In recent years, the use of software in the medical field has become increasingly common. One particular area of software that has gained attention is software as a medical device (SaMD). The concept of the medical device industry creating software based products that aren’t linked to hardware is relatively new. As technology continues to advance in all areas of healthcare, software has become increasingly important. It’s just as important that SaMD meets strict regulations and guidelines to ensure its safety and effectiveness, hence why the FDA started regulating this new concept.

SaMD is actually one of the areas of healthcare we focus on and more info can be found in our healthcare app development services section.

In this blog post we will take an inside look at the world of SaMD and cover topics such as:

-What is software as a medical device

-Benefits of SaMD

-Types or examples of SaMD

-Challenges with SaMD

What is software as a medical device (SaMD)

SaMD medical device is software that performs one or even more medical functions and it does this without being part of a hardware medical device. Software that is pertinent to the function of a hardware device for example, software that helps an MRI's magnets turn or animates an X-ray control panel is not contemplated in the definition of SaMD. This also applies to software that simply retrieves information, organizes data, or optimizes processes. SaMD can be used on many different types of platforms such as smartphones (mobile apps), desktop computers, and wearable devices.

Some clear examples could be software that can detect and diagnose a stroke by analyzing MRI images is considered software as a medical device, while the software that helps operate a pacemaker is not (it’s actually considered software in a medical device). Another example of SaMD is software that can be used to track the size of a mole over a specific period of time to determine the risk of melanoma while electronic health record systems are not considered SaMD.

Software as a medical device is heavily regulated by entities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), to ensure that it is safe and effective for its intended use. These requirements include many things such as labeling requirements, clinical testing, and post-market surveillance to monitor its safety and effectiveness in real-world use. The Software as a Medical Device WG, chaired by the FDA, agreed upon the framework for risk categorization. This provides criteria to categorize SaMD based on the significance of the information provided by the SaMD to the healthcare decision and the healthcare situation or condition associated with that SaMD. So what’s important is the intended use of that SaMD, such as treating and/or diagnosing, driving clinical management, or informing clinical management.

Benefits of software as a medical device

As we’ve seen, SaMD has the potential to transform healthcare in several ways, from improving access to care to reducing costs and improving patient outcomes. Let’s talk in detail about the main benefits we’ve seen.

They improve access to healthcare. SaMD can help to increase access to healthcare by allowing patients to receive medical care from the comfort of their own homes. This is of most importance for people who reside in remote areas or who have difficulty traveling to a healthcare facility.

They help to increase efficiency. SaMD can help improve efficiency by automating certain tasks that happened to previously be performed manually. This can aid in reducing errors, saving time, and overall lowering healthcare costs.

They help provide personalized care. SaMD can be used to provide personalized care by analyzing individual data and tailoring treatment plans in order to meet the specific needs of every patient.

They improve outcomes. They can help to improve patient outcomes by providing more accurate treatment recommendations and diagnosis. This leads to overall better health outcomes and a better quality of life for patients.

They help provide continuous monitoring. SaMD can be used for the continuous monitoring of patients, and they aid healthcare providers in detecting and responding to changes in a patient's condition in real-time.

They reduce risk of infection. SaMD can help to reduce the risk of infection by allowing patients to receive care remotely. This eliminates the need for them to visit a healthcare facility where they could be exposed to infectious diseases.

Overall, SaMD has the potential to improve healthcare outcomes, increase efficiency, and reduce costs, which makes it an important tool for patients and healthcare providers alike.

Types/examples of SaMD

As we’ve shown above it’s not always so cut and dry what’s considered SaMD. To make it clearer we’re listing some examples of SaMD below:


Clinical decision support software: These are software applications that collect data from multiple sources and provide healthcare professionals with clinical knowledge and patient-specific information in real time  in order to help them make better decisions about patient care.

Mobile health applications: These are apps that can be downloaded on mobile devices and can help people manage their own health and wellness, gain access to useful information when and where they need it, and overall promote healthy living. Examples include digital therapeutics applications (for example: to treat substance abuse disorders, ADHD, among others).

Medical image analysis software: These are software applications that are used to analyze medical images (for example X-rays, CT scans, or MRIs among others) to help diagnose medical conditions and come up with treatment plans.

Clinical trial software: These are software applications used in clinical trials to manage data, monitor patient safety, and help researchers make informed decisions about the trial.

Medical assistance software: An example of this could be software that analyzes images from a scope camera and then displays that information like vessels to avoid on screen in order to guide surgeons during surgery. Another example could be software that collects data from multiple sources (such as x-rays, scans, etc.) and transforms that data into 3D models which can be used by doctors for diagnosing or developing treatment plans.

Challenges with SaMD

Over the last few years, the FDA has been working to develop and clarify risk-based policies in order to better communicate requirements and align its regulatory approach with the evolving nature of digital devices.

The FDA unveiled its digital health innovation action plan in mid-2017, which included several commitments to advance the regulation of digital health products. To fulfill its plan, the FDA hired digital health staff, initiated a digital health software precertification pilot program (Pre-Cert pilot program), and issued three new guidance documents. Among these documents, two distinguished low-risk device types that are no longer required to undergo pre-market review, while the third provided new guidelines for evaluating SaMD medical device applications.

There have been different discussions in the news media and across the SaMD ecosystem as a result of the FDA releasing the digital action plan as well as making known their other efforts to modernize SaMD regulations. Different players have weighed in on these new developments.  

Another clear challenge is the unclear reimbursement pathway. There is a lot of uncertainty about how SaMD products will be reimbursed by payors, and this topic is still highly debated. This can create challenges for SaMD companies in terms of commercialization and revenue generation. If payors don’t reimburse for these types of treatments then physicians are less likely to prescribe them and patients are even less likely to adopt them.

We also need to consider and take into account user acceptance. SaMD products need to be user-friendly and easy to use. This is because healthcare professionals as well as patients may be reluctant to adopt these new technologies if they are not confident in their ability to use them effectively.

In conclusion, Software as a Medical Device (SaMD) is a field that’s rapidly evolving and it has the potential to transform healthcare. SaMD medical devices offer numerous benefits, including greater efficiency, accuracy and accessibility of medical care. However, the development and regulation of SaMDs also pose significant challenges, such as ensuring security, safety and interoperability.

Collaborative efforts from stakeholders are necessary to tackle the challenges of developing and regulating SaMD. A strong regulatory framework that fosters innovation and ensures patient safety must be established. SaMD developers have a responsibility to prioritize ethical use of these technologies and ensure compliance with established medical practices and guidelines.

As SaMD continues to gain traction, it’s important that all stakeholders remain vigilant and work collaboratively to ensure that these technologies live up to their promise and potential in delivering high-quality, safe, and effective medical care to patients.

Do you have a SaMD product you'd like to start building? Just reach out to us and we can help you get started.