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Manufacturers have more to scrutinize to maximize resources

As manufacturers consider how to overcome rapidly increasing demand, shortened product life cycles, and reduced margins, they would do well to take a good look in their own backyard.
A McKinsey Ins…

Driving Transparency – How Quality Management Systems Prevent Catastrophe

We have all heard about public disasters around potential systematic disregard for quality problems in companies – from the automotive industry (think emissions tests, brake failures) to the oil &amp…

Digitization vs. Digital Transformation in MedTech

We hear a lot of buzzwords – Industry 4.0, Internet of Things, Industrial Internet of Things, Digital Enterprise, Digital Twin, Virtual Factory, and so many more. We are going to focus on two here: D…

Quality Management – A Holistic Approach

Strategic quality management professionals envision a holistic solution across the entire product life cycle and supply chain that is able to

Support compliance
Detect risks and failures
Mit…

Global trends for Medical Device companies – An executive view from Terumo

In a series of interviews conducted by Dan Matlis, President of analyst firm Axendia, Terumo Cardiovascular Group executives Mark Lincoln, VP Global Operations, and Chris Zarecki, Director of Manufac…

Using Quality Systems to Gain Efficiency – Is that even possible?

Cost and Quality. They are often thought of as two sides in a game of “tug of war.” When one side gains traction the other loses. However, that is a very non-strategic view of how well-architected ma…

Why focusing on Quality rather than Compliance makes good business sense

In medical device manufacturing, as well as other regulated industries, we have served two masters. One is the end consumer, without whom we have no business. The other is the FDA (or other regulator…

Key criteria for getting faster ROI from your QMS implementation

Hopefully you are not thinking about how to get ROI on the Quality Management System you have already decided to invest in. If you’ve made the decision to invest funds, you’ve probably already made t…

Can you afford to aim for average? The cost of change in the med-tech industry

John F. Kennedy once said, “There are risks and costs to action. But they are far less than the long-range risks of comfortable inaction.” It is an appropriate concept for the state of the medical de…