Patient Engagement Estimation Tool and User Guide
Accelerate Innovative Medical Technology Through Early Patient Insight
Early-stage device teams face a recurring challenge: how to appropriately scope the level and type of patient engagement needed during discovery and design. Without a structured approach, engagement efforts can be ad hoc, misaligned, or left out entirely. Missing critical patient insights can influence usability and safety factors which ultimately define product direction.
The Patient Engagment (PE) Estimation Tool addresses this problem head-on. It provides an interactive, rapid assessment to help developers size and justify early patient engagement efforts. The Tool helps developers ensure product decisions are grounded in real patient priorities, not assumptions.
Developed by MDIC’s Center for Evidence & Patient Engagement and the Early-Phase Patient Engagement Working Group, this tool offers a first-of-its-kind roadmap tailored to the two key stages of early device development:
- Clinical Discovery: Where the target population and unmet need are known, but the device concept is still forming
- Product Design: Where a concept exists, and engagement is needed to inform usability, safety, and preference-sensitive features
By supporting patient-focused decision-making before clinical trials begin, the tool helps teams integrate meaningful patient input earlier. This aims to result in driving smarter development, regulatory alignment, and better outcomes throughout the product lifecycle.
What the PE Estimation Tool Offers for MedTech Developers
This resource, developed by the Medical Device Innovation Consortium (MDIC) and its Patient Engagement in Early Phase working group, introduces an Early Phase Patient Engagement (PE) Estimation Tool. It includes:
- 10-question needs assessment covering two key stages: Clinical Discovery and Product Design (five questions each).
- Three-point scoring scale with clear descriptors for every question, making completion fast and repeatable.
- Automatic graphical output that recommends a fit-for-purpose level of patient-engagement intensity and surfaces tailored research considerations.
- Benchmark library of Patient-Oriented Research Questions to guide deeper exploration as the product matures.
- Built in Microsoft Excel for easy integration into existing development workflows.
This Tool is designed for a wide range of stakeholders across MedTech, including:
- R&D Teams
- Product Development Teams
- Upstream Marketing, Product Managers
- Clinical Affairs Teams
- Design Engineers and UI/UX Designers
- Human Factors Researchers
- Patient Preference Researchers
- Regulatory & Strategy Teams
- Physicians and Caregivers
- Patient Engagement Teams
Whether you’re vetting an unmet clinical need or fine-tuning a device concept, the tool provides a roadmap for embedding patient voice early. It aims to de-risk downstream development and align early development with regulatory guidelines.
Overview and User Guide
MDIC has created an overview and user guide to help medical device manufacturers use the PE Estimation Tool. The accompanying user guide provides step-by-step instructions on how to assess development phase, complete the scoring inputs, interpret results, and iterate based on new insights. While the tool is not intended to replace a comprehensive patient engagement strategy, it offers a structured approach for integrating patient input into upstream decision-making. By aligning product development with real patient needs from the outset, the PE Estimation Tool supports smarter, more patient-centered innovation across the medical device total product lifecycle.