Welcome, MedTech Professionals.

W45 Edition of The MedTech AI Monitor

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Hey there,

Thanks for reading this week's MedTech update- where I keep all things AI short, sweet, and to the point. Today we are talking about risk. Specifically, AI-enabled device risk management.

Have a great rest of the week!

Greg

tl;dr

• MIT AI Repository aids MedTech risk management
• Example: Assess AI diagnostic tool for safety, data integrity, security.
• Align audits with FDA/ISO standards for lifecycle risk management.

MIT's AI risk database: What it is and how to use it.

You're a quality and regulatory professional in MedTech. Managing AI-related risks is essential for safe and compliant device development.

​MIT’s new database organizes 777 AI risks into a simple framework.

It provides a structured way to identify and address these risks, ensuring the integrity of AI-driven MedTech solutions.

Here’s how I leverage it for risk assessments…

Imagine you’re part of a quality team at a company developing an AI-enabled diagnostic tool to help radiologists identify early signs of lung cancer.

Here’s how the AI Risk Repository can support your risk assessment:

1. Mapping AI Risks: Start by using the Domain Taxonomy to address AI System Safety & Failures and Human-Computer Interaction. Identify risks like potential misinterpretation of images or the AI’s influence on clinical decisions, which could overshadow human judgment.

1. Lifecycle Risk Assessment: Use the Causal Taxonomy to assess risks across stages. For pre-deployment or pre-production, examine training data integrity—does the AI-enabled device perform equally well across diverse demographics? For post-deployment, focus on data security to protect patient privacy.

1. Audit and Compliance: Benchmark these findings against FDA and ISO standards (13485 and 42001) and refine your strategy for model validation and monitoring.

By leveraging the AI Risk Repository, your team can enhance risk management and regulatory readiness for safer, more reliable AI solutions.

Looking for help completing a risk assessment? Put some time on my calendar- let's talk. https://calendly.com/greg-avip/25min​

Tweet of the week:

I don't always agree with the AI "doom-and-gloom"- I do agree that the biggest risks won't be from some hyper-intelligent model, but from slowly enabling AI in bad use cases.