RPM Device Selection Checklist
Essential Criteria for Remote Patient Monitoring Success
Version 1.5 | January 2025
Essential Criteria for Remote Patient Monitoring Success
Version 1.5 | January 2025
FDA 510(k) Clearance - Medical device registration required
Upper Arm Cuff Design - More accurate than wrist monitors
Automatic Inflation - Reduces user error
Cellular Connectivity - Direct data transmission
Memory Storage - Minimum 100 readings
Large Display - Easy reading for elderly patients
Irregular Heartbeat Detection - Clinical safety feature
400+ lb Capacity - Accommodate all patient sizes
0.2 lb Precision - Detect small weight changes
Auto-on Function - Step-on activation
Cellular Transmission - Automatic data upload
Non-slip Surface - Patient safety feature
Low Battery Indicator - Reliability assurance
FDA Medical Grade - Clinical accuracy standards
±2% SpO2 Accuracy - Clinical-grade precision
Bluetooth/Cellular - Data transmission capability
Perfusion Index - Signal quality indicator
Motion Tolerance - Reduce false readings
Long Battery Life - 30+ day operation
ISO 15197:2013 Compliance - International accuracy standard
Small Blood Sample - 0.5 μL or less
5-Second Results - Fast measurement time
Alternative Site Testing - Palm/forearm options
Data Management - 500+ reading memory
Strip Coding - Automatic or no coding required
| Feature | Minimum Requirement | Preferred |
|---|---|---|
| Connectivity | Bluetooth + Cellular | Dual-band cellular (4G/5G) |
| Battery Life | 30 days normal use | 60+ days |
| Data Storage | 100 readings minimum | 500+ readings |
| Transmission Frequency | Daily automatic | Real-time transmission |
| User Interface | Simple one-button operation | Voice prompts + visual |
Large, Clear Display - 1.5+ inch screen
High Contrast Text - Black text on white background
Minimal Buttons - One-touch operation preferred
Audio Feedback - Voice prompts and confirmations
Lightweight Design - Easy to handle and store
Intuitive Setup - No complex programming required
FDA Medical Device - 510(k) clearance or equivalent
HIPAA Compliant - Data encryption and privacy
FCC Certification - Wireless transmission approval
Clinical Validation - Peer-reviewed accuracy studies
ISO 27001 - Information security management
| Criteria | Weight | Evaluation Points |
|---|---|---|
| Technical Support | 25% | 24/7 helpdesk, training materials, troubleshooting |
| Device Reliability | 20% | Failure rate, warranty terms, replacement process |
| Data Integration | 20% | EHR compatibility, API availability, data formats |
| Cost Structure | 15% | Device costs, monthly fees, setup charges |
| Patient Experience | 10% | Ease of use, satisfaction scores, adoption rates |
| Scalability | 10% | Volume discounts, deployment speed, support capacity |
Shipping & Logistics - Direct-to-patient delivery
Activation Process - Remote or automated setup
Patient Training - Video tutorials and phone support
Technical Support - 24/7 helpdesk availability
Device Replacement - Quick turnaround for failures
Return Process - Prepaid return shipping
| Cost Component | Typical Range | Considerations |
|---|---|---|
| Device Hardware | $50-$200 per device | One-time or lease options |
| Cellular Service | $10-$25 per month | Data plan and transmission costs |
| Platform Fees | $15-$40 per patient/month | Software licensing and support |
| Support Services | $5-$15 per patient/month | Technical support and training |
Clinical Accuracy - AAMI/ESH protocol validation
Cuff Sizes - Multiple sizes available (pediatric to bariatric)
Memory Capacity - Minimum 100 reading storage
Arrhythmia Detection - Irregular heartbeat notification
Connectivity - Bluetooth, cellular, or WiFi transmission
Battery Life - Minimum 6 months operation
FDA Accuracy - System accuracy requirements compliance
Test Strip Availability - Wide pharmacy distribution
Sample Size - Small blood sample requirement (<1µL)
Test Time - Results in <15 seconds
Temperature Range - Wide operating temperature tolerance
Data Management - Automatic result transmission
Weight Capacity - Support up to 400+ lbs
Measurement Precision - 0.2 lb accuracy
Platform Size - Large, stable weighing surface
Auto Recognition - Multi-user identification
BMI Calculation - Automatic body mass index computation
Trend Analysis - Weight change tracking and alerts
| Integration Type | Requirements | Evaluation Criteria |
|---|---|---|
| EHR Integration | HL7 FHIR R4 compatibility | Direct data flow to patient records |
| API Connectivity | RESTful API with OAuth 2.0 | Secure, authenticated data exchange |
| Data Format | Structured data with timestamps | Standardized measurement units |
| Real-time Alerts | Configurable threshold notifications | Immediate critical value alerts |
Setup Complexity - Average setup time <10 minutes
Daily Use - Single-button operation preferred
Display Readability - Large, high-contrast display
Audio Feedback - Voice prompts and confirmations
Error Recovery - Clear error messages and resolution steps
Maintenance - Minimal cleaning and calibration requirements
Population View - Multi-patient monitoring dashboard
Trend Analysis - Historical data visualization
Alert Management - Customizable threshold settings
Clinical Decision Support - Evidence-based recommendations
Reporting Tools - Automated outcome reports
Mobile Access - Provider smartphone/tablet app
| Scale Factor | Considerations | Evaluation Questions |
|---|---|---|
| Patient Volume | Support for 100-10,000+ patients | Can system handle projected growth? |
| Geographic Coverage | Nationwide cellular connectivity | Coverage in rural and urban areas? |
| Device Portfolio | Multiple device types from single vendor | Can vendor support diverse patient needs? |
| Support Infrastructure | Scalable customer service capacity | Support team size and availability? |
Year 1 Costs (100 patients):
Revenue Potential: