Software as a Medical Device: Everything You Need To Know About SaMD
A brief overview
Healthcare software development agencies and healthcare mobile app development companies are adopting new emerging innovations and diving headfirst into an age where emerging innovations catalyze transformational growth. Technological growth — both in and out of medical devices — has exploded in the last 20 years because of the Internet of Things, digital networking, cloud computing, AI and analytics, and other factors.
These advances are transforming the treatment-centric approach into one that is more patient-centered and collaborative. These applications or services, or Software as a Medical System (SaMD), which are medical devices in and of themselves, quickly become an integral part of consumers’ lives in terms of both care and supervision and treatment. SaMD creates new opportunities and challenges for both medical device providers and regulators to enable creativity while protecting patient safety and therapeutic efficacy.
In general, Medical system software is divided into four categories:
1. Software as a medical device (SaMD) is stand-alone software that functions as a stand-alone medical product.
2. Software in a medical device (SiMD) is a medical product component, such as embedded software in medical equipment.
3. Software that is a supplement to a medical system
4. General-purpose applications that are not stand-alone medical devices.
Introduction
Software as a Medical Device (SaMD) is described by the International Medical Device Regulators Forum (IMDRF) as the software built to be useful for more than one medical purpose and serve these purposes without being a part of a hardware medical device. In another way, think of SaMD as a piece of software that can be used as a medical system on its own.
A SaMD, for example, is the medical system app that allows you to display photographs from an MRI on your computer. However, the program that allows an MRI system to perform its test isn’t a SaMD. Software must not be the primary driver of a hardware computer to be classified as SaMD.
Benefits of SaMD
Within the broader world of healthcare, SaMD is a relatively recent type of advanced computing resource. Screening and diagnosis, surveillance and alerting, chronic illness and diabetes control, and remote therapeutics are examples of SaMD applications. SaMD suppliers are using artificial intelligence and machine learning systems to reinvent their goods to help support health care providers, optimize patient care, and save time.
The main features of SaMD are as follows:
1. Better health results driven by vast amounts of vital data collection.
2. Increased processing and input to fuel faster innovation in less time.
3. cut-edge technology SaMD platforms will transform patient quality and management while lowering costs and improving health outcomes.
4. Ensure data integrity and accuracy; enable remote diagnosis.
5. Promote interoperability and efficiency in preventive activities.
6. Possibility of transforming healthcare delivery environments by improving protection, accessibility, and overall performance.
SaMD life cycle
According to the IEC 62304 specification for medical device product life-cycle creation, SaMD developers must use a risk-based decision model to identify testing criteria.
Some of the values that foster protection about SaMD are mentioned below:
1. Risk administration
2. Quality control
3. Device engineering that is methodical and rigorous under best industry practices.
4. Supervision of software creation.
5. Clinical proof of safety and efficacy.
6. Specific reporting proof under relevant norms and guidelines.
7. Mechanisms used for post-market regulation, including end-user traceability.
8. Framework for ensuring regulatory enforcement while protecting protection and privacy.
Challenges of SaMD
Though networking medical devices is a welcoming advancement of Connected Health engineering, it does bring complexities and regulatory concerns. One of the most difficult problems is the absence of a cohesive platform for medical device software production and the inability to consider the actual state of the development processes.
To grow regulatory-compliant SaMD, SaMD manufacturers should follow best practices and short feedback loops recommended by authorities. Since SaMD creates its distinct regulatory criteria, manufacturers must consider “how the certification and designation” relate to their products. A part/module of a medical device includes software and applies an acceptable regulatory strategy for global enforcement and growth.
Conclusion
SaMD’s technology becomes affordable, more available, and more advanced as it delivers specific capabilities, allowing it to leverage accessibility to devices and consumers for continuous protection and effectiveness. While it could be more difficult to use than other software devices, it is expected to play a growing role in health care delivery, precision medicine, and medical science.
To reap out the full benefits, manufacturers must develop risk-based requirements and be prepared to comply with the quickly changing regulations to meet the rapidly emerging SaMD technology.
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