SaMD vs Traditional Medical Device Software: Quick Comparison
- Beng Ee Lim
- Jun 17
- 5 min read
TLDR: Software as Medical Device (SaMD) operates independently as a medical device, while traditional medical device software works as part of a physical medical device. This fundamental distinction affects FDA classification, regulatory pathways, and development requirements.
SaMD vs Traditional Medical Device Software
Aspect | SaMD | Traditional Medical Device Software |
Definition | Software that IS the medical device | Software that's PART OF a medical device |
Hardware | Runs on smartphones, tablets, computers | Integrated with specific medical hardware |
FDA Path | Independent device classification | Part of overall device submission |
Distribution | App stores, cloud platforms | Embedded in physical device |
Updates | Over-the-air software updates | Often requires device service |
Examples | ECG analysis app, AI diagnostic tool | MRI software, ventilator controls |
What is SaMD (Software as Medical Device)?
SaMD is software intended for medical purposes that performs these purposes without being part of a hardware medical device.
Think mobile apps, cloud platforms, or desktop software that diagnose, treat, or monitor patients.
Key SaMD Characteristics
Platform Independence
Runs on general-purpose devices (phones, tablets, computers)
No specialized medical hardware required
Distributed through app stores or web platforms
Medical Function
Diagnoses disease or conditions
Prevents, monitors, or treats disease
Calculates drug dosages or treatment plans
Real SaMD Examples
High-Risk SaMD
AI software that detects cancer in medical images
Apps that interpret ECGs for heart conditions
Software that calculates insulin dosing
Lower-Risk SaMD
Apps that track symptoms for doctor review
Software that reminds patients to take medication
Platforms that store and organize health records
What is Traditional Medical Device Software?
Traditional medical device software (also called Software in Medical Device or SiMD) is software that's built into a hardware medical device and can't function without it.
Key Traditional Software Characteristics
Hardware Dependency
Requires specific medical device hardware
Often embedded or integrated into the device
Cannot run on general-purpose computers
Device Integration
Controls device functions and operations
Processes data from medical sensors
Manages device safety and alarms
Real Traditional Software Examples
Hospital Equipment
MRI software that controls imaging and reconstruction
Ventilator software managing breathing parameters
Surgical robot software enabling precise movements
Implantable Devices
Pacemaker firmware controlling heart rhythm
Insulin pump software managing glucose delivery
Cochlear implant software processing sound
Critical Regulatory Differences
FDA Classification Approach
SaMD Gets Its Own Classification
Classified as Class I, II, or III based on risk
Uses IMDRF framework (Categories I-IV)
Risk depends on healthcare situation and decision type
Traditional Software Follows Device Classification
Software risk assessed as part of overall device
Classification depends on complete device system
Software documentation part of device submission
Regulatory Pathways Breakdown
SaMD Pathways
510(k) Clearance: Most of SaMD submissions
De Novo: For novel SaMD without predicates
PMA: Class III SaMD requiring clinical trials
Traditional Software Pathways
Follows parent device pathway
Software validation part of overall device testing
Timeline depends on device complexity and risk
Development and Documentation Requirements
SaMD Development Must-Haves
Core Standards
Key Documentation
Software Requirements Specification
Software Architecture and Design
Risk Management File
Clinical Evaluation (for higher-risk SaMD)
Most Common Documentation Issues:
Inadequate risk analysis
Missing software requirements
Insufficient cybersecurity documentation
Traditional Software Development
Integrated Approach
Hardware-software co-design
Real-time system requirements
Safety-critical system design
Electromagnetic compatibility
Documentation Integration
Part of Device Master Record (DMR)
Included in Design History File (DHF)
Integrated risk analysis
System-level verification and validation
Common FDA Feedback: FDA reviewers frequently request additional information for SaMD submissions, with incomplete software documentation being a leading cause of delays. Proper preparation significantly reduces review time.
