Cardiovascular Device Development: From Idea to Reality with Nicole Haratani

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.

Connect with Nicole Haratani

Company: Supira Medical

Selected Links from the Episode:

1. Regulatory Affairs Professionals Society (RAPS)
2. Regulatory Affairs Certification (RAC) 
3. FDA Premarket Approval (PMA) Overview 
4. FDA PMA Database 
5. FDA Q-Submission Program Guidance (Pre-Sub / Q-Sub) 
6. FDA Investigational Device Exemption (IDE) Overview 
7. FDA IDE Application (Sponsor Instructions) 
8. FDA IDE Approval Process 
9. FDA Early Feasibility Studies (EFS) Program 
10. FDA Guidance: IDEs for Early Feasibility (FIH) Studies 
11. FDA Guidance: Use of Data Monitoring Committees (DMC/DSMB) 
12. 21 CFR Part 814 (PMA Regulations) 
13. 21 CFR Part 58 (Good Laboratory Practice / GLP) 
14. EU Medical Device Regulation (MDR) 2017/745 (EUR-Lex) 
15. ISO 13485 Overview (Medical Devices QMS) 
16. BSI ISO 13485 Training Courses 
17. Medical Device Innovation Consortium (MDIC) 
18. Cardiovascular Research Foundation (CRF) 
19. TCT Conference (Transcatheter Cardiovascular Therapeutics) 
20. TCTMD (Interventional cardiology news and education) 
21. UCSC Extension: Clinical Trials Design and Management Certificate 
22. Abbott: St. Jude Medical is now Abbott 

   Books:

• “Lean In: Women, Work, and the Will to Lead” by Sheryl Sandberg (Amazon, Barnes & Noble)
• “The Alter Ego Effect” by Todd Herman (Amazon, Barnes & Noble)
• “A Hope More Powerful Than the Sea” by Melissa Fleming (Amazon)

Show Notes

[0:00] Podcast Intro

• The Clinical Trial Podcast opens with the show’s mission and intro.

[0:20] Episode Overview + Guest Introduction

• Kunal previews a deep dive into cardiovascular device development and what it takes to bring a high-risk Class III device to market.
• Nicole’s experience spans first-in-human through pivotal randomized trials and PMA strategy.

[2:11] Welcome + Setting the Conversation Arc

• Kunal welcomes Nicole and frames the interview around career growth and practical clinical affairs insights.

[3:11] Nicole’s Career Journey: ICU Nurse to Clinical Research Leader

• Nicole shares her background as an ICU cardiac surgery nurse and her early clinical practice experience.
• Transition to the U.S. and the shift from bedside nursing into clinical research.
• First industry role at St. Jude Medical; learning IRB/ICF concepts and wearing multiple hats.
• Formal learning: clinical trials design/management coursework to build foundational knowledge.

[11:40] Continuous Learning Mindset + Regulatory Exposure

• Recurring theme: staying curious and treating your career as continuous learning.
• Discussion touches on the rigor of RAC-style learning and the value of structured study.

[12:56] Learning Ecosystems: Internal Programs + CRF Exposure

• Internal education models (e.g., lunchtime physician talks, anatomy/case reviews) can accelerate cross-functional learning.
• Exposure to academic-style discussions and program design through organizations like CRF.
• Value of being in the room where physicians debate clinical strategy and trial design.

[17:18] Building Teams and Developing Leaders

• Transition from career story into people leadership and motivating teams.
• The importance of balancing business milestones with quality and sustainable execution.

[17:53] Motivating Teams: Work Hard, Play Hard + Recognition

• Nicole shares practical leadership tactics: team-building cadence, celebrating milestones, and creating connection.
• Recognition matters: thank-you notes, small gestures, and consistent appreciation.
• COVID/remote work increased the need for intentional relationship-building.

[20:02] Transition to Device Development from Concept to Market

• Kunal bridges from leadership tactics into the idea to reality device development pathway.

[21:05] The Cardiovascular Device Lifecycle: Concept  Preclinical Clinical Market

• Starts with a back-of-the-napkin idea, prototypes, and user feedback loops.
• Bench testing evolves prototypes; animal studies follow (GLP vs non-GLP considerations).
• Early interaction with FDA is critical before first-in-human.
• First-in-human informs feasibility, which informs pivotal study design.
• Post-market data collection supports ongoing safety and possible indication expansion.
• Emphasis on cross-functional handoffs across R&D, manufacturing, clinical, quality, and regulatory.

[28:58] Designing Pivotal Trials: Integrity, Safety, and Endpoints

• What changes as programs scale: more sites, more patients, more scrutiny.
• The role of blinding/randomization and protecting scientific integrity.
• Aligning endpoints with the therapy area and regulatory expectations.

