Cardiovascular Device Development: From Idea to Reality

About this episode

This episode discusses the complexities of bringing a cardiovascular device from concept to patient care, focusing on clinical trial design and execution.

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…

People in this episode

Host: Kunal Sampat

Guest: Nicole Haratani

Topics covered

• cardiovascular device development
• clinical trials
• medical device research
• regulatory collaboration
• patient recruitment

Keywords

• Class III devices
• feasibility trials
• pivotal trials
• FDA PMA process
• career advice

Mentioned in this episode

Products: Supira Medical

Books & works: the Clinical Trial Podcast

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