Software as a Medical Device: Everything You Need To Know About SaMD

Software: Making Healthcare More Efficient

Powering game-changing developments in varying fields of medicine, including 3D printing, point-of-care diagnostics, robotics, bioinformatics, synthetic biology, genomics, and more, the impact of software is changing how clinicians practice medicine.

As software in healthcare continues to evolve and become more commonplace, it has become integrated into healthcare in four ways:

  • Software as a Medical Device (SaMD) is specific software that serves as a medical product.
  • Software in a Medical Device (SiaMD) is software that is implemented into a medical product.
  • Software as an accessory to a medical device.
  • General-purpose software that is not a medical product

These four types of software provide their own solutions, however because of its relative newness, the limitations of Software as a Medical Device (SaMD) are few and far between.

What is Software as a Medical Device (SaMD)?

Software as a Medical Device (SaMD) is well-defined as a class of medical software built to carry out one or more medical functions without the need to be interfaced with other medical devices. It is any software that is developed to be used for medical purposes without being integrated into an actual device.

The international medical device regulators forum describes SaMD as a type of software that can work on general-purpose computing platforms or in combination with other products like medical devices.

What is Software as a Medical Device What can Software as a Medical Device (SaMD) do? The Future of Medical Device Software in HealthcareDue to the fact there is no hardware involved in SaMD, there are fewer constraints to fast feedback loops, providing new opportunities to the healthcare industry.

What can Software as a Medical Device (SaMD) do?

Benefits: SaMD tools help to speed up the discovery, management, and treatment of a wide range of medical issues, automating certain features of care to save time.

By being able to swiftly assemble numerous data sets, SaMD can also ask for user feedback through its availability on multiple devices.

Two of the biggest benefits include enriched health outcomes through more accurate data, as well as quicker production and feedback, leading to faster innovation.

Other benefits of the implementation of SaMD include:

  • Improved screening and diagnosing
  • Independent monitoring and alerting
  • Better management of  chronic conditions and diseases
  • Introduction of digital therapeutics

Challenges: Although the potential benefits of SaMD are innumerable, this relatively new process can run into core challenges with inexperienced builders.

The mistake inexperienced builders often make is during the process of integrating modern product methodology designed for an ever-evolving world into our current healthcare system.

Some companies forget to take into consideration the numerous compliance and patient safety guidelines to which they must adhere, and then have to start retooling the software from the very first step in order to be compliant.

The Future of Medical Device Software in Healthcare

Software as a Medical Device (SaMD) provides features that extend beyond traditional medical devices or hardware. It powers technology and connectivity to devices in order to continuously monitor safety, efficiency, and performance.

Companies, who navigate this new terrain and become familiar with it, will benefit enormously, whereas companies who refuse to adapt, will be left behind.

Being a pioneer in the medical device software industry, Dash is an experienced builder of SaMD solutions for healthcare providers across the United States.

If you are planning on implementing medical device service software or want to see how SaMD can make your hospital more efficient, reach out to us and let’s see how we can find a solution, together.

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