The Difference Between SaMD and Embedded Software

Ben Trombold

Published on: February 17th, 2025

The Difference Between SaMD and Embedded Software

Understanding the distinction between Software as a Medical Device (SaMD) and embedded software is essential for anyone involved in medical technology development. While both are critical to advancing healthcare, their roles, regulatory requirements, and deployment differ significantly. This guide explores the key differences, helping you align your development efforts with industry needs.

What is Embedded Software?

Embedded software is integral to the operation of hardware medical devices. It’s designed to perform specific tasks within the hardware it supports, ensuring seamless functionality and safety.

Key Characteristics of Embedded Software

Hardware-Dependent: Embedded software is tied to specific medical devices, such as pacemakers or infusion pumps.
Device-Specific Functionality: It directly controls the hardware’s operation, such as regulating dosage or monitoring vital signs.
Real-Time Operation: Often includes time-critical functionality, ensuring reliable device performance.

Examples of Embedded Software

Software in a pacemaker that regulates heart rhythm.
Control systems in an insulin pump managing dosage delivery.
Firmware in diagnostic imaging machines, like MRI scanners.

What is SaMD?

Software as a Medical Device (SaMD) operates independently of specific hardware. It performs medical functions such as diagnosis, monitoring, or treatment, often leveraging advanced analytics and cloud-based platforms.

Key Characteristics of SaMD

Hardware-Independent: SaMD runs on general-purpose devices like smartphones, tablets, or cloud servers.
Medical Decision Support: Provides diagnostic or therapeutic recommendations directly to clinicians or patients.
Advanced Technologies: Frequently incorporates AI, machine learning, and big data analytics.

Examples of SaMD

AI-powered software that analyzes medical images to detect abnormalities.
Mobile apps that monitor chronic conditions like diabetes.
Cloud-based platforms that enable remote patient monitoring.

Key Differences Between SaMD and Embedded Software

1. Dependency on Hardware

Embedded Software: Relies on the hardware it is built into, such as medical devices used in hospitals or at home.
SaMD: Runs independently and does not require proprietary hardware to function.

2. Functionality

Embedded Software: Ensures the proper operation of a medical device.
SaMD: Performs standalone medical functions, such as diagnostics or monitoring.

3. Deployment

Embedded Software: Installed directly onto the hardware it supports.
SaMD: Deployed on general-purpose platforms or via cloud-based systems.

4. Regulatory Classification

Embedded Software: Regulated as part of the overall medical device.
SaMD: Evaluated as an independent product, following frameworks like the FDA’s SaMD guidance or IMDRF standards.

When Do SaMD and Embedded Software Overlap?

Some systems combine SaMD and embedded software, creating hybrid solutions:

A wearable device with embedded software collects raw physiological data.
SaMD analyzes this data remotely, providing diagnostic or therapeutic insights.

Example: An ECG monitor’s embedded software processes initial signals, while a SaMD app evaluates heart rhythms for potential anomalies.

Why the Difference Matters

1. Compliance and Regulation

Understanding the distinction ensures you meet the correct regulatory requirements. SaMD follows unique risk-based frameworks, while embedded software compliance is tied to its hardware.

2. Development Strategies

SaMD requires expertise in software design, data analysis, and cloud integration.
Embedded software development focuses on firmware engineering and hardware-software interaction.

3. Market Opportunities

SaMD opens doors to broader distribution channels, such as app stores or subscription-based cloud platforms, while embedded software is tied to the hardware’s sales.

Conclusion

The differences between Software as a Medical Device (SaMD) and embedded software highlight the diverse opportunities and challenges in medical technology development. SaMD’s standalone nature enables greater flexibility and scalability, while embedded software ensures hardware functionality and safety.

For more insights, check out these related articles:

FDA SaMD Guidelines: Navigating Compliance

By understanding these distinctions, you can align your development strategy with industry needs, ensuring innovation and compliance in the evolving MedTech landscape.