Technical Implementation Differences
SaMD Technical Considerations
Multi-Platform Design
iOS, Android, Windows, macOS compatibility
Responsive design for different screen sizes
Cloud connectivity and API integrations
Cybersecurity for distributed systems
Secure software development practices
Vulnerability management programs
Strong authentication and access controls
Data encryption and protection
Traditional Software Technical Requirements
Real-Time Performance
Deterministic response times
Safety-critical timing constraints
Hardware interrupt handling
Reliable operation in medical environments
Hardware Integration
Medical sensor interfaces
Actuator and control system integration
Specialized display and user interfaces
Device-specific communication protocols
Post-Market and Updates
SaMD Post-Market Management
Software Updates
Over-the-air updates and patches
User notification requirements
Change control documentation
Version management across platforms
Continuous Monitoring
Algorithm performance tracking
Real-world evidence collection
User experience analytics
Adverse event reporting
Traditional Software Updates
Device-Integrated Updates
Often requires on-site service
Hardware compatibility verification
Complete system revalidation
Coordinated with device maintenance
Surveillance Integration
Software issues reported as device malfunctions
Field corrective actions for software defects
Periodic safety updates through device service
Cost and Market Access
SaMD Economics
Development Costs
Based on industry surveys and regulatory consulting firms:
Initial SaMD development: $150,000 - $800,000
FDA 510(k) submission fees: $12,745 - $63,725 (depending on company size)
Clinical validation: $200,000 - $1.2M (required for higher-risk SaMD)
Annual platform maintenance: $50,000 - $150,000
Market Performance
Industry analysis shows:
SaMD market experiencing strong growth in recent years
Faster time-to-market compared to traditional devices
Increasing adoption of agile development methodologies
Distribution Channels
Medical app stores (Apple, Google)
Direct physician portals
Healthcare system integrations
Prescription vs. over-the-counter models
Traditional Software Economics
Integrated Development
Software represents 30-60% of total device cost
Hardware-software integration adds 20-40% complexity
Validation integrated into device testing budget
Market Access
Medical device distributors
Direct hospital sales
Capital equipment purchasing
Long-term service contracts
Making the Right Choice
Choose SaMD When:
Software can function independently
Targeting multiple platforms or devices
Frequent updates or AI/ML improvements needed
Serving diverse healthcare settings
Leveraging cloud computing capabilities
Choose Traditional When:
Software requires specialized medical hardware
Real-time performance is critical
Complex hardware-software integration
Established device distribution channels
Safety-critical embedded systems
Common Mistakes to Avoid
SaMD Mistakes
Underestimating cybersecurity requirements
Inadequate clinical validation planning
Poor change control for updates
Insufficient platform testing
Traditional Software Mistakes
Separating software and hardware risk analysis
Inadequate real-time performance validation
Poor hardware-software interface documentation
Insufficient system-level testing
Key Takeaways
Independence is the key differentiator - SaMD works alone, traditional software needs medical hardware
Regulatory pathways differ significantly - SaMD gets independent classification, traditional follows device path
Development approaches vary - SaMD focuses on platform compatibility, traditional on hardware integration
Post-market obligations differ - SaMD enables rapid updates, traditional requires device-level changes
Market access strategies are distinct - SaMD uses digital channels, traditional follows device distribution
Understanding these differences is crucial for regulatory strategy, development planning, and successful market entry. Whether building SaMD or traditional medical device software, the choice impacts everything from team composition to regulatory timeline.
Next Steps
Ready to navigate medical device software regulation? Complizen AI streamlines both SaMD and traditional software compliance with:
Automated documentation generation
Real-time regulatory guidance
AI-powered submission preparation
Start your free trial or explore our complete SaMD resource hub for deeper technical guidance.
Frequently Asked Questions
Q: Can software be both SaMD and traditional medical device software?
A: No. Software is classified as either SaMD (independent medical device) or traditional medical device software (part of a hardware device). According to FDA guidance document "Software as Medical Device (SaMD): Clinical Evaluation", the distinction is based on independence from specialized medical hardware.
Q: Do all SaMD products need clinical studies?
A: Not all. Many SaMD clearances rely on analytical validation alone. Clinical studies are typically required for Class III SaMD or Class II SaMD that diagnose critical conditions.
Q: How long does SaMD FDA approval typically take?
510(k) clearance: ~90 days average (standard review)
De Novo classification: ~150-200 days average
PMA approval: varies significantly based on complexity
Q: What's the biggest regulatory risk for SaMD companies?
A: Cybersecurity compliance. The FDA's 2023 cybersecurity guidance requires comprehensive security documentation, and cybersecurity deficiencies are increasingly common in Additional Information requests.
Need help determining if your software qualifies as SaMD? Our regulatory experts provide free initial consultations to help clarify your pathway.
