Feasibility & Usability Framework for Wearables in Trials

Overview

Before deploying a digital health technology (DHT) in a pivotal clinical trial, organizations need confidence that the device will perform as expected in real-world conditions. Feasibility studies with healthy volunteers provide this evidence—evaluating technical performance, user acceptance, and operational logistics before high-stakes deployment.

This work established a structured approach to DHT feasibility evaluation, applied across multiple wearable technologies and therapeutic contexts.

The Challenge

Introducing a new DHT into a clinical trial without feasibility data introduces significant risks:

• Poor compliance: Participants may not wear devices as instructed, leading to missing data
• Technical failures: Device-specific issues (battery life, connectivity, data transfer) may only surface in real-world use
• User burden: Complex interactions or discomfort can drive participant dropout
• Operational surprises: Site staff may struggle with unfamiliar procedures
• Data quality issues: Problems with data integrity or completeness may not be apparent until too late

Feasibility studies address these risks before they impact pivotal endpoints, but require clear protocols, standardized metrics, and robust analysis plans.

Framework Design

1. Standardized Feasibility Metrics

Defined a core set of metrics applicable across DHT types:

• Wear time: Percentage of expected wear hours achieved
• Compliance rate: Proportion of participants meeting minimum wear thresholds
• Data completeness: Percentage of expected data points successfully captured
• Technical success rate: Device uptime, data transfer success, battery adequacy
• User-reported burden: Comfort, interference with daily activities, perceived difficulty

2. Protocol Template

Created a modular protocol template for healthy volunteer feasibility studies, including:

• Study objectives and success criteria
• Participant inclusion/exclusion criteria
• Device deployment procedures
• Data collection schedule
• Usability questionnaire administration
• Safety reporting procedures

3. Study Execution

Acted as lead investigator for multiple feasibility evaluations:

• Coordinated with cross-functional teams (Clinical Operations, Biostatistics, Regulatory)
• Oversaw participant recruitment and study conduct
• Monitored incoming data for early signals of issues
• Documented findings and recommendations

4. Decision-Support Reporting

Designed standardized reporting templates that synthesize feasibility findings into actionable recommendations. Reports clearly communicate:

• Go/no-go recommendation with supporting evidence
• Specific risks identified and proposed mitigations
• Operational considerations for pivotal study planning

Outcomes

• Informed decisions: Feasibility data enabled evidence-based go/no-go decisions for DHT deployment in pivotal programs
• Risk reduction: Identified and addressed potential issues before they could impact pivotal trial endpoints
• Process standardization: Reusable templates and metrics accelerated future feasibility evaluations
• Knowledge building: Findings contributed to internal knowledge base for DHT selection and deployment

Key Learnings

• Define success upfront: Establishing clear success criteria before study start prevents post-hoc rationalization of results
• Listen to participants: Qualitative feedback often reveals issues that quantitative metrics miss
• Plan for operational realities: What works in a controlled feasibility study may face different challenges at scale
• Communicate clearly: Decision-makers need actionable recommendations, not just data dumps

Example Metrics Framework

Metric	Target	Measurement Method
Daily wear time	≥18 hours/day	Device-reported wear detection
Compliance rate	≥90% of participants meeting wear target	Aggregated across study period
Data completeness	≥95% of expected data points captured	Comparison to expected vs. actual data
System Usability Scale (SUS)	≥70	Validated questionnaire
Technical failure rate	<5%	Device malfunction reports

Note: Specific targets vary by DHT type and therapeutic context. Values shown are illustrative.