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 

If you’re interested in our services or partnering with us, schedule a Discovery Session: https://meetings.hubspot.com/blue-goat-cyber/discovery-session 

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 

Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/ 

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Feedback? Questions? Contact: https://bluegoatcyber.com/contact/ 

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 

The Med Device Cyber Podcast is your essential resource for medical device cybersecurity. Each episode we dive into the latest threats, solutions, and best practices to protect modern healthcare technology. Whether you're a provider, a manufacturer, or a cybersecurity professional, gain the knowledge to safeguard patient safety by subscribing to the Med Device Cyber Podcast. 

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This episode was produced by Story On Media: https://www.storyon.co/