What is software as a medical device (SaMD)?

In 2019, the International Medical Device Regulators Forum defined Software as a Medical Device (SaMD) as software that is used for medical purposes without being part of any hardware medical equipment.

SaMD is gaining its popularity thanks to the increasing role of the Internet of Things, telemedicine, artificial intelligence, and cloud computing. At the same time, the ever-growing number of smartphone users specify the business interest towards building healthcare apps that are compatible with mobile devices. According to the recent predictions, the global Software as a Medical Device market is likely to have reached $86.5 million by 2027, which is definitely a promising start.

What are examples of Software as a Medical Device?

Below are several examples of how SaMD is utilized in healthcare:

• An image processing app which is used to detect pneumonia.
• Software that utilizes a microphone to identify interrupted breathing.
• A solution which gets data from glucometers and calculates relevant insulin dosage, and more.

In this article, we are going to dive deeper into the topic and find out the main features of Software as a Medical Device, its advantages, disadvantages, and spheres of application.

What is not SaMD?

To avoid confusion, let’s first figure out what solutions will not be considered medical device software even if used by medical personnel within healthcare institutions.

• Software that has no medical purpose but still utilizes data collected from various medical devices.
• General-purpose software used for communication with patients and colleagues: chats, voice and audio calls.
• Solutions for carrying out general-purpose administrative tasks such as patient management, registration, scheduling, inventory management, etc.
• Specific systems that control the proper functioning of a medical device, analyze its quality, and find errors.

Basic features of SaMD

Software as Medical Device classification and features

SaMD offers functionality that goes beyond devices used in healthcare. Below are the major features of Software as a Medical Device:

• SaMD corresponds to the intended purpose as required by the Medical Device Directives.
• It complies with Food and Drug Administration (FDA), Health Insurance Portability and Accountability Act (HIPAA), International Organization for Standardization (ISO), Centers for Disease Control and Prevention (CDC) regulations and standards.
• The SaMD operation results in the automatic interpretation of obtained data.
• Software as a Medical Device can run on non-medical platforms and devices (smartphones, tablets, PCs).
• It can, but not necessarily, be integrated with hardware medical devices or other medical solutions.
• This software can utilize any element of the device it runs on, including a camera or a microphone.

Challenges of SaMD development

The most important issue is to provide complete software security of SaMD as any vulnerability may be risky, especially when it comes to confidential medical data. Developers should stop hackers from invading software and ensure that the system can detect malware. This is achieved via multi-factor authentication and data encryption.

One more challenge is to comply with the FDA Software Pre-certification Pilot Program, which allows building a future regulatory model for digital health, including SaMD. The program is based on five criteria: patient security, cybersecurity responsibility, product quality, clinical responsibility, and proactive culture.

Benefits of SaMD

Advantages of SaMD

SaMD can significantly enhance the quality and speed of providing healthcare services, at the same time reducing their costs. Other advantages of these systems are as follows:

• Software as a Medical Device helps to facilitate and automate a diagnosis and further treatment, thus preventing multiple health issues.
• When integrated with other medical devices, including wearables, it can collect and manage vital signs and offer relevant treatment options.
• SaMD is often used to mitigate chronic conditions, for instance, sleep apnea.
• Patients can monitor their health conditions themselves and have real-time recommendations concerning physical activity or drug dosage.
• Such software is utilized for medical image processing and 3D modeling.

Conclusion

The functionality of Software as a Medical Device goes far beyond that of traditional medical equipment. With the help of other technologies, SaMD efficiently improves the quality of medical analytics, as well as simplifies the collection of medical data from household sensors.

The Internet of Things will continue to develop and have even a greater effect on healthcare in the future. The number of mobile devices used in healthcare will undoubtedly increase, thus speeding up the implementation of SaMD.

If you are looking for a reliable partner for medical device software development, EffectiveSoft is here to turn your ideas into an advanced solution.