What risks do you take when cybersecurity is left off your development roadmap?
In this episode, Christian, Trevor and guest Jim Goodmiller explore how cybersecurity intersects with regulatory expectations and quality systems, creating new challenges and opportunities for MedTech innovators. Jim helps to explain why founders must integrate cybersecurity from concept through commercialization, especially as FDA scrutiny increases.
Key points:
00:48 Why cybersecurity now influences every part of the regulatory landscape.
04:48 How technologies can create serious safety and compliance risks when not fully vetted.
10:45 Cybersecurity as a mandatory component of regulatory planning.
14:52 The need for iterative penetration testing
22:16 Challenges of upgrading legacy devices
25:37 Avoiding serious legal consequences.
29:29 Preparing a complete roadmap for investor confidence
40:08 The role of communication
The Med Device Cyber Podcast is brought to you by Blue Goat Cyber, cybersecurity professionals specializing in providing elite cyber solutions for medical devices. Learn more about securing your product and business from cyber-criminals by visiting https://bluegoatcyber.com
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Thanks to Jim Goodmiller for being on the show.
Connect with Jim on LinkedIn: https://www.linkedin.com/in/jimgoodmiller/
Christian Espinosa is the CEO and founder of Blue Goat Cyber. Trevor Slattery is the Chief Technology Officer / Director of MedTech Cybersecurity at Blue Goat Cyber.
Christian Espinosa on LinkedIn: https://www.linkedin.com/in/christianespinosa/
Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9
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Learn more about Christian Espinosa, buy his books, or invite him to speak on your stage: https://christianespinosa.com/
Christian Espinosa on YouTube: http://www.youtube.com/@ChristianEspinosaOfficial
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