HeartHero Automated External Defibrillator
Elliot is an intelligent, intuitive, virtually indestructible, lightweight, affordable, and reliable AED
World’s smallest 2kV AED
Safe for consumer use
Won 6 design awards
BlackHägen Design (BH) has presented a proposal summary for HeartHero/EIR, Inc., detailing the development of their consumer-focused portable Automated External Defibrillator (AED). Building on HeartHero’s feasibility prototype, BH aims to create a commercial device that meets stringent market requirements, including compact dimensions (5x3x1 inches), lightweight construction (1 lb), rapid charge time (60 seconds), and a cost of goods of $200. The project is structured into five key phases—Project Planning, Conceptual Design, System Design, Alpha Prototype Development, Beta Prototype Development, and V&V Support/Agency Submission—ensuring alignment with regulatory standards (ISO 13485, 21CFR 820) and user needs. BH will conduct design optimization, component sourcing, and usability testing, while collaborating with third-party experts and adhering to a Time & Materials framework to refine the AED’s performance and compliance for a timely FDA submission.
•Compact, Affordable AED Development: BH will design a portable AED for HeartHero, meeting market demands for a 5x3x1-inch, 1 lb device with a $200 cost of goods and 60-second charge time.
•Phased Approach with Regulatory Compliance: The project spans five development phases, focusing on system design, usability testing, and FDA submission while adhering to ISO 13485 and 21CFR 820 standards.
•Collaborative and Flexible Execution: BH will work with third-party experts and HeartHero to optimize design tradeoffs, leveraging a Time & Materials framework for adaptable progress at key Stage-Gates.
Commercial Design Development
• Advance proof-of-concept H-bridge electronic design for a miniaturized design
• Conduct human factors research on consumer-based AED user-needs
• Develop feasibility brassboards for a 2000V, 165J, 30 second recharge time system design architecture
• Develop industrial design for a minimum footprint design
• Create super-backlit and verbal UI for guided use instructions
• Optimize DfX with molding suppliers and global CMOs
• Collaborate with electrode manufacturer to create most compact, fast-deploying setup solution
• Commercial design won 6 design awards prior to launch
