Patient Engagement Estimation Tool: Tackling the Early-Stage Patient Input Challenge

Medical device development teams consistently face a fundamental planning challenge: how do you determine the appropriate level and type of patient engagement required during the earliest stages of device development?  

While teams universally believe they consider the patient perspective, the reality is that systematic patient input often gets deprioritized or inadequately planned during critical early development phases. This is when foundational decisions about device concepts and features are being made. 

This widespread industry challenge prompted the formation of MDIC’s Patient Engagement in Early Phase Project Team, convened to develop approaches for incorporating patient perspectives into early development stages. The team includes medical device industry professionals, regulators from FDA, and patient advocates. 

The result of this collaborative effort is the Early Phase Patient Engagement (PE) Estimation Tool, which addresses the critical gap between good intentions and systematic implementation of patient-centered design principles.  

The tool provides a structured, 10-question needs assessment framework covering two critical early stages of the total product lifecycle: Clinical Discovery (5 questions) and Product Design (5 questions). During Clinical Discovery, the tool helps teams evaluate patient profiles, treatment gaps, patient-clinician integration, benefit-risk considerations, and effectiveness measures across the care continuum. In the Product Design stage, it assesses patient interaction expectations, patient motivation regarding device features, perceived risk levels, device novelty, and impact on quality of life. 

“I think the simplicity of this tool is crucial,” says Kori Jew, Senior Director of Enterprise Clinical Research & Medical Science at Medtronic. “Even though teams always think they consider the patient, by implementing this tool development teams take 10-15 dedicated minutes to think only about the patient in relation to the product.” 

What distinguishes this tool is its ability to generate tailored recommendations. Based on user responses, it provides graphical output indicating recommended PE intensity levels. (from “Limited PE in Product Development” to “Early and Frequent PE throughout Development”) along with specific patient-oriented research questions highlighted for each scenario.  

The tool’s strength lies in its ability to spark meaningful conversations beyond its initial assessment. As Jew explains, “It’s meant to be a simple short process, but I’m really hoping that as a team works through these questions that deeper conversations are sparked. And then – of course – they decide to go talk to patients as appropriate.” 

This systematic approach ensures that patient considerations aren’t just an afterthought but become integral to development decisions from the earliest stages, promoting patient-focused design that better meets clinical needs.