What does it take to turn an idea into an innovation that can be used by emergency caregivers to help patients?
In this episode of resus10, Sean Graham interviews Kathryn Janecke, senior director of regulatory, quality and clinical affairs for Stryker’s Emergency Care business unit. With a background in biochemistry, Kathryn has spent 20 years in the medical device industry, having worked on in vitro diagnostics, hematology, audiology and cardiology devices.
Kathryn discusses the often-complex journey a medical device must complete to be brought to market and how different regulatory pathways and environments help maintain a high standard of quality for these potentially lifesaving devices.