In this episode of BioTalk Unzipped, hosts Gregory Austin and Dr. Chad Briscoe welcome Dr. Alex Friedman, a seasoned expert in regulatory affairs for medical devices and AI as Software as a Medical Device.
Chapters
02:26 Introduction to BioTalk Unzipped
03:40 Charity Spotlight: Americares
05:01 Dr. Alex Friedman's Career Journey
11:52 The Regulatory Landscape of Medical Device Classifications
18:52 Regulatory Gameshow!: Classifying Medical Devices
22:28 AI Enabled Software as a Medical Device: An Overview
25:25 New News!! - Innovative Cardiac Health App: The Case of Antshrike
30:31 The Evolution of Wearable Health Technology
41:17 Liability and Risk in Medical Device Development
43:57 Clinical Decision Support Software - Challenges in Regulating AI in Healthcare
47:13 Self Updating AI Doctors?? - The Future of AI in Public Health
49:00 Navigating FDA Regulations for AI Technologies and Doc in a Box
56:27 New News!! - The Intersection of AI, Regulation, and Innovation
01:07:28 Measuring Success in Life and Work
HOW TO REACH US:
Alex Friedman
https://www.linkedin.com/in/alexfriedman/
Alex’s Charity: Americares
https://www.americares.org/
Dr. Chad Briscoe
https://www.linkedin.com/in/chadbriscoe/
Celerion - https://www.celerion.com/
Gregory Austin
https://www.linkedin.com/in/gregoryaustin1/
Celerion - https://www.celerion.com/
New News Story - Innovative app from Before Health Intelligence identifies early signs of cardiac issues using wearable device data
New News - 2025 forecast: How will AI, regulators and the government intersect? From Fierce MedTech
Mentioned in the podcast:
Concussion Mouthguard Sensors:
SISU Sense - https://www.sisuguard.com/sisusense/
HIT-IQ - https://www.hitiq.com/smart-mouthguard
Prevent Biometrics - https://preventbiometrics.com/
IDX-DR - Diagnosing Software
https://www.healthvisors.com/en/idx-dr/
Sound Bites
"The common thread is the science."
"Regulatory has to catch up."
"You can't sell snake oil."
"It's a multidisciplinary effort."
"Software as a medical device is a hot thing."
Image Credits:
Aliens -
https://www.reddit.com/r/LV426/comments/9i8omb/mildly_disappointing_according_to_the_viewscreens/
https://filmmusiccentral.com/2018/10/16/my-thoughts-on-aliens-1986/
keywords
medical devices, regulatory affairs, FDA, bioengineering, clinical decision support, AI in healthcare, Americares, healthcare innovation, medical technology, software as a medical device, AI in healthcare, regulatory challenges, wearable technology, health apps, FDA regulations, medical device liability, cardiovascular health, quality management system, innovative health solutions, AI, healthcare, clinical decision support, FDA regulations, public health, adaptive software, medical devices, innovation, technology, regulatory affairs
