Software Assurance Tech for MedTech w. Andrew Hendela

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Inside MedTech Innovation

Shannon Lantzy

31 episodes

1 week ago

Join Shannon Lantzy, as she brings you stories from inside the medtech ecosystem, featuring innovators, commercializers, regulators, and consumers. The show covers a wide array of topics, from patient-driven innovation to cybersecurity. We’ll examine the details that influence individual regulatory decisions and the broader impacts of emerging global issues, ensuring that great technology reaches the people who need it most.

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Software Assurance Tech for MedTech w. Andrew Hendela

Inside MedTech Innovation

40 minutes 3 seconds

6 months ago

Software Assurance Tech for MedTech w. Andrew Hendela

In this Tech for MedTech episode of Inside MedTech Innovation, I talk with Andrew Hendela, co-founder and CEO of cybersecurity company Karambit.AI, focused on software behavior analysis, about how software updates are quietly redefining safety and risk in connected medical devices.

Andrew shares the real-world implications of software supply chain vulnerabilities, including insights from the SolarWinds cyberattack, and how traditional testing methods often fail to catch malicious changes. We dig into why static software bills of materials aren’t enough, and how observing behavior, not just ingredients, can reveal hidden risks.

We also explore what the FDA’s evolving regulatory stance means for MedTech teams deploying AI and software-driven features, and how Andrew’s work is making it possible to validate safety at speed. For developers, regulators, and clinical leaders, this episode sheds light on a critical, but often overlooked, pillar of digital health: ensuring that every software update is safe, explainable, and ready for patient-facing use.

0:00 Introduction and Overview

01:29 Meet the Expert: Andrew Hendela

02:30 The SolarWinds Attack and Its Implications

04:01 Challenges in Software Assurance

04:46 The Role of Software Bill of Materials

06:48 Andrew's Background and Career

09:07 Applying Cybersecurity to MedTech

12:56 Behavior Analysis in Software

19:00 Third-Party Software and Compliance

21:08 Understanding Third-Party Software Risks

21:25 Challenges of Hospital Software Updates

21:53 Patient Monitor Vulnerabilities

22:55 Proving the Technology's Value

24:34 Navigating Compliance and Legal Hurdles

25:52 Collaborations and Research Opportunities

27:43 Regulatory Challenges and Solutions

36:47 The Importance of Tangible Impact

39:20 Final Thoughts and Contact Information

Follow Shannon and Andrew:

Connect with Shannon:

LinkedIn: https://www.linkedin.com/in/shannonlantzy

Website: https://www.shannonlantzy.com

Connect with Andrew:

LinkedIn: https://www.linkedin.com/in/andrew-hendela/

Website: https://karambit.ai/