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.

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