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

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. ​ 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/ Tune in and subscribe to DeviceTalks on all major podcast channels and follow youtube.com/@DeviceTalks to ensure you never miss an episode. Thank you for listening to MedtechWOMEN Talks!

Om Podcasten

The DeviceTalks Podcast Network is the ultimate destination for all things #MedTech. By subscribing to this single feed, you’ll gain access to every podcast in our diverse and growing portfolio—more than a dozen unique shows featuring senior leaders, groundbreaking technology insights, and in-depth discussions on the most important topics in the medical device industry. Each episode dives deep into critical areas like business strategy, market trends, surgical robotics, orthopedics, structural heart, neurology, and beyond. You’ll hear from leading voices at top companies—ranging from major OEMs to innovative startups—sharing their solutions, stories, and strategies for tackling the industry’s biggest challenges. Our Lineup of Shows Includes: • DeviceTalks Weekly • AbbottTalks • Boston Scientific Talks • DeviceTalks AI • IntuitiveTalks • MedtechWOMEN Talks • MedtronicTalks • Neuro Innovation Talks: J&J MedTech Neurovascular • Structural Heart Talks: Edwards Lifesciences • Ortho Innovation Talks: Enovis & Zimmer Biomet • StrykerTalks Why Subscribe? Subscribing here means you’ll never miss an update from any of our shows. Whether you want a broad overview of the entire industry or prefer to tune into a specific series, this single feed has you covered. If you discover a favorite topic, you can always subscribe to that individual show’s feed for a more tailored experience. Meet Your Hosts: • Tom Salemi, Editorial Director, DeviceTalks • Kayleen Brown, Managing Editor, DeviceTalks #DeviceTalks, Where Device Makers Connect.