S1E76 - Building Medical Devices Right the First Time with Helen Souris | Ep 76
Published: July 10, 2026
Duration: 31:22
Bringing an innovative medical device to market takes far more than a great idea. It requires regulatory strategy, cybersecurity, quality systems, and commercial planning from the very beginning.
In this episode of the Med Device Cyber Podcast, Christian Espinosa is joined by Helen Souris, CEO of CardiHab and Board Member of the Medical Technology Association of Australia (MTAA), to discuss why so many promising digital health companies struggle when they leave the startup phase and enter the realities of regulation.
Helen shares her experience leading a digital therapeutics company, raising investment in Australia, navigating software...