Early Cyber Strategies for MedTech Trailblazers

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