[32:26] Independent Safety Oversight: DSMB / Safety Committees

• Independence is non-negotiable for bias mitigation.
• Options: manage internally with qualified safety PMs vs outsource to a CRO/third party.
• Practical considerations: infrastructure, meeting logistics, quorum, and protocol comprehension.

[33:50] Inclusion/Exclusion Criteria: How it Evolves from FIH to PMA

• Pivotal trials should reflect intended use and eventual labeling/contraindications.
• First-in-human aims to reduce noise (confounding comorbidities) to understand device signal.
• Criteria broaden over time as safety/learning increases.
• FDA may push sponsors to reduce excessive exclusion criteria to support real-world usability.

[41:17] Protocol Feasibility: Study Coordinator Reality Check + Stakeholder Alignment

• Protocol feasibility is shaped by sites, coordinators, PIs, CROs, legal, and FDA requirements.
• Coordinators often identify workflow issues that aren’t obvious in sponsor-only planning.
• MDIC workshop-style collaboration can surface practical barriers especially for early feasibility studies.

[44:22] Keeping Criteria Broad Without Compromising Safety or Endpoints

• Decision rule: include patients unless it harms safety or undermines endpoint interpretability.
• Balance: market access and practical labeling vs scientific clarity and risk mitigation.

[46:17] Recruitment and Retention in Cardiovascular Device Studies

• Proactive planning for enrollment challenges is critical.
• Patient-facing materials and outreach strategies must align with IRB requirements.
• Levers include physician-to-physician education, coordinator working sessions, and regular enrollment problem-solving.
• Recognize different barriers for PIs vs coordinators (patients vs resources/tools).

[50:00] Working with KOLs: Transparency, Expectations, and Partnership

• KOL engagement works best when sponsors are transparent about timelines, resources, and constraints (e.g., burn rate realities).
• Collaboration is easier when the sponsor understands hospital culture and clinician workflows.

[1:03:22] Publications: Avoid Conflict by Planning Early

• Establish a publication committee early before the study ends.
• Set rules/expectations for authorship and topics up front; build a publication plan.
• Include biostatistics and key stakeholders to reduce end-of-study disputes.

[1:16:07] How Cardiovascular Tech has Evolved (TAVI, pVAD, and Rapid Innovation)

• Reflections on innovation cycles and how therapies evolve quickly.
• EU MDR initially created hesitation, but teams adapt and normalize new regulatory expectations.
• Nicole shares why cardiovascular continues to be a constant learning field.

[1:18:25] AI Tools for Clinical Trial Project Management

• AI-driven PM tools are emerging to automate matrices, updates, and cross-system tracking.
• Framing: AI as a tool to support teams, not replace them.

[1:19:29] Global Trial Strategy: One Protocol vs Fragmented Studies

• Preferred approach: one global study/protocol where possible.
• Warning: country-by-country protocols add cost, complexity, and operational risk.
• Consider sequencing approvals and timelines (US vs EU) with a clear business forecast.

[1:22:42] Training and Certifications: Practical Learning Paths

• Discussion of quality-focused training (e.g., ISO-related courses) and using education to strengthen execution.
• Emphasis on learning what’s needed for your role and staying current without burning out.

[1:25:34] Continuous Learning (even without maintaining every credential)

• Nicole shares why she focused on selective learning vs maintaining every certification indefinitely.
• Curiosity-driven learning: reading and digging into unfamiliar topics as they arise.

[1:28:13] Books and Closing Reflections: Resilience and Determination

• Nicole shares books that shaped her thinking on resilience and perseverance.
• Lean In (Sheryl Sandberg) and A Hope More Powerful Than the Sea (Melissa Fleming) are highlighted.
• Closing encouragement: growth comes from persistence, clarity of purpose, and belief that you can get there.

Major Themes

• Continuous learning as a career strategy: using structured education, curiosity, and feedback loops to grow from clinical roles into executive leadership.
• The end-to-end device development pathway: moving from concept and preclinical work into FIH, feasibility, pivotal trials, PMA, and post-market learning.
• Collaboration and governance: aligning FDA/regulatory strategy, KOL engagement, safety oversight (DSMB), publications planning, and global execution.

Selected Quotes

• “Work hard, play hard.”
• “Transparency is the key.”
• “It starts as a back-of-the-napkin concept.”

Audience Question

Have you been involved in cardiovascular device clinical trials? What part of cardiovascular device development do you find most challenging”early feasibility, pivotal trial design, safety oversight, or global execution” and why?