Go offline with the Player FM app!
104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew
Manage episode 378056399 series 3325357
On this episode, I was joined by Sara Waxberg MacNew, Chief Scientific Officer at Design Sciences. On this episode Sara and I discuss:
- New FDA Guidance:
- Critical Task Definition for Combination Products
- Pre-Clinical HF Studies in readiness for IND Submission
- URRA
- Human Factors Validation vs. Design Validation
Sara Waxberg McNew is the Chief Scientific Officer at Design Science, a human factors firm that specializes in healthcare. Sara has held roles previously in user centered design leadership at Eli Lilly, Philips Healthcare, and Baxter Healthcare. She is an active member of AAMI where she has contributed to the development and revision of human factors technical information reports and international standards. Learn more about Design Science's impact on Healthcare Technology by following @designscience on all social media platforms.
159 episodes
104 -New FDA Guidance, HF vs. Design Validation, Critical Tasks & Pre-IND HF Studies with Sara McNew
Manage episode 378056399 series 3325357
On this episode, I was joined by Sara Waxberg MacNew, Chief Scientific Officer at Design Sciences. On this episode Sara and I discuss:
- New FDA Guidance:
- Critical Task Definition for Combination Products
- Pre-Clinical HF Studies in readiness for IND Submission
- URRA
- Human Factors Validation vs. Design Validation
Sara Waxberg McNew is the Chief Scientific Officer at Design Science, a human factors firm that specializes in healthcare. Sara has held roles previously in user centered design leadership at Eli Lilly, Philips Healthcare, and Baxter Healthcare. She is an active member of AAMI where she has contributed to the development and revision of human factors technical information reports and international standards. Learn more about Design Science's impact on Healthcare Technology by following @designscience on all social media platforms.
159 episodes
All episodes
×Welcome to Player FM!
Player FM is scanning the web for high-quality podcasts for you to enjoy right now. It's the best podcast app and works on Android, iPhone, and the web. Signup to sync subscriptions across devices.