There has been a dramatic increase in the application of software in medical devices in the last few decades. This has been especially evident in the last two decades because of the availability of technology through smartphones, wireless internet, cheaper portable sensors, cloud computing, big data, and artificial intelligence (AI) utilization.
As compared to other industries healthcare has a smaller stride towards the utilization of such technology. Nevertheless, this sector is also welcoming up-and-coming applications to give patient care a new and improved face.
Of course, all this technology is tightly bound to the use of software and so the prevalence of both is steadily increasing in the form of highly functional medical devices.
A SaMD[i] is a software that is to be used for one or more medical purposes. The SaMD doesn’t need hardware to perform its function. Therefore, such software still counts as SaMD regardless of the fact that they need hardware during execution. The software can use IT equipment, or a cloud-based concept as long as it is not necessary to have the presence of hardware in order to fulfil its original medical purpose it can still be called a SaMD.[ii]
Whilst software for a medical device is software that has been designed to operate with medical device hardware. This hardware has to have a medical purpose and has to be used in a regulated environment. An example of such software would include an insulin dose calculator that is used to drive the infusion pump. In this example, the insulin dose calculator is the software and the hardware is a medical device called an infusion pump, this pump allows the calculated dose of insulin to enter the body.
Another example includes software that has been used to extract better imaging results through evaluating electromagnetic activity deeper in the body. This allows radiologists to gain a better insight into the condition of the patient and even decreases the risk of overlooking anomalies. This software is designed to be used with radiological machines for medical purposes.[iii]
When discussing both these topics it is necessary to know what devices qualify as medical devices. This tends to become different according to which part of the world we are in. Keeping this in mind, the software itself can be considered as a medical device under certain circumstances. For example, Oncologists use software that assists them in making treatment plans. This is especially useful as all tumours present with different parameters. The software assists in collecting data from these parameters and analyzing the best route of therapy.
At SofTx Innovations, we aid the transition of traditional healthcare systems to cloud-based, centralized, cost-effective, and portable solutions. Our practice heavily utilizes software to manage many modalities that assist physicians as well as patients. Our goal is to better healthcare systems for both the healthcare provider and receiver.