Companion Diagnostic App Interface Brief

Role: Principal Usability Strategist specializing in regulated Software as a Medical Device (SaMD).

Context

• Device Manufacturer: {{biotech_brand}}
• Hardware Connection Type: {{device_hardware_pairing}}
• Primary Operator: {{caregiver_accessibility_level}}
• Regulatory Class: {{regulatory_classification}}
• Primary Diagnostic Output: {{critical_diagnostic_metric}}
• Network Reliability Constraint: {{offline_sync_protocol}}

Task

Create a comprehensive UX design brief for a companion diagnostic mobile interface that ensures accurate sample processing, transparent hardware pairing, and safe comprehension of test results.

Method

1. Define step-by-step physical-to-digital pairing sequences tailored to {{device_hardware_pairing}}.
2. Analyze operator vulnerability and stress levels during {{critical_diagnostic_metric}} testing cycles.
3. Draft instructional microcopy for sample collection, scanning, and countdown states.
4. Design error-recovery state flows for corrupted reads, disconnected sensors, and invalid samples.
5. Specify deterministic offline behavior and visual indicators based on {{offline_sync_protocol}}.
6. Structure results disclosure layouts that separate immediate action items from detailed clinical records.
7. Align usability specifications with IEC 62366-1 usability engineering controls for {{regulatory_classification}}.

Constraints

• MUST provide unambiguous confirmation states before initiating irreversible diagnostic procedures.
• MUST NOT display indeterminate results without actionable direct guidance or clinical escalation paths.
• Pairing sequence must resolve or offer structured troubleshooting within 20 seconds.
• Typography and layout must remain legible at 30cm viewing distance under poor lighting.

Output format

• SaMD Interface Objectives (max 100 words)
• User Journey & State Flow Architecture (Pairing, Processing, Disclosure, History)
• Diagnostic Result UI Patterns (Normal, Elevated, Invalid, Crisis states)
• Hardware-Fault & Offline Interaction Blueprint (table with 4 edge cases)
• Human Factors Validation Plan (3 formative testing criteria)

Self-review

• Does the result presentation prevent self-misdiagnosis while empowering {{caregiver_accessibility_level}}?
• Are bluetooth and hardware error states clearly distinct from clinical diagnostic errors?
• Is the {{offline_sync_protocol}} communicated clearly without technical terminology?