One Less Risk
Increasingly, inspectors for the U.S. Food and Drug Administration (FDA) will evaluate your CMMS provider’s security controls—not just your internal procedures.
Increasingly, inspectors for the U.S. Food and Drug Administration (FDA) will evaluate your CMMS provider’s security controls—not just your internal procedures.
The digitalization of society during the last decade has created many opportunities for businesses and organizations.
The manufacturing industry is undergoing a transformation driven by rapid technological advancements, changing consumer preferences, and evolving regulatory frameworks.
Early-stage medtech companies are under tremendous pressure to develop quickly, prove value, and obtain regulatory approval or clearance as fast as possible.
When I first became involved in lean (continuous improvement), I was the VP of operations at a privately held company in the Midwest.
“Do you not know that there comes a midnight hour when everyone has to throw off his mask?”—Søren Kierkegaard
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.
As we look ahead to 2026, the medtech sector stands at an intersection of regulatory evolution, technological advancement, and operational transformation.
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.
The demos look slick, the promises even slicker. In slides and keynotes, agentic assistants plan, click, and ship your work while you sip coffee.
Performance rarely collapses with fanfare. More often, it flatlines quietly; sales soften, productivity slows, priorities blur, and yet teams run hard without moving the needle.
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