01
Advised on clinical problem framing, product strategy, and technical feasibility for AI-enabled breast-cancer detection.
Project 04Life & MedTech Consulting
Advised on AI-enabled breast-cancer detection — from clinical problem framing through SaMD regulatory pathway, risk management, and verification & validation considerations.
The problem
What does it take for an AI healthcare idea to become a credible medical product?
Approach
Advisory work across product, clinical, technical, and regulatory considerations, including FDA and Health Canada pathways.
Outcome
Supported partners developing AI-enabled breast-cancer detection solutions.
What I led and delivered
01
Advised on clinical problem framing, product strategy, and technical feasibility for AI-enabled breast-cancer detection.
02
Connected software-as-a-medical-device development to FDA and Health Canada regulatory pathways, risk management, verification, and validation.
03
Translated research and diagnostic needs into practical product and evidence-generation considerations.
Demonstrates
Healthcare AI fluency · SaMD context · careful translation