Evaluating Connected Injectable Device Adoption in Phase II Clinical Trials

Overview

A global medical device company partnered with Phronesis Partners to evaluate the opportunities and challenges associated with adopting connected injectable devices in clinical trials, with particular focus on Phase II studies.

The company needed to understand how pharmaceutical sponsors and CRO professionals viewed connected devices in order to inform its product and go-to-market strategy.

Objective

Their primary objectives were to:

• Assess the value connected injectable devices offer pharmaceutical sponsors
• Understand the specific challenges tied to their use in Phase II trials
• Identify the key considerations device manufacturers need to prioritize

Approach

Phronesis Partners employed a structured methodology to meet the client's objectives:

• Stakeholder Interviews: Conducted seven in-depth interviews with pharmaceutical sponsors and CRO professionals with direct expertise in decentralized clinical trials and connected device integration
• Interview Design: Structured discussions around the current landscape of decentralized trials, adoption drivers, data requirements, and device selection criteria for Phase II studies
• Data Analysis: Applied coding and thematic analysis to identify common themes and patterns across interviews

Business Outcome

The research gave the medical device company a clearer view of where connected injectable devices create value and where they still face real constraints:

• Validated that connected devices can ease patient compliance and enable trial participation from home, supporting reduced trial costs
• Clarified that patient safety and safety-related data collection remain key considerations in Phase II trials, where automatic data collection may not be feasible
• Confirmed that device-generated data offers real-time, high-quality information, strengthening the evidence package for drug submissions
• These findings pointed device manufacturers toward building simple, flexible devices that work across multiple therapy areas, supported by adequate training and shaped by patient input