Management
The manufacturing industry is undergoing a transformation driven by rapid technological advancements, changing consumer preferences, and evolving regulatory frameworks. Manufacturers everywhere face unprecedented challenges as they seek to remain competitive, profitable, and sustainable in the…
Early-stage medtech companies are under tremendous pressure to develop quickly, prove value, and obtain regulatory approval or clearance as fast as possible. The pace of innovation in the industry has increased tremendously, thanks to more options for outsourcing and new technology like 3D…
When I first became involved in lean (continuous improvement), I was the VP of operations at a privately held company in the Midwest. It was 2003, and as a newly promoted senior executive I was eager to find a strategy that could make a real difference in our operations.
I quickly…
In this article I want to spend time with Søren Kierkegaard. I’ve been interested in his ideas because he occupies an unusual place in the history of thought. He’s considered a pioneer of existentialism, and yet he was also a man of faith.
Most of the existentialist thinkers who…
As we look ahead to 2026, the medtech sector stands at an intersection of regulatory evolution, technological advancement, and operational transformation.
The landscape for quality and regulatory affairs (QARA) professionals continues to shift, driven by emerging AI capabilities,…
Your IT team enabled Copilot and Gemini last quarter without checking with the lawyers. Now your employees are putting company secrets into systems that nobody owns, nobody governs, and nobody can reliably retrieve when opposing counsel sends a subpoena.
You have a discovery…