Software as a Medical Device, or SaMD, can be described as a class of medical software designed to carry out one or more medical functions without the need for actual hardware. This can comprise of software or applications intended to treat diagnose, cure, mitigate or prevent disease. SaMD is typically used with non-medical computing platforms connected to virtual networks or other general-use hardware.
Within the general field of healthcare, Software as a Medical Device, or SaMD, is a particularly new category of software resource with a specialized role. Understanding more about what SaMD is and how it works can benefit a company looking at acquiring healthcare solutions.
What is SaMD?
According to the International Medical Device Regulators Forum (IMDRF) Software as a Medical Device is defined as, “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” In other words, think of SaMD as a software which, on its own, is a medical device. For instance, the medical device software used to view images from an MRI on your phone would be a SaMD. But the software that enables an MRI machine to run its test wouldn’t be. To be considered SaMD, software must not principally drive a hardware device.
SaMD software products serve different purposes, generally related to diagnosis, disease prevention, modernizing care, or treatment of an illness or injury. Another example of SaMD software on the consumer end is fertility apps. These tools help users control conception or otherwise deal with reproductive outcomes. Some other examples include software that allows a smartphone to look at images from an MRI as well as computer-aided detection software to provide image post-processing to help detect breast cancer.
Another example of SaMD involves software with a medical purpose operating on a general-purpose computing platform (one that doesn’t have a medical purpose). I.e., software intended for diagnosis using the tri-axial accelerometer operating on a consumer digital camera. Software which is connected to a hardware medical device (rather than being an accessory) but isn’t needed to achieve that medical device’s intended medical purpose is considered SaMD.
Benefits of SaMD
SaMD tools help accelerate the discovery, management and treatment of a wide range of medical issues, automating certain aspects of care to save time.
By being able to collect large amounts of data, and doing so quickly, SaMD can also solicit user feedback through its availability on multiple devices. Two of the biggest advantages include improved health outcomes through more accurate data as well as quicker production and feedback, leading to faster innovation. Companies using or developing SaMD can use this fast feedback loop to enable faster product iterations, drive faster innovation and get to market quicker. It also makes collecting data quick and simple, providing high-quality data leading to better health outcomes. Some of the applications of SaMD platforms can be seen below.
- Screening and diagnosis
- Monitoring and alerting
- Chronic condition and disease management
- Digital therapeutics
One of the groups regulating and monitoring the emergence of Software as a Medical Device is the IMDRF, mentioned above. This voluntary group of medical device regulators connects people from around the world to reach harmony in regards to medical device regulation. It develops internationally agreed-upon documents for a range of topics having to do with medical devices. The IMDRF presents information on SaMD classification, including the responsibilities of a manufacturer as well as labeling and instruction standards for these types of software.
Another group with an interest in SaMD is the U.S. Food and Drug Administration. The FDA has released various guidelines relating to SaMD that aim to help control the process of using this type of software in the field. The Software as a Medical Device Working Group (WG) — formed in 2013 by the IMDRF and chaired by the FDA — was created to develop guidance supporting innovation as well as access to safe and effective SaMDs throughout the world.
The FDA has developed various guidelines in efforts to make more universal, consistent rules for software classified under Software as a Medical Device.
One such rule is that the Software as a Medical Device must support clinical vocabulary for its use; this has to do with proper instruction and linguistic design in the interface. Another rule involves addressing clinical evaluation methods and clinical evidence relevant to the use of the SaMD software.
The FDA says Software as a Medical Device products should also have various recommendations attached to the software for analytical purposes and that manufacturers should outline potential adverse consequences.
Given the uniqueness of SaMD and the proposed framework, one question asked by the regulating groups has to do with whether or not there is any impact on currently regulated devices or any possible adverse consequences.
SaMD Life Cycle
In general, the makers of SaMD products are supposed to be gathering specific kinds of information, analyzing that data, and delivering it along with the software as evidence that the software in question has been designed for safety and effectiveness.
No matter what medical field SaMD is a part of, whether it’s oncology, radiology, or general patient care, the interface must support clinical work in specific ways. The software should be fully documented to identify its role and its place within the clinical environment.
Outcomes for Software Sellers
The bottom line is that when a piece of healthcare or medical software is categorized as Software as a Medical Device, it’s going to generate its own unique regulatory requirements. Vendors need to know how this classification applies and what it means for vendor products. This is in addition to other major healthcare regulatory programs such as the Health Insurance Portability and Accountability Act or HIPAA, which closely governs a patient’s medical data and information.
Think about how guidance and standards from the FDA and other groups impact a company’s use of SaMD products, and how it drives the conversation between the customer and the vendor. Ask relevant questions before purchase to understand how these tools will help clinicians to provide a higher quality of care to patients.
Challenges with SaMD
While SaMD is able to improve health outcomes using data and fast feedback loops to drive quicker product iteration, there are some underlying fundamental challenges faced by many SaMD builders. Perhaps the biggest challenge involves integrating modern product development methodology — designed for an ever-evolving Internet of Everything world — with patient safety and regulatory compliance. While this can be difficult, companies who can successfully do this will benefit immensely while those who cannot are likely to fall behind.
For the FDA, the primary concern or challenge is how to ensure patient safety and clinical effectiveness without sacrificing faster innovation. It’s worth noting that there is no “one-size fits all” approach when it comes to SaMD. For larger organizations, in particular, starting off with pilot programs to implement best practices and fast feedback loops is usually the preferred approach.
While it may be a little confusing in comparison to other software, SaMD provides unique features that extend beyond those of the traditional medical device or hardware. Unlike other devices, SaMD is able to leverage technology and connectivity to devices as well as people that can continuously monitor safety, effectiveness and performance.
Despite the unique nature of standalone health applications, developers should make risk-based criteria and clinical evaluation a priority. In the end, your
company can choose to ignore the effects of IoT and face disruptions or engage and build this capacity internally.
Still have questions about Software as a Medical Device? How has your company benefited from the use of SaMD? Let us know below in the comments.