What are some strategies founders can use to incorporate cybersecurity into the early stages of developing a medtech product?
In this episode, Christian and Trevor break down the critical role of cybersecurity in early-stage medtech startups. They explore why cybersecurity is often overlooked, what the real-world consequences are, and how startups can shift left to avoid costly pitfalls. From VC funding to FDA requirements, they offer a roadmap for founders who want to get it right from the start.
Key points:
(0:33) The Cybersecurity Awareness Gap
* Many early-stage medtech startups don't consider cybersecurity until it's too late.
(5:36) Budgeting for Cyber from the Start
* Cybersecurity costs extend beyond hiring a firm—developers must also build secure code.
* Developers with medtech experience and adherence to IEC/ISO standards are essential.
(10:18) Picking the Right Dev Partners
* Evaluate software firms based on documentation, process, and compliance with medtech standards.
* Founders need teams who think about security proactively, not reactively.
(15:42) Cybersecurity as a Funding Factor
* VCs now look for cybersecurity as part of the startup's roadmap.
* Cybersecurity must be iterative—not a one-time checkbox before FDA submission.
(20:22) Safety and Security
* Cybersecurity isn't just about software—hardware choices matter too.
* Awareness of risk classes (Class A, B, C) impacts cybersecurity needs.
* Safety and security are intertwined, especially when patient harm is possible.
Resources mentioned in this episode:
* FDA Guidance on Cybersecurity in Medical Devices
* ISO 13485 – Medical Devices Quality Management Systems
* IEC 62304 – Medical Device Software Lifecycle Processes
* AAMI TIR57 – Principles for Medical Device Security Risk Management
* ISO 14971 – Application of Risk Management to Medical Devices
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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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/
Blue Goat Cyber on LinkedIn: https://www.linkedin.com/company/blue-goat-cyber/
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Trevor Slattery on LinkedIn: https://www.linkedin.com/in/trevor-slattery-34852b1a9
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
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This episode was produced by Story On Media: https://www.storyon.co/
