The increase in the use of software for medical purposes poses a serious question: can software be considered a medical device? The world has agreed that it can and should. The use of software has not only allowed medical personnel to perform tasks better. It is also helping patients to seek out solutions in more independent, efficient, and cost-effective ways. However, because of its life or death potential, this leaves us with an even more troubling question: when can we consider ‘Software as a Medical Device’, also known as SaMD? This is a difficult question to answer.
In a world where software has gained more and more protagonism in the medical profession through one way or another, it becomes impossible to accept every software solution as a medical device. Medical software requires thorough scrutiny before being able to come into contact with patients. Poorly designed algorithms or graphic interfaces can cause harm to patients.
At Koombea, after years of working in the MedTech industry, we understand that this is a very complex topic that combines insights from a variety of disciplines. In this post we explain what Software as a Medical Device (SaMD) is, describe some examples, and analyze briefly how it is regulated. Lastly, we also consider if apps can be considered as SaMD.
What is Software as a Medical Device
Although there are various attempts to define what can be considered as a SaMD, it is best to analyze each individual case. The best starting point is to define what a medical device is. Medical devices need to be recognized as such by the competent institutions due to their potential impacts on patients. Not doing so entails great risks.
The EU MDR states that a medical device is “an instrument, apparatus or appliance or software intended by the manufacturer to be used alone or in combination for humans for medical purposes”. This leaves a wide spectrum of things that can be considered as such. In the case of the FDA, a medical device must first be recognized as such, which is not really a helpful definition.
The best way to know if specific software is a medical device is to refer to the International Medical Device Regulators Forum (IMDRF), of which both the EU and the USA are members. The IMDRF states that for software to be recognized as a medical device, it needs to be used for one or more medical purposes without being part of a hardware medical device. In other words, it needs to have a purpose of its own.
SaMD is Different from Hardware
It is important to clarify that SaMD is not the same as its hardware. It usually occurs that software is embedded in the hardware of a physical device, but one thing is what happens on the inside of a device, and another is what the software does. Although some machines have software operating inside them, this does not mean that the software is a medical device.
A SaMD can be connected to other products without being part of them. This includes tools like the internet, data, or even other SaMD. However, keep in mind that just because a program works with medical data or is integrated into hardware does not make it automatically a medical device. As a result, we can simply think of SaMD as any type of software that performs one or more medical functions by itself.
Examples of SaMD
Some of the most common uses of SaMD are disease management, monitoring, alerting, and digital therapeutics. In particular, SaMD is widely used for collecting patient data in order to help medical staff make decisions. This is done through sensors and wearable tech such as the Apple Watch.
Many types of software are commonly confused with medical devices. Some of the most common mistakes are confusing the software embedded in machines like pacemakers, x-ray machines, or health management systems with SaMD. On the contrary, specialized software that processes data in order to calculate risks, or even machine learning algorithms used to identify health anomalies in images, are considered medical devices.
You are probably wondering if a SaMD can be developed in the form of an app, and lucky you, the answer is yes. For regulators, it does not matter how the software comes as long as it meets the requirements mentioned. Therefore, an app that serves a medical purpose can be described as a medical device as long as it is approved as such. A good way to think about it is as if it were a medical device app.
There are many great apps that are revolutionizing the MedTech industry thanks to their potential to help medical staff take care of patients. Some apps even allow patients to take care of themselves, although many of them revolve around a thin line between medical devices and non-medical devices.
If you are planning on getting started on medical app development, and wish for it to be considered as a medical device, you should definitely contact someone who can advise you on the subject. At Koombea, we’ve been building great apps for the medical industry since 2007. We understand the importance of working hand in hand with your needs in order to deliver great products that are easy to use and comply with data protection requirements. Contact us and take the next step towards building that great SaMD app.