AliveCor - From Clinician to $100M MedTech Giant

In this episode of The Hardtech Podcast, hosts DeAndre Harakas and Grant Chapman sit down with Dr. David Albert; serial founder, inventor with 100+ patents, former chief scientist of GE Healthcare Cardiology, and the mind behind AliveCor's KardiaMobile, the world's first smartphone-connected FDA-cleared EKG. Dr. Albert shares how a viral YouTube video in 2010 accidentally launched AliveCor into the spotlight, attracting investors like Vinod Khosla, Qualcomm Ventures, Mayo Clinic, and GE Healthcare. He details the first-principles engineering that went into bypassing Apple's locked-down Bluetooth by transmitting EKG data ultrasonically through the iPhone's microphone, a workaround that still powers products today. The conversation covers the full spectrum of building regulated hardware at scale: bootstrapping $1M in first-year revenue by selling to veterinarians before FDA clearance, designing custom automated test equipment for overseas factories, navigating ISO 13485 and international regulatory frameworks, diversifying supply chains across Asia, and balancing two very different customer bases, direct-to-consumer wellness buyers and clinical cardiology teams. Whether you're a first-time hardware founder or deep in the regulated device world, this episode is packed with hard-won lessons on resilience, quality systems, and why the root word of hardware is hard. Topics covered: The origin story of AliveCore and the accidental viral video that started it all First-principles engineering: ultrasonic data transmission, Mophie case prototypes, and RadioShack components Guerrilla go-to-market: selling to veterinarians before FDA 510(k) clearance Scaling regulated hardware manufacturing under ISO 13485 Custom automated test equipment and supply chain diversification Navigating FDA, European MDR, cybersecurity, and AI regulations Balancing DTC consumer electronics with B2B clinical healthcare Advice for first-time founders entering regulated device spaces Special Guest: David Albert.