The Future of Software as a Medical Device: What to Expect in 2025
Understanding Software as a Medical Device (SaMD)
Software as a Medical Device (SaMD) is defined by regulatory bodies like the FDA and IMDRF as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."
Software as a medical device distinguishes itself from conventional medical device software, which is associated with proprietary hardware such as MRI machines using algorithms, data analysis, & artificial intelligence to deliver clinical results like disease diagnosis or chronic condition tracking through sensor readings and user input. Software as a medical device is independent of proprietary hardware. The global SaMD market is projected to reach $5.0 billion by 2033, growing at a compound annual growth rate (CAGR) of 13.6% from $1.4 billion in 2023. This signifies that it is scalable and deployable on platforms like mobile apps, cloud infrastructures, and AI diagnostic platforms.
In contrast, Software in a Medical Device
(SiMD) is integral to the functioning of a hardware medical device. SiMD cannot
operate independently and remains essential for the device's functionality.
Some examples are software that operates the inflation process of blood
pressure cuffs and software that manages insulin delivery through pumps.
Examples of SaMD include:
- Diagnostic imaging software analyzes MRI and CT scans for
the purpose of detecting medical conditions, including strokes & tumors.
- Chronic disease management mobile applications enable
patients to monitor their glucose levels.
Artificial intelligence systems that help diagnose skin cancer through image analysis and predict potential heart attack incidents.
Regulatory Framework for Software as a Medical Device (SaMD) in 2025
The regulatory system for Software as a Medical Device (SaMD) has transformed to support safety & efficacy while fostering innovation as digital technologies become more prevalent in healthcare. To ensure compliance and innovation, stakeholders engaged in medical device software development and integration software must understand the current regulatory framework.
United States: FDA's Approach
In January 2025, the FDA shared a draft guide called Artificial Intelligence-Enabled Device Software Functions: Lifecycle
Management and Marketing Submission Recommendations. The
document presents a Total Product Lifecycle (TPLC) approach that details
recommendations for developing, modifying, and monitoring AI-enabled SaMD aftermarket
release. Key aspects include:
·
Lifecycle Management: SaMD
performance and safety depend on ongoing monitoring and regular updates through
iterative improvements.
·
Transparency and Bias Mitigation: This
document provides guidance for developing strategies that will reduce biases in
AI algorithms and promote fair results.
· Marketing Submissions: Recommending the essential documentation & information needed for FDA safety and effectiveness evaluation.
International Medical Device
Regulators Forum (IMDRF) Guidelines
The International Medical Device Regulators Forum (IMDRF) played a key
role in standardizing worldwide regulations for Software as a Medical Device
(SaMD). The final document, Characterization Considerations for Medical Device
Software and Software-Specific Risk (IMDRF/SaMD WG/N81
FINAL:2025), was released by IMDRF in January 2025. This guidance provides a
framework for:
- Risk Characterization: Potential
hazards of medical device software can be determined through analysis of
intended applications and technological features.
- Device Characterization: The
standardization of vocabulary and methodology for medical device software
descriptions helps stakeholders communicate more effectively.
Integration of these considerations allows developers to effectively handle medical device software development challenges and meet global standards.
Adhering to International Standards
Central to medical device software development is compliance with
international standards that ensure safety and efficacy:
- IEC 62304: This
standard outlines the life cycle requirements for medical device software,
emphasizing processes like software development planning, risk management, and
maintenance.
- ISO 14971: ISO 14971 directs software developers for medical devices to apply risk management techniques that help them detect and minimize dangers throughout the product’s entire life cycle.
- IEC 82304-1: The standard establishes necessary safety and performance standards for health software products, which include medical device integration software that needs to fulfill quality benchmarks.
- Software Bill of Materials (SBOM): If you're making software for medical
devices, you need to provide a detailed SBOM. This document should list all the
components, dependencies, and any third-party elements you used in your
software. Being open about this info helps with managing vulnerabilities and
keeps the software supply chain safer.
These standards combined act as a blueprint to create medical device software that is reliable & compliant.
Best Practices for Protecting Patient Data in Software as a Medical Device (SaMD)
The protection of patient data in Software as a Medical Device (SaMD) is
crucial in the year 2025. These fundamental practices provide the necessary
steps to maintain data security and regulatory compliance.
- Encrypt Data: Protect data
transfers and storage between medical device software platforms through AES-256
encryption to ensure secure confidentiality.
- Implement Multi-Factor Authentication (MFA): Strengthen
access security by implementing MFA requirements that minimize unauthorized
entry into medical device integration software systems.
- Conduct Regular Security Assessments: Performing routine vulnerability scans and penetration tests allows for the identification and remediation of potential security threats in medical device software.
- Limit Access: Implement
role-based access controls within your medical device software to eliminate
unauthorized data access.
- Maintain a Software Bill of Materials (SBOM): An updated
software inventory is essential for tracking all medical device software
components to manage vulnerabilities effectively.
- Ensure Regulatory Compliance: To fulfill
international data protection standards, the medical device developers should
comply with HIPAA and GDPR regulations as well as FDA guidelines.
The implementation of these best practices allows the developers &
manufacturers to strengthen medical device software security while securing
both regulatory compliance and trust of patients.
Future Outlook for Software as a Medical Device (SaMD)
Software as a Medical Device has a promising future, although it faces
significant challenges. The following developments emerge in 2025 &
continue:
Emerging Trends of SaMD in 2025
AI & Machine Learning
Integration
Medical device software development will experience significant growth
in AI/ML applications, which will
power advanced diagnostics, personalized treatment plans, and predictive
analysis software.
Global Regulatory Harmonization
The IMDRF works to establish worldwide unified standards that assist
developers with easier cross-border compliance with medical device software
development.
Cloud-First Infrastructure
Secure cloud platforms will become essential for SaMD solutions to
achieve scalability and faster deployment, enhancing medical device integration
software performance.
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