What Is SaMD? A Quick Guide for Medical Device Startups and Investors

SaMD (Software as a Medical Device) has been a growing area of development over the last few years and is increasingly being integrated into devices built to promote patient safety.

New technologies have allowed SaMD to advance rapidly in terms of capabilities and applications for different patient populations. It’s still a relatively new category for the medical device field, with regulatory requirements evolving over time.

For medical device startups thinking of branching into SaMD or investors interested in backing SaMD companies, it’s important to know a bit about Software as a Medical Device, what it means and how medical device manufacturers are steadily working to bring digital health technology to a growing competitive market.

Here’s our quick guide:

What is SaMD?

International Medical Device Regulators Forum (IMDRF) provides a simple 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.”

So, in contrast to hardware medical devices, for SaMD, the software is the device.

Software as a Medical Device is one of three types of medical device software – the others include software in a medical device and software that is used for the manufacture or maintenance of a medical device.

SaMD may comprise of applications that are intended to treat, diagnose, mitigate, cure or prevent medical conditions or diseases. Mobile apps are a common medium for building and distributing SaMD.  Examples include apps built for the Apple Watch, which had to go through FDA clearance and are classified as SaMD. Another example of leveraging mobile devices and building digital health applications include fertility apps, which are designed to help users track and determine their fertility.

Benefits of SaMD

SaMD can bring several benefits that ultimately are good for patients, SaMD companies, and their investors. One major benefit is that SaMD can facilitate rapid data collection and analysis – far outpacing the capabilities of human operators working in clinical management. This means that medical conditions or changes in basic monitoring data can be quickly gathered and assessed, helping to provide better patient outcomes. In this respect, SaMD can be widely expanded to be able to be utilized for medical purposes and help manage and facilitate treatment for a multitude of public health issues.

For example, patient vital signs might shift subtly over time, perhaps without enough movement that the patient – or even their health care provider – notices symptoms. SaMD can monitor in real-time and alert physicians to any patterns that need investigating. It just might make the difference between a patient becoming critically ill, or receiving preventive care before that can happen — a much better patient outcome.

The ability of SaMD to rapidly gather data also facilitates feedback and analysis that can lead to quicker improvements or innovations. Data tends to be of higher quality as it is gathered directly from the source and can be easily obtained at scale. Valuable insights can be more quickly found for disease treatment and trajectory by using SaMD.

With this data-gathering ability, SaMD is increasingly popular as a source for Clinical Decision Support. This refers to the tools and software systems that gather and analyze data, note trends, and provide alerts or prompts to clinicians. Medical device companies design these systems so they are fully equipped to support the decisions clinicians make and/or empower them to take prompt action. They are not intended to be final decision-makers.

We could also say that the stricter regulatory burden placed on SaMD is a benefit. We know, it doesn’t sound like it to developers or investors, but hear us out! Firstly, the regulatory process means that not everyone is prepared to put the time and effort into development, which can limit your field of competitors, especially if they can’t use your device as a predicate under 510(k).

Secondly, because SaMD is strictly regulated, those that make it to market are known to have been rigorously developed and tested. This can help to boost the confidence among clinicians of device efficacy and increase their willingness to adopt the usage of the device along with the other medical products they rely upon. It could also improve the chances of your device being accepted under large-scale programs, such as Medicare reimbursements.

How is SaMD regulated?

As we indicated above, SaMD is more strictly regulated than other software products that are not directly involved in the delivery of care. SaMD manufacturers are required to maintain certain requirements and gather data across the entire device’s product lifecycle. Just one key element that regulatory bodies are keen to ensure the integrity of the device data. Issues such as privacy and the security of the software are part of the regulatory process. Of course, they also want to know that the data gathered genuinely supports the purpose of the device.

You’ll see SaMD treated slightly differently in the various regulatory markets, although IMDRF has worked to create some harmonization. As a general rule, just like other types of medical devices, SaMD is classified based on its risk profiles. Could a failure cause critical harm to a patient? If so, the device is probably in a higher risk category and subject to tighter medical device regulations.

Why did the Apple Watch need FDA clearance for EKGs while some other devices providing medical information don’t? A key is that their EKG function claims to directly influence the medical care someone receives. If you wear the watch, you should reasonably expect that the mobile device is giving you accurate heart information to act off.

Other healthcare software products may not necessarily fall under SaMD regulations if it is classified as a “wellness product”, that is, it is informational but not intended to be used for medical monitoring. Apple’s pulse oximeter feature falls under this status. This means that you might take that information as an indicator that you should get checked out, but not as a diagnosis or in place of professional clinical management of your symptoms. From both a developer and investor perspective, one thing to consider is that these types of devices are relatively easy to copy and have less practical applications for medical care.

Trends in SaMD and connected health

SaMD is a rapidly growing field and we’re seeing more talented developers taking up the challenge to create life-changing devices. Key trends include:

Wearable devices 

Sure, wearables have been a thing for a while now, but they’re moving into more and more advanced data gathering, as seen in the newer Apple Watches. Wearables are already popular among fitness communities but have many possible applications to explore for patient care. Just one example could be giving doctors the ability to remotely monitor their patient’s blood pressure or heart rate.

The Internet of Medical Things (ioMT) 

One challenge is managing all of the data that SaMD can gather in a way that is useful and cohesive for physicians and patients. The Internet of Medical Things (IoMT) is a system of connecting devices and healthcare systems so that data can be shared in the right places to help with accurate decision-making. For example, many SaMD developers create partnerships with healthcare systems to facilitate better data sharing.

Telehealth 

The COVID-19 pandemic saw the need for rapid shifts in how medical care or consultations are provided. While telehealth already existed, the pandemic encouraged device manufacturers to pursue the development of more robust and user-friendly platforms. SaMD has a role to play in terms of vital data gathering from a distance. Connected devices are on the rise and playing a growing role in healthcare monitoring and decision-making.

Final thoughts

SaMD (Software as a Medical Device) is a field worth looking at, both for medical device developers and investors. Digital health technology isn’t on the horizon – it’s already here and is widely used by healthcare providers. You could argue that SaMD is a huge part of the future of healthcare, offering myriad benefits and development opportunities to use for medical purposes, along with the betterment of public health.

Connectivity via a secure and compliant cloud infrastructure is a key part of SaMD, and that’s where Galen Data can help. Our cloud platform is purpose-built for medical device connectivity and helps to streamline your SaMD, digital health products, and other smart devices to be in full compliance with regulations.