Episode breakdown:
00:00 – Why Cybersecurity is a New FDA Blocker
02:50 – Meet Blue Goat Cyber: Medtech-Only Cybersecurity
04:18 – FDA’s 2023 Final Guidance on Cybersecurity
07:00 – 68% of Devices Are Network Connected (Here’s the Risk)
09:45 – Why Retrofitting Security Fails
13:30 – FDA Risk Management: ISO 14971 vs TIR5717:10 – Secure Software Dev: IEC 62304 & Who Actually Follows It
20:08 – Is ISO 27001 Enough? What the FDA Actually Wants
25:53 – Most Common Deficiency: Insecure Design
30:30 – Blue Goat’s 5-Phase Submission Strategy
36:30 – Hidden Costs of Submitting Late (Cyber ROI)
40:00 – When to Engage Cyber Experts (and What Happens if You Don’t)
Don’t Let Cybersecurity Risks Delay Your Medical Device Premarket Approval. Check out BlueGoatCyber.com
Are you a medtech CEO in need of some marketing help attracting investors, growing sales pipeline, and more? Go to GrowMyMedtech.com to book time for a free analysis.
Subscribe to our Youtube Channel
https://www.youtube.com/channel/UCGpL_rGt1LQJwinMq_K7gfg
Subscribe to our LinkedIn Newsletter
https://www.stateofmedtechpodcast.com/
Follow The State of MedTech on
LinkedIn https://www.linkedin.com/company/thestateofmedtech
Instagram https://www.instagram.com/stateofmedtech/
TikTok https://www.tiktok.com/@stateofmedtech
X https://twitter.com/StateofMedTech
Facebook https://www.facebook.com/stateofmedtech/
Follow Omar M. Khateeb on
LinkedIn https://www.linkedin.com/in/okhateeb/
Instagram https://www.instagram.com/omar.m.khateeb/
TikTok https://www.tiktok.com/@omarkhateebofficial
Popular Podcasts
24/7 News: The Latest
The latest news in 4 minutes updated every hour, every day.
Crime Junkie
Does hearing about a true crime case always leave you scouring the internet for the truth behind the story? Dive into your next mystery with Crime Junkie. Every Monday, join your host Ashley Flowers as she unravels all the details of infamous and underreported true crime cases with her best friend Brit Prawat. From cold cases to missing persons and heroes in our community who seek justice, Crime Junkie is your destination for theories and stories you won’t hear anywhere else. Whether you're a seasoned true crime enthusiast or new to the genre, you'll find yourself on the edge of your seat awaiting a new episode every Monday. If you can never get enough true crime... Congratulations, you’ve found your people. Follow to join a community of Crime Junkies! Crime Junkie is presented by audiochuck Media Company.
The Clay Travis and Buck Sexton Show
The Clay Travis and Buck Sexton Show. Clay Travis and Buck Sexton tackle the biggest stories in news, politics and current events with intelligence and humor. From the border crisis, to the madness of cancel culture and far-left missteps, Clay and Buck guide listeners through the latest headlines and hot topics with fun and entertaining conversations and opinions.