As new technology continues to evolve, so does the role it plays in many different industries. Recent technological innovations in healthcare have resulted in significant positive effects on the field. An example of this is Software as a Medical Device (SaMD). This article takes a closer look at what SaMD is, and explores a few examples of it.
What Is SaMD?
The definition used by the International Medical Device Regulators Forum (IMDRF) for Software as a Medical Device is “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” To better understand what SaMD tools do, it might help to view them in this way: SaMD permits the acceleration of the diagnosis, management, and treatment of a wide spectrum of medical conditions and diseases by automating some aspects of care. It is through this automation SaMD can save time. However, as Orthogonal explains, not all medical software is considered SaMD.
How SaMD Works
SaMD tools are used to collect massive amounts of data. The data is collected quicker than would be possible by any traditional means and some SaMD applications permit the addition of feedback from patients. This type of information gathering has two key benefits. First, the collection of information is more accurate, providing a better foundation to improve health outcomes. Second, faster production and feedback allow for faster innovation. The data collected by SaMD not only aids in patient recovery, but also the future development of newer, more innovative SaMD tools.
Who Regulates SaMD?
Two main bodies monitor the development and implementation of SaMD: the International Medical Device Regulators Forum (IMDRF) and the Food and Drug
Administration (FDA). The IMDRF is a group of volunteer medical device regulators pulled from around the globe. Their main purpose is to set harmonious standards for the regulation of medical devices. These guidelines include the responsibilities of a medical device manufacturing company and the proper labeling and instruction standards for the manufactured devices. The FDA’s involvement includes the development of guidelines intended to control how SaMD is used in the field. In 2013, the IMDRF created the Software as a Medical Device Working Group (WG) to develop global guidelines to support innovation and access to safe and effective SaMD. The WG is chaired by the FDA.
Guidelines developed by the FDA are designed to create consistent, universal standards for software that falls under the Software as a Medical Device category. This includes the requirement that SaMD supports the clinical vocabulary for its use. Clinical evaluation methods and clinical evidence relevant to the software use of SaMD are the focus of another guideline. Also, numerous recommendations should be put on the software by manufacturers for analytical purposes, and any potentially adverse situations should be outlined. They are to explain to consumers what to expect and what to be aware of when using SaMD.
Examples of SaMD
Here are five examples of SaMD to further explain how these devices assist medical professions in collecting the data they need to make better medical decisions to help patients recover from various types of health issues.
Patient Data SaMD
Several SaMD fall under this heading and include such things as the software used to collect patient data in real-time measurements that can be displayed and monitored remotely by a medical professional. The data may include heart rate stats, blood pressure readings, and other similar pieces of vital statistics. The data collected with this SaMD allow for treatment plans to be developed off-site eliminating the need for a visit to a clinic or office to gather these stats. Plus, SaMD in this application provides ongoing data collection so treatment options can be altered quickly and effectively.
Image Data SaMD
By analyzing and manipulating images and data collected from radiation-emitting imaging devices, this software can create 3D models. Then the models are analyzed and the results are used to help formulate a treatment plan. The SaMD in this application prevents the need for invasive exploratory surgery and additional exposure to radiation that would result from other data collection methods including MRIs, CT scans, and x-rays.
Treatment Data SaMD
Patient information is analyzed with this type of new technology software that is used as an algorithm. The final result of the analysis is the development of a treatment plan. The patient data collected for the algorithm includes age, weight, heart rate, and blood pressure. This SaMD will also gather additional information when required, depending on the type of treatment needed. The software is required for the medical professional to decipher the data that has been collected.
Sleep Data SaMD
Rather than using a sleep lab setting, this software analyzes the physiological signals collected when a patient is sleeping. Using the microphone/camera of a smartphone, this SaMD can determine sleep stages, record snoring measurements, and detect arousals in the assessment of the quality of sleep. It can also identify obstructive sleep apnea. The data is analyzed and becomes the basis of a treatment plan.
Breast Screening SaMD
This software uses the identical digital mammogram that radiologists use and calculates breast density percentage with it. Mammograms aid in the assessment of breast tissue composition and the SaMD offers an evaluation based on digital image analysis regarding an individual’s breast cancer risk. The software aids in the decision-making process that may result in either a treatment plan or the need for further screening.
Software as a Medical Device is still a relatively new technology. As this technology continues to grow, so will the role it plays in healthcare. Considering that SaMD has already led to better patient outcomes from the faster collection of patient data and aids in creating more specific treatment plans from accurate data, it is easy to see that the future of healthcare will continue to include SaMD. Expect to see additional uses for SaMD as the implementation of this innovative technology reaches deeper into the healthcare industry.