Bringing a high-risk cardiovascular device from concept to patient care requires more than innovation - it requires carefully designed clinical trials, strong operational execution, and close collaboration with regulators and physician investigators.

In this episode of the Clinical Trial Podcast, Kunal Sampat speaks with Nicole Haratani about how cardiovascular device clinical trials are actually designed and run. Nicole is Vice President of Clinical Affairs at Supira Medical and has spent more than two decades working in medical device clinical research, particularly in cardiovascular technologies.

Nicole shares insights from her experience leading clinical and regulatory programs across feasibility and pivotal trials, and explains the operational realities behind Class III device studies.

In this episode, we discuss:

• How cardiovascular devices move from concept to clinical trials
• Designing feasibility and pivotal trials for Class III devices
• How inclusion and exclusion criteria are developed
• Challenges in patient recruitment for cardiovascular studies
• Collaborating with key opinion leaders and investigators
• Working with the FDA during the PMA process
• Career advice for professionals interested in medical device clinical research

If you're interested in cardiovascular device development, clinical trial operations, or building a career in medical device research, this episode provides a practical look at how complex device trials are executed.