AI! AI! Oh?
A playful but serious reflection on AI as assistant, reviewer and decision-maker—and why fluent answers still need evidence, judgement and accountability.
Leadership & organisation
Build capable teams, effective governance and the conditions for reliable delivery.
AI has accelerated medical-device development—but not manufacturer responsibility
AI changes the speed and economics of medical-device development, but it does not remove the need for product definition, objective evidence, competent review or manufacturer accountability.
You outsourced the development—not the accountability
Why outsourcing medical-device development increases the need for intelligent manufacturer oversight—and what must be controlled before an audit or submission exposes the gaps.
Who is responsible for medical-device development? From startup founder to corporate leadership
How the responsibilities of startup founders, SME management and corporate leaders differ—and why qualified external advice is most valuable before major development commitments are made.