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  • Uday Sirohi

Software as a Medical Device (SaMD) - What is it and What are the Challenges?

Software is becoming increasingly important and widespread in the healthcare industry. Given the availability of a multitude of technology platforms like personal computers, smartphones, etc, as well as increased ease of access and distribution, software created for both medical and non-medical purposes is being widely used in this industry. The term “Software as a Medical Device” (SaMD) 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. For instance, the medical device software used to display images from an MRI on your smartphone would be a SaMD. But the software that helps an MRI machine to run its test wouldn’t be. Within the field of healthcare, SaMD is a particularly new category of software resource with a specialized role. While such software won’t be replacing doctors anytime soon, they nevertheless represent an emerging critical tool to provide better treatment to patients. To give an example, virtual reality (VR) is being used in neuroscience, to decode the internal working of the human brain. By tasking people and rodents with solving puzzles inside virtual spaces, neuroscientists hope to learn how the brain navigates the environment and remembers spatial information.

SaMD’s Defining Characteristics Include:

  1. Better health reports powered by data: SaMD can increase the effectiveness and efficiency of medical devices and existing treatment plans, as it enables easy and fast collection of better-quality data, which leads to better health outcomes.

  2. Faster production and feedback: SaMD enhances and builds on existing medical device functionality through faster software solutions, and often cheaper, to update than hardware. It also uses the latest technologies to share health data and integrate it across many platforms, including the smartphones, cloud, and much more.

  3. Because SaMD can collect huge amounts of data quickly, it can also easily get user feedback through its availability on, for example, mobile devices. For organizations that are using or developing such software, this feedback loop can enable faster product iterations, shorten time to market, and drive faster innovation growth.

Software as a Medical Device Examples:

SaMD ranges from software that allows a mobile device to view images obtained from an MRI medical device for diagnostic purposes to CAD software that does image post-processing to help detect breast cancer.

Other examples include:

  1. Disease management and Chronic condition: SaMD allows both clinicians and patients to collect and interpret health data, and make changes to the treatment plans for them to be more helpful for the patient.

  2. Screening and diagnosis: By using complex algorithms, SaMD can accurately predict the risk and harm of chronic disease and help in treatment decisions.

  3. Monitoring and alerting: This software can be designed such that they use wearable sensors to collect multiple readings of a patient, which can then be monitored using the software. The software records and makes use of this data to enable targeted recommendations & alerts for both doctors and patients. For example, the glucose levels of a patient can be monitored through the Internet of Things, i.e. IoT Based Glucose Monitoring Systems.

  4. Digital therapeutics: SaMD also plays a significant role in the treatment or mitigation of serious illnesses thanks to its ability to generate and input highly relevant clinical data into “general-purpose actuators, medicinal products, other medical devices, or other means of providing therapy to a human body.”

Examples of Software That Are Not SaMD?

If the software is part of a hardware medical device, it does not meet the definition of Software as a Medical Device. Examples include:

  1. Software that gives parameters that become the input for software as a medical device is not a SaMD if it does not have a medicinal purpose.

  2. Software used in closed-loop control in an implantable pacemaker; or software used to "control or drive" the pumping of medication in an infusion pump and motors; or other types of hardware medical devices. These types of software sometimes referred to as "firmware", "microcode" or "embedded software" are not SaMD. Click here to know more about “3D-Printed Medical Implants.”

  3. Software required by a hardware device is used for medical purposes to perform the hardware's intended use, even if sold separately from the hardware medical device.

  4. Software that relies on data from a medical device, but does not have a medical purpose, e.g., software that encrypts data for transmission from a medical device.

  5. Software that is used for clinical communication and workflow including scheduling visits, patient registration, and calling.

  6. Software that keeps a check on performance or proper functioning of a device, or software that analyzes laboratory quality control data.

Growth of SaMD Market

The market of SaMD is projected to grow at a compound annual growth rate (CAGR) of 69.3% from 2019 to 2026. Geographically, North America holds the largest market share owing to several companies getting FDA clearances for their software coupled with the increasing investment in the healthcare industry by big countries such as the U.S. and Canada. The growth will be followed by Africa, and Europe Middle East while the Asia Pacific is projected to grow with the highest CAGR over the period of 2020-2025 due to the growing demand for SaMD keeping in view the high geriatric population of Japan and the growing health awareness among individuals of emerging economies such as China and India.


While SaMD can improve health outcomes using fast feedback and data loops to enable faster product iteration, there are still some underlying challenges faced by these devices. Perhaps the major challenge involves integrating modern product development methodology with patient safety and regulatory compliance. While this can be hard, companies that can successfully do this will benefit greatly. For the FDA, the major concern is how to ensure effectiveness and patient safety without limiting faster innovation growth. It is worth noting that there is no single approach when it comes to SaMD. For bigger organizations, in particular, starting with pilot programs to implement best practices and fast feedback loops is usually the preferred approach.

How are Regulators Addressing the Challenges with SaMD?

Given the unique characteristics of SaMD that are way beyond any traditional medical device or hardware, regulators across the world recognized the need to converge on a common framework and principles for SaMD that enables all stakeholders, including regulators, to promote safe innovation and protect patient safety.

The International Medical Device Regulators Forum (IMDRF) is a group of regulators from around the globe. It makes globally agreed-upon documents related to a broad range of topics related to medical devices. In 2013, IMDRF formed the SaMD Working Group (WG) to develop guidance supporting innovation and timely access to effective and safe Software as a Medical Device globally. Chaired by the FDA, the SaMD WG agreed upon the framework for risk categorization for Software as a Medical Device, the Quality Management System for Software as a Medical Device, key definitions for Software Medical Device, and the clinical evaluation of Software as a Medical Device.


While SaMD may be a little confusing in comparison to other software, it provides features that extend beyond those of the traditional medical device or hardware. Unlike other devices, SaMD can use technology and connectivity to devices and people that are continuously monitoring effectiveness, safety, and performance. Despite the unique nature of standalone health applications, developers should make a clinical evaluation and risk-based criteria a priority. The future of SaMD is exhilarating for not only the patients and clinicians but also the society at large. As we look ahead, some of the technology that brings the most value may not necessarily be new devices, but the companion software that assembles critical data analyzes it and then shares it with relevant parties.









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