What Is Software as a Medical Device?
As if we weren’t up to our ears in acronyms, SaMD has joined the likes of SaaS and IoT in the software-development gold rush.
It stands for “Software as a Medical Device.” And understanding SaMD is not just important for software developers following its ascent in hopes of designing the next big thing. It’s important for the end users as well—healthcare professionals looking for apps to enable new services or make their current services better.
Why? Because the FDA has taken notice. The regulatory body now chairs the Software as a Medical Device Working Group, convened in 2013 to build a framework for the regulation of SaMD.
A whole new world of compliance burden is opening up, and both the developers and the end users need to be ready for the new responsibilities that will come along with the opportunities presented by SaMD.
Definition of Software as a Medical Device
The designation “Software as a Medical Device” suggests that a software product can be a medical device. How is that possible? Can a computer program be a medical device?
Technically, it can, and the International Medical Device Regulators Forum (IMDRF) says as much in its official definition of SaMD: “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
In the context of this definition, a software could be considered SaMD when the software is the medical device; the software performs a medical function in and of itself, regardless of whether that software is loaded into a Samsung Galaxy, an Apple Watch, a Chromebook, or any other device. The device doesn’t matter—the software is the medical device.
The previous term to describe this kind of app was “standalone software.” The term SaMD was coined to prevent it from being confused with more vague industry terms like “health software,” “healthcare software,” and “medical software.”
Difference Between SaMD and SiMD
SaMD neatly contrasts with “Software in a Medical Device (SiMD).” According to Orthogonal, SiMD, as the name implies, is software that is dependent on the medical device it is installed in.
Think of the software that operates a digital thermometer, or the software that directs the magnet in an MRI machine. These software programs are useless without the device into which they are loaded. What use is the program that controls an MRI magnet sitting in an iPhone?
Examples of SaMD
To understand what counts as SaMD, it helps to look at what is already on the market. Examples of SaMD in action include:
- Software that Uses Tri-Axial Accelerometers. Many mobile devices contain tri-axial accelerometers. These devices can detect the motion of the device and cause various responses as a result of the device’s speed or orientation. This could take the form of a smartwatch activating when it detects the wearer raising his/her arm, or a phone activating when it detects that it has been oriented upright.
Certain SaMD apps can access the tri-axial accelerometer and use it to gather motion data to detect certain motor conditions, like Parkinson’s disease or seizure disorders. Because this kind of app would work in any device with a compatible tri-axial accelerometer, it is not device-dependent in the performance of its function and qualifies as SaMD.
- Software that Uses Image Recognition. Many devices, including smartphones, tablets, and computers, incorporate digital cameras. These cameras get better and better, often rivalling the capabilities of commercially-available or professional cameras.
The same device camera used for Instagram posts or YouTube videos can be repurposed for medical uses. Image recognition software is advancing to the point where it can be used to recognize patterns in images for diagnostic purposes, like differentiating between benign moles and cancerous moles based on a digital camera snapshot. This is a clear example of SaMD since it will work with any device that has a web camera of sufficient resolution.
- Software that Uses Microphones. Nearly every mobile or desktop device, from computers to smartphones to tablets to smartwatches, contains some sort of microphone. This is how you can use a smartphone as a phone, and you can do it with every other device as well. The microphone also allows the device to be used to create voice notes, audio-video content, and interact with AI assistants like Siri or Alexa.
SaMD companies design apps that use device microphones to detect breathing irregularities, which may be able to measure oxygen usage or sleep cycles, as well as provide early warnings for certain cardio-pulmonary conditions and save lives.
- Software that Regulates Another Medical Device. Some SaMD applications are harder to classify because they work in tandem with a particular kind of SiMD. For example, an implanted pacemaker or blood glucose monitor has software of its own. Because that software is useless without the implanted device, it would be considered SiMD.
However, a separate software app could interface with the medical device, via a wireless technology such as Bluetooth. This could be the app that calibrates, collects data, performs diagnostics on, or sends instructions to the main device. While the software running the device is SiMD, the software that creates a human interface with the device would be SaMD, since it could operate from any device.
- Software that Uses Data to Perform Diagnostics. Artificial intelligence and machine learning plays a big role in the future of healthcare. These applications can take in vast datasets, gleaned from lab results or clinical trials, and learn to recognize subtle patterns and detect diseases far earlier than what was possible in the past.
The recognition and detection of diseases by these powerful applications is the medical purpose, even if different software was used to obtain the data. Such applications meet the definition of SaMD for this reason. The devices that interface with this kind of SaMD are sometimes referred to as the Internet of Medical Things (IoMT).
There’s no question that the FDA’s recognition of and separate rules for SaMD opens up fresh questions about what constitutes a “medical device.” Companies that want to play in this promising sandbox need to be aware of what regulations apply to this growing field.
What is beyond doubt, however, is that the devices that permeate our lives have medical applications that the designers can scarcely have dreamt of, secret keys that repurpose the phones in our pockets and the watches on our wrists into watchdogs for our health and wellbeing.
Photos courtesy of gettyimages.com