Overview
Digital health is growing fast, and software is key in changing how healthcare is delivered. A key advancement in this area is Software as a Medical Device (SaMD). This software operates independently. It handles medical tasks without needing a physical device. AI imaging tools and insulin management apps are changing how we diagnose, treat, and manage health conditions.
In this blog, we’ll look at what SaMD means. We’ll cover the types of medical software, share real-world examples, and discuss how SaMD is classified and regulated. We’ll also highlight key points to consider when developing it. If you’re a developer, innovator, or healthcare worker, knowing about SaMD is key. It helps you navigate the changing world of medical technology.
What is SaMD ?
According to Experts International Medical Devices regulator forum, (IMDRF) SaMD is defined as Software as a Medical Device (SaMD) refers to software intended for medical use that performs medical tasks without being part of a physical device. SaMD can function independently on platforms like computers, smartphones, or cloud systems.
There are four main types of medical software:
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SaMD (Software as a Medical Device): SaMD is software that works on its own to perform medical tasks. It does not need any physical hardware. It can diagnose, monitor, or treat health issues. It uses data analysis, algorithms, or AI. SaMD runs on common platforms like smartphones, tablets, or cloud servers.
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SiMD (Software in a Medical Device): SiMD is software built into a medical device. It is crucial for how the device works. Examples include software inside pacemakers, infusion pumps, or MRI machines. This type of software controls, monitors, or enables specific functions of the hardware. It closely integrates with the physical parts. Its reliability is crucial for the device’s performance and safety.
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Software as an Accessory to a Medical Device: This software cannot perform medical functions by itself. Instead, it provides important support. It helps improve a medical device's performance. For example, it could be an app that calibrates a blood glucose monitor. It might also manage data from a wearable health tracker. Even though it’s not the main function of the device, it is still regulated. This is because it affects the device's accuracy and reliability.
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General Purpose Software: This type of software includes applications not made for medical use. However, they can be adapted for healthcare settings. Examples include spreadsheet tools for tracking patient data and messaging platforms for doctor-patient chats. Though not medical software by default, using them in clinics may need extra checks or rules. This helps ensure patient safety and data integrity.
Examples of SaMD
- ECG Interpretation Software:
This software analyzes ECG (electrocardiogram) data to detect arrhythmias (irregular heartbeats). It helps doctors make accurate diagnoses by interpreting complex heart data, without the need for manual calculations or external devices. Since the software makes independent medical decisions, it qualifies as SaMD.
2. Medical Imaging AI:
Artificial intelligence (AI) software used to analyze medical images, such as X-rays, MRIs, or CT scans, to identify conditions like cancer or fractures. The software provides diagnostic assistance by highlighting potential issues for radiologists. This AI software is considered SaMD because it performs a medical function on its own.
- Retinal Scanning Software:
A mobile app that uses the smartphone’s camera to capture images of a person’s retina and then analyzes the images to detect signs of diabetic retinopathy or other eye conditions. This software is SaMD because it offers a medical diagnosis without needing a physical medical device.
4. Digital Blood Pressure Monitor App:
A smartphone app that connects with a wireless blood pressure cuff. The app records the blood pressure data, analyzes it, and provides insights or alerts about high blood pressure trends. While the cuff is a physical device, the app’s analytical function makes it SaMD.
5. Insulin Management Software: Software that analyzes glucose levels from a continuous glucose monitor (CGM) and provides insulin dose recommendations to diabetics. It assists users in managing their insulin intake without the need for doctor intervention, making it a SaMD.
SaMD can be used on a variety of platforms, including medical device platforms, virtual networks, and commercial platforms.
Classification of SaMD
Similar to Medical devices, The FDA classifies Software as a Medical Device (SaMD) into four risk levels based on its impact on patient’s health to determine the regulatory requirements for SaMD.
Class I: Lowest risk:
These devices possess low risk to a patient's health.
Example: Software that analyzes data from continuous glucose monitors after it's been collected.
Class II: Moderate risk:
This software has a medium level of risk as they often interact with internal organs or help with diagnosing conditions
Example: Software that tracks patient vitals like heart rate and blood pressure for better understanding consider a tool that allow doctors to view X-rays or CT scans but don't make medical decisions.
Class III: High risk:
These devices carry the highest risk as they are often life-supporting, implanted, or could lead to serious harm
Examples: software for eye surgeries is considered to be in this category.
Now why is the classification so important or why do we classify?
Classification defines how the software will be regulated. High-risk SaMD requires more thorough testing and regulatory approvals, ensuring patient safety is always prioritized.
Risk classification for SaMD
When it comes to Software as a Medical Device (SaMD), failures can cause serious problems, and the level of harm can differ greatly
Minor Failures
Think of fitness tracking apps or general wellness tools. A minor failure example might be a fitness app providing inaccurate step counts or miscalculating daily activity levels. In this case the Users may experience mild inconvenience, but it doesn’t impact any medical decisions or treatments.
Moderate Failures
Tools like diabetes management apps or software that provides health-related information but isn’t directly controlling life-critical systems. In this case, the failure could result in delayed or incorrect information. The error might not be fatal, but it can disrupt a patient’s treatment and potentially cause harm if unaddressed.
Major Failures
Consider the case of a heart monitoring app that is supposed to detect irregular heartbeats. If this app fails to identify a potentially fatal heart rhythm disturbance, or worse, provides false negatives, the patient may not seek immediate treatment.
This delay in care could result in catastrophic outcomes, such as a heart attack or stroke.
This classification helps developers and regulators to manage risks better and ensures the right level of regulation is applied.
Misconceptions about SaMD
A common misbelief is that SaMD (Software as a Medical Device) has to be treated differently from the other traditional medical devices to achieve regulatory compliance.
Although SaMD does not have physical components, it still has important features that must meet the same regulatory requirements.
Let’s understand with some examples,
- Image resolutions: High-quality images for accurate medical assessments.
- Calculation accuracy: Ensuring precise results for diagnosis or treatment.
- Data integrity protection: Safeguarding sensitive patient information.
- Response times: Fast, reliable responses to user inputs or critical alerts.
- Data processing times: Quick and efficient handling of large volumes of patient data.
SaMD and other types of medical devices
- Usually making changes in software is much faster than making the same changes in traditional devices
- The Modern software development methods like Scrum or CI/CD don't always fit well with traditional design control processes and can be frustrating and challenging.
- SaMD can provide healthcare services remotely, so it helps the patients with mobility issues while traditional medical devices require physical availability
- We can use the SaMD can on multiple devices such as tablets, mobile phones, computers which makes it flexible.
- SaMD can be easily updated or modified to keep up with new medical research and advancements, on the other hand Traditional medical devices require redesign or full replacement.
Summary
SaMD plays an important role in modern healthcare to deliver medical insights. but it faces unique regulatory challenges because of its broad use and software-based design.
As SaMD continues to evolve, developers must follow regulatory rules to balance innovation and patient safety.
I sincerely hope this article helped you learn more about SAMD, I would like to introduce the Medical Device Development Service at Delighteck. If you’re interested in building medical devices or you are already in the process of building it, and you need our help to accelerate, we’ll be happy to help, please send WhatsApp +65 89520272.