Software as a Medical Device: An Insight growing digitization in healthcare has widened the scope for software to integrate into various healthcare applications. The software itself is considered as a medical device by the name software-as-a-medical device (SaMD) and constitutes one of the types of software linked to medical devices. As per the definition by the IMDRF, SaMD is defined as a software that is intended to be utilized for one or more than one application performing its function without losing its ability to function even in the absence of a hardware medical device. It was previously referred to as a standalone device as well by the industry, regulators and healthcare providers. Other names include medical device software and health software.

The utilization of software as a medical device is continuing to surge and it is being utilized across a wide range of tech platforms that include medical device platforms, commercial off-the-shelf platforms, and virtual networks among others.

Companies developing SaMD solutions are further contributing to surging the software as a medical device market growth. For example, ScienceSoft, an IT consulting and software development company based out of the United States initially started as a small AI product company now deals in developing software as a medical device solution as one of its products. The company develops software as a medical device that runs on desktop computers, tablets, and smartphones providing assistance to patients and medical specialists in planning treatments, viewing medical images, image recognition, monitoring heart rate, and drug dosage calculation among others.

software as a medical device market

Challenges and Future of SAMD

Even though there are immense opportunities for SaMD that will help in improving the healthcare system, it contains new challenges for the regulators and industry players. The challenges include cybersecurity, tracking, and interoperability. However, regulators worldwide are working on addressing challenges posed by SaMD through recognizing the need to converge on a common framework and principles, thus, enabling all the stakeholders to encourage safe innovation and further contribute to the protection of patient safety. 

Additionally, this indicates that the industry and the regulators must abide by the globally executed device identification and coding standards for identifying and tracking SaMD throughout its lifetime. As these devices are different from the traditional medical devices, they can be physically labelled using a Unique Device Identifier.

Cybersecurity issues may pose a significant challenge to software security. These may lead to the introduction of certain risks during device usage.  It may allow the cyber attacker in controlling the device and change its functionality, further resulting in affecting the safety and effectiveness of SaMD. Hence, this may further lead to the leaking of critical patient information.

The US FDA’s Software Pre-Certification Program, currently at its pilot test-phase according to 2019 information, is designed to help to notify the development of a future regulatory model for digital health technology like a SaMD. The program, at first, is working on the examination of the software developer in order to demonstrate a robust culture of quality and organizational excellence, this is different from the conventional approach of assessing a medical device product.

What All Devices Are Included to Be Called as Software as a Medical Device and What Not?

A Software as a medical device spans from a software that allows the usage of a smartphone for viewing images acquired from an MRI medical device for diagnosis to a CAD software that is capable of performing image post-processing in order to detect a cancer, for example lung cancer. SAMD can also be interfaced with other medical devices that include hardware medical devices or medical software. In addition, they can be used with a general-purpose software. For instance, software for treatment planning that helps in supplying information used in a medical device is also software as a medical device. Other examples include, software with a medical purpose operating on a general-purpose computing platform, for example, a computer system that is not installed for a specific medical purpose will also be considered as a software as a medical device. Additionally, a software attached to a hardware medical device, but is not required by that medical device for achieving its intended medical objective is also considered as a software as a medical device. Moreover, a software as a medical device that is capable of working on a general-purpose computing platform can be located in a hardware medical device. Hence, with the increasing number of hardware devices, medical or non-medical devices, that may help as a platform for SaMD in order to encourage an efficient functioning of a medical operation will continue to increase the software as a medical device market demand. This can be highly beneficial for remote healthcare operations to carry out in a smooth manner, therefore, helping in decreasing the number of hospital visits, further promoting to reducing healthcare costs to a greater extent.

Following Are the List of Examples Not Considered as Software as a Medical Device:

If a software is a part of a hardware medical device, it does not qualify for meeting the definition of a SaMD. A software that is utilized for driving or controlling the motors or is used for the pumping of a medication in a drug delivery system, it is not considered as a software as a medical device. Embedded software that is used in an implantable cardiac device like a pacemaker is not a SaMD.

A software that is required by a hardware medical device for performing the hardware device intended medical motive, even in the case of separate sales of the software is not a SaMD. A software that is dependent on an information provided by a medical device, but does not have a medical purpose is not a SaMD. For instance, a software that coverts a data into a code in order to transfer it from a medical device is not considered as SaMD. Additionally, a software that is capable of enabling a clinical communication and workflow comprising patient registration, visits, calling and others is not a SaMD. A software that is used for monitoring a medical device performance in order to assess the need for servicing the device is also not considered a SaMD. For example, a software that is integrated for analyzing laboratory quality control data for identifying errors. Furthermore, a software that serves as an input for a SaMD is not considered as a software as a medical device if it does not have a medical objective. For instance, a database containing search and query functions either all alone or when utilized by a software as a medical device.