In this episode of MedtechWOMEN Talks, Christina Hawley, Sr. Director, of Clinical Operations at May Health helps to unravel the clinical trial process for medical devices, emphasizing the non-linear path from early feasibility to pivotal trials and post-market studies; and delves into the meticulous process of gaining FDA approval and even the nuanced differences between clinical affairs and regulatory affairs.
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TL;DR – Key takeaways:
- Close collaboration with cross-functional teams, including R&D, regulatory, quality, and marketing, is key to the success of clinical trials.
- Clinical trials must consider the specific regulatory requirements of the targeted geographical markets.
- There is no standardized approach to any of the different clinical trials, each must 

Tune in to gain insights into the complex and surprisingly creative world of clinical research in the medical device industry.

Thank you to our season one sponsors Aptyx, Catalyze Healthcare, Confluent Medical Technologies, and Cretex Medical!
https://aptyx.com/ 
https://catalyzehealthcare.com/ 
https://confluentmedical.com/
https://www.cretex.com/

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How do I navigate the clinical affairs process effectively? with Christina Hawley, May Health

In this episode of AbbottTalks, Sandra Lesenfants, SVP of Abbott’s structural heart business, discusses the latest advancements in structural heart care, focusing on Abbott's transformative TriClip device for tricuspid regurgitation.

Lesenfants highlights Abbott’s commitment to patient-centered innovation, emphasizing the importance of creating solutions that meet patients’ needs through safe and effective technologies. She also shares Abbott’s approach to expanding access to minimally invasive therapies, particularly in underserved populations worldwide, and the role of physician partnerships in advancing structural heart interventions.

Lastly, Lesenfants underscores the company’s efforts to increase diversity in clinical trials, noting the importance of intentional inclusivity across gender and ethnicity to better serve diverse patient populations.

Thank you to Confluent Medical Technologies for sponsoring this episode of AbbottTalks. For more information on how Confluent Medical works with medical device companies, visit https://confluentmedical.com/.

Thank you for listening to the AbbottTalks Podcast. Tune in and subscribe to DeviceTalks on all major podcast channels to never miss an episode.

Abbott’s Lesenfants shares TriClip progress, patient-centered innovation & clinical trial diversity

The DeviceTalks Podcast Network delivers news, insights and commentary from MedTech industry leaders, primarily from the largest OEMs in healthcare. Our podcasts will inspire MedTech professionals to create better MedTech devices and companies.

Explore the DeviceTalks Podcast Network, home to more than 11 podcasts:

• DeviceTalks Weekly
• AbbottTalks
• Boston Scientific Talks
• DeviceTalks AI
• IntuitiveTalks
• MedtechWOMEN Talks
• MedtronicTalks
• Neuro Innovation Talks: J&J MedTech Neuro
• Structural Heart Talks: Edwards Lifesciences
• Ortho Innovation Talks: Zimmer Biomet
• StrykerTalks

WATCH our video podcasts on www.youtube.com/@DeviceTalks

Connect with the hosts:
Tom Salemi, Editorial Director, DeviceTalks https://www.linkedin.com/in/tom-salemi-7118948/
Kayleen Brown, Managing Editor, DeviceTalks https://www.linkedin.com/in/kayleenbrown/

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How do I navigate the clinical affairs process effectively? with Christina Hawley, May Health

DeviceTalks

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