283. Avoiding FDA Cybersecurity Rejections: A Medtech Playbook with Blue Goat Cyber

Episode breakdown:00:00 – Why Cybersecurity is a New FDA Blocker02:50 – Meet Blue Goat Cyber: Medtech-Only Cybersecurity04:18 – FDA’s 2023 Final Guidance on Cybersecurity07:00 – 68% of Devices Are Network Connected (Here’s the Risk)09:45 – Why Retrofitting Security Fails13:30 – FDA Risk Management: ISO 14971 vs TIR5717:10 – Secure Software Dev: IEC 62304 & Who Actually Follows It20:08 – Is ISO 27001 Enough? What the FDA Actually Wants25:53 – Most Common Deficiency: Insecure Design30:30 – Blue Goat’s 5-Phase Submission Strategy36:30 – 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.comAre 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 Channelhttps://www.youtube.com/channel/UCGpL_rGt1LQJwinMq_K7gfgSubscribe to our LinkedIn Newsletterhttps://www.stateofmedtechpodcast.com/Follow The State of MedTech onLinkedIn https://www.linkedin.com/company/thestateofmedtechInstagram https://www.instagram.com/stateofmedtech/TikTok https://www.tiktok.com/@stateofmedtechX https://twitter.com/StateofMedTechFacebook https://www.facebook.com/stateofmedtech/Follow Omar M. Khateeb onLinkedIn https://www.linkedin.com/in/okhateeb/Instagram https://www.instagram.com/omar.m.khateeb/TikTok https://www.tiktok.com/@omarkhateebofficialX https://twitter.com/OmarMKhateebFacebook 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.