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283. Avoiding FDA Cybersecurity Rejections: A Medtech Playbook with Blue Goat Cyber
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/
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Follow Omar M. Khateeb on
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This podcast is for informational and educational purposes only and does not constitute financial, investment, legal, or medical advice. The views and opinions expressed by hosts and guests are their own and do not necessarily reflect those of State of MedTech LLC. Nothing discussed on this podcast should be interpreted as a recommendation to buy, sell, or hold any investment or security. Listeners should conduct their own due diligence and consult with a qualified financial advisor, attorney, or other professional before making any financial or investment decisions.
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By State of MedtechEpisode 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
X https://twitter.com/OmarMKhateeb
Facebook https://www.facebook.com/OmarMKhateeb/
This podcast is for informational and educational purposes only and does not constitute financial, investment, legal, or medical advice. The views and opinions expressed by hosts and guests are their own and do not necessarily reflect those of State of MedTech LLC. Nothing discussed on this podcast should be interpreted as a recommendation to buy, sell, or hold any investment or security. Listeners should conduct their own due diligence and consult with a qualified financial advisor, attorney, or other professional before making any financial or investment decisions.