User Needs List

​

Summary

The User Needs List captures what your users expect and require from your medical device, serving as the foundational document that drives all design decisions, requirements development, risk management activities, and validation testing throughout your device development process.

​

Why is a User Needs List Important?

A comprehensive User Needs List provides the regulatory foundation for medical device development by establishing clear user expectations before design begins. Without well-documented user needs, development becomes unfocused and reactive, leading to feature creep, missed requirements, and validation failures that can prevent regulatory approval and market success.

This document transforms abstract user expectations into concrete development inputs that guide every subsequent design decision. It establishes the basis for requirements traceability, ensuring that every system requirement, software feature, and risk control can be traced back to a specific user need. This traceability is essential for demonstrating regulatory compliance and design rationale.

For medical device development, user needs serve as your design compass by defining what success looks like from the user’s perspective. They prevent over-engineering by focusing development efforts on features that truly matter to users while ensuring safety and effectiveness requirements are captured early. The document also provides the foundation for validation activities that demonstrate your device meets its intended use.

​

Regulatory Context

​

Guide

Your User Needs List must comprehensively capture what users expect from your device while providing clear guidance for all subsequent development activities.

​

User Research and Stakeholder Input

Begin with comprehensive user research to understand the problems your device should solve. Conduct interviews with intended users including clinicians, patients, caregivers, and technical staff. Observe current workflows and identify pain points, inefficiencies, and unmet needs. Review complaints about existing devices and analyze competitive products for insights.

Engage multiple stakeholder groups throughout the research process. Primary users directly interact with your device and have functional needs. Secondary users may be affected by device use and have different requirements. Technical stakeholders understand integration requirements and system constraints. Regulatory and quality teams provide compliance perspectives.

​

User Needs Development

Write high-level statements that describe what users expect from your device without specifying how those needs will be met. Focus on user outcomes rather than technical solutions. Each user need should be clear, measurable, and focused on the user’s perspective rather than internal technical requirements.

Structure user needs to be solution-neutral and broad enough to accommodate future design changes while specific enough to guide development decisions. Avoid technical implementation details or specific feature descriptions. Instead, focus on the fundamental problems users need solved and the outcomes they expect to achieve.

​

Categorization and Organization

Organize user needs into logical categories that reflect different aspects of device use. Common categories include:

• Functional needs: What the device must do or accomplish
• Performance needs: How well the device must perform its functions
• Usability needs: How easy and intuitive the device must be to use
• Safety needs: How the device must protect users from harm
• Compatibility needs: How the device must work with other systems
• Environmental needs: How the device must perform in its use environment

Assign unique identifiers to each user need using a consistent format (e.g., UN001, UN002) that supports traceability throughout development. Include priority levels or criticality ratings to help guide design trade-off decisions when resources are limited.

​

Essential vs. Product-Specific Needs

Distinguish between essential user needs that apply to all devices of your type and product-specific needs unique to your particular device. Essential needs often relate to basic safety, regulatory compliance, and fundamental usability requirements that any device in your category must meet.

Product-specific needs reflect the unique value proposition of your device and the specific problems it solves differently than existing solutions. These needs drive innovation and differentiation while ensuring your device provides meaningful benefits to users.

​

Validation and Review

Establish review processes to ensure user needs are complete, accurate, and achievable. Involve multidisciplinary teams including clinical, technical, quality, and regulatory representatives. Review user needs against intended use statements and ensure consistency with regulatory requirements.

Plan for user needs validation through appropriate methods such as user interviews, surveys, usability testing, or clinical evaluation. Validation should confirm that identified needs accurately reflect user expectations and that meeting these needs will result in a successful device.

​

Traceability and Change Management

Implement traceability systems that link each user need to derived system requirements, software requirements, risk controls, and verification activities. This traceability demonstrates that all user needs are addressed in your design and that all requirements serve a user purpose.

Establish change control procedures for user needs updates throughout development. Changes may be driven by new user research, regulatory feedback, or design discoveries. Document the rationale for changes and assess their impact on derived requirements and verification activities.

​

Documentation Standards

Document user needs in a structured format that supports regulatory review and team communication. Include sufficient detail for team members to understand user expectations while maintaining solution neutrality. Provide context about user environments and constraints that influence how needs should be met.

Ensure documentation quality through clear writing, consistent terminology, and logical organization. User needs should be understandable to both technical and non-technical stakeholders while providing sufficient detail to guide design decisions.

​

Example

Scenario: You’re developing a wearable stress monitoring device that helps office workers understand and manage their stress levels throughout the workday. The device collects physiological data and provides personalized recommendations through a mobile app. Users include busy professionals who want objective stress insights without disrupting their workflow.

​

User Needs List

ID: UNL-StressWear-2024-001

Device: StressWear Stress Monitoring System

Purpose: To provide office workers with objective stress monitoring and personalized stress management recommendations through a comfortable wearable device and intuitive mobile application.

User Needs:

Expected Lifetime: 5 years

Regulatory References:

• EU MDR 2017/745
• ISO 13485:2016 - Medical devices Quality management systems Requirements for regulatory purposes
• IEC 62366-1:2015 - Medical devices Part 1: Application of usability engineering to medical devices

Mapping to Standards:

​

Q&A