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AI

When you have a hammer, everything looks like a nail

April 12, 2025
AI
Strategic Thinking
Software

This post outlines how product managers can effectively use AI by evaluating whether problems are deterministic or probabilistic. It provides a diagnostic tool for selecting the appropriate AI approach and a strategic framework for implementing AI solutions that align with business objectives.

The EU AI Act

March 28, 2024
AI
Medical Devices
SaMD

Lessons Learned from MDR & the Rights-focused product lifecycle. This piece will discuss parallels with the EU MDR transition & lessons learned and how manufacturers can integrate ethical evaluations into their product development lifecycle.

Opportunity Overload: Navigating the Maze of Professional Development in the Gen AI Era

March 14, 2024
AI
Management
Culture

Wonder how to unlock your potential in the AI revolution? I share some considerations and questions to ask when evaluating where to spend your hard earned professional development dollars. 

Choosing the Right Tool: Is AI Over-Hyped?

March 6, 2024
AI
Strategic Thinking
Software

AI's current hype mirrors the early mobile era, blending optimism with caution. Let's discuss the hype and how to evaluate the AI use case.

Crafting OKRs for AI-Driven Products: Beyond Traditional SaaS Frameworks

March 6, 2024
AI
Culture
Software

The inherent complexity, unpredictability, and ethical considerations surrounding AI demand a tailored approach to setting and achieving objectives.‍ Read on for OKR setting.

The AI Driven Software Development Lifecycle (SDLC)

March 6, 2024
AI
Software
Culture

Introducing an SLDC approach, that not only embraces AI's capabilities but also addresses the complexities of modern software development, including risk management, data models, and validation processes.

Product Management & FDA's AI Good Machine Learning Practices

January 25, 2024
AI
Regulatory Analysis
Software

A mindmap for AI validation and actionable steps Product Managers can take when incorporating AI/ML into digital health, biopharma, or medical device products in order to speed the product to market.

Navigating the Regulatory Horizon: Predicting FDA Guidance for 2024 and Staying Nimble

January 24, 2024
Data Governance
AI
Regulatory Analysis

As we step into 2024, medical device manufacturers are poised for a year of regulatory evolution, guided by the FDA's upcoming guidance documents.

Striking the Balance: Safeguarding Clinical Trials with AI

January 24, 2024
Data Governance
AI
Regulatory Analysis

This is the first post in a series on using AI/ML in drug development, considerations for benefit-risk analysis, and potential mitigations to support responsible AI.

Securing AI: A Practical Checklist for the Board

December 30, 2023
Software
AI
Board Guidance

Assessing an organization's security posture concerning AI (Artificial Intelligence) is crucial as AI technologies become increasingly integrated into various business processes.

Exploring the Challenges of Securing AI Systems and Algorithms

December 30, 2023
Software
AI
Board Guidance

Here's a non-technical dive into the challenges of securing AI systems and algorithms, designed for executives that want a little more than the bare minimum, but don’t want a degree in cybersecurity. What risks are these systems susceptible to? How can we mitigate these risks? Let's explore.