors your heart rate through your smartwatch.

Benefits of SaMD

SaMD is quickly becoming so popular in the world of healthcare because of all the benefits it provides to both healthcare providers and the average patient. Here is how SaMD benefits these two groups in 2021.

Benefits for Medical Professionals

Doctors, nurses, and other industry staff benefit greatly from SaMD. This software makes medicine more agile and more portable. Instead of needing big medical machinery to accomplish tasks, SaMD can provide the same capabilities on a doctor or nurse’s smartphone or laptop. It also makes medicine cheaper which is good for business. In addition to replacing expensive machinery, SaMD can make the diagnosis and treatment process faster and more streamlined, making medical professionals more efficient, which in turn saves money.

The speed with which SaMD provides information also helps medical professionals do their job better. SaMD devices used by patients can provide real-time health data that was previously only knowable during an in-person visit. This gives doctors a better picture of what is really happening with a patient’s health and allows them to treat the patient in the most effective way possible far more regularly and at an earlier stage of the condition or disease.

Benefits for Patients

On the patient side, SaMD gives patients more control over their own healthcare. It helps each patient be an engaged, active participant in their own health monitoring and treatment which contributes to better outcomes and overall health. This access to personal medical devices also helps put more healthcare technology within reach of people who, based on geographic, physical, or socioeconomic reasons, previously did not have much access to such life saving assists.


SaMD is growing rapidly in 2021 and is a technological and medical advancement that should not be ignored by anyone. It is in action now and is certainly the way of the future. This short SaMD primer gave you a basic understanding of SaMD.  You can take this newfound knowledge and continue to build on it with further reading about SaMD.

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