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Software as a Medical Device (SaMD) technology is having a moment in 2021. SaMD is defined as any type of software that fits two criteria. First, it provides a medical benefit and may cause a risk for a patient if it is misused or doesn’t work properly. Second, it functions and provides its benefits completely independently of another medical device. If software fits these two classifications, it is SaMD.
In the last few years, SaMD has become more prevalent throughout the medical world, both on the patient and the provider sides. Factors have conspired recently to give SaMD even more importance now and going forward for medical professionals and patients alike. It is a quickly developing industry and one that bears watching.
Whether you are in the industry, an investor, or just an interested third party, there are plenty of reasons to keep an eye on where SaMD is going in 2021. To help guide or even stoke your interest in this exciting sector, here are five developments in Software as a Medical Device to watch in the coming year.
1. Wider-Spread Adoption of SaMD
Software as a medical device has been on the rise for a while, as Orthogonal notes in their SaMD overview. Like a lot of technology though, the COVID-19 pandemic has supercharged its growth. With social distancing measures in place and in-person medical visits being curtailed during the pandemic, more people than ever turned to SaMD products to help them through this trying time.
Now we’re in 2021 and (hopefully) at the tail end of this global health crisis. While COVID might be going away, the SaMD technology that proliferated during this time is not. During the pandemic, medical professionals have found that SaMD has helped them do their jobs more efficiently and has saved their businesses money. It has also allowed them to get health data from their patients in real-time, which is key to improving patient outcomes.
On the patient side, SaMD has given patients more input and control over their treatments. Being a more active participant in your own healthcare is another factor that helps improve outcomes. SaMD also gives the average patient more access to technology that once could only be found at medical facilities, and more access to care that some people couldn’t get because of where they live.
2. The Internet of Things is Growing
SaMD is part of the Internet of Things (IoT). This is the broad term for a range of objects that are connected to the internet. It includes everything from smart manufacturing machinery to the smart thermostat or virtual assistant in your home. The fate of SaMD is inexplicably tied to the trajectory of IoT technology and both are on the rise.
As more objects join the IoT and more people and companies add an IoT component to their homes, offices, or business practices, the capacity for all IoT technology, including IoT technology increases. Fifth-generation broadband cellular networks, commonly known as 5G, are becoming increasingly widespread in 2021. The greater bandwidth that comes with 5G, coupled with the higher download speeds, makes it possible to operate more devices at faster speeds on these networks.
These accelerations will allow SaMD and other technologies to proliferate faster and be used in more places. It will also allow developers to create SaMD with more power and more capabilities without sacrificing connectivity and speed. In 2021 and beyond, 5G is the rising tide that lifts all IoT technology, including SaMD.
3. Fast Feedback Loops Get Faster
One of the biggest benefits to SaMD over traditional medical devices is that they offer fast feedback loops. When someone uses software or some type of device, provides feedback on how it can be improved, and then those responsible for improvements make the necessary changes, that is a feedback loop. One of the major benefits of SaMD is that it creates a much faster feedback loop than traditional medical devices.
Many medical devices have software that can be updated to improve the device’s functioning. But if the device has other, more extensive issues, changes cannot be made until the next generation of the product comes out. Because SaMD is all software, it can be updated and improved much faster than the average medical device.
High-speed broadband like 5G (see above) will help speed this process up as will users and developers improving at the process. As users get more comfortable using SaMD and giving actionable feedback to developers and developers become more proficient in offering patches and updates that improve the device, the fast feedback loop will become even faster. This will allow SaMD to be constantly improved, almost in real-time.
4. SaMD Gets More Support
This year might not be the year when we see the most development of new SaMD products but may be the year that we see the release of more companion software products than ever. In 2021, what could drive the SaMD explosion is more supporting software that helps gather, analyze, and share data that is created by SaMD with the relevant parties.
It is this kind of value-added software that could propel SaMD to the next level. There are already a lot of SaMD products on the market so adding more won’t necessarily revolutionize the industry. But adding capabilities and features around these products could be a game-changer. Users and investors should watch how these types of products are supported or modified.
5. Security is More Important Than Ever
One of the major lessons of 2020 is that cybercriminals are willing to hit any target at any time to gain access to sensitive data. They demonstrated this by ramping up attacks on vulnerable organizations as they were being put under enormous stress due to COVID. SaMD handles some of the most sensitive information in the world–people’s private health information–which makes them a big target.
Security has been a priority for SaMD developers and, in 2021, SaMD makers will continue to focus on security. SaMD must be designed from beginning to end with the latest and greatest security technology. And because cyber threats are constantly evolving, SaMD products must be able to adapt on the fly as new challenges arise. Protecting people’s health data is among the most important things that SaMD must do.
Conclusion
SaMD is having a moment in 2021 for many different reasons. What will the category look like in 2022 and beyond? No one knows for sure, but keeping an eye on the five trends above can help inform you as to what will happen next.
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