Last reviewed: May 1, 2026
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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
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