SaMD (Software as a Medical Device) has been a growing area of development over the last few years.
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 they are brought to 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, 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. A basic example is the Apple Watch, which had to go through FDA clearance and is classified as SaMD due to the software providing its heart monitoring features. Another example includes fertility apps that 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. This means that medical conditions or changes in basic monitoring data can be quickly gathered and assessed, helping to provide better patient outcomes.
For example, patient vital signs might shift subtly over time, perhaps without enough movement that the patient 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.
With this data-gathering ability, SaMD are increasingly popular as sources 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. These systems are there to support the decisions clinicians make and prompt action, not be the final decision maker.
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 are 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 the adoption of the device. 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, with manufacturers required to maintain certain requirements and gather data across the entire lifecycle of the device. 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 are classified based on their 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 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 it is giving you accurate heart information to act off.
Other software doesn’t 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. 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
SaMD is a rapidly growing field and we’re seeing more talented developers taking up the challenge to create life-changing devices. In fact, one trend is the high demand for good developers! Other 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. 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 the development of more robust and user-friendly platforms. SaMD has a role to play in terms of that vital data gathering from a distance. Connected devices are on the rise and playing a growing role in healthcare monitoring and decision-making.
SaMD (Software as a Medical Device) is a field worth looking at, both for medical device developers and investors. You could argue that SaMD is a huge part of the future of healthcare, offering myriad benefits and development opportunities.
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 compliance with regulations.