Software As A Medical Device Basics: What To Know

Software As A Medical Device Basics

Thanks to the ever-evolving world of technology, devices have become smaller and more efficient. Plus, portable electronic devices have found uses outside of their traditional territory. One such place is the healthcare industry where standalone software has become known as Software as a Medical Device or SaMD. With the innovation of this technology, service delivery, and patient outcomes have improved considerably.

In this article, we will look at what these pieces of software are, how they function, and what you can expect should you require the use of SaMD in the diagnosis or treatment of a specific condition.

A Brief History of Medical Software

Medical software technology dates back to the 1960s when computerized handling of medical information was first introduced. It wasn’t until the 1970s and 1980s when computers experienced widespread use in the healthcare industry. It was at this time when the concept of medical software as a tool for data and operations management became more important.

In 1993, the European Medical Devices Directive was created which resulted in the development of the ISO 9000-3 standard. It worked to help harmonize existing laws concerning medical devices and the software required to operate them. It was in 2006 when the IEC 62304 standard was added and this further formulated guidelines on how medical device software was to be developed and tested.

The creation and evolution of smartphone technology led to the development of thousands of stand-alone medical and health-related software apps. Many of which were entering a gray area concerning regulations. Software in a Medical Device (SiMD) was the focus at the time of the International Medical Device Regulators Forum (IMDRF), however, Software as a Medical Device (SaMD) was not being fully addressed as it did not seem to fit regulatory standards of the day. That changed in 2011 when the Food and Drug Administration (FDA) issued draft guidance on “mobile medical applications” which led to better standards of development and testing. Quality management system principles were developed for SaMD in 2015 by the IMDRF.

What SaMD Actually Is?

The FDA Classifies SaMD as a type of software that has been designed to carry out one or more medical functions. This means that software or mobile apps that are meant to diagnose, treat, cure, mitigate, or prevent diseases or other conditions are considered SaMD. The key defining point is that this software accomplishes these goals without the need for hardware. SaMD is typically used in concert with non-medical computing platforms.

These platforms may or may not be connected to virtual networks, other general-use hardware, or any traditional medical device. With the World Health Organization (WHO) estimate of over 1.5-million medical devices in use globally and about 10,000 different types, SaMD is part of a much bigger picture. Here you’ll find a good explanation of the criteria for what constitutes software as a medical device.

How SaMD Works

SaMD devices essentially piggyback atop various other connected technologies and leverage their benefits. For example, SaMD can be used with smaller, less expensive, more sophisticated sensors which provide quick and easy internet access. In other words, SaMD provides patients with a means to gather many types of data, depending on the device in use, remotely.

With internet access, the SaMD data can be shared directly with a medical professional in a different part of the same community, across the state, country, or in another part of the world. The collected data is then analyzed to assist with the diagnosis and development of a treatment plan. The more data that can be collected, the better the diagnosis and treatment. SaMD, combined with data mobility, enables the device to deliver more detailed information which leads to precise, tailored treatment options.

Here is a breakdown of the general uses of SaMD:

1 – Screening and Diagnosis

While SaMD leverages complex algorithms, the ability to accurately predict chronic disease risk from data collected is possible which results in assisting with treatment options that are best suited for a patient rather than a generic solution. With the assistance of SaMD data collection, the patient receives a tailor-made treatment plan which can result in a better outcome.

2 – Monitoring and Alerting

Various vital statistics can be collected by SaMD when used with wearable sensors. The vitals can be tracked by the software and monitors them sending alerts to the patient and medical professional should values fall or rise too far out of a specific target range. This helps to identify potential triggers and the data collected becomes the basis for a treatment plan.

3 – Chronic Condition and Disease Management

Health data can be tracked and analyzed by both patients and healthcare professionals through the use of SaMD. With the data collected, health treatment plans can be adjusted based on the up-to-date information being gathered. This reduces the need for clinical visits and testing that may be conducted at intervals greater than the SaMD data is being collected.

4 – Digital Therapeutics

Because SaMD can send relevant information on a patient’s condition to other medical devices, it can enhance the ability to treat or mitigate critical illnesses. An example is sleep apnea where the microphone of a smart device can detect interrupted breathing during sleep. This provides more accurate data and prevents the need for attendance at a sleep lab.

How SaMD Is Regulated

A volunteer group of medical device regulators from around the world formed the International Medical Device Regulators Forum (IMDRF) which has been tasked with creating harmonious guidelines on the development, testing, and use of SaMD. The group works alongside the Food and Drug Administration (FDA) to standardize everything related to SaMD.


Technology continues to spin into the future. Along with it, innovation keeps evolving. Part of the evolution saw the development of Software as a Medical Device. With SaMD, the healthcare industry has seen an improvement in the delivery of services helping patients receive better outcomes and helping medical professionals to develop accurate treatment plans based on data that has been collected by SaMD. The future looks bright as technology keeps changing, proving the platform for newer, faster, and more types of SaMD to combat health conditions not already covered by this form of software.

I am a full-time professional blogger from India. I like reading various tech magazines and several other blogs on the internet.

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