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Summary

User needs define 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. These documented needs ensure regulatory traceability and prevent costly redesigns by establishing clear user expectations before development begins.

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Regulatory Context

Under 21 CFR Part 820.30 (Design Controls), the FDA requires:
  • Documented user needs as design inputs establishing device requirements
  • Traceability from user needs through design requirements to verification and validation
  • Design review of user needs to ensure completeness and accuracy
  • User needs validation through clinical evaluation or usability testing
  • Change control for user needs updates throughout development
Standards applicable:
  • FDA Human Factors Guidance - Use-related risk analysis and usability engineering
  • IEC 62366-1:2015 - Usability engineering for medical devices
  • ISO 14971:2019 - Application of risk management to medical devices
  • ISO 13485:2016 - Medical devices quality management systems
Special attention required for:
  • Software as Medical Device (SaMD) user needs must address clinical workflow integration and decision-making support
  • Combination devices require user needs for both hardware and software components with clear interfaces
  • Cybersecurity considerations must be reflected in user needs for connected devices
  • Usability engineering per FDA Human Factors guidance requires user needs to address use-related risks

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Overview

User needs serve as the foundational cornerstone of medical device development by capturing what users truly expect and require from your device before any design decisions are made. This critical documentation transforms abstract user expectations into concrete development inputs that guide every subsequent design decision throughout your product lifecycle. The User Needs List represents your comprehensive capture of user expectations across all stakeholder groups including primary users, secondary users, technical staff, and regulatory considerations. This document establishes the basis for requirements traceability by ensuring every system requirement, software feature, and risk control can be traced back to a specific user need. The list must be solution-neutral and broad enough to accommodate future design changes while remaining specific enough to guide meaningful development decisions. Effective user needs development requires comprehensive user research involving interviews with intended users, observation of current workflows, and analysis of pain points and inefficiencies in existing solutions. This research must engage multiple stakeholder groups to understand different perspectives on device use including functional needs, performance expectations, usability requirements, safety considerations, and environmental constraints. The documentation distinguishes between essential user needs that apply to all devices in your category and product-specific needs that reflect your device’s unique value proposition. Essential needs often relate to basic safety, regulatory compliance, and fundamental usability requirements, while product-specific needs drive innovation and differentiation by addressing the unique problems your device solves. User needs establish the validation foundation for your entire development process 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 documented needs also provide the foundation for validation activities that demonstrate your device meets its intended use through appropriate testing methods. Throughout development, user needs require ongoing maintenance and validation through methods such as user interviews, usability testing, clinical evaluation, or pilot studies. Change control procedures must assess the impact of user needs updates on derived requirements, design decisions, and verification activities while maintaining traceability throughout the development process. The comprehensive user needs documentation serves as your design compass throughout development while providing regulatory authorities with clear evidence that your device development is grounded in real user requirements and validated through appropriate methods. This systematic approach to user needs development ensures your device development remains focused on solving meaningful user problems while maintaining regulatory compliance and market relevance.