Tag Archives: Focus Article – Homepage

post market surveillance

Why Organizations Miss Emerging Product Risk: Understanding the engineering mechanisms that remain hidden long before complaint trends become visible

By Aalap Patel, MS, CQE, CSSBB
post market surveillance

Emerging medical-device risks are often missed because early warning signs are fragmented across complaints, manufacturing, suppliers, returned products, clinical observations, and other data sources; not immediately as statistically significant trends. An engineering-centered, cross-functional approach connecting these weak signals to underlying mechanisms sooner, can improve designs, verification, manufacturing controls, and risk management before isolated issues become widespread quality problems.

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post market surveillance

From Compliance to Clinical Action: Fixing the Broken Loop in Post-Market Surveillance

By Aalap Patel, MS, CQE, CSSBB
post market surveillance

Post-market surveillance (PMS) systems in the medical device industry have become increasingly sophisticated in collecting complaints, monitoring adverse events, and generating regulatory reports. However, many organizations still struggle to translate these insights into timely clinical action and meaningful patient safety improvements. This article examines the growing disconnect between regulatory reporting and operational decision-making, explores the challenges of signal detection and prioritization, and outlines practical strategies for building closed-loop PMS systems that improve patient safety outcomes and organizational responsiveness.

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Medtronic Bets on Cardiovascular Realignment Amid Stock Pressure and Facility Closures

By MedTech Intelligence Staff

Medtronic is overhauling its cardiovascular business in a major restructuring that includes new operating divisions, ongoing acquisitions, and a strategic push into higher-growth cardiac technologies. At the same time, the company plans to close its longtime Santa Rosa facility, affecting hundreds of employees and marking a significant shift in its U.S. manufacturing footprint. The changes come as Medtronic navigates investor pressure, intensifying competition, and a rapidly evolving cardiovascular device market.

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QMS Interoperability

Chicken or the Egg: Should Device Interoperability or QMS Interoperability Come First?

By Carl Washburn
QMS Interoperability

To achieve medical Device Interoperability, system boundaries need to be defined, system architecture needs to be aligned, and interfaces and communication protocols need to be established across individual components of the medical device. In some cases, it is as important to design and implement QMS Interoperability as it is to design Device Interoperability.

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