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MedTech Case Study: Engineering Defibrio’s Smartphone-Powered AED

Sudden cardiac arrest (SCA) requires immediate intervention, yet traditional automated external defibrillators (AEDs) are often inaccessible when needed most. Defibrio developed the world’s first smartphone-powered AED to address this gap, integrating defibrillation technology with mobile accessibility.

Developing this device required multidisciplinary engineering, regulatory compliance, and strategic collaboration. Andrews Cooper (AC) designed key innovations in energy conversion, heart rhythm detection, and ruggedization, conducting extensive testing and iteration while developing hundreds of test protocols for third-party validation. A coordinated network of industry partners contributed expertise in UX design, supply chain and manufacturing readiness, and MedTech regulatory compliance to bring the AED from concept to production.

The result is a regulatory-compliant, scalable medical device designed for FDA Class III and EU MDR approval, balancing technological innovation with real-world feasibility.

Download the case study for the full engineering journey and the collaborative approach behind the Defibrio AED.

ENGINEERING DEFIBRIO’S LIFE-SAVING INNOVATION

✅ Low-Power Conversion
✅ Real-Time Heart Rhythm Recognition
✅ Affordable Ruggedization
✅ Supply Chain and Manufacturing
✅ Transformative UX Mobile App
✅ For FDA Class III and EU MDR Standards
Download Case Study

Engineer the Impossible in HardTech

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Power conversion & energy transfer
Extracting sufficient energy from a smartphone battery for a high-voltage defibrillation shock.
Rhythm recognition algorithm
Ensuring real-time, clinically validated heart rhythm detection.
Ruggedization & usability
Balancing durability and portability while maintaining ease of use for non-expert responders.
Manufacturing & supply chain readiness
Securing scalable production through early supply chain integration and contract manufacturer selection.
Regulatory compliance
Developing extensive test protocols and documentation to meet FDA Class III and EU MDR standards for a smooth path to market approval.
Motiv
Motiv refined the form factor and user experience to ensure the device was intuitive for non-expert responders.
Visit Motiv
Rightpoint
Rightpoint developed a seamless mobile interface to guide users through each critical step.
Visit Rightpoint
OnTap Consulting
OnTap Consulting optimized the supply chain and contract manufacturing strategy, ensuring scalable production.
Visit OnTap Consulting
RQMIS
RQMIS provided regulatory expertise, aligning the AED with FDA Class III and EU MDR requirements.
Visit RQMIS

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