Design Principles

Introduction

The enMedD Design System is a comprehensive library designed for creating consistent, modern, and intuitive user interfaces for Digital Health Solutions, including Software as a Medical Device (SaMD) and Medical Device Software (MDSW). It ensures compliance with IEC 62366, W3C Accessibility, and FDA Human-Factor Guidelines, consolidating thousands of symbols into a validated library.

Key Features

• Unified Experience: Designed for both UX designers and developers.
• Validated Against Standards: Compliant with IEC 62366, W3C Accessibility, and FDA Human-Factor Guidelines.
• Comprehensive Library: Includes design kits, templates, and UI patterns for SaMDs and MDSWs.

Core Design Principle

1. Mitigate risk to Patient Life and Reduce Medical Errors

• Life-centric compliance - Ensure that enMedD Design System upholds to the standards that specifically address and mitigate the risks associated with patient mortality. Prioritize features and components that contribute directly to patient safety and survival.
• Error-Reduction Design - Develop user interfaces and interaction that are specifically tailored to minimize the risk of healthcare professional errors that could lead to patient harm and fatality. Incorporate fail-safes, alerts, guides, and intuitive navigation to support decision-making in critical care scenarios.

2. Primary Focus: Patient Safety and Quality of Care

• Patient Safety Assurance - Patient safety is the core of our design philosophy by creating solutions that prioritize clear communication, error prevention, and rapid access to essential functions in life-critical situations.
• Security as Patient Protection - Enforce robust security measures within the design system to protect patient data as means of safeguarding their well-being, recognizing that breaches can lead to life-threatening situations.

3. Secondary Focus: Healthcare Professional Support

• Empowerment through accuracy - Empower Health-care professionals with tools that enhance precision in medical practice, reducing the likelihood of errors that could compromise patient safety or lead to fatality.
• Guide Usage for Risk Mitigation - Provide comprehensive guidelines and usage patterns within the design system to ensure healthcare professionals can leverage the tools effectively, fully, and reducing the cognitive load and potential for mistakes in high-stake environments.

General Principles

• Risk-Focused Iteration - Commit to an iterative design process that prioritizes the identification and mitigation of risks associated with patient mortality, continuously refining components to enhance safety outcomes.
• Transparent Validation for Life Preservation - Maintain transparent validation processes for all components, patterns, and design tokens, ensuring that each has been rigorously tested for scenarios that could impact the patient's survival, with a clear record of provenance.
• Proactive Component Libraries - Develop a compliant design system library that proactively address common and risk related to patient care, ensuring that device manufacturers can integrate these life-saving tools seamlessly into their products.
• Collaborative Risk Management - Build a community around enMedD Design System that actively engage in identifying potential risks to patients and healthcare professionals, fostering environment of collective responsibility of preventing fatalities through design.