Cardiovascular Device Development: From Idea to Reality with Nicole Haratani

Описание: Cardiovascular devices are some of the most complex and high-risk products developed in healthcare. Bringing one from concept to patient care requires careful clinical trial design, strong operational execution, and close collaboration with regulators and physician investigators.

In this episode, Nicole Haratani shares how cardiovascular device trials are actually designed and executed. Nicole is Vice President of Clinical Affairs at Supira Medical and has spent more than two decades working in clinical research for medical devices, particularly in cardiovascular technologies.

We discuss how Class III device trials move from feasibility studies to pivotal trials, how inclusion and exclusion criteria are developed, and the operational challenges of enrolling and managing patients in complex cardiovascular studies. Nicole also shares practical advice for professionals interested in building a career in medical device clinical research.

Resources Mentioned:
Guest Name: Nicole Haratani (  / nicoleharatani  )
Guest Organization: Supira Medical (https://supiramedical.com)

Clinical Trial Podcast Show Notes: (https://clinicaltrialpodcast.com/card...)

Podcast Links:
Spotify: (https://open.spotify.com/episode/1LrV...)
Apple Podcast: (https://podcasts.apple.com/us/podcast...)
Pocket Cast: (https://pca.st/xfo6q06i)
Overcast: (https://overcast.fm/+J1T90304w)

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Show Notes:
0:00 Podcast Intro
0:20 Episode Overview + Guest Introduction
2:11 Welcome + Setting the Conversation Arc
3:11 Nicole's Career Journey: ICU Nurse to Clinical Research Leader
11:40 Continuous Learning Mindset + Regulatory Exposure
12:56 Learning Ecosystems: Internal Programs + CRF Exposure
17:18 Building Teams and Developing Leaders
17:53 Motivating Teams: Work Hard, Play Hard + Recognition
20:02 Transition to Device Development from Concept to Market
21:05 The Cardiovascular Device Lifecycle: Concept Preclinical Clinical Market
28:58 Designing Pivotal Trials: Integrity, Safety, and Endpoints
32:26 Independent Safety Oversight: DSMB / Safety Committees
33:50 Inclusion/Exclusion Criteria: How it Evolves from FIH to PMA
41:17 Protocol Feasibility: Study Coordinator Reality Check + Stakeholder Alignment
44:22 Keeping Criteria Broad Without Compromising Safety or Endpoints
46:17 Recruitment and Retention in Cardiovascular Device Studies
50:00 Working with KOLs: Transparency, Expectations, and Partnership
1:03:22 Publications: Avoid Conflict by Planning Early
1:16:07 How Cardiovascular Tech has Evolved (TAVI, pVAD, and Rapid Innovation)
1:18:25 AI Tools for Clinical Trial Project Management
1:19:29 Global Trial Strategy: One Protocol vs Fragmented Studies
1:22:42 Training and Certifications: Practical Learning Paths
1:25:34 Continuous Learning (even without maintaining every credential)
1:28:13 Books and Closing Reflections: Resilience and Determination

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