Med Tech

What is Software as a Medical Device?

There are around 1.5 million medical devices globally, across more than 10,000 types ranging from simple equipment like stethoscopes to more complex, expensive devices like MRI machines.

The amount of software used both in and around medical devices has drastically increased over the last 40 years. The use of software in various medical devices has accelerated due to the emergence of the ‘Internet of things’ (IoT) and its corresponding technologies such as smartphones, wireless connectivity, cheaper and better sensors, cloud computing, big data and AI. Thus medical software devices have transformed the healthcare sector altogether. 

Medical device software comes in 4 primary subclasses:

  • Software as a medical device (SaMD): a standalone software that serves as a medical product in and of itself;
  • Software in a medical device (SiMD): software that’s part of a medical product, such as implanted software in medical equipment;
  • Software as an accessory to a medical device;
  • General-purpose software that is not a medical product by itself.

Software as a Medical Device (SaMD) refers to any kind of Medical Software that carries out one or more medical functions without the need of any kind of actual hardware. According to the FDA, SaMD is a class of software that is designed to carry out one or more medical functions. This includes software or mobile apps intended to treat, diagnose, cure, mitigate, or prevent disease or other conditions. SaMD is typically used alongside non-medical computing platforms, which may be connected to virtual networks, traditional medical devices or other general-use hardware.

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The main characteristics of SaMD are: 

  1. Improved health outcomes: SaMD amplifies the effectiveness of medical devices and existing treatment plans, through an easy and fast collection of high-quality data (lab results, medical images, genomics data, environment signal, phenotype data, patient demographic information, vital signs medication diagnoses, immunisation dates, allergies, symptoms) which leads to better health outcomes.
  2. Faster feedback: SaMD enhances and builds on existing medical device functions through software solutions that are faster, and cheaper, than hardware. It also utilizes the latest technologies to integrate and share health data across various platforms, including the cloud, connected medical devices, and smartphones.

The medical device software used to view images from an MRI on a smartphone would be considered as SaMD. However, the software that enables an MRI machine to run its test would be an SiMD and not SaMD. Another example of SaMD software is fertility applications. These tools help users control conception or otherwise deal with reproductive outcomes. 

SaMD software products serve different purposes, generally related to diagnosis, disease prevention, modernizing care, or treatment of an illness or injury. The various applications of SaMD include: 

  1. Screening and diagnosis: Through complex algorithms, software programs can accurately predict the risk of chronic disease and aid in treatment decisions. SaMD devices can use smart algorithms capable of detecting anomalies and thus help in the detection of various types of cancer and hence, can help deliver personalized treatment plans. This can also help clinicians get a better picture of a patient’s medical condition, history and real-time status, allowing them to make a better, more precise diagnosis and treatment decision.
  2. Monitoring and alerting: SaMD systems can be designed as wearable sensors which collect and track multiple vital signs. The software monitors and uses this data to provide the appropriate treatments and alerts for both patients and clinicians. SaMD can help patients better monitor their condition by identifying triggers and providing real-time recommendations on everything from drug dosages to physical activity to environmental conditions. It can also help improve overall patient adherence to treatment, and thus leading to better clinical outcomes.
  3. Chronic condition and disease management: SaMD allows both patients and clinicians to track and interpret health data, and adjust treatment plans to be more effective. Connected care systems promote greater patient ownership of treatment decisions. Thanks to SaMD, patients can monitor their health activity or status in real-time and seek medical help if needed. SaMD tools assist physicians in designing personalized treatment plans for patients with chronic diseases based on data collected by the software, such as blood glucose or cardiac enzyme levels.

SaMD provides unique features that extend beyond those of the traditional medical device or hardware. Unlike other devices, SaMD is able to leverage technology and connectivity to devices as well as people that can continuously monitor safety, effectiveness and performance. SaMD combines the best of technology with medicine to provide the most suitable treatment options for patients and help out healthcare professionals. 

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