Everything You Need to Know About Software as a Medical Device (SaMD)

Technology is reshaping health and medicine, from diagnosis to care delivery and beyond. Software as a Medical Device (SaMD) is at the forefront of this digital health transformation, and it’s no wonder why—digital solutions like SaMD are revolutionizing the way patients and providers interact, as well as the way data is shared, tracked and analyzed. When we surveyed top life sciences executives, we found that over 90% of them anticipated that digital core regulated products would be central to their business within five years.

5 Questions About Software as a Medical Device (SaMD), Answered

Find out why SaMD is top of mind for the world’s leading biopharma and medtech companies. Here are answers to five common questions about this important evolution in digital health.

1. What is SaMD?

SaMD is software that was developed specifically to be used for medical purposes, from preventing diseases to diagnosing, treating or managing conditions. Unlike Software in a medical device (SiMD), SaMD doesn’t require its own hardware. SaMD software performs the function of a medical device, though it may be run as an app on a smartphone, tablet, desktop computer or even a smartwatch. The Food and Drug Adminstration (FDA) has adopted the International Medical Device Regulators Forum 2013 definition of SaMD that calls it “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Though SaMD functions outside other medical hardware by definition, it can be, and often is, interoperable with other technology platforms and devices.

Related: Software as a Medical Device (SaMD) Solutions

2. How do patients benefit from using SaMD?

Moving beyond the capabilities of popular health and wellness tracking devices, SaMD can actually enable patients to track and adjust dosing, increase adherence, manage chronic diseases and more. It also allows them to connect to their providers virtually and report data in real time, which in turn helps their care teams to adjust treatments and catch changes in their condition––all of which can lead to better patient outcomes.

3. How do clinicians benefit from using SaMD?

SaMD solutions leverage powerful algorithms to help providers diagnose patients more quickly and accurately. And they can help match patients to the right therapies. SaMD solutions gather and analyze large amounts of data, which help care teams capture valuable insights. Clinicians can trust the data and insights generated in SaMD to quickly spot abnormalities and tweak treatment plans without the need for an office visit. With the unprecedented adoption of virtual healthcare visits, SaMD solutions will be crucial for expanding the potential of telehealth by giving clinicians the tools to monitor patient health between visits and opening lines of secure digital interaction.

4. How is SaMD regulated?

SaMD requirements are at least as vigorous as those for other medical devices, and in some cases more so. This is a good thing—patients and providers know they can trust regulated solutions. SaMD regulations are based on the existing biopharma regulatory and quality systems, so if you’re looking to learn about the regulations, you don’t need to start from scratch. The FDA recently updated its SaMD draft guidance. For more information, read 3 Things You Need to Know About the FDA's New Software as a Medical Device (SaMD) Guidance.

In the EU, SaMD is regulated a little differently. First of all, the word “SaMD” isn’t used. Instead, they use the term “medical device software” or “MDSW.” The differences go much further than nomenclature, though. Instead of using prior products to categorize classification letters as part of the regulatory process (as is done in the US), the EU uses a rules-based framework, with 22 rules that must be addressed to get a classification output. To learn more about the differences in the classification process, read our blog post, Key Differences in How the US and EU Approach SaMD Regulations.

5. What should I keep in mind when building a SaMD solution?

There are several things you should keep in mind:

SaMD has the power to improve the experiences of patients and clinicians––and save lives. With the recent rise of telehealth solutions, SaMD is at its most relevant, and will continue to gain importance as more SaMD solutions hit the market.

BrightInsight & SaMD

BrightInsight has deep SaMD experience, with seven SaMD launches on behalf of our leading biopharma clients in 2021 alone. Check out our webinar with a Roche/Genentech executive to learn how they partnered with BrightInsight to launch a CE-marked SaMD dosing calculator for treating patients with hemophilia A in less than 6 months.

We’d love to hear your thoughts and questions about how to develop, launch and maintain SaMD in a compliant manner. Please reach out to us directly to discuss this article.


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