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!