How can medical device startups avoid missteps in cybersecurity, quality, and compliance?

In this episode, Trevor Slattery speaks with Ashkon Rasooli about the intersection of quality systems and cybersecurity in medical devices. They unpack why treating cybersecurity as a bolt-on checklist is ineffective and even dangerous. They also discuss regulatory realities, risk management frameworks, and how early-stage teams can avoid costly pitfalls by planning smarter from the start.

Ashkon Rasooli is the CEO of EnGenius Solutions, a boutique consulting firm focused on medical device software development. With a background in both hands-on coding and compliance, Ashkon helps medtech startups navigate quality systems and regulatory strategy.

Key points:

(0:31) Why Regulations and Cybersecurity Are Intertwined

* How EnGenius helps small medtech companies plan early.

* Challenging the idea that cybersecurity and QMS are separate disciplines.

(7:12) Planning Cybersecurity Early

* Business model, product design, and geography all shape your compliance path.

(12:16) Culture Over Checklists in MedTech Security

* Ashkon’s “Non-BS Manifesto” based on Agile principles.

* Real-world examples of ransomware causing patient harm.

(20:38) Why Probabilistic Risk Scoring Falls Short

* How exploitability trumps probability in FDA guidance.

* How cybersecurity attackers differ from typical safety failures.

(28:14) Planning Compliance

* Dick Cheney’s pacemaker becomes a cautionary tale of targeted threats.

Thanks to Ashkon Rasooli for being on the show. Connect with him: https://www.linkedin.com/in/ashkonrasooli

Check out EnGenius Solutions: https://www.engeniussolutions.com

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

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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